{"protocolSection":{"identificationModule":{"nctId":"NCT04847557","orgStudyIdInfo":{"id":"17757"},"secondaryIdInfos":[{"id":"I8F-MC-GPID","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial","officialTitle":"A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)"},"statusModule":{"statusVerifiedDate":"2025-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-04-20","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-07-02","type":"ACTUAL"},"completionDateStruct":{"date":"2024-07-02","type":"ACTUAL"},"studyFirstSubmitDate":"2021-02-26","studyFirstSubmitQcDate":"2021-04-13","studyFirstPostDateStruct":{"date":"2021-04-19","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-07-02","resultsFirstSubmitQcDate":"2025-08-15","resultsFirstPostDateStruct":{"date":"2025-08-20","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-08-15","lastUpdatePostDateStruct":{"date":"2025-08-20","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The main purpose of this study is to assess the efficacy and safety of Tirzepatide (LY3298176) in participants with heart failure with preserved ejection fraction and obesity.","detailedDescription":"The study will continue until approximately 52 weeks after the last participant is randomized. The maximum duration of an individual's participation is estimated to be \\~120 weeks and will depend on duration of study enrollment."},"conditionsModule":{"conditions":["Obesity","Heart Failure With Preserved Ejection Fraction (HFpEF)"],"keywords":["Heart Failure with Preserved Ejection Fraction (HFpEF)"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":731,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Tirzepatide","type":"EXPERIMENTAL","description":"Participants received a starting dose of 2.5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW) and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or maximum tolerated dose (MTD) tolerated by the participant (5 mg QW or 10 mg QW).","interventionNames":["Drug: Tirzepatide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received placebo administered SC QW.","interventionNames":["Other: Placebo"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC","armGroupLabels":["Tirzepatide"],"otherNames":["LY3298176"]},{"type":"OTHER","name":"Placebo","description":"Administered SC","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)","description":"The KCCQ is a 23-item, participant self-administered questionnaire that assesses impacts of heart failure \"over the past 2 weeks\" on the following 7 domains:\n\n* Physical Limitation (6)\n* Symptom Stability (1)\n* Symptom Frequency (4)\n* Symptom Burden (3)\n* Self-Efficacy (2)\n* Quality of Life (3)\n* Social Limitation (4)\n\nEach of the 23 individual items are answered on Likert scales of varying lengths (5, 6, or 7-point scales).\n\nKCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are obtained by averaging the associated individual items and transforming the score to a 0 to 100 range. Higher scores indicate better health status.\n\nLeast Square (LS) mean was determined using ANCOVA model with Baseline + HF Decompensation Within 12 Months of Screening + T2DM Status + Baseline BMI group (\\<35, \\>=35 kg/m2) + Treatment (Type III sum of squares) as variables .","timeFrame":"Baseline, Week 52"},{"measure":"First Occurrence of the Composite Endpoint of Heart Failure (HF) Outcomes","description":"Clinical Endpoint Committe confirmed Occurrences of CV outcomes were reported here. HF outcomes consisted of cardiovascular death and HF events.\n\nThe HF events were defined as worsening clinical symptoms or signs related to HF, which are meaningful to the participant and require intensification of treatment characterized by 1 or more of the following:\n\n* hospitalization for heart failure regardless of duration or treatment received\n* use of intravenous drug, usually an intravenous diuretic, but may include intravenous vasodilators or positive inotropic drugs, or\n* augmentation or increase in oral diuretic therapy.","timeFrame":"Baseline Up To 160 weeks"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Exercise Capacity as Measured by 6-Minute Walk Distance (6MWD)","description":"Participants performed an exercise capacity assessment using the 6-Minute Walk Test (6MWT) and the distance covered (6MWD) was assessed in meters. The 6MWT was performed indoors on a straight, flat, hard surface that is at least 30 meters in length. The greater distance walked meant better physical capacity.\n\nLS Mean was determined using ANCOVA model with Baseline + HF Decompensation Within 12 Months of Screening + T2DM Status + Baseline BMI group (\\<35, \\>=35 kg/m2) + Treatment (Type III sum of squares) as variables.","timeFrame":"Baseline, Week 52"},{"measure":"Percent Change From Baseline in Body Weight","description":"Percent change in bodyweight was reported. LS mean was determined using ANCOVA model with Baseline + HF Decompensation Within 12 Months of Screening + T2DM Status + Baseline BMI group (\\<35, \\>=35 kg/m2) + Treatment (Type III sum of squares) as variables.","timeFrame":"Baseline, Week 52"},{"measure":"Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)","description":"Percent change from baseline in hsCRP was reported. LS Mean was determined using ANCOVA model with log (actual measurement/baseline) = log (baseline) + HF decompensation within 12 months of screening + T2DM status + baseline BMI group (\\<35, \\>=35 kg/m2) + Treatment (Type III sum of squares) as variables.","timeFrame":"Baseline, Week 52"},{"measure":"Win Percentage of the Hierarchical Composite Endpoint","description":"Hierarchical Composite Endpoint included time to all-cause death, number of HF events, time to first HF events, KCCQ-CSS, 6MWD.\n\nThe winner was determined in each pair-wise comparison in the following order:\n\n* A delayed first occurrence of all-cause death\n* If the pair cannot be differentiated based on death, winner has fewer HF events\n* If the pair cannot be differentiated by number of HF events, winner has delayed time to occurrence of first HF event\n* If the pair still cannot be differentiated, winner has a more favorable category for change from baseline in 6MWD\n* If the pair still cannot be differentiated, winner has a more favorable category for change from baseline in KCCQ-CSS\n* Otherwise the pair will be recorded as tied.\n\nReported unit is the total percent of \"wins\" for each treatment group from performing such a hierarchical comparison across stratification factors in the study.","timeFrame":"Baseline Up To 160 Weeks"},{"measure":"Percentage of Participants With New York Heart Association (NYHA) Class Change","description":"Percentage of participants with NYHA class change at Week 52 was reported.","timeFrame":"Week 52"},{"measure":"Number of Participants With Time to All-Cause Death","description":"All-cause mortality is death due to any cause. Number of participants with time to all-cause mortality are presented.","timeFrame":"Baseline Up To 160 Weeks"},{"measure":"Number of Participants With Time to First Occurrence of HF Events","description":"Number of participants with time to first occurrence of HF events are reported.","timeFrame":"Baseline Up To 160 Weeks"},{"measure":"Number of HF Events and All-Cause Death","description":"Number of HF events and all-cause death are reported.","timeFrame":"Baseline Up To 160 Weeks."},{"measure":"Number of Recurrent HF Events","description":"Number of recurrent HF events were reported.","timeFrame":"Baseline Up To 160 Weeks."}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have a diagnosis of stable heart failure (NYHA class II-IV) and left ventricular ejection fraction (LVEF) ≥50%\n* Elevated NT-proBNP (N-terminal pro B-type natriuretic peptide) \\> 200 picogram/milliliter (pg/ml) for participants without atrial fibrillation (AF), or \\>600 pg/ml for participants with AF, Structural heart disease (Left atrial enlargement) or Elevated left ventricular filling pressure\n* Estimated glomerular filtration rate (eGFR) \\<70 milliliter (ml)/minute (min)/1.73m² at screening, or HF decompensation within 12 months of screening,\n* Stable dose of heart failure medications within 4 weeks of screening\n* Body mass index (BMI) ≥30 kilograms per meter squared (kg/m²)\n* 6MWD 100-425 meters\n* KCCQ CSS ≤80\n\nExclusion Criteria:\n\n* Have had a major cardiovascular event within the last 90 days of screening\n* Have had acute decompensated heart failure within 4 weeks of screening\n* Have non cardiac causes of functional impairment such as pulmonary arterial hypertension (PAH), severe chronic obstructive pulmonary disease (COPD), anemia, thyroid disease, musculoskeletal disease or orthopedic conditions\n* Presence of cardiac amyloidosis, cardiac accumulation disease, cardiomyopathy and severe valvular heart disease\n* HbA1c ≥9.5% or uncontrolled diabetes\n* History of proliferative diabetic retinopathy or diabetic maculopathy\n* Have a history of pancreatitis\n* eGFR \\<15 mL/min/1.73 m² or requiring dialysis at screening","healthyVolunteers":false,"sex":"ALL","minimumAge":"40 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Heart Center Research","city":"Huntsville","state":"Alabama","zip":"35801","country":"United States","geoPoint":{"lat":34.7304,"lon":-86.58594}},{"facility":"Westside Medical Associates of Los Angeles","city":"Beverly Hills","state":"California","zip":"90211","country":"United States","geoPoint":{"lat":34.07362,"lon":-118.40036}},{"facility":"Valley Clinical Trials, Inc.","city":"Covina","state":"California","zip":"91723","country":"United 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Effects of Tirzepatide in Obesity-Related HFpEF by Sex: A Prespecified Secondary Analysis From the SUMMIT Trial. JACC Heart Fail. 2026 Jul 7:103218. doi: 10.1016/j.jchf.2026.103218. Online ahead of print."},{"pmid":"40903131","type":"DERIVED","citation":"Packer M, Zile MR, Kramer CM, DiMaria JM, Baum SJ, Litwin SE, Murakami M, Zhou C, Ou Y, Koeneman L, Borlaug BA; SUMMIT Trial Study Group. Influence of Type 2 Diabetes on the Effects of Tirzepatide in Patients With Heart Failure and a Preserved Ejection Fraction With Obesity: A Prespecified Stratification-Based Analysis. J Am Coll Cardiol. 2025 Sep 9;86(10):696-707. doi: 10.1016/j.jacc.2025.06.058."},{"pmid":"40701669","type":"DERIVED","citation":"Borlaug BA, Zile MR, Kramer CM, Ye W, Ou Y, Hurt K, Murakami M, Packer M; SUMMIT Trial Study Group. Impact of Body Mass Index, Central Adiposity, and Weight Loss on the Benefits of Tirzepatide in HFpEF: The SUMMIT Trial. J Am Coll Cardiol. 2025 Jul 29;86(4):242-255. doi: 10.1016/j.jacc.2025.04.059."},{"pmid":"40162940","type":"DERIVED","citation":"Packer M, Zile MR, Kramer CM, Murakami M, Ou Y, Borlaug BA; SUMMIT Trial Study Group. Interplay of Chronic Kidney Disease and the Effects of Tirzepatide in Patients With Heart Failure, Preserved Ejection Fraction, and Obesity: The SUMMIT Trial. J Am Coll Cardiol. 2025 May 13;85(18):1721-1735. doi: 10.1016/j.jacc.2025.03.009. Epub 2025 Mar 31."},{"pmid":"39566869","type":"DERIVED","citation":"Kramer CM, Borlaug BA, Zile MR, Ruff D, DiMaria JM, Menon V, Ou Y, Zarante AM, Hurt KC, Murakami M, Packer M; SUMMIT Trial Study Group. Tirzepatide Reduces LV Mass and Paracardiac Adipose Tissue in Obesity-Related Heart Failure: SUMMIT CMR Substudy. J Am Coll Cardiol. 2025 Feb 25;85(7):699-706. doi: 10.1016/j.jacc.2024.11.001. Epub 2024 Nov 18."},{"pmid":"39556714","type":"DERIVED","citation":"Zile MR, Borlaug BA, Kramer CM, Baum SJ, Litwin SE, Menon V, Ou Y, Weerakkody GJ, Hurt KC, Kanu C, Murakami M, Packer M; SUMMIT Trial Study Group. Effects of Tirzepatide on the Clinical Trajectory of Patients With Heart Failure, Preserved Ejection Fraction, and Obesity. Circulation. 2025 Mar 11;151(10):656-668. doi: 10.1161/CIRCULATIONAHA.124.072679. Epub 2024 Nov 18."},{"pmid":"39555826","type":"DERIVED","citation":"Packer M, Zile MR, Kramer CM, Baum SJ, Litwin SE, Menon V, Ge J, Weerakkody GJ, Ou Y, Bunck MC, Hurt KC, Murakami M, Borlaug BA; SUMMIT Trial Study Group. Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity. N Engl J Med. 2025 Jan 30;392(5):427-437. doi: 10.1056/NEJMoa2410027. Epub 2024 Nov 16."},{"pmid":"39551891","type":"DERIVED","citation":"Borlaug BA, Zile MR, Kramer CM, Baum SJ, Hurt K, Litwin SE, Murakami M, Ou Y, Upadhyay N, Packer M. Effects of tirzepatide on circulatory overload and end-organ damage in heart failure with preserved ejection fraction and obesity: a secondary analysis of the SUMMIT trial. Nat Med. 2025 Feb;31(2):544-551. doi: 10.1038/s41591-024-03374-z. Epub 2024 Nov 17."},{"pmid":"38699780","type":"DERIVED","citation":"Reese-Petersen AL, Holm Nielsen S, Bulow Sand JM, Schattenberg JM, Bugianesi E, Karsdal MA. The sclerotic component of metabolic syndrome: Fibroblast activities may be the central common denominator driving organ function loss and death. Diabetes Obes Metab. 2024 Jul;26(7):2554-2566. doi: 10.1111/dom.15615. Epub 2024 May 3."}],"seeAlsoLinks":[{"label":"A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)","url":"https://trials.lillytrialguide.com/en-US/trial/4deAJHqkMfFYm9JjtgeqTl"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","infoTypes":["STUDY_PROTOCOL","SAP","CSR"],"timeFrame":"Data are available 6 months after the primary publication and approval of the indication studied in the US and European (EU), whichever is later. Data will be indefinitely available for requesting.","accessCriteria":"A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.","url":"http://vivli.org/"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Tirzepatide - MTD","description":"Participants received a starting dose of 2.5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW) and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or maximum tolerated dose (MTD) tolerated by the participant (5 mg QW or 10 mg QW)."},{"id":"FG001","title":"Placebo","description":"Participants received placebo administered SC QW."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"364"},{"groupId":"FG001","numSubjects":"367"}]},{"type":"Received At Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"364"},{"groupId":"FG001","numSubjects":"367"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"332"},{"groupId":"FG001","numSubjects":"331"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"36"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"15"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"14"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All participants who received at least one dose of study drug.","groups":[{"id":"BG000","title":"Tirzepatide - MTD","description":"Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW)."},{"id":"BG001","title":"Placebo","description":"Participants received placebo administered SC QW."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"364"},{"groupId":"BG001","value":"367"},{"groupId":"BG002","value":"731"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"65.50","spread":"10.53"},{"groupId":"BG001","value":"65.00","spread":"10.87"},{"groupId":"BG002","value":"65.20","spread":"10.70"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"200"},{"groupId":"BG001","value":"193"},{"groupId":"BG002","value":"393"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"164"},{"groupId":"BG001","value":"174"},{"groupId":"BG002","value":"338"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"195"},{"groupId":"BG001","value":"205"},{"groupId":"BG002","value":"400"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"164"},{"groupId":"BG001","value":"159"},{"groupId":"BG002","value":"323"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"8"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"23"},{"groupId":"BG002","value":"47"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"58"},{"groupId":"BG001","value":"73"},{"groupId":"BG002","value":"131"}]},{"title":"Native Hawaiian or Other Pacific 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Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"Argentina","categories":[{"measurements":[{"groupId":"BG000","value":"101"},{"groupId":"BG001","value":"103"},{"groupId":"BG002","value":"204"}]}]},{"title":"Brazil","categories":[{"measurements":[{"groupId":"BG000","value":"51"},{"groupId":"BG001","value":"54"},{"groupId":"BG002","value":"105"}]}]},{"title":"China","categories":[{"measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"55"}]}]},{"title":"India","categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"20"}]}]},{"title":"Israel","categories":[{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"38"}]}]},{"title":"Mexico","categories":[{"measurements":[{"groupId":"BG000","value":"41"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"81"}]}]},{"title":"Russia","categories":[{"measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"21"}]}]},{"title":"Taiwan","categories":[{"measurements":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"56"}]}]},{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"83"},{"groupId":"BG001","value":"68"},{"groupId":"BG002","value":"151"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)","description":"The KCCQ is a 23-item, participant self-administered questionnaire that assesses impacts of heart failure \"over the past 2 weeks\" on the following 7 domains:\n\n* Physical Limitation (6)\n* Symptom Stability (1)\n* Symptom Frequency (4)\n* Symptom Burden (3)\n* Self-Efficacy (2)\n* Quality of Life (3)\n* Social Limitation (4)\n\nEach of the 23 individual items are answered on Likert scales of varying lengths (5, 6, or 7-point scales).\n\nKCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are obtained by averaging the associated individual items and transforming the score to a 0 to 100 range. Higher scores indicate better health status.\n\nLeast Square (LS) mean was determined using ANCOVA model with Baseline + HF Decompensation Within 12 Months of Screening + T2DM Status + Baseline BMI group (\\<35, \\>=35 kg/m2) + Treatment (Type III sum of squares) as variables .","populationDescription":"All participants who received at least one dose of study drug and had evaluable data for this outcome.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Score on a scale","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"Tirzepatide - MTD","description":"Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW)."},{"id":"OG001","title":"Placebo","description":"Participants received placebo administered SC QW."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"301"},{"groupId":"OG001","value":"313"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"19.51","spread":"1.24"},{"groupId":"OG001","value":"12.68","spread":"1.25"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Stratified Wilcoxon","statisticalComment":"Stratified Wilcoxon test used to control for stratification factors of HF decompensation within 12 months of screening,diagnosed T2DM \\& baseline BMI","paramType":"Median Difference (Net)","paramValue":"6.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.3","ciUpperLimit":"10.6","estimateComment":"The Hodges-Lehmann estimate for the median difference and 95% CIs was reported."}]},{"type":"PRIMARY","title":"First Occurrence of the Composite Endpoint of Heart Failure (HF) Outcomes","description":"Clinical Endpoint Committe confirmed Occurrences of CV outcomes were reported here. HF outcomes consisted of cardiovascular death and HF events.\n\nThe HF events were defined as worsening clinical symptoms or signs related to HF, which are meaningful to the participant and require intensification of treatment characterized by 1 or more of the following:\n\n* hospitalization for heart failure regardless of duration or treatment received\n* use of intravenous drug, usually an intravenous diuretic, but may include intravenous vasodilators or positive inotropic drugs, or\n* augmentation or increase in oral diuretic therapy.","populationDescription":"All participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Number of events","timeFrame":"Baseline Up To 160 weeks","groups":[{"id":"OG000","title":"Tirzepatide - MTD","description":"Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW)."},{"id":"OG001","title":"Placebo","description":"Participants received placebo administered SC QW."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"364"},{"groupId":"OG001","value":"367"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"56"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Heart Failure Outcomes","nonInferiorityType":"SUPERIORITY","pValue":"0.026","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.62","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.41","ciUpperLimit":"0.95"}]},{"type":"SECONDARY","title":"Change From Baseline in Exercise Capacity as Measured by 6-Minute Walk Distance (6MWD)","description":"Participants performed an exercise capacity assessment using the 6-Minute Walk Test (6MWT) and the distance covered (6MWD) was assessed in meters. The 6MWT was performed indoors on a straight, flat, hard surface that is at least 30 meters in length. The greater distance walked meant better physical capacity.\n\nLS Mean was determined using ANCOVA model with Baseline + HF Decompensation Within 12 Months of Screening + T2DM Status + Baseline BMI group (\\<35, \\>=35 kg/m2) + Treatment (Type III sum of squares) as variables.","populationDescription":"All participants who received at least one dose of study drug and had evaluable data for this outcome,","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"meters","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"Tirzepatide - MTD","description":"Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW)."},{"id":"OG001","title":"Placebo","description":"Participants received placebo administered SC QW."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"314"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"26.04","spread":"3.81"},{"groupId":"OG001","value":"10.10","spread":"3.94"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Stratified Wilcoxon","statisticalComment":"Stratified Wilcoxon test used to control for stratification factors of HF decompensation within 12 months of screening,diagnosed T2DM \\& baseline BMI","paramType":"Median Difference (Net)","paramValue":"18.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"9.9","ciUpperLimit":"26.7","estimateComment":"The Hodges-Lehmann estimate for the median difference and 95% CIs was reported."}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Body Weight","description":"Percent change in bodyweight was reported. LS mean was determined using ANCOVA model with Baseline + HF Decompensation Within 12 Months of Screening + T2DM Status + Baseline BMI group (\\<35, \\>=35 kg/m2) + Treatment (Type III sum of squares) as variables.","populationDescription":"All participants who received at least one dose of study drug and had evaluable data for this outcome.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percent change","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"Tirzepatide - MTD","description":"Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW)."},{"id":"OG001","title":"Placebo","description":"Participants received placebo administered SC QW."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"331"},{"groupId":"OG001","value":"333"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-13.85","spread":"0.43"},{"groupId":"OG001","value":"-2.24","spread":"0.46"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-11.62","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-12.85","ciUpperLimit":"-10.38"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)","description":"Percent change from baseline in hsCRP was reported. LS Mean was determined using ANCOVA model with log (actual measurement/baseline) = log (baseline) + HF decompensation within 12 months of screening + T2DM status + baseline BMI group (\\<35, \\>=35 kg/m2) + Treatment (Type III sum of squares) as variables.","populationDescription":"All participants who received at least one dose of study drug and had evaluable data for this outcome.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percent change","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"Tirzepatide - MTD","description":"Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW)."},{"id":"OG001","title":"Placebo","description":"Participants received placebo administered SC QW."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"305"},{"groupId":"OG001","value":"298"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-38.76","spread":"4.47"},{"groupId":"OG001","value":"-5.88","spread":"5.25"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-34.91","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-45.60","ciUpperLimit":"-22.17"}]},{"type":"SECONDARY","title":"Win Percentage of the Hierarchical Composite Endpoint","description":"Hierarchical Composite Endpoint included time to all-cause death, number of HF events, time to first HF events, KCCQ-CSS, 6MWD.\n\nThe winner was determined in each pair-wise comparison in the following order:\n\n* A delayed first occurrence of all-cause death\n* If the pair cannot be differentiated based on death, winner has fewer HF events\n* If the pair cannot be differentiated by number of HF events, winner has delayed time to occurrence of first HF event\n* If the pair still cannot be differentiated, winner has a more favorable category for change from baseline in 6MWD\n* If the pair still cannot be differentiated, winner has a more favorable category for change from baseline in KCCQ-CSS\n* Otherwise the pair will be recorded as tied.\n\nReported unit is the total percent of \"wins\" for each treatment group from performing such a hierarchical comparison across stratification factors in the study.","populationDescription":"All participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Win percentage","timeFrame":"Baseline Up To 160 Weeks","groups":[{"id":"OG000","title":"Tirzepatide - MTD","description":"Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW)."},{"id":"OG001","title":"Placebo","description":"Participants received placebo administered SC QW."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"364"},{"groupId":"OG001","value":"367"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"57.90"},{"groupId":"OG001","value":"35.43"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Win Ratio","paramValue":"1.63","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.17","ciUpperLimit":"2.28","estimateComment":"The win ratio was reported as the measure of treatment effect based on the principle that each participant is compared with every other participant within each stratum in a pair-wise manner that proceeds in a hierarchical fashion."}]},{"type":"SECONDARY","title":"Percentage of Participants With New York Heart Association (NYHA) Class Change","description":"Percentage of participants with NYHA class change at Week 52 was reported.","populationDescription":"All participant who received at least one dose of study drug and had evaluable data for this outcome.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Tirzepatide - MTD","description":"Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW)."},{"id":"OG001","title":"Placebo","description":"Participants received placebo administered SC QW."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"328"},{"groupId":"OG001","value":"327"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"33.27"},{"groupId":"OG001","value":"20.39"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Odds Ratio (OR)","paramValue":"2.28","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.53","ciUpperLimit":"3.40"}]},{"type":"SECONDARY","title":"Number of Participants With Time to All-Cause Death","description":"All-cause mortality is death due to any cause. Number of participants with time to all-cause mortality are presented.","populationDescription":"All participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"timeFrame":"Baseline Up To 160 Weeks","groups":[{"id":"OG000","title":"Tirzepatide - MTD","description":"Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW)."},{"id":"OG001","title":"Placebo","description":"Participants received placebo administered SC QW."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"364"},{"groupId":"OG001","value":"367"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"15"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"1.245","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.633","ciUpperLimit":"2.452"}]},{"type":"SECONDARY","title":"Number of Participants With Time to First Occurrence of HF Events","description":"Number of participants with time to first occurrence of HF events are reported.","populationDescription":"All participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"timeFrame":"Baseline Up To 160 Weeks","groups":[{"id":"OG000","title":"Tirzepatide - MTD","description":"Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW)."},{"id":"OG001","title":"Placebo","description":"Participants received placebo administered SC QW."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"364"},{"groupId":"OG001","value":"367"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"52"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"0.539","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.342","ciUpperLimit":"0.850"}]},{"type":"SECONDARY","title":"Number of HF Events and All-Cause Death","description":"Number of HF events and all-cause death are reported.","populationDescription":"All participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"Baseline Up To 160 Weeks.","groups":[{"id":"OG000","title":"Tirzepatide - MTD","description":"Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW)."},{"id":"OG001","title":"Placebo","description":"Participants received placebo administered SC QW."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"364"},{"groupId":"OG001","value":"367"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"82"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Rate Ratio","paramValue":"0.72","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.46","ciUpperLimit":"1.14"}]},{"type":"SECONDARY","title":"Number of Recurrent HF Events","description":"Number of recurrent HF events were reported.","populationDescription":"All participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"Baseline Up To 160 Weeks.","groups":[{"id":"OG000","title":"Tirzepatide - MTD","description":"Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW)."},{"id":"OG001","title":"Placebo","description":"Participants received placebo administered SC QW."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"364"},{"groupId":"OG001","value":"367"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"68"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Rate Ratio","paramValue":"0.62","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.37","ciUpperLimit":"1.05"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline Up To 162 Weeks","description":"All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.","eventGroups":[{"id":"EG000","title":"Tirzepatide - MTD","description":"Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW).","deathsNumAffected":19,"deathsNumAtRisk":364,"seriousNumAffected":96,"seriousNumAtRisk":364,"otherNumAffected":221,"otherNumAtRisk":364},{"id":"EG001","title":"Placebo","description":"Participants received placebo administered SC QW.","deathsNumAffected":15,"deathsNumAtRisk":367,"seriousNumAffected":94,"seriousNumAtRisk":367,"otherNumAffected":137,"otherNumAtRisk":367}],"seriousEvents":[{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":364},{"groupId":"EG001","numEvents":7,"numAffected":5,"numAtRisk":367}]},{"term":"Acute coronary syndrome","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":364},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":367}]},{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":6,"numAtRisk":364},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":367}]},{"term":"Angina pectoris","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":364},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":367}]},{"term":"Angina unstable","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":364},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":367}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":9,"numAffected":7,"numAtRisk":364},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":367}]},{"term":"Atrial flutter","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":364},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":367}]},{"term":"Atrioventricular block complete","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":364},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":367}]},{"term":"Bradycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":364},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":367}]},{"term":"Cardiac arrest","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":364},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":367}]},{"term":"Cardiac failure","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":17,"numAffected":12,"numAtRisk":364},{"groupId":"EG001","numEvents":27,"numAffected":18,"numAtRisk":367}]},{"term":"Cardiac failure acute","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":364},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":367}]},{"term":"Cardiac failure chronic","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":364},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":367}]},{"term":"Cardiac failure congestive","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":364},{"groupId":"EG001","numEvents":18,"numAffected":12,"numAtRisk":367}]},{"term":"Cardiac valve disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":364},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":367}]},{"term":"Cardio-respiratory arrest","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":364},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":367}]},{"term":"Cardiogenic shock","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":364},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":367}]},{"term":"Coronary artery disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":364},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":367}]},{"term":"Heart failure with preserved ejection fraction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":364},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":367}]},{"term":"Myocarditis","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":364},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":367}]},{"term":"Paroxysmal atrioventricular block","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":364},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":367}]},{"term":"Sinus node dysfunction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":364},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":367}]},{"term":"Stress cardiomyopathy","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":364},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":367}]},{"term":"Ventricular extrasystoles","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":364},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":367}]},{"term":"Ventricular tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":364},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":367}]},{"term":"Myocardial bridging","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":364},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":367}]},{"term":"Vertigo","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":364},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":367}]},{"term":"Hyperthyroidism","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":364},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":367}]},{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":364},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":367}]},{"term":"Acute abdomen","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":364},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":367}]},{"term":"Ascites","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":364},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":367}]},{"term":"Colitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":364},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":367}]},{"term":"Colitis ischaemic","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":364},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":367}]},{"term":"Diabetic gastroparesis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":364},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":367}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":2,"numAtRisk":364},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":367}]},{"term":"Gastrointestinal haemorrhage","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":364},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":367}]},{"term":"Haematochezia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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