{"protocolSection":{"identificationModule":{"nctId":"NCT03882970","orgStudyIdInfo":{"id":"16997"},"secondaryIdInfos":[{"id":"I8F-MC-GPGH","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"2018-003422-84","type":"EUDRACT_NUMBER"},{"id":"2018","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2018"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes","officialTitle":"A Randomized, Phase 3, Open-Label Trial Comparing the Effect of LY3298176 Versus Titrated Insulin Degludec on Glycemic Control in Patients With Type 2 Diabetes","acronym":"SURPASS-3"},"statusModule":{"statusVerifiedDate":"2022-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-04-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-12-11","type":"ACTUAL"},"completionDateStruct":{"date":"2021-01-04","type":"ACTUAL"},"studyFirstSubmitDate":"2019-03-19","studyFirstSubmitQcDate":"2019-03-19","studyFirstPostDateStruct":{"date":"2019-03-20","type":"ACTUAL"},"resultsFirstSubmitDate":"2021-12-02","resultsFirstSubmitQcDate":"2022-01-14","resultsFirstPostDateStruct":{"date":"2022-01-19","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-01-14","lastUpdatePostDateStruct":{"date":"2022-01-19","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 this study is to compare the effect of the study drug tirzepatide to insulin degludec on blood sugar levels in participants with type 2 diabetes. The study will last about 67 weeks and may include up to 22 visits."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"],"keywords":["T2DM"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":1444,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"5 mg Tirzepatide","type":"EXPERIMENTAL","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.","interventionNames":["Drug: Tirzepatide"]},{"label":"10 mg Tirzepatide","type":"EXPERIMENTAL","description":"10 mg tirzepatide administered SC once a week.","interventionNames":["Drug: Tirzepatide"]},{"label":"15 mg Tirzepatide","type":"EXPERIMENTAL","description":"15 mg tirzepatide administered SC once a week.","interventionNames":["Drug: Tirzepatide"]},{"label":"Insulin Degludec","type":"ACTIVE_COMPARATOR","description":"Insulin degludec administered SC once a day.","interventionNames":["Drug: Insulin Degludec"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC","armGroupLabels":["10 mg Tirzepatide","15 mg Tirzepatide","5 mg Tirzepatide"],"otherNames":["LY3298176"]},{"type":"DRUG","name":"Insulin Degludec","description":"Administered SC","armGroupLabels":["Insulin Degludec"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates Baseline + Pooled Country + Baseline Oral Antihyperglycemic Medication (OAM) Use (Metformin (Met), Met plus SGLT-2i) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"}],"secondaryOutcomes":[{"measure":"Change From Baseline in HbA1c (5 mg)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates Baseline + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline in Body Weight","description":"LS mean was determined by MMRM model with Baseline + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares) as covariates.","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline in Fasting Serum Glucose","description":"LS mean was determined by MMRM model with variables Baseline + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Percentage of Participants Achieving an HbA1c Target Value of <7%","description":"Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing. Missing endpoint measures are imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for Baseline Value, Pooled Country, Baseline OAM Use (Met, Met plus SGLT-2i), Treatment, Visit and Visit\\*Treatment.","timeFrame":"Week 52"},{"measure":"Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values","description":"The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. LS mean was determined by mixed-model repeated measures (MMRM) model with variables Baseline + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Percentage of Participants Who Achieved Weight Loss ≥5%","description":"Percentage of Participants who Achieved Weight Loss ≥5%","timeFrame":"Week 52"},{"measure":"Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction Score","description":"DTSQc, an 8-item questionnaire, assesses relative change in treatment satisfaction perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia from baseline to week 52 or early termination.The treatment satisfaction score ranges from -18 to 18 where the higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. The hyperglycemia and hypoglycemia scores range from -3 to 3 where negative scores indicate fewer problems with blood glucose levels and positive scores indicate more problems than before. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline DTSQs + Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Baseline OAM Use (Met, Met plus SGLT-2i) + Treatment (Type III sum of squares).","timeFrame":"Week 52"},{"measure":"Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 (Millimole/Liter (mmol/L))] or Severe Hypoglycemia","description":"The hypoglycemia events were defined by participant reported events with blood glucose \\<54mg/dL (\\<3.0 mmol/L) or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: Number of episodes = Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment, with log (exposure in days/365.25) as an offset variable.","timeFrame":"Baseline through Safety Follow-Up (Up to Week 56)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Participants must:\n\n  * Have been diagnosed with type 2 diabetes mellitus (T2DM)\n  * Have HbA1c between ≥7.0% and ≤10.5%\n  * Be on stable treatment with unchanged dose of metformin or metformin plus an SGLT-2 inhibitor for at least 3 months before screening\n  * Be of stable weight (± 5%) for at least 3 months before screening\n  * Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening\n\nExclusion Criteria:\n\n* Participants must not:\n\n  * Have type 1 diabetes mellitus\n  * Have had chronic or acute pancreatitis any time prior to study entry\n  * Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment\n  * Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss\n  * Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level \\>3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if their ALT level is ≤3.0 the ULN for the reference range\n  * Have an estimated glomerular filtration rate \\<45 mL/minute/1.73 m2 (or lower than the country specific threshold for using the protocol required dose of metformin per local label)\n  * Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months\n  * Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2\n  * Have been taking any other diabetes medicines other than metformin, or metformin plus an SGLT-2 inhibitor during the last 3 months\n  * Have been taking weight loss drugs, including over-the-counter medications during the last 3 months","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 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Diabetes Ther. 2023 Nov;14(11):1833-1852. doi: 10.1007/s13300-023-01451-z. Epub 2023 Aug 1."},{"pmid":"37000390","type":"DERIVED","citation":"Viljoen A, Pantalone KM, Galindo RJ, Cui X, Huh R, Hemmingway A, Fernandez Lando L, Patel H. Time to Reach Glycaemic and Body Weight Loss Thresholds with Tirzepatide in Patients with Type 2 Diabetes: A Pre-planned Exploratory Analysis of SURPASS-2 and SURPASS-3. Diabetes Ther. 2023 May;14(5):925-936. doi: 10.1007/s13300-023-01398-1. Epub 2023 Mar 31."},{"pmid":"35468325","type":"DERIVED","citation":"Gastaldelli A, Cusi K, Fernandez Lando L, Bray R, Brouwers B, Rodriguez A. Effect of tirzepatide versus insulin degludec on liver fat content and abdominal adipose tissue in people with type 2 diabetes (SURPASS-3 MRI): a substudy of the randomised, open-label, parallel-group, phase 3 SURPASS-3 trial. Lancet Diabetes Endocrinol. 2022 Jun;10(6):393-406. doi: 10.1016/S2213-8587(22)00070-5. Epub 2022 Apr 22."},{"pmid":"35468321","type":"DERIVED","citation":"Battelino T, Bergenstal RM, Rodriguez A, Fernandez Lando L, Bray R, Tong Z, Brown K. Efficacy of once-weekly tirzepatide versus once-daily insulin degludec on glycaemic control measured by continuous glucose monitoring in adults with type 2 diabetes (SURPASS-3 CGM): a substudy of the randomised, open-label, parallel-group, phase 3 SURPASS-3 trial. Lancet Diabetes Endocrinol. 2022 Jun;10(6):407-417. doi: 10.1016/S2213-8587(22)00077-8. Epub 2022 Apr 22."},{"pmid":"35210595","type":"DERIVED","citation":"Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nat Med. 2022 Mar;28(3):591-598. doi: 10.1038/s41591-022-01707-4. Epub 2022 Feb 24."},{"pmid":"34370970","type":"DERIVED","citation":"Ludvik B, Giorgino F, Jodar E, Frias JP, Fernandez Lando L, Brown K, Bray R, Rodriguez A. Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. Lancet. 2021 Aug 14;398(10300):583-598. doi: 10.1016/S0140-6736(21)01443-4. Epub 2021 Aug 6."}],"seeAlsoLinks":[{"label":"A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes","url":"https://trials.lillytrialguide.com/en-US/trial/76cf8Mdt50agkx23op5368"}]},"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. 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HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.\n\nHemoglobin A1c Analysis Population Description: All randomized participants who had a HbA1c baseline value.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Percentage of HbA1c","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"358"},{"groupId":"BG001","value":"360"},{"groupId":"BG002","value":"359"},{"groupId":"BG003","value":"360"},{"groupId":"BG004","value":"1437"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"8.17","spread":"0.89"},{"groupId":"BG001","value":"8.18","spread":"0.89"},{"groupId":"BG002","value":"8.21","spread":"0.94"},{"groupId":"BG003","value":"8.12","spread":"0.94"},{"groupId":"BG004","value":"8.17","spread":"0.91"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates Baseline + Pooled Country + Baseline Oral Antihyperglycemic Medication (OAM) Use (Metformin (Met), Met plus SGLT-2i) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days)","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG001","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week SC."},{"id":"OG002","title":"Insulin Degludec","description":"Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.\n\nThe starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) \\<90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"291"},{"groupId":"OG001","value":"294"},{"groupId":"OG002","value":"317"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.20","spread":"0.051"},{"groupId":"OG001","value":"-2.37","spread":"0.050"},{"groupId":"OG002","value":"-1.34","spread":"0.049"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"nonInferiorityType":"NON_INFERIORITY","nonInferiorityComment":"The study was powered for superiority in HbA1c. The sample size provided \\>99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-0.86","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.00","ciUpperLimit":"-0.72"},{"groupIds":["OG001","OG002"],"nonInferiorityType":"NON_INFERIORITY","nonInferiorityComment":"The study was powered for superiority in HbA1c. The sample size provided \\>99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-1.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.17","ciUpperLimit":"-0.90"}]},{"type":"SECONDARY","title":"Change From Baseline in HbA1c (5 mg)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates Baseline + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days)","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"OG001","title":"Insulin Degludec","description":"Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.\n\nThe starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) \\<90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"312"},{"groupId":"OG001","value":"317"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.93","spread":"0.050"},{"groupId":"OG001","value":"-1.34","spread":"0.049"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"NON_INFERIORITY","nonInferiorityComment":"The study was powered for superiority in HbA1c. The sample size provided \\>99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-0.59","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.73","ciUpperLimit":"-0.45"}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight","description":"LS mean was determined by MMRM model with Baseline + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares) as covariates.","populationDescription":"All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days)","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Kilograms (kg)","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week SC."},{"id":"OG003","title":"Insulin Degludec","description":"Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.\n\nThe starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) \\<90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"310"},{"groupId":"OG001","value":"291"},{"groupId":"OG002","value":"295"},{"groupId":"OG003","value":"317"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-7.5","spread":"0.37"},{"groupId":"OG001","value":"-10.7","spread":"0.37"},{"groupId":"OG002","value":"-12.9","spread":"0.37"},{"groupId":"OG003","value":"2.3","spread":"0.37"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-9.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-10.8","ciUpperLimit":"-8.8"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-13.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-14.0","ciUpperLimit":"-11.9"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-15.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-16.2","ciUpperLimit":"-14.2"}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Serum Glucose","description":"LS mean was determined by MMRM model with variables Baseline + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days)","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milligram per Deciliter (mg/dL)","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week SC."},{"id":"OG003","title":"Insulin Degludec","description":"Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.\n\nThe starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) \\<90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"309"},{"groupId":"OG001","value":"291"},{"groupId":"OG002","value":"293"},{"groupId":"OG003","value":"314"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-48.2","spread":"1.82"},{"groupId":"OG001","value":"-54.8","spread":"1.86"},{"groupId":"OG002","value":"-59.2","spread":"1.85"},{"groupId":"OG003","value":"-55.7","spread":"1.81"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.004","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"7.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.4","ciUpperLimit":"12.5"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.751","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"0.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.3","ciUpperLimit":"5.9"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.168","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-3.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-8.7","ciUpperLimit":"1.5"}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving an HbA1c Target Value of <7%","description":"Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing. Missing endpoint measures are imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for Baseline Value, Pooled Country, Baseline OAM Use (Met, Met plus SGLT-2i), Treatment, Visit and Visit\\*Treatment.","populationDescription":"All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days)","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week SC."},{"id":"OG003","title":"Insulin Degludec","description":"Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.\n\nThe starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) \\<90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"353"},{"groupId":"OG001","value":"350"},{"groupId":"OG002","value":"353"},{"groupId":"OG003","value":"351"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"82.44"},{"groupId":"OG001","value":"89.71"},{"groupId":"OG002","value":"92.63"},{"groupId":"OG003","value":"61.25"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"3.45","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.38","ciUpperLimit":"5.01"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"7.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"4.55","ciUpperLimit":"10.84"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"10.79","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"6.65","ciUpperLimit":"17.48"}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values","description":"The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. LS mean was determined by mixed-model repeated measures (MMRM) model with variables Baseline + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days)","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week SC."},{"id":"OG003","title":"Insulin Degludec","description":"Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.\n\nThe starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) \\<90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"281"},{"groupId":"OG001","value":"263"},{"groupId":"OG002","value":"274"},{"groupId":"OG003","value":"288"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-52.6","spread":"1.20"},{"groupId":"OG001","value":"-59.7","spread":"1.22"},{"groupId":"OG002","value":"-60.6","spread":"1.20"},{"groupId":"OG003","value":"-48.0","spread":"1.18"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved Weight Loss ≥5%","description":"Percentage of Participants who Achieved Weight Loss ≥5%","populationDescription":"All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days)","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week SC."},{"id":"OG003","title":"Insulin Degludec","description":"Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.\n\nThe starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) \\<90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"353"},{"groupId":"OG001","value":"350"},{"groupId":"OG002","value":"353"},{"groupId":"OG003","value":"351"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"66.01"},{"groupId":"OG001","value":"83.71"},{"groupId":"OG002","value":"87.82"},{"groupId":"OG003","value":"6.27"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"29.78","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"18.35","ciUpperLimit":"48.35"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"79.88","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"47.56","ciUpperLimit":"134.17"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"110.77","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"64.73","ciUpperLimit":"189.55"}]},{"type":"SECONDARY","title":"Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction Score","description":"DTSQc, an 8-item questionnaire, assesses relative change in treatment satisfaction perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia from baseline to week 52 or early termination.The treatment satisfaction score ranges from -18 to 18 where the higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. The hyperglycemia and hypoglycemia scores range from -3 to 3 where negative scores indicate fewer problems with blood glucose levels and positive scores indicate more problems than before. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline DTSQs + Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Baseline OAM Use (Met, Met plus SGLT-2i) + Treatment (Type III sum of squares).","populationDescription":"All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days)","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week SC."},{"id":"OG003","title":"Insulin Degludec","description":"Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.\n\nThe starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) \\<90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"306"},{"groupId":"OG001","value":"293"},{"groupId":"OG002","value":"292"},{"groupId":"OG003","value":"313"}]}],"classes":[{"title":"Hyperglycemia","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"306"},{"groupId":"OG001","value":"293"},{"groupId":"OG002","value":"292"},{"groupId":"OG003","value":"312"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.4","spread":"0.11"},{"groupId":"OG001","value":"-1.4","spread":"0.11"},{"groupId":"OG002","value":"-1.6","spread":"0.11"},{"groupId":"OG003","value":"-1.1","spread":"0.11"}]}]},{"title":"Hypoglycemia","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"306"},{"groupId":"OG001","value":"293"},{"groupId":"OG002","value":"292"},{"groupId":"OG003","value":"313"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.1","spread":"0.12"},{"groupId":"OG001","value":"-0.9","spread":"0.12"},{"groupId":"OG002","value":"-1.0","spread":"0.12"},{"groupId":"OG003","value":"-0.7","spread":"0.12"}]}]},{"title":"Treatment Satisfaction Score","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"305"},{"groupId":"OG001","value":"293"},{"groupId":"OG002","value":"292"},{"groupId":"OG003","value":"313"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"15.6","spread":"0.27"},{"groupId":"OG001","value":"15.5","spread":"0.28"},{"groupId":"OG002","value":"15.6","spread":"0.28"},{"groupId":"OG003","value":"12.6","spread":"0.27"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"groupDescription":"Hyperglycemia","nonInferiorityType":"SUPERIORITY","pValue":"0.096","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.26","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.57","ciUpperLimit":"0.05"},{"groupIds":["OG001","OG003"],"groupDescription":"Hyperglycemia","nonInferiorityType":"SUPERIORITY","pValue":"0.113","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.25","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.57","ciUpperLimit":"0.06"},{"groupIds":["OG002","OG003"],"groupDescription":"Hyperglycemia","nonInferiorityType":"SUPERIORITY","pValue":"0.003","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.47","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.78","ciUpperLimit":"-0.16"},{"groupIds":["OG000","OG003"],"groupDescription":"Hypoglycemia","nonInferiorityType":"SUPERIORITY","pValue":"0.014","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.41","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.74","ciUpperLimit":"-0.08"},{"groupIds":["OG001","OG003"],"groupDescription":"Hypoglycemia","nonInferiorityType":"SUPERIORITY","pValue":"0.280","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.18","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.51","ciUpperLimit":"0.15"},{"groupIds":["OG002","OG003"],"groupDescription":"Hypoglycemia","nonInferiorityType":"SUPERIORITY","pValue":"0.129","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.26","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.59","ciUpperLimit":"0.07"},{"groupIds":["OG000","OG003"],"groupDescription":"Treatment Satisfaction Score","nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"3.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.26","ciUpperLimit":"3.75"},{"groupIds":["OG001","OG003"],"groupDescription":"Treatment Satisfaction Score","nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"2.90","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.15","ciUpperLimit":"3.65"},{"groupIds":["OG002","OG003"],"groupDescription":"Treatment Satisfaction Score","nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"2.99","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.24","ciUpperLimit":"3.74"}]},{"type":"SECONDARY","title":"Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 (Millimole/Liter (mmol/L))] or Severe Hypoglycemia","description":"The hypoglycemia events were defined by participant reported events with blood glucose \\<54mg/dL (\\<3.0 mmol/L) or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: Number of episodes = Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment, with log (exposure in days/365.25) as an offset variable.","populationDescription":"All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Episodes/participant/365.25 days","timeFrame":"Baseline through Safety Follow-Up (Up to Week 56)","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week SC."},{"id":"OG003","title":"Insulin Degludec","description":"Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.\n\nThe starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) \\<90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"356"},{"groupId":"OG001","value":"360"},{"groupId":"OG002","value":"359"},{"groupId":"OG003","value":"358"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0137","spread":"0.0056"},{"groupId":"OG001","value":"0.0108","spread":"0.0044"},{"groupId":"OG002","value":"0.0275","spread":"0.0143"},{"groupId":"OG003","value":"0.1020","spread":"0.0568"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline Up To 56 Weeks","description":"All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.","eventGroups":[{"id":"EG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.","deathsNumAffected":1,"deathsNumAtRisk":358,"seriousNumAffected":29,"seriousNumAtRisk":358,"otherNumAffected":124,"otherNumAtRisk":358},{"id":"EG001","title":"10 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.","deathsNumAffected":2,"deathsNumAtRisk":360,"seriousNumAffected":20,"seriousNumAtRisk":360,"otherNumAffected":157,"otherNumAtRisk":360},{"id":"EG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week SC.","deathsNumAffected":1,"deathsNumAtRisk":359,"seriousNumAffected":26,"seriousNumAtRisk":359,"otherNumAffected":179,"otherNumAtRisk":359},{"id":"EG003","title":"Insulin Degludec","description":"Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.\n\nThe starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) \\<90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values.","deathsNumAffected":1,"deathsNumAtRisk":360,"seriousNumAffected":22,"seriousNumAtRisk":360,"otherNumAffected":66,"otherNumAtRisk":360}],"seriousEvents":[{"term":"Neutropenia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":358},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":360},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":359},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":360}]},{"term":"Thrombocytopenia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":358},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":360},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":359},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":360}]},{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":358},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":360},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":359},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":360}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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