{ "FullStudy":{ "Rank":217784, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516879", "OrgStudyIdInfo":{ "OrgStudyId":"20110109" }, "Organization":{ "OrgFullName":"Amgen", "OrgClass":"INDUSTRY" }, "BriefTitle":"Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study", "OfficialTitle":"A Double-Blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Long-Term Tolerability and Durable Efficacy of AMG 145 (Evolocumab) on LDL-C in Hyperlipidemic Subjects", "Acronym":"DESCARTES" }, "StatusModule":{ "StatusVerifiedDate":"November 2018", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 5, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 14, 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"October 14, 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"August 28, 2015", "ResultsFirstSubmitQCDate":"August 28, 2015", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"September 29, 2015", "ResultsFirstPostDateType":"Estimate" }, "DispFirstSubmitDate":"May 15, 2014", "DispFirstSubmitQCDate":"May 15, 2014", "DispFirstPostDateStruct":{ "DispFirstPostDate":"May 28, 2014", "DispFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"November 1, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"November 28, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Amgen", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.", "DetailedDescription":"Eligible participants with screening central laboratory low-density lipoprotein cholesterol (LDL-C) values ≥ 75 mg/dL (1.9 mmol/L) were instructed to follow National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP) Therapeutic Lifestyle Changes (TLC) diet and were assigned to 1 of the following 4 background lipid-lowering therapies for a 4-week stabilization period based upon their screening LDL-C and its distance from the individual's required goal as stipulated by their NCEP ATP III risk category:\n\nno drug therapy required - diet alone\nlow dose drug therapy required - diet plus atorvastatin 10 mg orally (PO) once daily (QD)\nhigh dose drug therapy required - diet plus atorvastatin 80 mg PO QD\nmaximal drug therapy required - diet plus atorvastatin 80 mg PO QD plus ezetimibe 10 mg PO QD.\n\nIf the participant met entry criteria at the end of the lipid stabilization period they were randomized 2:1 to receive evolocumab 420 mg or placebo subcutaneously once a month for 52 weeks in addition to their background therapy." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Hypercholesterolemia" ] }, "KeywordList":{ "Keyword":[ "Cholesterol", "High Cholesterol", "Elevated Cholesterol", "Raised Cholesterol" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"905", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Evolocumab", "ArmGroupType":"Experimental", "ArmGroupDescription":"Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: Evolocumab", "Drug: Atorvastatin", "Drug: Ezetimibe", "Other: Diet Only" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: Placebo", "Drug: Atorvastatin", "Drug: Ezetimibe", "Other: Diet Only" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Biological", "InterventionName":"Evolocumab", "InterventionDescription":"Administered by subcutaneous injection once a month", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Evolocumab" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "AMG 145", "Repatha" ] } },{ "InterventionType":"Biological", "InterventionName":"Placebo", "InterventionDescription":"Administered by subcutaneous injection once a month", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } },{ "InterventionType":"Drug", "InterventionName":"Atorvastatin", "InterventionDescription":"Background lipid lowering therapy: 10 mg or 80 mg atorvastatin orally once daily.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Evolocumab", "Placebo" ] } },{ "InterventionType":"Drug", "InterventionName":"Ezetimibe", "InterventionDescription":"Background lipid lowering therapy: ezetimibe 10 mg orally once a day", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Evolocumab", "Placebo" ] } },{ "InterventionType":"Other", "InterventionName":"Diet Only", "InterventionDescription":"Diet only, no lipid lowering background drug given", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Evolocumab", "Placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Percent Change From Baseline in LDL-C at Week 52", "PrimaryOutcomeDescription":"Cholesterol was measured by means of ultracentrifugation.", "PrimaryOutcomeTimeFrame":"Baseline and Week 52" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change From Baseline in LDL-C at Week 52", "SecondaryOutcomeDescription":"Cholesterol was measured by means of ultracentrifugation.", "SecondaryOutcomeTimeFrame":"Baseline and Week 52" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With an LDL-C Response at Week 52", "SecondaryOutcomeDescription":"An LDL-C response is defined as LDL-C level < 70 mg/dL (1.8 mmol/L) at Week 52.", "SecondaryOutcomeTimeFrame":"Week 52" },{ "SecondaryOutcomeMeasure":"Percent Change From Baseline in LDL-C at Week 12", "SecondaryOutcomeDescription":"Cholesterol was measured by means of ultracentrifugation.", "SecondaryOutcomeTimeFrame":"Baseline and Week 12" },{ "SecondaryOutcomeMeasure":"Percent Change From Baseline in Total Cholesterol at Week 12", "SecondaryOutcomeTimeFrame":"Baseline and Week 12" },{ "SecondaryOutcomeMeasure":"Percent Change From Baseline in Total Cholesterol at Week 52", "SecondaryOutcomeTimeFrame":"Baseline and Week 52" },{ "SecondaryOutcomeMeasure":"Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 52", "SecondaryOutcomeTimeFrame":"Baseline and Week 52" },{ "SecondaryOutcomeMeasure":"Percent Change From Baseline in Apolipoprotein B at Week 52", "SecondaryOutcomeTimeFrame":"Baseline and Week 52" },{ "SecondaryOutcomeMeasure":"Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 52", "SecondaryOutcomeTimeFrame":"Baseline and Week 52" },{ "SecondaryOutcomeMeasure":"Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 52", "SecondaryOutcomeTimeFrame":"Baseline and Week 52" },{ "SecondaryOutcomeMeasure":"Percent Change From Baseline in Lipoprotein(a) at Week 52", "SecondaryOutcomeTimeFrame":"Baseline and Week 52" },{ "SecondaryOutcomeMeasure":"Percent Change From Baseline in Triglycerides at Week 52", "SecondaryOutcomeTimeFrame":"Baseline and Week 52" },{ "SecondaryOutcomeMeasure":"Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 52", "SecondaryOutcomeTimeFrame":"Baseline and Week 52" },{ "SecondaryOutcomeMeasure":"Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 52", "SecondaryOutcomeDescription":"Cholesterol was measured by means of ultracentrifugation.", "SecondaryOutcomeTimeFrame":"Baseline and Week 52" },{ "SecondaryOutcomeMeasure":"Percent Change From Week 12 to Week 52 in LDL-C", "SecondaryOutcomeDescription":"Cholesterol was measured by means of ultracentrifugation.", "SecondaryOutcomeTimeFrame":"Week 12 and Week 52" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nSubject has provided informed consent.\n\nFasting LDL-C ≥ 75 mg/dL and meeting the following LDL-C values on background lipid-lowering therapy:\n\n< 100 mg/dL for subjects with diagnosed coronary heart disease (CHD) or CHD risk equivalent\n< 130 mg/dL for subjects without diagnosed CHD or CHD risk equivalent\nOR on maximal background lipid-lowering therapy defined as atorvastatin 80 mg PO QD and ezetimibe 10 mg PO QD\nFasting triglycerides ≤ 400 mg/dL\n\nExclusion Criteria:\n\nNew York Heart Association (NYHA) II-IV heart failure, or last known left ventricular ejection fraction < 30%\nUncontrolled cardiac arrhythmia\nMyocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization, type 1 diabetes, newly diagnosed or poorly controlled type 2 diabetes\nUncontrolled hypertension", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"80 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"MD", "OverallOfficialAffiliation":"Amgen", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Research Site", "LocationCity":"Birmingham", "LocationState":"Alabama", "LocationZip":"35216", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Little Rock", "LocationState":"Arkansas", "LocationZip":"72205", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Anaheim", "LocationState":"California", "LocationZip":"92801", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Encinitas", "LocationState":"California", "LocationZip":"92024", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Spring Valley", 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} }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"29221604", "ReferenceType":"background", "ReferenceCitation":"Toth PP, Sattar N, Blom DJ, Martin SS, Jones SR, Monsalvo ML, Elliott M, Davis M, Somaratne R, Preiss D. Effect of Evolocumab on Lipoprotein Particles. Am J Cardiol. 2018 Feb 1;121(3):308-314. doi: 10.1016/j.amjcard.2017.10.028. Epub 2017 Nov 8." },{ "ReferencePMID":"27619750", "ReferenceType":"background", "ReferenceCitation":"Blom DJ, Koren MJ, Roth E, Monsalvo ML, Djedjos CS, Nelson P, Elliott M, Wasserman SM, Ballantyne CM, Holman RR. Evaluation of the efficacy, safety and glycaemic effects of evolocumab (AMG 145) in hypercholesterolaemic patients stratified by glycaemic status and metabolic syndrome. Diabetes Obes Metab. 2017 Jan;19(1):98-107. doi: 10.1111/dom.12788. Epub 2016 Oct 14." },{ "ReferencePMID":"28844508", "ReferenceType":"background", "ReferenceCitation":"Sattar N, Toth PP, Blom DJ, Koren MJ, Soran H, Uhart M, Elliott M, Cyrille M, Somaratne R, Preiss D. Effect of the Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Evolocumab on Glycemia, Body Weight, and New-Onset Diabetes Mellitus. Am J Cardiol. 2017 Nov 1;120(9):1521-1527. doi: 10.1016/j.amjcard.2017.07.047. Epub 2017 Jul 31." },{ "ReferencePMID":"28249876", "ReferenceType":"background", "ReferenceCitation":"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." },{ "ReferencePMID":"29736889", "ReferenceType":"background", "ReferenceCitation":"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." },{ "ReferencePMID":"29353350", "ReferenceType":"background", "ReferenceCitation":"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. Review." },{ "ReferencePMID":"29768954", "ReferenceType":"background", "ReferenceCitation":"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." },{ "ReferencePMID":"26228031", "ReferenceType":"derived", "ReferenceCitation":"Blom DJ, Djedjos CS, Monsalvo ML, Bridges I, Wasserman SM, Scott R, Roth E. Effects of Evolocumab on Vitamin E and Steroid Hormone Levels: Results From the 52-Week, Phase 3, Double-Blind, Randomized, Placebo-Controlled DESCARTES Study. Circ Res. 2015 Sep 25;117(8):731-41. doi: 10.1161/CIRCRESAHA.115.307071. Epub 2015 Jul 30." },{ "ReferencePMID":"24678979", "ReferenceType":"derived", "ReferenceCitation":"Blom DJ, Hala T, Bolognese M, Lillestol MJ, Toth PD, Burgess L, Ceska R, Roth E, Koren MJ, Ballantyne CM, Monsalvo ML, Tsirtsonis K, Kim JB, Scott R, Wasserman SM, Stein EA; DESCARTES Investigators. A 52-week placebo-controlled trial of evolocumab in hyperlipidemia. N Engl J Med. 2014 May 8;370(19):1809-19. doi: 10.1056/NEJMoa1316222. Epub 2014 Mar 29." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"AmgenTrials clinical trials website", "SeeAlsoLinkURL":"http://www.amgentrials.com" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"Patients were assigned to 1 of 4 background lipid-lowering regimens for a 4-12 week stabilization period: diet alone, diet and 10 mg atorvastatin daily, diet and 80 mg atorvastatin daily, or diet, 80 mg atorvastatin and 10 mg ezetimibe daily. Patients meeting criteria were randomized 2:1 to evolocumab or placebo, stratified by background therapy.", "FlowRecruitmentDetails":"Adults with fasting low-density lipoprotein cholesterol (LDL-C) ≥ 75 mg/dL and triglycerides ≤ 400 mg/dL were eligible. The first patient enrolled on 5 January 2012 and the last patient enrolled on 12 October 2012. All patients were counseled on the National Cholesterol Education Program Adult Treatment Panel III Therapeutic Lifestyle Changes diet.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Placebo", "FlowGroupDescription":"Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Evolocumab", "FlowGroupDescription":"Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"303" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"602" } ] } },{ "FlowMilestoneType":"Received Treatment", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"302" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"599" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"287" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"568" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"16" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"34" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"9" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"11" } ] } },{ "FlowDropWithdrawType":"Death", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"11" } ] } },{ "FlowDropWithdrawType":"Other", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"5" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"10" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Placebo", "BaselineGroupDescription":"Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Evolocumab", "BaselineGroupDescription":"Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"303" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"602" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"905" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"56.6", "BaselineMeasurementSpread":"10.3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"55.9", "BaselineMeasurementSpread":"10.9" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"56.1", "BaselineMeasurementSpread":"10.7" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"162" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"312" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"474" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"141" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"290" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"431" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race/Ethnicity, Customized", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"American Indian or Alaska Native", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"3" } ] } } ] } },{ "BaselineClassTitle":"Asian", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"41" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"57" } ] } } ] } },{ "BaselineClassTitle":"Black or African American", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"23" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"53" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"76" } ] } } ] } },{ "BaselineClassTitle":"Native Hawaiian or Other Pacific Islander", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } } ] } },{ "BaselineClassTitle":"White", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"249" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"478" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"727" } ] } } ] } },{ "BaselineClassTitle":"Other", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"13" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"26" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"39" } ] } } ] } },{ "BaselineClassTitle":"Mixed Race", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race/Ethnicity, Customized", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Hispanic/Latino", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"17" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"33" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"50" } ] } } ] } },{ "BaselineClassTitle":"Not Hispanic/Latino", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"286" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"569" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"855" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Background Therapy", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Diet Only", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"38" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"74" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"112" } ] } } ] } },{ "BaselineClassTitle":"Diet + Atorvastatin 10 mg", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"129" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"256" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"385" } ] } } ] } },{ "BaselineClassTitle":"Diet + Atorvastatin 80 mg", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"73" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"146" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"219" } ] } } ] } },{ "BaselineClassTitle":"Diet + Atorvastatin 80 mg + Ezetimibe 10 mg", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"63" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"126" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"189" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Low-density Lipoprotein Cholesterol (LDL-C) Concentration", "BaselineMeasureDescription":"Cholesterol was measured by means of ultracentrifugation. Data are provided for the Full Analysis Set (all participants who were randomized and received at least 1 dose of study treatment).", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"mg/dL", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"104.0", "BaselineMeasurementSpread":"21.6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"104.2", "BaselineMeasurementSpread":"22.1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"104.1", "BaselineMeasurementSpread":"22.0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Total Cholesterol", "BaselineMeasureDescription":"Data are provided for the Full Analysis Set", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"mg/dL", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"179.1", "BaselineMeasurementSpread":"27.2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"176.8", "BaselineMeasurementSpread":"27.5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"177.6", "BaselineMeasurementSpread":"27.4" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) Concentration", "BaselineMeasureDescription":"Data are provided for the Full Analysis Set", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"mg/dL", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"125.6", "BaselineMeasurementSpread":"26.9" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"124.2", "BaselineMeasurementSpread":"25.6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"124.6", "BaselineMeasurementSpread":"26.1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Apolipoprotein B Concentration", "BaselineMeasureDescription":"Data are provided for the Full Analysis Set", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"mg/dL", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"87.5", "BaselineMeasurementSpread":"16.3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"87.0", "BaselineMeasurementSpread":"16.3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"87.2", "BaselineMeasurementSpread":"16.3" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Total Cholesterol/High Density Lipoprotein-Cholesterol (HDL-C) Ratio", "BaselineMeasureDescription":"Data are provided for the Full Analysis Set", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"ratio", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3.603", "BaselineMeasurementSpread":"1.11" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"3.597", "BaselineMeasurementSpread":"1.04" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"3.599", "BaselineMeasurementSpread":"1.06" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Apolipoprotein B/Apolipoprotein A-1 Ratio", "BaselineMeasureDescription":"Data are provided for the Full Analysis Set", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"ratio", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0.586", "BaselineMeasurementSpread":"0.170" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0.593", "BaselineMeasurementSpread":"0.170" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0.590", "BaselineMeasurementSpread":"1.70" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Lipoprotein(a) Concentration", "BaselineMeasureDescription":"Data are provided for the Full Analysis Set", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"nmol/L", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"89.3", "BaselineMeasurementSpread":"108.6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"84.0", "BaselineMeasurementSpread":"98.5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"85.8", "BaselineMeasurementSpread":"102.0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Triglycerides Concentration", "BaselineMeasureDescription":"Data are provided for the Full Analysis Set", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"mg/dL", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"127.8", "BaselineMeasurementSpread":"65.8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"119.8", "BaselineMeasurementSpread":"63.2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"122.5", "BaselineMeasurementSpread":"64.1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"High-density Lipoprotein Cholesterol (HDL-C) Concentration", "BaselineMeasureDescription":"Data are providedfor the Full Analysis Set", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"mg/dL", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"53.5", "BaselineMeasurementSpread":"16.1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"52.6", "BaselineMeasurementSpread":"15.5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"52.9", "BaselineMeasurementSpread":"15.7" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Very Low-density Lipoprotein Cholesterol (VLDL-C) Concentration", "BaselineMeasureDescription":"Data are provided for the Full Analysis Set", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"mg/dL", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"21.5", "BaselineMeasurementSpread":"13.4" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"20.0", "BaselineMeasurementSpread":"11.4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"20.5", "BaselineMeasurementSpread":"12.1" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percent Change From Baseline in LDL-C at Week 52", "OutcomeMeasureDescription":"Cholesterol was measured by means of ultracentrifugation.", "OutcomeMeasurePopulationDescription":"Full Analysis Set (all randomized subjects who received at least 1 dose of study drug).", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"percent change", "OutcomeMeasureTimeFrame":"Baseline and Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Evolocumab", "OutcomeGroupDescription":"Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"302" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"599" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.83", "OutcomeMeasurementSpread":"1.75" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-50.14", "OutcomeMeasurementSpread":"1.24" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 52 in LDL-C between evolocumab 420 mg and placebo, and the alternative hypothesis was that a mean difference did exist.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Repeated measures linear effects model", "OutcomeAnalysisStatisticalComment":"The model included treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.", "OutcomeAnalysisParamType":"LS Mean Treatment Difference", "OutcomeAnalysisParamValue":"-56.97", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-61.08", "OutcomeAnalysisCIUpperLimit":"-52.85", "OutcomeAnalysisDispersionType":"Standard Error of the Mean", "OutcomeAnalysisDispersionValue":"2.10", "OutcomeAnalysisEstimateComment":"Treatment difference using placebo as the reference." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in LDL-C at Week 52", "OutcomeMeasureDescription":"Cholesterol was measured by means of ultracentrifugation.", "OutcomeMeasurePopulationDescription":"Full Analysis Set", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"mg/dL", "OutcomeMeasureTimeFrame":"Baseline and Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Evolocumab", "OutcomeGroupDescription":"Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"302" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"599" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.1", "OutcomeMeasurementSpread":"1.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-52.7", "OutcomeMeasurementSpread":"1.4" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Repeated measures linear effects model", "OutcomeAnalysisStatisticalComment":"The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.", "OutcomeAnalysisParamType":"LS Mean Treatment Difference", "OutcomeAnalysisParamValue":"-57.8", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-62.3", "OutcomeAnalysisCIUpperLimit":"-53.3", "OutcomeAnalysisDispersionType":"Standard Error of the Mean", "OutcomeAnalysisDispersionValue":"2.3", "OutcomeAnalysisEstimateComment":"Treatment difference using placebo as the reference." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With an LDL-C Response at Week 52", "OutcomeMeasureDescription":"An LDL-C response is defined as LDL-C level < 70 mg/dL (1.8 mmol/L) at Week 52.", "OutcomeMeasurePopulationDescription":"Full Analysis Set", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Evolocumab", "OutcomeGroupDescription":"Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"302" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"599" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.4", "OutcomeMeasurementLowerLimit":"4.1", "OutcomeMeasurementUpperLimit":"10.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"82.3", "OutcomeMeasurementLowerLimit":"78.8", "OutcomeMeasurementUpperLimit":"85.3" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisStatisticalComment":"CMH test stratified by the stratification factor. For testing, non-achievement was imputed for participants with a missing value at Week 52.", "OutcomeAnalysisParamType":"Treatment Difference", "OutcomeAnalysisParamValue":"75.8", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"70.8", "OutcomeAnalysisCIUpperLimit":"79.7", "OutcomeAnalysisEstimateComment":"Treatment difference using placebo as the reference." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percent Change From Baseline in LDL-C at Week 12", "OutcomeMeasureDescription":"Cholesterol was measured by means of ultracentrifugation.", "OutcomeMeasurePopulationDescription":"Full Analysis set", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"percent change", "OutcomeMeasureTimeFrame":"Baseline and Week 12", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Evolocumab", "OutcomeGroupDescription":"Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"302" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"599" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.17", "OutcomeMeasurementSpread":"1.31" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-54.35", "OutcomeMeasurementSpread":"0.96" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Repeated measures linear effects model", "OutcomeAnalysisStatisticalComment":"The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.", "OutcomeAnalysisParamType":"LS Mean Treatment Difference", "OutcomeAnalysisParamValue":"-57.51", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-60.57", "OutcomeAnalysisCIUpperLimit":"-54.45", "OutcomeAnalysisDispersionType":"Standard Error of the Mean", "OutcomeAnalysisDispersionValue":"1.56", "OutcomeAnalysisEstimateComment":"Treatment difference using placebo as the reference." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percent Change From Baseline in Total Cholesterol at Week 12", "OutcomeMeasurePopulationDescription":"Full Analysis Set", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"percent change", "OutcomeMeasureTimeFrame":"Baseline and Week 12", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Evolocumab", "OutcomeGroupDescription":"Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"302" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"599" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.85", "OutcomeMeasurementSpread":"0.87" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-32.30", "OutcomeMeasurementSpread":"0.63" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Repeated measures linear effects model", "OutcomeAnalysisStatisticalComment":"The model includes treatment group, stratification factor, scheduled visit and the 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"OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Evolocumab", "OutcomeGroupDescription":"Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"302" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"599" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.26", "OutcomeMeasurementSpread":"1.16" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-28.18", "OutcomeMeasurementSpread":"0.84" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Repeated measures linear effects model", "OutcomeAnalysisStatisticalComment":"The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.", "OutcomeAnalysisParamType":"LS Mean Treatment Difference", "OutcomeAnalysisParamValue":"-33.45", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-36.21", "OutcomeAnalysisCIUpperLimit":"-30.68", "OutcomeAnalysisDispersionType":"Standard Error of the Mean", "OutcomeAnalysisDispersionValue":"1.41", "OutcomeAnalysisEstimateComment":"Treatment difference using placebo as the 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"OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"302" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"599" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.44", "OutcomeMeasurementSpread":"1.68" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-41.82", "OutcomeMeasurementSpread":"1.21" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Repeated measures linear effects model", "OutcomeAnalysisStatisticalComment":"The model includes treatment group, stratification 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"OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Evolocumab", "OutcomeGroupDescription":"Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"302" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"599" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.94", "OutcomeMeasurementSpread":"1.41" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-41.26", "OutcomeMeasurementSpread":"1.02" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Repeated measures linear effects model", "OutcomeAnalysisStatisticalComment":"The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.", "OutcomeAnalysisParamType":"LS Mean Treatment Difference", "OutcomeAnalysisParamValue":"-44.21", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-47.56", "OutcomeAnalysisCIUpperLimit":"-40.85", "OutcomeAnalysisDispersionType":"Standard Error of the Mean", "OutcomeAnalysisDispersionValue":"1.71", "OutcomeAnalysisEstimateComment":"Treatment difference using placebo as the reference." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 52", "OutcomeMeasurePopulationDescription":"Full Analysis Set", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"percent change", "OutcomeMeasureTimeFrame":"Baseline and Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Evolocumab", "OutcomeGroupDescription":"Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"302" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"599" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.47", "OutcomeMeasurementSpread":"1.37" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-30.67", "OutcomeMeasurementSpread":"0.99" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Repeated measures linear effects model", "OutcomeAnalysisStatisticalComment":"The model includes treatment group, stratification 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"OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Evolocumab", "OutcomeGroupDescription":"Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"302" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"599" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.46", "OutcomeMeasurementSpread":"1.50" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-41.75", "OutcomeMeasurementSpread":"1.09" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Repeated measures linear effects model", "OutcomeAnalysisStatisticalComment":"The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.", "OutcomeAnalysisParamType":"LS Mean Treatment Difference", "OutcomeAnalysisParamValue":"-46.21", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-49.79", "OutcomeAnalysisCIUpperLimit":"-42.63", "OutcomeAnalysisDispersionType":"Standard Error of the Mean", "OutcomeAnalysisDispersionValue":"1.82", "OutcomeAnalysisEstimateComment":"Treatment difference using placebo as the reference." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percent Change From Baseline in Lipoprotein(a) at Week 52", "OutcomeMeasurePopulationDescription":"Full Analysis Set", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"percent change", "OutcomeMeasureTimeFrame":"Baseline and Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Evolocumab", "OutcomeGroupDescription":"Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"302" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"599" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-5.37", "OutcomeMeasurementSpread":"1.62" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-27.72", "OutcomeMeasurementSpread":"1.19" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Repeated measures linear effects model", "OutcomeAnalysisStatisticalComment":"The model 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"OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Evolocumab", "OutcomeGroupDescription":"Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"302" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"599" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.99", "OutcomeMeasurementSpread":"2.39" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-2.55", "OutcomeMeasurementSpread":"1.72" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Repeated measures linear effects model", "OutcomeAnalysisStatisticalComment":"The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.", "OutcomeAnalysisParamType":"LS Mean Treatment Difference", "OutcomeAnalysisParamValue":"-11.54", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-17.21", "OutcomeAnalysisCIUpperLimit":"-5.86", "OutcomeAnalysisDispersionType":"Standard Error of the Mean", "OutcomeAnalysisDispersionValue":"2.89", "OutcomeAnalysisEstimateComment":"Treatment difference using placebo as the reference." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 52", "OutcomeMeasurePopulationDescription":"Full Analysis Set", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"percent change", "OutcomeMeasureTimeFrame":"Baseline and Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Evolocumab", "OutcomeGroupDescription":"Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"302" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"599" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.35", "OutcomeMeasurementSpread":"0.90" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5.77", "OutcomeMeasurementSpread":"0.65" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Repeated measures linear effects model", "OutcomeAnalysisStatisticalComment":"The model includes treatment group, 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"OutcomeMeasureUnitOfMeasure":"percent change", "OutcomeMeasureTimeFrame":"Baseline and Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Evolocumab", "OutcomeGroupDescription":"Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"302" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"599" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"31.89", "OutcomeMeasurementSpread":"4.69" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.74", "OutcomeMeasurementSpread":"3.36" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Repeated measures linear effects model", "OutcomeAnalysisStatisticalComment":"The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.", "OutcomeAnalysisParamType":"LS Mean Treatment Difference", "OutcomeAnalysisParamValue":"-29.15", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-40.23", "OutcomeAnalysisCIUpperLimit":"-18.08", "OutcomeAnalysisDispersionType":"Standard Error of the Mean", "OutcomeAnalysisDispersionValue":"5.64", "OutcomeAnalysisEstimateComment":"Treatment difference using placebo as the reference." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percent Change From Week 12 to Week 52 in LDL-C", "OutcomeMeasureDescription":"Cholesterol was measured by means of ultracentrifugation.", "OutcomeMeasurePopulationDescription":"The Effect Durability Analysis Set included participants in the FAS who adhered to the scheduled study drug and had nonmissing LDL-C values at Baseline, Week 12 and Week 52.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"percent change", "OutcomeMeasureTimeFrame":"Week 12 and Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Participants received 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