Viewing Study NCT01763918

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-25 @ 5:04 AM
Ignite Modification Date: 2026-03-02 @ 7:43 AM
Study NCT ID: NCT01763918
Status: COMPLETED
Last Update Posted: 2019-06-17
First Post: 2013-01-07
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

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'}]}}, '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': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.', 'otherNumAtRisk': 54, 'otherNumAffected': 5, 'seriousNumAtRisk': 54, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.', 'otherNumAtRisk': 55, 'otherNumAffected': 10, 'seriousNumAtRisk': 55, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.', 'otherNumAtRisk': 110, 'otherNumAffected': 17, 'seriousNumAtRisk': 110, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.', 'otherNumAtRisk': 110, 'otherNumAffected': 24, 'seriousNumAtRisk': 110, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Colonoscopy abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Endoscopy gastrointestinal abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', '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': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.02', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '5.53', 'spread': '3.25', 'groupId': 'OG001'}, {'value': '-61.25', 'spread': '1.77', 'groupId': 'OG002'}, {'value': '-55.74', 'spread': '2.25', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-59.23', 'ciLowerLimit': '-65.11', 'ciUpperLimit': '-53.35', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.98', 'groupDescription': 'Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '-61.27', 'ciLowerLimit': '-69.00', 'ciUpperLimit': '-53.55', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.91', 'groupDescription': 'Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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. Least squares (LS) means are from a repeated measures linear effects model; missing values were not imputed.'}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.08', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '2.30', 'spread': '2.41', 'groupId': 'OG001'}, {'value': '-61.23', 'spread': '1.71', 'groupId': 'OG002'}, {'value': '-63.25', 'spread': '1.70', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-60.15', 'ciLowerLimit': '-65.83', 'ciUpperLimit': '-54.46', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.88', 'groupDescription': 'Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '-65.55', 'ciLowerLimit': '-71.27', 'ciUpperLimit': '-59.83', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.90', 'groupDescription': 'Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': 'Change From Baseline in LDL-C at the Mean of Weeks 10 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.5', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '4.1', 'groupId': 'OG001'}, {'value': '-101.7', 'spread': '3.0', 'groupId': 'OG002'}, {'value': '-98.8', 'spread': '2.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-95.2', 'ciLowerLimit': '-105.1', 'ciUpperLimit': '-85.2', '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', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '-97.4', 'ciLowerLimit': '-107.1', 'ciUpperLimit': '-87.7', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.9', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.5', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '5.2', 'groupId': 'OG001'}, {'value': '-101.3', 'spread': '3.0', 'groupId': 'OG002'}, {'value': '-87.2', 'spread': '3.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-92.9', 'ciLowerLimit': '-102.9', 'ciUpperLimit': '-82.8', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.1', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '-91.3', 'ciLowerLimit': '-103.8', 'ciUpperLimit': '-78.9', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.3', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '9.9'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '9.8'}, {'value': '67.0', 'groupId': 'OG002', 'lowerLimit': '57.7', 'upperLimit': '75.1'}, {'value': '80.4', 'groupId': 'OG003', 'lowerLimit': '71.9', 'upperLimit': '86.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '65.1', 'ciLowerLimit': '52.8', 'ciUpperLimit': '73.4', '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', 'statisticalComment': 'Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '78.5', 'ciLowerLimit': '66.9', 'ciUpperLimit': '85.1', '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', 'statisticalComment': 'Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use.'}], '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': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '10.3'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '11.3'}, {'value': '68.3', 'groupId': 'OG002', 'lowerLimit': '58.8', 'upperLimit': '76.4'}, {'value': '63.1', 'groupId': 'OG003', 'lowerLimit': '53.5', 'upperLimit': '71.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '66.3', 'ciLowerLimit': '53.7', 'ciUpperLimit': '74.6', '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', 'statisticalComment': 'Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '60.9', 'ciLowerLimit': '47.6', 'ciUpperLimit': '69.8', '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', 'statisticalComment': 'Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use.'}], '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-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.21', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '2.72', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '-55.79', 'spread': '1.63', 'groupId': 'OG002'}, {'value': '-57.28', 'spread': '1.56', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-56.00', 'ciLowerLimit': '-61.41', 'ciUpperLimit': '-50.59', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.74', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '-60.01', 'ciLowerLimit': '-65.24', 'ciUpperLimit': '-54.77', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.65', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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 Non-HDL-C at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.39', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '5.29', 'spread': '2.94', 'groupId': 'OG001'}, {'value': '-56.19', 'spread': '1.71', 'groupId': 'OG002'}, {'value': '-49.67', 'spread': '2.04', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-54.79', 'ciLowerLimit': '-60.47', 'ciUpperLimit': '-49.12', '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', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '-54.95', 'ciLowerLimit': '-61.95', 'ciUpperLimit': '-47.96', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.54', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.19', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '2.21', 'spread': '1.97', 'groupId': 'OG001'}, {'value': '-49.58', 'spread': '1.48', 'groupId': 'OG002'}, {'value': '-52.76', 'spread': '1.36', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-49.39', 'ciLowerLimit': '-54.32', 'ciUpperLimit': '-44.46', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.50', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '-54.98', 'ciLowerLimit': '-59.58', 'ciUpperLimit': '-50.38', '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', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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 Apolipoprotein B at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.67', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '4.60', 'spread': '2.70', 'groupId': 'OG001'}, {'value': '-49.75', 'spread': '1.63', 'groupId': 'OG002'}, {'value': '-44.81', 'spread': '1.80', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-49.09', 'ciLowerLimit': '-54.55', 'ciUpperLimit': '-43.63', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.76', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '-49.41', 'ciLowerLimit': '-55.73', 'ciUpperLimit': '-43.10', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.19', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': 'SECONDARY', 'title': 'Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.86', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '4.14', 'spread': '2.13', 'groupId': 'OG001'}, {'value': '-45.74', 'spread': '1.45', 'groupId': 'OG002'}, {'value': '-45.02', 'spread': '1.50', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.59', 'ciLowerLimit': '-51.43', 'ciUpperLimit': '-41.76', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.45', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '-49.16', 'ciLowerLimit': '-54.21', 'ciUpperLimit': '-44.11', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.56', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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 the Total Cholesterol/HDL-C Ratio at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '7.11', 'spread': '3.13', 'groupId': 'OG001'}, {'value': '-45.95', 'spread': '1.56', 'groupId': 'OG002'}, {'value': '-38.32', 'spread': '2.15', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.08', 'ciLowerLimit': '-51.27', 'ciUpperLimit': '-40.88', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.63', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '-45.42', 'ciLowerLimit': '-52.86', 'ciUpperLimit': '-37.98', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.77', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.78', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '1.65', 'spread': '2.35', 'groupId': 'OG001'}, {'value': '-52.39', 'spread': '1.56', 'groupId': 'OG002'}, {'value': '-53.91', 'spread': '1.60', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-53.17', 'ciLowerLimit': '-58.35', 'ciUpperLimit': '-47.99', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.62', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '-55.56', 'ciLowerLimit': '-61.08', 'ciUpperLimit': '-50.05', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.79', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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 Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.54', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '4.23', 'spread': '3.66', 'groupId': 'OG001'}, {'value': '-52.74', 'spread': '1.75', 'groupId': 'OG002'}, {'value': '-45.31', 'spread': '2.42', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-54.28', 'ciLowerLimit': '-60.16', 'ciUpperLimit': '-48.41', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.97', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '-49.55', 'ciLowerLimit': '-58.14', 'ciUpperLimit': '-40.96', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.35', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': 'SECONDARY', 'title': 'Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.34', 'spread': '2.97', 'groupId': 'OG000'}, {'value': '5.35', 'spread': '2.95', 'groupId': 'OG001'}, {'value': '-24.03', 'spread': '2.09', 'groupId': 'OG002'}, {'value': '-25.65', 'spread': '2.07', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-31.37', 'ciLowerLimit': '-38.33', 'ciUpperLimit': '-24.41', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.52', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '-31.00', 'ciLowerLimit': '-37.91', 'ciUpperLimit': '-24.09', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.50', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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 Lipoprotein (a) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.68', 'spread': '3.27', 'groupId': 'OG000'}, {'value': '6.69', 'spread': '3.16', 'groupId': 'OG001'}, {'value': '-22.89', 'spread': '2.31', 'groupId': 'OG002'}, {'value': '-21.55', 'spread': '2.17', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-31.57', 'ciLowerLimit': '-39.28', 'ciUpperLimit': '-23.87', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.90', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '-28.24', 'ciLowerLimit': '-35.61', 'ciUpperLimit': '-20.88', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.73', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': 'SECONDARY', 'title': 'Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.09', 'spread': '3.02', 'groupId': 'OG000'}, {'value': '7.49', 'spread': '3.26', 'groupId': 'OG001'}, {'value': '-13.27', 'spread': '2.14', 'groupId': 'OG002'}, {'value': '-9.25', 'spread': '2.27', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.36', 'ciLowerLimit': '-29.48', 'ciUpperLimit': '-15.24', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.60', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '-16.74', 'ciLowerLimit': '-24.43', 'ciUpperLimit': '-9.05', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.89', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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 Triglycerides at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.50', 'spread': '3.51', 'groupId': 'OG000'}, {'value': '6.43', 'spread': '4.15', 'groupId': 'OG001'}, {'value': '-16.09', 'spread': '2.49', 'groupId': 'OG002'}, {'value': '-5.13', 'spread': '2.84', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.59', 'ciLowerLimit': '-27.92', 'ciUpperLimit': '-11.26', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.22', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '-11.56', 'ciLowerLimit': '-21.38', 'ciUpperLimit': '-1.74', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.97', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': 'SECONDARY', 'title': 'Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.45', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '-2.86', 'spread': '1.84', 'groupId': 'OG001'}, {'value': '7.93', 'spread': '1.20', 'groupId': 'OG002'}, {'value': '6.62', 'spread': '1.29', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.38', 'ciLowerLimit': '4.36', 'ciUpperLimit': '12.40', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.04', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '9.48', 'ciLowerLimit': '5.10', 'ciUpperLimit': '13.85', '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', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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 HDL-C at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.15', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '-3.73', 'spread': '2.35', 'groupId': 'OG001'}, {'value': '8.05', 'spread': '1.35', 'groupId': 'OG002'}, {'value': '5.35', 'spread': '1.62', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.20', 'ciLowerLimit': '4.66', 'ciUpperLimit': '13.74', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.30', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '9.07', 'ciLowerLimit': '3.48', 'ciUpperLimit': '1466', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.83', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': 'SECONDARY', 'title': 'Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.66', 'spread': '2.90', 'groupId': 'OG000'}, {'value': '6.34', 'spread': '3.27', 'groupId': 'OG001'}, {'value': '-13.97', 'spread': '2.06', 'groupId': 'OG002'}, {'value': '-9.20', 'spread': '2.27', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.63', 'ciLowerLimit': '-29.46', 'ciUpperLimit': '-15.81', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.46', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '-15.54', 'ciLowerLimit': '-23.25', 'ciUpperLimit': '-7.84', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.90', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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 VLDL-C at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.73', 'spread': '3.50', 'groupId': 'OG000'}, {'value': '4.10', 'spread': '4.17', 'groupId': 'OG001'}, {'value': '-17.25', 'spread': '2.48', 'groupId': 'OG002'}, {'value': '-5.06', 'spread': '2.84', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.97', 'ciLowerLimit': '-29.29', 'ciUpperLimit': '-12.66', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.21', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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': '-9.17', 'ciLowerLimit': '-19.01', 'ciUpperLimit': '0.68', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.98', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment group, baseline LDL-C and ezetimibe 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'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'FG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'FG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'FG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '111'}, {'groupId': 'FG003', 'numSubjects': '110'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '110'}, {'groupId': 'FG003', 'numSubjects': '110'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '101'}, {'groupId': 'FG003', 'numSubjects': '108'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Men and women 18 to 80 years old with a diagnosis of heterozygous familial hypercholesterolemia (HeFH) on stable doses of an approved statin with fasting low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL were eligible for this study. The first participant enrolled on 07 February 2013 and the last participant enrolled 03 September 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 LDL-C level (\\< 160 mg/dL vs ≥ 160 mg/dL) and ezetimibe use.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}, {'value': '110', 'groupId': 'BG003'}, {'value': '331', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.'}, {'id': 'BG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.'}, {'id': 'BG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.'}, {'id': 'BG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.1', 'spread': '14.1', 'groupId': 'BG000'}, {'value': '46.8', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '52.3', 'spread': '12.6', 'groupId': 'BG002'}, {'value': '51.9', 'spread': '12.0', 'groupId': 'BG003'}, {'value': '51.1', 'spread': '12.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '140', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '191', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}, {'value': '298', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}, {'value': '329', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Stratification Factor: Low-Density Lipoprotein Cholesterol (LDL-C) Level', 'classes': [{'title': '< 160 mg/dL', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}, {'value': '210', 'groupId': 'BG004'}]}]}, {'title': '≥ 160 mg/dL', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '121', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Ezetimibe Use', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '129', 'groupId': 'BG004'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '202', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'LDL-C Concentration', 'classes': [{'categories': [{'measurements': [{'value': '151.1', 'spread': '36.5', 'groupId': 'BG000'}, {'value': '151.5', 'spread': '42.5', 'groupId': 'BG001'}, {'value': '161.4', 'spread': '51.0', 'groupId': 'BG002'}, {'value': '153.6', 'spread': '43.3', 'groupId': 'BG003'}, {'value': '155.5', 'spread': '44.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Data are provided for the full analysis set (all randomized participants who received at least\n\n1 dose of investigational product)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration', 'classes': [{'categories': [{'measurements': [{'value': '175.4', 'spread': '43.9', 'groupId': 'BG000'}, {'value': '175.4', 'spread': '45.9', 'groupId': 'BG001'}, {'value': '187.4', 'spread': '56.7', 'groupId': 'BG002'}, {'value': '178.5', 'spread': '45.8', 'groupId': 'BG003'}, {'value': '180.4', 'spread': '49.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Data are provided for the full analysis set', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Apolipoprotein B Concentration', 'classes': [{'categories': [{'measurements': [{'value': '114.3', 'spread': '29.8', 'groupId': 'BG000'}, {'value': '110.3', 'spread': '21.7', 'groupId': 'BG001'}, {'value': '119.0', 'spread': '30.7', 'groupId': 'BG002'}, {'value': '114.9', 'spread': '25.5', 'groupId': 'BG003'}, {'value': '115.4', 'spread': '27.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Data are provided for the full analysis set', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total cholesterol/HDL-C Ratio', 'classes': [{'categories': [{'measurements': [{'value': '4.695', 'spread': '1.905', 'groupId': 'BG000'}, {'value': '4.844', 'spread': '1.435', 'groupId': 'BG001'}, {'value': '5.159', 'spread': '2.031', 'groupId': 'BG002'}, {'value': '4.842', 'spread': '1.801', 'groupId': 'BG003'}, {'value': '4.924', 'spread': '1.845', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Data are provided for the full analysis set', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Apolipoprotein B/Apolipoprotein A1 Ratio', 'classes': [{'categories': [{'measurements': [{'value': '0.815', 'spread': '0.264', 'groupId': 'BG000'}, {'value': '0.851', 'spread': '0.249', 'groupId': 'BG001'}, {'value': '0.888', 'spread': '0.322', 'groupId': 'BG002'}, {'value': '0.850', 'spread': '0.331', 'groupId': 'BG003'}, {'value': '0.857', 'spread': '0.305', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Data are provided for the full analysis set', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Lipoprotein(a) Concentration', 'classes': [{'categories': [{'measurements': [{'value': '44.0', 'groupId': 'BG000', 'lowerLimit': '24.0', 'upperLimit': '105.0'}, {'value': '87.0', 'groupId': 'BG001', 'lowerLimit': '36.0', 'upperLimit': '219.0'}, {'value': '77.5', 'groupId': 'BG002', 'lowerLimit': '29.0', 'upperLimit': '205.5'}, {'value': '61.0', 'groupId': 'BG003', 'lowerLimit': '17.0', 'upperLimit': '194.0'}, {'value': '65.0', 'groupId': 'BG004', 'lowerLimit': '25.0', 'upperLimit': '199.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'Data are provided for the full analysis set', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Triglyceride Concentration', 'classes': [{'categories': [{'measurements': [{'value': '95.8', 'groupId': 'BG000', 'lowerLimit': '74.5', 'upperLimit': '143.0'}, {'value': '102.0', 'groupId': 'BG001', 'lowerLimit': '79.0', 'upperLimit': '151.0'}, {'value': '118.5', 'groupId': 'BG002', 'lowerLimit': '86.5', 'upperLimit': '160.5'}, {'value': '112.5', 'groupId': 'BG003', 'lowerLimit': '84.5', 'upperLimit': '156.5'}, {'value': '110.0', 'groupId': 'BG004', 'lowerLimit': '81.5', 'upperLimit': '154.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'Data are provided for the full analysis set', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Very Low-Density Lipoprotein Cholesterol (VLDL-C) Concentration', 'classes': [{'categories': [{'measurements': [{'value': '23.1', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '23.9', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '25.9', 'spread': '11.8', 'groupId': 'BG002'}, {'value': '24.9', 'spread': '11.7', 'groupId': 'BG003'}, {'value': '24.8', 'spread': '11.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Data are provided for the full analysis set', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HDL-C Concentration', 'classes': [{'categories': [{'measurements': [{'value': '53.2', 'spread': '16.5', 'groupId': 'BG000'}, {'value': '49.1', 'spread': '12.7', 'groupId': 'BG001'}, {'value': '50.4', 'spread': '16.1', 'groupId': 'BG002'}, {'value': '51.9', 'spread': '16.0', 'groupId': 'BG003'}, {'value': '51.1', 'spread': '15.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Data are provided for the full analysis set', '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': 331}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'dispFirstSubmitDate': '2014-05-02', 'completionDateStruct': {'date': '2013-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-03', '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': '2019-06-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-11-18', 'studyFirstPostDateStruct': {'date': '2013-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11-27', '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-High-Density Lipoprotein Cholesterol (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/HDL-C 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/HDL-C 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 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 Very Low-Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12', 'timeFrame': 'Baseline and Weeks 10 and 12'}, {'measure': 'Percent Change From Baseline in VLDL-C 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': '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': '25282519', 'type': 'BACKGROUND', 'citation': 'Raal FJ, Stein EA, Dufour R, Turner T, Civeira F, Burgess L, Langslet G, Scott R, Olsson AG, Sullivan D, Hovingh GK, Cariou B, Gouni-Berthold I, Somaratne R, Bridges I, Scott R, Wasserman SM, Gaudet D; RUTHERFORD-2 Investigators. PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): a randomised, double-blind, placebo-controlled trial. Lancet. 2015 Jan 24;385(9965):331-40. doi: 10.1016/S0140-6736(14)61399-4. Epub 2014 Oct 1.'}, {'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.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female ≥ 18 to ≤ 80 years of age\n* Diagnosis of heterozygous familial hypercholesterolemia\n* On a stable dose of an approved statin and lipid regulating medication\n* Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L)\n* Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)\n\nExclusion Criteria:\n\n* Homozygous familial hypercholesterolemia\n* LDL or plasma apheresis\n* New York Heart Association (NYHA) III or IV heart failure\n* Uncontrolled cardiac arrhythmia\n* Uncontrolled hypertension\n* Type 1 diabetes, poorly controlled type 2 diabetes\n* Uncontrolled hypothyroidism or hyperthyroidism'}, 'identificationModule': {'nctId': 'NCT01763918', 'acronym': 'RUTHERFORD-2', 'briefTitle': 'Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Subjects With Heterozygous Familial Hypercholesterolemia', 'orgStudyIdInfo': {'id': '20110117'}, 'secondaryIdInfos': [{'id': '2012-001365-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.', 'interventionNames': ['Biological: Evolocumab']}, {'type': 'EXPERIMENTAL', 'label': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.', 'interventionNames': ['Biological: Evolocumab']}], 'interventions': [{'name': 'Evolocumab', 'type': 'BIOLOGICAL', 'otherNames': ['AMG 145', 'Repatha'], 'description': 'Administered by subcutaneous injection', 'armGroupLabels': ['Evolocumab Q2W', 'Evolocumab QM']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered by subcutaneous injection', 'armGroupLabels': ['Placebo Q2W', 'Placebo QM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '45227', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '2015', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '6000', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'N6A 5K8', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'G7H 7K9', 'city': 'Chicoutimi', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 48.41963, 'lon': -71.06369}}, {'zip': 'H2W 1R7', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3A 1A1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75651', 'city': 'Paris', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'New Territories', 'country': 'Hong Kong', 'facility': 'Research Site', 'geoPoint': {'lat': 22.42441, 'lon': 114.11095}}, {'zip': '3813 TZ', 'city': 'Amersfoort', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.155, 'lon': 5.3875}}, {'zip': '1091 AC', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '2803 HH', 'city': 'Gouda', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.01667, 'lon': 4.70833}}, {'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '1625 HV', 'city': 'Hoorn', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.6425, 'lon': 5.05972}}, {'zip': '5022 GC', 'city': 'Tilburg', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '8011', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Research Site', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '0373', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Research Site', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '2193', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '1685', 'city': 'Midrand', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -25.976, 'lon': 28.118}}, {'zip': '7925', 'city': 'Observatory', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -33.93613, 'lon': 18.46787}}, {'zip': '7505', 'city': 'Parow', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -33.89723, 'lon': 18.59992}}, {'zip': '14004', 'city': 'Córdoba', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '50009', 'city': 'Zaragoza', 'state': 'Aragon', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': '43204', 'city': 'Reus', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.15612, 'lon': 1.10687}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '111 35', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '141 86', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '4153', 'city': 'Reinach', 'country': 'Switzerland', 'facility': 'Research Site', 'geoPoint': {'lat': 47.49702, 'lon': 7.59172}}, {'zip': 'CV2 2DX', 'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W6 8RF', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}