{"protocolSection":{"identificationModule":{"nctId":"NCT04255433","orgStudyIdInfo":{"id":"17073"},"secondaryIdInfos":[{"id":"I8F-MC-GPGN","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"2019-002735-28","type":"EUDRACT_NUMBER"},{"id":"2023-507846-96-00","type":"CTIS"},{"id":"2023","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2023"},{"id":"2019","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2019"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes","officialTitle":"The Effect of Tirzepatide Versus Dulaglutide on Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes (SURPASS-CVOT)","acronym":"SURPASS-CVOT"},"statusModule":{"statusVerifiedDate":"2026-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-05-29","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2025-06-12","type":"ACTUAL"},"completionDateStruct":{"date":"2025-06-12","type":"ACTUAL"},"studyFirstSubmitDate":"2020-02-03","studyFirstSubmitQcDate":"2020-02-03","studyFirstPostDateStruct":{"date":"2020-02-05","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-06-11","resultsFirstSubmitQcDate":"2026-06-11","resultsFirstPostDateStruct":{"date":"2026-07-08","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-06-11","lastUpdatePostDateStruct":{"date":"2026-07-08","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"],"keywords":["Diabetes Mellitus","Diabetes Mellitus, Type 2","Glucose Metabolism Disorders","Metabolic Diseases","Endocrine System Diseases","Hypoglycemic Agents","Physiological Effects of Drugs","Tirzepatide","Incretins","Glucagon-Like Peptide 1","Gastric Inhibitory Polypeptide","Hormones","Hormones, Hormone Substitutes, and Hormone Antagonists"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":13299,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Tirzepatide - Maximum Tolerated Dose (MTD)","type":"EXPERIMENTAL","description":"Participants received a starting dose of 2.5 milligrams (mg) tirzepatide administered as subcutaneous (SC) injection once weekly (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) for up to 5 years.","interventionNames":["Drug: Tirzepatide"]},{"label":"1.5 mg Dulaglutide","type":"EXPERIMENTAL","description":"Participants received 1.5 mg dulaglutide administered as SC injection QW for up to 5 years.","interventionNames":["Drug: Dulaglutide"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC","armGroupLabels":["Tirzepatide - Maximum Tolerated Dose (MTD)"],"otherNames":["LY3298176"]},{"type":"DRUG","name":"Dulaglutide","description":"Administered SC","armGroupLabels":["1.5 mg Dulaglutide"],"otherNames":["LY2189265"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants From Randomization to First Occurrence of Death From MACE-3 [Composite Endpoint of Major Adverse Cardiovascular Events Death From Cardiovascular Causes, Myocardial Infarction (MI) or Stroke]","description":"Number of participants with first occurrence of Clinical Endpoint Committee (CEC), a composite endpoint i.e., from time of randomization to first occurrence of cardiovascular (CV) death, myocardial infarction and stroke combined data was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of any of these events during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.","timeFrame":"From randomization (week 0) up to week 259"}],"secondaryOutcomes":[{"measure":"Number of Participants From Randomization to Time to Occurrence of All-Cause Death","description":"The number of participants from randomization to time to occurrence of Clinical Endpoint Committee (CEC) confirmed all-cause death was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of all-cause death during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.","timeFrame":"From randomization (week 0) up to week 259"},{"measure":"Number of Participants From Randomization to Time of Occurrence of CV Death","description":"Number of participants from time of randomization to time to occurrence of CEC confirmed CV death was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of CV death during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.","timeFrame":"From randomization (week 0) up to week 259"},{"measure":"Number of Participants From Randomization to Time to First Occurrence of Myocardial Infarction (MI)","description":"The number of participants from randomization to first occurrence of CEC confirmed MI was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of nonfatal MI during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.","timeFrame":"From randomization (week 0) up to week 259"},{"measure":"Number of Participants From Randomization toTime to First Occurrence of Stroke","description":"The number of participants from randomization to first occurrence of CEC confirmed stroke was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of nonfatal stroke during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.","timeFrame":"From randomization (week 0) up to week 259"},{"measure":"Number of Participants From Randomization to Time to First Occurrence of the Expanded Composite of CV Death, MI, Stroke or Coronary Revascularization (MACE-4)","description":"The number of participants from randomization to first occurrence of MACE-4 was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of any of these events during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.","timeFrame":"From randomization (week 0) up to week 259"},{"measure":"Number of Participants From Randomization to Time to First Occurrence of CV Deaths or Heart Failure Events Requiring Hospitalization and/or Urgent Heart Failure Visits","description":"The number of participants from randomization to first occurrence of Clinical Endpoint Committee (CEC) confirmed heart failure requiring hospitalisation or urgent heart failure was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of any of these events during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.","timeFrame":"From randomization (week 0) up to week 259"},{"measure":"Number of Participants From Randomization to Time to First Occurrence of Revascularization","description":"The number of participants from randomization to first occurrence of coronary revascularization was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of revascularization during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.","timeFrame":"From randomization (week 0) up to week 259"},{"measure":"Number of Participants From Randomization to Time to First Occurrence of New or Worsening Nephropathy","description":"New or worsening nephropathy (Composite Endpoint 1) was defined as the first occurrence of any of the following events:\n\npersistent macroalbuminuria (urine albumin-to-creatinine ratio \\>300 mg/g), persistent doubling of serum creatinine with eGFR \\<45 mL/min/1.73 m², onset of end-stage renal disease (including initiation of chronic dialysis or kidney transplantation), or death due to renal disease.\n\nTime to event was defined as the number of days from the date of randomization to the first occurrence any of these events. during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.","timeFrame":"From randomization (week 0) up to week 259"},{"measure":"Change From Baseline to 36 Months in Estimated Glomerular Filtration Rate (eGFR) in Patients With High or Very-high Risk Chronic Kidney Disease (CKD)","description":"Change from baseline in eGFR calculated as difference between value at 36 months and baseline value. Participants included in this analysis were classified as having high or very high risk of chronic kidney disease at baseline based on their kidney function (eGFR) and urine albumin-to-creatinine ratio (UACR). High risk included participants with eGFR 45 to less than 60 milliliters/minutes/1.73 square metres (mL/min/1.73 m²) and UACR greater than 30 mg/g, or eGFR 60 mL/min/1.73 m² or higher with UACR greater than 300 mg/g. Very high risk included participants with eGFR less than 45 mL/min/1.73 m² or severely increased UACR (greater than 300 mg/g). These criteria are associated with an increased risk of worsening kidney function. Least squares (LS) mean was calculated using analysis of covariance (ANCOVA) model for endpoint measures: Variable = Baseline + Treatment + Analysis Country + Baseline sodium-glucose cotransporter-2 (SGLT-2) Use Flag.","timeFrame":"Baseline, 36 Months"},{"measure":"Change From Baseline to 36 Months in Hemoglobin A1c (HbA1c)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Change in HbA1c from baseline up to 36 months during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.\n\nLS mean was calculated using ANCOVA model for endpoint measures: Variable = Baseline + Treatment + Analysis Country + Baseline SGLT-2i Use Flag (Type III sum of squares).","timeFrame":"Baseline, 36 Months"},{"measure":"Percent Change From Baseline to 36 Months in Body Weight","description":"LS mean was calculated using ANCOVA model for endpoint measures: Variable = Baseline + Treatment + Analysis Country + Baseline SGLT-2i Use Flag (Type III sum of squares)","timeFrame":"Baseline, 36 Months"},{"measure":"Percent Change From Baseline to 36 Months in Urinary Albumin to Creatinine Ratio (UACR)","description":"Urine samples were collected for the analysis of UACR. UACR (gram per kilograms \\[g/kg\\]) was calculated as urine albumin (gram per liter \\[g/L\\])/urine creatinine (kg/L). Percent change from baseline at 36 months was calculated as: \\[(UACR at 36 months - baseline UACR) / baseline UACR\\] × 100.\n\nLS mean was calculated using ANCOVA model for endpoint measures: log(Actual Measurement/Baseline) = log(Baseline) + Treatment + Analysis Country + Baseline SGLT-2i Use Flag (Type III sum of squares).","timeFrame":"Baseline, 36 Months"},{"measure":"Percent Change From Baseline to 24 Months in Blood Lipids (Total Cholesterol (TC), Low-Density Lipoprotein Cholesterol (LDL-C), High-Density Lipoprotein Cholesterol (HDL-C), and Triglycerides (TG))","description":"Blood samples of participants who had fasted for 12 to 14 hours were collected for lipid profile (TC, LDL-C, HDL-C, TG) assessment. The lipid profile asesses the risk of heart disease. Percent change from baseline = 100\\*(post-baseline assessment - baseline assessment)/baseline assessment.\n\nLS mean was calculated using ANCOVA model for endpoint measures: log(Actual Measurement/Baseline) = log(Baseline) + Treatment + Analysis Country + Baseline SGLT-2i Use Flag.","timeFrame":"Baseline, 24 Months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Men or women at least 40 years old with a diagnosis of type 2 diabetes\n* Established cardiovascular disease, including at least 1 of the following:\n\n  * Coronary artery disease (CAD) with any of the following:\n\n    * Documented history of spontaneous myocardial infarction (MI)\n    * ≥50% stenosis in 1 or more major coronary arteries, determined by invasive angiography\n    * ≥50% stenosis in 2 or more major coronary arteries, determined by computed tomography coronary angiography (CTCA)\n    * History of surgical or percutaneous coronary revascularization procedure\n  * Cerebrovascular disease - any of the following:\n\n    * Documented history of ischemic stroke\n    * Carotid arterial disease with ≥50% stenosis, documented by carotid ultrasound, magnetic resonance imaging (MRI), or angiography\n    * Carotid stenting or surgical revascularization\n  * Peripheral arterial disease with either of the following:\n\n    * Intermittent claudication and ankle-brachial index \\<0.9\n    * Prior nontraumatic amputation or peripheral vascular procedure (eg, stenting or surgical revascularization), due to peripheral arterial ischemia\n  * Note: Supporting medical documentation is required in all instances\n* HbA1c ≥7% (≥53 mmol/mol) and ≤10.5% (≤91.3 mmol/mol) based on central laboratory assessment at screening\n* Body mass index (BMI) ≥25 kg/m2\n* At the time of signing the informed consent: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials.\n\n  * Male patients: Men, regardless of their fertility status, with nonpregnant women of childbearing potential (WOCBP) partners must agree to either remain abstinent (if this is their preferred and usual lifestyle) or use condoms, as well as 1 additional highly effective (less than 1% failure rate) method of contraception (such as combination oral contraceptives, implanted contraceptives, or intrauterine devices) or effective method of contraception (such as diaphragms with spermicide or cervical sponges) for the duration of the study and until their plasma concentrations are below the level that could result in a relevant potential exposure to a possible fetus, predicted to be 90 days following the last dose of study drug.\n\n    * Men and their partners may choose to use a double-barrier method of contraception. (Barrier protection methods without concomitant use of a spermicide are not an effective or acceptable method of contraception. Thus, each barrier method must include use of a spermicide. It should be noted, however, that the use of male and female condoms as a double barrier method is not considered acceptable due to the high failure rate when these barrier methods are combined).\n    * Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation methods), declaration of abstinence just for the duration of a trial, and withdrawal are not acceptable methods of contraception.\n  * Men with pregnant partners should use condoms during intercourse for the duration of the study and until the end of the estimated relevant potential exposure in WOCBP (90 days). Men should refrain from sperm donation for the duration of the study and until their plasma concentrations are below the level that could result in a relevant potential exposure to a possible fetus, predicted to be 90 days following the last dose of study drug. Men who are in exclusively same-sex relationships (as their preferred and usual lifestyle) are not required to use contraception.\n  * Female patients: Women of childbearing potential who are abstinent (if this is complete abstinence, as their preferred and usual lifestyle) or in a same-sex relationship (as part of their preferred and usual lifestyle) must agree to either remain abstinent or stay in a same-sex relationship without sexual relationships with males. Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation methods), declaration of abstinence just for the duration of a trial, and withdrawal are not acceptable methods of contraception. Otherwise, WOCBP participating must agree to use 2 forms of effective contraception, where at least 1 form is highly effective (less than 1% failure rate), for the entirety of the study. Contraception must continue following completion of study drug administration for the entirety of the study and for 30 days thereafter.\n\n    * WOCBP participating must test negative for pregnancy prior to initiation of treatment as indicated by a negative serum pregnancy test at the screening visit followed by a negative urine pregnancy test within 24 hours prior to exposure.\n    * Two forms of effective contraception, where at least 1 form is highly effective, (such as combination oral contraceptives, implanted contraceptives, or intrauterine devices) will be used. Effective contraception (such as male or female condoms with spermicide, diaphragms with spermicide, or cervical sponges) may be used as the second therapy. Barrier protection methods without concomitant use of a spermicide are not a reliable or acceptable method. Thus, each barrier method must include use of a spermicide (ie, condom with spermicide, diaphragm with spermicide, or female condom with spermicide). It should be noted that the use of male and female condoms as a double barrier method is not considered acceptable due to the high failure rate when these methods are combined.\n  * Women not of childbearing potential may participate and include those who are:\n\n    * infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis, or\n    * postmenopausal - defined as either: A woman at least 40 years of age with an intact uterus, not on hormone therapy, who has cessation of menses for at least 1 year without an alternative medical cause, AND a follicle-stimulating hormone \\>40 mIU/mL; or ii. A woman 55 or older not on hormone therapy, who has had at least 12 months of spontaneous amenorrhea; or A woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy.\n* In the investigator's opinion, are well motivated, capable, and willing to:\n\n  * learn how to self-inject treatment (tirzepatide or dulaglutide), as required for this protocol (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject the study drug; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the study drug),\n  * inject study drug weekly,\n  * have a sufficient understanding of 1 of the provided languages of the country such that they will be able to complete the patient questionnaires, and\n  * make themselves available for the duration of the study, and who will comply with the required study visits.\n* Capable of giving signed informed consent\n\nExclusion Criteria:\n\n* Have type 1 diabetes mellitus\n* Have uncontrolled diabetes requiring immediate therapy (such as diabetic ketoacidosis) at screening or randomization, in the judgment of the physician\n* Have had 1 or more events of severe hypoglycemia and/or 1 or more events of hypoglycemia unawareness within 6 months prior to screening\n* Are currently planning treatment for diabetic retinopathy and/or macular edema.\n* Have been hospitalized for congestive heart failure (CHF) within 2 months prior to screening\n* Have chronic New York Heart Association Functional Classification IV CHF\n* Are currently planning a coronary, carotid, or peripheral artery revascularization\n* Had chronic or acute pancreatitis any time prior to screening, irrespective of etiology\n* Have a known clinically significant gastric emptying abnormality such as severe gastroparesis or gastric outlet obstruction, or have undergone or currently planning any gastric bypass (bariatric) surgery or restrictive bariatric surgery\n* Have acute or chronic hepatitis, signs or symptoms of any other liver disease, an alanine aminotransferase (ALT) level ≥3 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory (Note: Patients with nonalcoholic fatty liver disease are eligible to participate if their ALT level is \\<3 times the ULN for the reference range)\n* Have known chronic severe renal failure (defined as a known estimated glomerular filtration rate (eGFR) \\<15 mL/minute/1.73 m2) or are on chronic dialysis\n* Have evidence of a significant, uncontrolled endocrine abnormality (eg, thyrotoxicosis or adrenal crises)\n* Have a family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (MTC) or personal history of nonfamilial MTC\n* Have a serum calcitonin level at screening of: (based on central laboratory results)\n\n  * ≥20 ng/L at Visit 1, if eGFR ≥60 mL/min/1.73 m2, or\n  * ≥35 ng/L at Visit 1, if eGFR \\<60 mL/min/1.73 m2\n* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years. An exception for this criterion is basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer\n* Have a history of any other condition (such as known drug or alcohol abuse or psychiatric disorder) that, in the opinion of the investigator, may preclude the patient from following and completing the protocol\n* Have had a transplanted organ (corneal transplants \\[keratoplasty\\] allowed) or awaiting an organ transplant\n* Have any other condition (eg, hypersensitivity) that is a contraindication to any incretin or glucagon-like peptide-1 (GLP-1) receptor agonist (RA)\n* Have had an MI, percutaneous coronary revascularization procedure, ischemic stroke, carotid stenting or surgical revascularization, nontraumatic amputation, or peripheral vascular procedure (eg, stenting or surgical revascularization) less than 60 days prior to screening\n* Have had coronary artery bypass graft surgery less than 5 years prior to screening\n* Have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hematological conditions that may interfere with HbA1c measurement\n* Treatment with GLP-1 RA or pramlintide, in a period of 3 months prior to Visit 1\n* Discontinuation of GLP-1 RA or pramlintide, due to intolerability any time prior to Visit 1\n* Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study\n* Have participated within the last 30 days in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed\n* Have previously completed or withdrawn from this study or randomized into any other study investigating tirzepatide","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":"University of Alabama at Birmingham Medical Center","city":"Birmingham","state":"Alabama","zip":"35294-0012","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"John Muir Medical Center - Concord Campus","city":"Concord","state":"California","zip":"94520","country":"United States","geoPoint":{"lat":37.97798,"lon":-122.03107}},{"facility":"Valley Clinical Trials, Inc.","city":"Covina","state":"California","zip":"91723","country":"United States","geoPoint":{"lat":34.09001,"lon":-117.89034}},{"facility":"AMCR Institute","city":"Escondido","state":"California","zip":"92025","country":"United States","geoPoint":{"lat":33.11921,"lon":-117.08642}},{"facility":"Valley Research","city":"Fresno","state":"California","zip":"93720","country":"United States","geoPoint":{"lat":36.74773,"lon":-119.77237}},{"facility":"NorCal Medical Research, Inc","city":"Greenbrae","state":"California","zip":"94904","country":"United States","geoPoint":{"lat":37.94854,"lon":-122.5247}},{"facility":"UCSD - Altman Clinical and Translational Research Institute (ACTRI)","city":"La Jolla","state":"California","zip":"92037","country":"United States","geoPoint":{"lat":32.84727,"lon":-117.2742}},{"facility":"First Valley Medical Group","city":"Lancaster","state":"California","zip":"93534","country":"United States","geoPoint":{"lat":34.69804,"lon":-118.13674}},{"facility":"Monterey Endocrine & Diabetes Institute, Inc.","city":"Monterey","state":"California","zip":"93940","country":"United States","geoPoint":{"lat":36.60024,"lon":-121.89468}},{"facility":"Riverside University Health System - Medical Center","city":"Moreno Valley","state":"California","zip":"92555","country":"United States","geoPoint":{"lat":33.93752,"lon":-117.23059}},{"facility":"Diabetes Associates Medical Group","city":"Orange","state":"California","zip":"92868","country":"United States","geoPoint":{"lat":33.78779,"lon":-117.85311}},{"facility":"Pasadena Clinical Research","city":"Pasadena","state":"California","zip":"91105","country":"United States","geoPoint":{"lat":34.14778,"lon":-118.14452}},{"facility":"LCGK Research","city":"San Carlos","state":"California","zip":"94070","country":"United States","geoPoint":{"lat":37.50716,"lon":-122.26052}},{"facility":"Norcal Endocrinology & Internal Medicine","city":"San Ramon","state":"California","zip":"94583","country":"United States","geoPoint":{"lat":37.77993,"lon":-121.97802}},{"facility":"Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center","city":"Torrance","state":"California","zip":"90502","country":"United States","geoPoint":{"lat":33.83585,"lon":-118.34063}},{"facility":"University of Colorado Anschutz Medical Campus","city":"Aurora","state":"Colorado","zip":"80045","country":"United States","geoPoint":{"lat":39.72943,"lon":-104.83192}},{"facility":"CMR of Greater New Haven, LLC","city":"Hamden","state":"Connecticut","zip":"06517","country":"United States","geoPoint":{"lat":41.39593,"lon":-72.89677}},{"facility":"Chase Medical Research, LLC","city":"Waterbury","state":"Connecticut","zip":"06708","country":"United States","geoPoint":{"lat":41.55815,"lon":-73.0515}},{"facility":"Orlando Heart & Vascular Institute, LLC","city":"Altamonte Springs","state":"Florida","zip":"32714","country":"United States","geoPoint":{"lat":28.66111,"lon":-81.36562}},{"facility":"Excel Medical Clinical Trials","city":"Boca Raton","state":"Florida","zip":"33434","country":"United States","geoPoint":{"lat":26.35869,"lon":-80.0831}},{"facility":"Encore Medical Research","city":"Hollywood","state":"Florida","zip":"33024","country":"United States","geoPoint":{"lat":26.0112,"lon":-80.14949}},{"facility":"East Coast Institute for Research, LLC","city":"Jacksonville","state":"Florida","zip":"32204","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Jacksonville Center for Clinical Research","city":"Jacksonville","state":"Florida","zip":"32216","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Accel Research Sites - 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Cardiorenal Outcomes With Tirzepatide Compared With Dulaglutide in Patients With Diabetes and Cardiovascular Disease: A Post Hoc Analysis of the SURPASS-CVOT Randomized Clinical Trial. JAMA Cardiol. 2026 Jun 1;11(6):544-552. doi: 10.1001/jamacardio.2026.0767."},{"pmid":"41406444","type":"DERIVED","citation":"Nicholls SJ, Pavo I, Bhatt DL, Buse JB, Del Prato S, Kahn SE, Lincoff AM, McGuire DK, Miller D, Nauck MA, Nishiyama H, Nissen SE, Sattar N, Weerakkody G, Wiese RJ, Zinman B, Zoungas S, Basile J, Davies MJ, Giorgino F, Kellerer M, Ji L, Varkonyi T, Menon V, Broder JC, Herschtal A, D'Alessio D; SURPASS-CVOT Investigators. Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes. N Engl J Med. 2025 Dec 18;393(24):2409-2420. doi: 10.1056/NEJMoa2505928."},{"pmid":"40746703","type":"DERIVED","citation":"Khawaji A, A Jaly A, A Bakri H, Ravi R, Hattan A, Khawaji A, Najmi W. Weight Loss Efficacy of Tirzepatide Compared to Placebo or GLP-1 Receptor Agonists in Adults With Obesity or Overweight: A Meta-Analysis of Randomized Controlled Trials With >/= 20 Weeks Treatment Duration. J Obes. 2025 Jul 24;2025:3442754. doi: 10.1155/jobe/3442754. eCollection 2025."},{"pmid":"35949358","type":"DERIVED","citation":"Kaneko S. Tirzepatide: A Novel, Once-weekly Dual GIP and GLP-1 Receptor Agonist for the Treatment of Type 2 Diabetes. touchREV Endocrinol. 2022 Jun;18(1):10-19. doi: 10.17925/EE.2022.18.1.10. Epub 2022 Jun 16."}],"seeAlsoLinks":[{"label":"A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes","url":"https://trials.lillytrialguide.com/en-US/trial/7Hobv37NARjOCQyknTYfRZ"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.","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 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 - Maximum Tolerated Dose (MTD)","description":"Participants received a starting dose of 2.5 milligrams (mg) tirzepatide administered as subcutaneous (SC) injection once weekly (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) for up to 5 years."},{"id":"FG001","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg dulaglutide administered as SC injection QW for up to 5 years."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"6648"},{"groupId":"FG001","numSubjects":"6651"}]},{"type":"Safety Population","comment":"Safety 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Kingdom","categories":[{"measurements":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"39"},{"groupId":"BG002","value":"78"}]}]},{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"750"},{"groupId":"BG001","value":"751"},{"groupId":"BG002","value":"1501"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants From Randomization to First Occurrence of Death From MACE-3 [Composite Endpoint of Major Adverse Cardiovascular Events Death From Cardiovascular Causes, Myocardial Infarction (MI) or Stroke]","description":"Number of participants with first occurrence of Clinical Endpoint Committee (CEC), a composite endpoint i.e., from time of randomization to first occurrence of cardiovascular (CV) death, myocardial infarction and stroke combined data was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of any of these events during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.","populationDescription":"Modified Intention-to-treat (mITT) Population included all randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"From randomization (week 0) up to week 259","groups":[{"id":"OG000","title":"Tirzepatide (MTD)","description":"Participants received a starting dose of 2.5 mg tirzepatide administered as SC injection 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) for up to 5 years."},{"id":"OG001","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg dulaglutide administered as SC injection QW for up to 5 years."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6586"},{"groupId":"OG001","value":"6579"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"801"},{"groupId":"OG001","value":"862"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomization to Time to Occurrence of All-Cause Death","description":"The number of participants from randomization to time to occurrence of Clinical Endpoint Committee (CEC) confirmed all-cause death was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of all-cause death during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.","populationDescription":"mITT Population included all randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"From randomization (week 0) up to week 259","groups":[{"id":"OG000","title":"Tirzepatide (MTD)","description":"Participants received a starting dose of 2.5 mg tirzepatide administered as SC injection 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) for up to 5 years."},{"id":"OG001","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg dulaglutide administered as SC injection QW for up to 5 years."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6586"},{"groupId":"OG001","value":"6579"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"566"},{"groupId":"OG001","value":"669"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomization to Time of Occurrence of CV Death","description":"Number of participants from time of randomization to time to occurrence of CEC confirmed CV death was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of CV death during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.","populationDescription":"mITT Population included all randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"From randomization (week 0) up to week 259","groups":[{"id":"OG000","title":"Tirzepatide (MTD)","description":"Participants received a starting dose of 2.5 mg tirzepatide administered as SC injection 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) for up to 5 years."},{"id":"OG001","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg dulaglutide administered as SC injection QW for up to 5 years."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6586"},{"groupId":"OG001","value":"6579"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"367"},{"groupId":"OG001","value":"408"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomization to Time to First Occurrence of Myocardial Infarction (MI)","description":"The number of participants from randomization to first occurrence of CEC confirmed MI was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of nonfatal MI during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.","populationDescription":"mITT Population included all randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"From randomization (week 0) up to week 259","groups":[{"id":"OG000","title":"Tirzepatide (MTD)","description":"Participants received a starting dose of 2.5 mg tirzepatide administered as SC injection 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) for up to 5 years."},{"id":"OG001","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg dulaglutide administered as SC injection QW for up to 5 years."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6586"},{"groupId":"OG001","value":"6579"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"311"},{"groupId":"OG001","value":"357"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomization toTime to First Occurrence of Stroke","description":"The number of participants from randomization to first occurrence of CEC confirmed stroke was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of nonfatal stroke during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.","populationDescription":"mITT Population included all randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"From randomization (week 0) up to week 259","groups":[{"id":"OG000","title":"Tirzepatide (MTD)","description":"Participants received a starting dose of 2.5 mg tirzepatide administered as SC injection 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) for up to 5 years."},{"id":"OG001","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg dulaglutide administered as SC injection QW for up to 5 years."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6586"},{"groupId":"OG001","value":"6579"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"249"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomization to Time to First Occurrence of the Expanded Composite of CV Death, MI, Stroke or Coronary Revascularization (MACE-4)","description":"The number of participants from randomization to first occurrence of MACE-4 was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of any of these events during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.","populationDescription":"mITT Population included all randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"From randomization (week 0) up to week 259","groups":[{"id":"OG000","title":"Tirzepatide (MTD)","description":"Participants received a starting dose of 2.5 mg tirzepatide administered as SC injection 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) for up to 5 years."},{"id":"OG001","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg dulaglutide administered as SC injection QW for up to 5 years."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6586"},{"groupId":"OG001","value":"6579"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1089"},{"groupId":"OG001","value":"1217"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomization to Time to First Occurrence of CV Deaths or Heart Failure Events Requiring Hospitalization and/or Urgent Heart Failure Visits","description":"The number of participants from randomization to first occurrence of Clinical Endpoint Committee (CEC) confirmed heart failure requiring hospitalisation or urgent heart failure was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of any of these events during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.","populationDescription":"mITT Population included all randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"From randomization (week 0) up to week 259","groups":[{"id":"OG000","title":"Tirzepatide (MTD)","description":"Participants received a starting dose of 2.5 mg tirzepatide administered as SC injection 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) for up to 5 years."},{"id":"OG001","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg dulaglutide administered as SC injection QW for up to 5 years."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6586"},{"groupId":"OG001","value":"6579"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"512"},{"groupId":"OG001","value":"557"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomization to Time to First Occurrence of Revascularization","description":"The number of participants from randomization to first occurrence of coronary revascularization was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of revascularization during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.","populationDescription":"mITT Population included all randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"From randomization (week 0) up to week 259","groups":[{"id":"OG000","title":"Tirzepatide (MTD)","description":"Participants received a starting dose of 2.5 mg tirzepatide administered as SC injection 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) for up to 5 years."},{"id":"OG001","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg dulaglutide administered as SC injection QW for up to 5 years."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6586"},{"groupId":"OG001","value":"6579"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"527"},{"groupId":"OG001","value":"617"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Randomization to Time to First Occurrence of New or Worsening Nephropathy","description":"New or worsening nephropathy (Composite Endpoint 1) was defined as the first occurrence of any of the following events:\n\npersistent macroalbuminuria (urine albumin-to-creatinine ratio \\>300 mg/g), persistent doubling of serum creatinine with eGFR \\<45 mL/min/1.73 m², onset of end-stage renal disease (including initiation of chronic dialysis or kidney transplantation), or death due to renal disease.\n\nTime to event was defined as the number of days from the date of randomization to the first occurrence any of these events. during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up.","populationDescription":"mITT Population included all randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"From randomization (week 0) up to week 259","groups":[{"id":"OG000","title":"Tirzepatide (MTD)","description":"Participants received a starting dose of 2.5 mg tirzepatide administered as SC injection 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) for up to 5 years."},{"id":"OG001","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg dulaglutide administered as SC injection QW for up to 5 years."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6586"},{"groupId":"OG001","value":"6579"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"373"},{"groupId":"OG001","value":"442"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to 36 Months in Estimated Glomerular Filtration Rate (eGFR) in Patients With High or Very-high Risk Chronic Kidney Disease (CKD)","description":"Change from baseline in eGFR calculated as difference between value at 36 months and baseline value. Participants included in this analysis were classified as having high or very high risk of chronic kidney disease at baseline based on their kidney function (eGFR) and urine albumin-to-creatinine ratio (UACR). High risk included participants with eGFR 45 to less than 60 milliliters/minutes/1.73 square metres (mL/min/1.73 m²) and UACR greater than 30 mg/g, or eGFR 60 mL/min/1.73 m² or higher with UACR greater than 300 mg/g. Very high risk included participants with eGFR less than 45 mL/min/1.73 m² or severely increased UACR (greater than 300 mg/g). These criteria are associated with an increased risk of worsening kidney function. Least squares (LS) mean was calculated using analysis of covariance (ANCOVA) model for endpoint measures: Variable = Baseline + Treatment + Analysis Country + Baseline sodium-glucose cotransporter-2 (SGLT-2) Use Flag.","populationDescription":"mITT Population included all randomized participants who were grouped according to the treatment assigned at randomization and had both baseline and at least one post-baseline assessment, with evaluable data for this outcome.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milliliters/minutes/1.73 square metres","timeFrame":"Baseline, 36 Months","groups":[{"id":"OG000","title":"Tirzepatide (MTD)","description":"Participants received a starting dose of 2.5 mg tirzepatide administered as SC injection 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) for up to 5 years."},{"id":"OG001","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg dulaglutide administered as SC injection QW for up to 5 years."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1520"},{"groupId":"OG001","value":"1403"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.72","spread":"0.437"},{"groupId":"OG001","value":"-8.90","spread":"0.393"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to 36 Months in Hemoglobin A1c (HbA1c)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Change in HbA1c from baseline up to 36 months during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.\n\nLS mean was calculated using ANCOVA model for endpoint measures: Variable = Baseline + Treatment + Analysis Country + Baseline SGLT-2i Use Flag (Type III sum of squares).","populationDescription":"mITT Population included all randomized participants who were grouped according to the treatment assigned at randomization and had both baseline and at least one post-baseline assessment, with evaluable data for this outcome.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Baseline, 36 Months","groups":[{"id":"OG000","title":"Tirzepatide (MTD)","description":"Participants received a starting dose of 2.5 mg tirzepatide administered as SC injection 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) for up to 5 years."},{"id":"OG001","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg dulaglutide administered as SC injection QW for up to 5 years."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6586"},{"groupId":"OG001","value":"6579"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.66","spread":"0.0211"},{"groupId":"OG001","value":"-0.88","spread":"0.0235"}]}]}]},{"type":"SECONDARY","title":"Percent Change From Baseline to 36 Months in Body Weight","description":"LS mean was calculated using ANCOVA model for endpoint measures: Variable = Baseline + Treatment + Analysis Country + Baseline SGLT-2i Use Flag (Type III sum of squares)","populationDescription":"mITT Population included all randomized participants who were grouped according to the treatment assigned at randomization and had both baseline and at least one post-baseline assessment, with evaluable data for this outcome.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, 36 Months","groups":[{"id":"OG000","title":"Tirzepatide (MTD)","description":"Participants received a starting dose of 2.5 mg tirzepatide administered as SC injection 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) for up to 5 years."},{"id":"OG001","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg dulaglutide administered as SC injection QW for up to 5 years."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6586"},{"groupId":"OG001","value":"6578"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-11.6","spread":"0.122"},{"groupId":"OG001","value":"-4.82","spread":"0.0995"}]}]}]},{"type":"SECONDARY","title":"Percent Change From Baseline to 36 Months in Urinary Albumin to Creatinine Ratio (UACR)","description":"Urine samples were collected for the analysis of UACR. UACR (gram per kilograms \\[g/kg\\]) was calculated as urine albumin (gram per liter \\[g/L\\])/urine creatinine (kg/L). Percent change from baseline at 36 months was calculated as: \\[(UACR at 36 months - baseline UACR) / baseline UACR\\] × 100.\n\nLS mean was calculated using ANCOVA model for endpoint measures: log(Actual Measurement/Baseline) = log(Baseline) + Treatment + Analysis Country + Baseline SGLT-2i Use Flag (Type III sum of squares).","populationDescription":"mITT Population included all randomized participants who were grouped according to the treatment assigned at randomization and had both baseline and at least one post-baseline assessment, with evaluable data for this outcome.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, 36 Months","groups":[{"id":"OG000","title":"Tirzepatide (MTD)","description":"Participants received a starting dose of 2.5 mg tirzepatide administered as SC injection 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) for up to 5 years."},{"id":"OG001","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg dulaglutide administered as SC injection QW for up to 5 years."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6472"},{"groupId":"OG001","value":"6482"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-26.42","spread":"1.202"},{"groupId":"OG001","value":"-7.23","spread":"1.641"}]}]}]},{"type":"SECONDARY","title":"Percent Change From Baseline to 24 Months in Blood Lipids (Total Cholesterol (TC), Low-Density Lipoprotein Cholesterol (LDL-C), High-Density Lipoprotein Cholesterol (HDL-C), and Triglycerides (TG))","description":"Blood samples of participants who had fasted for 12 to 14 hours were collected for lipid profile (TC, LDL-C, HDL-C, TG) assessment. The lipid profile asesses the risk of heart disease. Percent change from baseline = 100\\*(post-baseline assessment - baseline assessment)/baseline assessment.\n\nLS mean was calculated using ANCOVA model for endpoint measures: log(Actual Measurement/Baseline) = log(Baseline) + Treatment + Analysis Country + Baseline SGLT-2i Use Flag.","populationDescription":"mITT Population included all randomized participants who were grouped according to the treatment assigned at randomization and had both baseline and at least one post-baseline assessment, with evaluable data for this outcome.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, 24 Months","groups":[{"id":"OG000","title":"Tirzepatide (MTD)","description":"Participants received a starting dose of 2.5 mg tirzepatide administered as SC injection 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) for up to 5 years."},{"id":"OG001","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg dulaglutide administered as SC injection QW for up to 5 years."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6412"},{"groupId":"OG001","value":"6431"}]}],"classes":[{"title":"Total Cholesterol (TC)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6412"},{"groupId":"OG001","value":"6431"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-4.09","spread":"0.318"},{"groupId":"OG001","value":"-2.78","spread":"0.324"}]}]},{"title":"Low-Density Lipoprotein Cholesterol (LDL-C)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6028"},{"groupId":"OG001","value":"6037"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.61","spread":"0.562"},{"groupId":"OG001","value":"-2.87","spread":"0.550"}]}]},{"title":"High-Density Lipoprotein Cholesterol (HDL-C)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6403"},{"groupId":"OG001","value":"6426"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"9.34","spread":"0.284"},{"groupId":"OG001","value":"2.45","spread":"0.266"}]}]},{"title":"Triglycerides (TG)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6393"},{"groupId":"OG001","value":"6407"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-24.18","spread":"0.453"},{"groupId":"OG001","value":"-10.17","spread":"0.537"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline Up to 259 Weeks","description":"All randomized participants who received at least 1 dose of double-blind study drug. Gender-specific events occurring exclusively in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen.\n\nAll participants from safety population were included for adverse event reporting, and all randomized participants were included for all-cause mortality.","eventGroups":[{"id":"EG000","title":"Tirzepatide (MTD)","description":"Participants received a starting dose of 2.5 mg tirzepatide administered as SC injection 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) for up to 5 years.","deathsNumAffected":568,"deathsNumAtRisk":6648,"seriousNumAffected":2117,"seriousNumAtRisk":6647,"otherNumAffected":4718,"otherNumAtRisk":6647},{"id":"EG001","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg dulaglutide administered as SC injection QW for up to 5 years.","deathsNumAffected":670,"deathsNumAtRisk":6651,"seriousNumAffected":2121,"seriousNumAtRisk":6647,"otherNumAffected":4297,"otherNumAtRisk":6647}],"seriousEvents":[{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":32,"numAffected":28,"numAtRisk":6647},{"groupId":"EG001","numEvents":27,"numAffected":22,"numAtRisk":6647}]},{"term":"Anaemia macrocytic","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6647},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":6647}]},{"term":"Anaemia of chronic disease","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":6647},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":6647}]},{"term":"Anaemia vitamin b12 deficiency","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6647},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":6647}]},{"term":"Aplastic anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":6647},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":6647}]},{"term":"Blood loss anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6647},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":6647}]},{"term":"Bone marrow oedema","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":6647},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":6647}]},{"term":"Febrile neutropenia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":2,"numAtRisk":6647},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":6647}]},{"term":"Hypochromic anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":6647},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":6647}]},{"term":"Immune thrombocytopenia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6647},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":6647}]},{"term":"Iron deficiency anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":12,"numAffected":11,"numAtRisk":6647},{"groupId":"EG001","numEvents":11,"numAffected":11,"numAtRisk":6647}]},{"term":"Leukocytosis","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6647},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":6647}]},{"term":"Lymphadenopathy","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6647},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":6647}]},{"term":"Lymphadenopathy mediastinal","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6647},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":6647}]},{"term":"Microcytic anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":6647},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":6647}]},{"term":"Myelosuppression","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":6647},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":6647}]},{"term":"Nephrogenic anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6647},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":6647}]},{"term":"Normocytic anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6647},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":6647}]},{"term":"Pancytopenia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6647},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":6647}]},{"term":"Retroperitoneal lymphadenopathy","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":6647},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":6647}]},{"term":"Splenic infarction","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6647},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":6647}]},{"term":"Spontaneous haematoma","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":6647},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":6647}]},{"term":"Thrombocytopenia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6647},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":6647}]},{"term":"Thrombocytosis","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6647},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":6647}]},{"term":"Acute coronary syndrome","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":6647},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":6647}]},{"term":"Acute left ventricular failure","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":6647},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":6647}]},{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":11,"numAffected":11,"numAtRisk":6647},{"groupId":"EG001","numEvents":21,"numAffected":19,"numAtRisk":6647}]},{"term":"Adams-stokes syndrome","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":6647},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":6647}]},{"term":"Angina pectoris","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":42,"numAffected":40,"numAtRisk":6647},{"groupId":"EG001","numEvents":44,"numAffected":43,"numAtRisk":6647}]},{"term":"Angina unstable","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":66,"numAffected":63,"numAtRisk":6647},{"groupId":"EG001","numEvents":62,"numAffected":58,"numAtRisk":6647}]},{"term":"Aortic valve disease mixed","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":6647},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":6647}]},{"term":"Aortic valve incompetence","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":6647},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":6647}]},{"term":"Aortic valve stenosis","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":9,"numAffected":9,"numAtRisk":6647},{"groupId":"EG001","numEvents":8,"numAffected":8,"numAtRisk":6647}]},{"term":"Arrhythmia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6647},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":6647}]},{"term":"Arrhythmia supraventricular","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":6647},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":6647}]},{"term":"Arrhythmic storm","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":3,"numAtRisk":6647},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":6647}]},{"term":"Arteriosclerosis coronary artery","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":7,"numAtRisk":6647},{"groupId":"EG001","numEvents":6,"numAffected":5,"numAtRisk":6647}]},{"term":"Arteriospasm coronary","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6647},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":6647}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":68,"numAffected":57,"numAtRisk":6647},{"groupId":"EG001","numEvents":68,"numAffected":55,"numAtRisk":6647}]},{"term":"Atrial flutter","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":16,"numAffected":16,"numAtRisk":6647},{"groupId":"EG001","numEvents":8,"numAffected":8,"numAtRisk":6647}]},{"term":"Atrial tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":6647},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":6647}]},{"term":"Atrial thrombosis","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":6647},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":6647}]},{"term":"Atrioventricular block","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":6647},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":6647}]},{"term":"Atrioventricular block complete","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":16,"numAffected":16,"numAtRisk":6647},{"groupId":"EG001","numEvents":17,"numAffected":17,"numAtRisk":6647}]},{"term":"Atrioventricular block first degree","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":6647},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":6647}]},{"term":"Atrioventricular block second degree","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":6647},{"groupId":"EG001","numEvents":20,"numAffected":19,"numAtRisk":6647}]},{"term":"Bradycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":8,"numAffected":8,"numAtRisk":6647},{"groupId":"EG001","numEvents":9,"numAffected":9,"numAtRisk":6647}]},{"term":"Bundle branch block left","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6647},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":6647}]},{"term":"Bundle branch block right","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6647},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":6647}]},{"term":"Cardiac aneurysm","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":6647},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":6647}]},{"term":"Cardiac arrest","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":12,"numAffected":12,"numAtRisk":6647},{"groupId":"EG001","numEvents":11,"numAffected":11,"numAtRisk":6647}]},{"term":"Cardiac disorder","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6647},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":6647}]},{"term":"Cardiac failure","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":35,"numAffected":34,"numAtRisk":6647},{"groupId":"EG001","numEvents":42,"numAffected":36,"numAtRisk":6647}]},{"term":"Cardiac failure acute","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":6647},{"groupId":"EG001","numEvents":8,"numAffected":8,"numAtRisk":6647}]},{"term":"Cardiac failure chronic","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":66,"numAffected":62,"numAtRisk":6647},{"groupId":"EG001","numEvents":69,"numAffected":62,"numAtRisk":6647}]},{"term":"Cardiac failure congestive","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":9,"numAffected":9,"numAtRisk":6647},{"groupId":"EG001","numEvents":16,"numAffected":15,"numAtRisk":6647}]},{"term":"Cardiac perfusion defect","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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