{"protocolSection":{"identificationModule":{"nctId":"NCT05260021","orgStudyIdInfo":{"id":"17121"},"secondaryIdInfos":[{"id":"I8F-MC-GPGV","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"2021-003612-31","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both","officialTitle":"A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study With an Open-Label Extension Assessing the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of Tirzepatide in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, or Basal Insulin, or Both","acronym":"SURPASS-PEDS"},"statusModule":{"statusVerifiedDate":"2025-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-04-13","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-07-30","type":"ACTUAL"},"completionDateStruct":{"date":"2025-01-28","type":"ACTUAL"},"studyFirstSubmitDate":"2022-02-25","studyFirstSubmitQcDate":"2022-02-25","studyFirstPostDateStruct":{"date":"2022-03-02","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-07-30","resultsFirstSubmitQcDate":"2025-09-08","resultsFirstPostDateStruct":{"date":"2025-09-26","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-09-08","lastUpdatePostDateStruct":{"date":"2025-09-26","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 learn more about the safety and efficacy of tirzepatide compared to placebo in children or teenagers with type 2 diabetes taking metformin, or basal insulin, or both.\n\nThe overall study will last about 60 weeks with up to 14 clinic visits and 6 phone visits. Clinic visits will include blood sample collection, physical exam and questionnaire."},"conditionsModule":{"conditions":["Type2 Diabetes","Diabetes Mellitus","Diabetes Mellitus, Type 2","T2D","T2DM (Type 2 Diabetes Mellitus)","Glucose Metabolism Disorders","Endocrine System Diseases","Metabolic Disease"],"keywords":["GLP-1 RA","Glucose-dependent insulinotropic polypeptide (GIP)","glucagon-like peptide-1 (GLP-1)","GIP/GLP-1 dual receptor agonist","Incretins"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":99,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Tirzepatide Dose 1","type":"EXPERIMENTAL","description":"Double-Blind:\n\nParticipants receive Tirzepatide by weekly subcutaneous (SC) injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 1 is reached.\n\nOpen-Label:\n\nParticipants will continue to receive Tirzepatide at the last dose level","interventionNames":["Drug: Tirzepatide Dose 1"]},{"label":"Tirzepatide Dose 2","type":"EXPERIMENTAL","description":"Double-Blind:\n\nParticipants receive Tirzepatide by weekly SC injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 2 is reached.\n\nOpen-Label:\n\nParticipants will continue to receive Tirzepatide at the last dose level","interventionNames":["Drug: Tirzepatide Dose 2"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Double-Blind:\n\nParticipants receive placebo during the 30-week double-blind period.\n\nOpen-Label:\n\nParticipants will switch to Tirzepatide by weekly SC injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 1 is reached.","interventionNames":["Drug: Tirzepatide Dose 1","Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide Dose 1","description":"Administered SC","armGroupLabels":["Placebo","Tirzepatide Dose 1"]},{"type":"DRUG","name":"Tirzepatide Dose 2","description":"Administered SC","armGroupLabels":["Tirzepatide Dose 2"]},{"type":"DRUG","name":"Placebo","description":"Administered SC","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 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 ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares)","timeFrame":"Baseline, Week 30"}],"secondaryOutcomes":[{"measure":"Change From Baseline in HbA1c (Individual Doses)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares).","timeFrame":"Baseline, Week 30"},{"measure":"Percentage of Participants Who Achieve ≤6.5% of 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. Imputed data includes observed value and imputed value if endpoint measure is missing.","timeFrame":"Week 30"},{"measure":"Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (Age and Sex-matched)","description":"BMI SDS (age and sex matched), calculated using the World Health Organization (WHO) growth reference standards. BMI is calculated as weight in kilograms divided by height in meters squared (kg/m²) and converted to a Z-score (SDS) based on WHO reference data. A Z-score of 0 represents the population mean for a given age and sex. A BMI SDS between -1 and +1 is considered normal. Obesity is defined as BMI SDS \\> +2. Reductions in BMI SDS indicate improvement in weight status for individuals with obesity.\n\nLS mean was determined by the ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares)","timeFrame":"Baseline, Week 30"},{"measure":"Change From Baseline in Fasting Serum Glucose (FSG)","description":"LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares).","timeFrame":"Baseline, Week 30"},{"measure":"Percent Change From Baseline in BMI","description":"LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares).","timeFrame":"Baseline, Week 30"},{"measure":"Percentage of Participants Who Achieve <5.7% of 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. Imputed data includes observed value and imputed value if endpoint measure is missing.","timeFrame":"Week 30"},{"measure":"Percentage of Participants Who Achieve <7.0% of 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. Imputed data includes observed value and imputed value if endpoint measure is missing.","timeFrame":"Week 30"},{"measure":"Percent Change From Baseline for Serum Lipid Levels","description":"Geometric LS mean was determined by the MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Baseline Antihyperglycemic medication + Baseline Age group + Treatment + Time + Treatment\\*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.","timeFrame":"Baseline, Week 30"},{"measure":"Change From Baseline in Height Standard Deviation Score (SDS)","description":"Height SDS (age and sex-matched), calculated using the World Health Organization (WHO) growth reference standards. Height SDS is derived by comparing a child's height to the median height for their age and sex in the WHO reference population, then expressing the difference in standard deviation units (Z-scores). A Z-score of 0 represents the population mean. A Height SDS below -2 indicates short stature. Positive changes in Height SDS from baseline reflect improvement in growth velocity or catch-up growth.\n\nLS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Baseline Age group + Baseline Antihyperglycemic medication + Treatment + Time + Treatment\\*Time(Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured","timeFrame":"Baseline, Week 30"},{"measure":"Change From Baseline in Weight SDS","description":"Weight SDS, calculated using Centers for Disease Control and Prevention (CDC) growth reference standards. Weight SDS is derived by comparing a child's weight to median weight for their age and sex in the CDC reference population, then expressing the difference in standard deviation units (Z-scores). A Z-score of 0 represents the population mean for a given age and sex. A Weight SDS below -2 may indicate underweight status, while a Weight SDS above +2 may indicate overweight or obesity. Change from baseline Weight SDS reflects shifts in growth trajectory, with positive changes indicating weight gain and negative changes indicating weight reduction.\n\nLS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Baseline Age group + Baseline Antihyperglycemic medication + Treatment + Time + Treatment\\*Time(Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured","timeFrame":"Baseline, Week 30"},{"measure":"Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale","description":"The PedsQL Measurement Model measures health-related quality of life (HRQOL) in children (ages 8 to 12) and teenagers (ages 13 to 18). The 23-item PedsQL Generic Core Scale includes physical, emotional, social, and school functioning dimensions. The PedsQL Generic Core yields two summary scores: Physical Summary and Psychosocial Summary. Scores are transformed on a 0-100 scale, with higher scores indicating better functioning. Each item is scored from 0 (never) to 4 (almost always). Items are reverse scored and linearly transformed to a 0-100 scale so that higher scores indicate better HRQOL; the total score therefore ranges from 0 (worst) to 100 (best). Higher scores indicate better health-related quality of life. LS mean was determined by the MMRM model for post-baseline measures: Variable = Baseline + Baseline Antihyperglycemic Medication + Baseline Age Group + Treatment + Time + Treatment\\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured.","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline PedsQL (3.2) Diabetic Module","description":"The PedsQL 3.2 Diabetes Module has 33 items for ages 13 years and older, and 32 items (1 less item for the Worry Scale) for ages 2 to 12 years. The 5 dimensions consist of diabetes symptoms (15 items), treatment barriers (5 items), treatment adherence (6 items), worry \\[2 items (3 for teens and adults)\\] and communication (4 items). Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores reflect fewer problems and better functioning. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment + Time + Treatment\\*Time(Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance- Covariance structure (Change from Baseline) = Unstructured.","timeFrame":"Baseline, Week 52"},{"measure":"Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide","description":"The steady-state AUCs were estimated from Tirzepatide concentrations at Weeks 0, 7, 16, and 29 using the population PK model by treatment group.","timeFrame":"Week 0: after the first dose anytime on the same day. Weeks 7, 16, and 29: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours post-dose, as assigned by IWRS."}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female, aged 10 to below 18 years at screening visit\n* Have type 2 diabetes, treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 90 days prior to study screening.\n* Have HbA1c \\>6.5% to ≤11% at screening\n* Have body weight ≥50 kilogram (kg) 110 pounds and BMI of \\>85th percentile of the general age and gender-matched population for that country or region.\n\nExclusion Criteria:\n\n* Have Type 1 diabetes mellitus (T1DM), or positive GAD65 or IA2 antibodies\n* After the T2DM diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome\n* Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months.\n* Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).\n* Had chronic or acute pancreatitis any time prior to study entry\n* Female participants who are pregnant or breast feeding or intending to become pregnant.\n* Using prescription or over the counter medications for weight loss within 90 days of the screening visit.","healthyVolunteers":false,"sex":"ALL","minimumAge":"10 Years","maximumAge":"18 Years","stdAges":["CHILD","ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"1-877-CTLilly (1877-285-4559) 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":"Children's Hospital Los Angeles","city":"Los Angeles","state":"California","zip":"90027","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"Center Of Excellence in Diabetes and Endocrinology","city":"Sacramento","state":"California","zip":"95821","country":"United States","geoPoint":{"lat":38.58157,"lon":-121.4944}},{"facility":"Rady Children's Hospital","city":"San Diego","state":"California","zip":"92123","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"Touro University California","city":"Vallejo","state":"California","zip":"94592","country":"United States","geoPoint":{"lat":38.10409,"lon":-122.25664}},{"facility":"Children's Hospital Colorado","city":"Aurora","state":"Colorado","zip":"80045","country":"United States","geoPoint":{"lat":39.72943,"lon":-104.83192}},{"facility":"Nemours Children's Health - 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Efficacy and safety of tirzepatide in children and adolescents with type 2 diabetes (SURPASS-PEDS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2025 Oct 4;406(10511):1484-1496. doi: 10.1016/S0140-6736(25)01774-X. Epub 2025 Sep 17."}],"seeAlsoLinks":[{"label":"A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both (SURPASS-PEDS)","url":"https://trials.lillytrialguide.com/en-US/trial/WoqX8k1IVNPugq1V1yyyL"}]},"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 European Union (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":"5 Milligram (mg) Tirzepatide/5 mg Tirzepatide","description":"Participants received 5 mg Tirzepatide once weekly (QW) administered as subcutaneous (SC) injection via single-dose pen (SDP) for 30 weeks in double-blind period and 22 weeks in open-label period with an additional 4 weeks of safety follow-up."},{"id":"FG001","title":"10 mg Tirzepatide/10 mg Tirzepatide","description":"Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period and 22 weeks in open-label period with an additional 4 weeks of safety follow-up."},{"id":"FG002","title":"Placebo/5 mg Tirzepatide","description":"Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period and 5 mg Tirzepatide QW administered as SC injection via SDP for 22 weeks in open-label period."}],"periods":[{"title":"Double-blind Period (30 Weeks)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"33"},{"groupId":"FG002","numSubjects":"34"}]},{"type":"Received Atleast One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"33"},{"groupId":"FG002","numSubjects":"34"}]},{"type":"Safety Analysis Set 1","comment":"Safety Analysis set 1 is defined as, data obtained from mITT participants (those who took at least 1 dose of study intervention was included in the analyses) during Double blind period, regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.","achievements":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"33"},{"groupId":"FG002","numSubjects":"34"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"29"},{"groupId":"FG002","numSubjects":"32"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Withdrawal due to Caregiver Circumstances","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Incorrectly Enrolled","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]}]},{"title":"Open-label Period (22 Weeks)","milestones":[{"type":"STARTED","comment":"A total of 90 participants continued study treatment at open label period. 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HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to the study intervention or initiation of rescue antihyperglycemic medication.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 30","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period."},{"id":"OG002","title":"Pooled Doses of Tirzepatide (5mg,10mg)","description":"Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period."},{"id":"OG003","title":"Placebo","description":"Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"33"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"34"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"79.6"},{"groupId":"OG001","value":"84.5"},{"groupId":"OG002","value":"82.1"},{"groupId":"OG003","value":"37.4"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"43.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"22.3","ciUpperLimit":"64.4"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"47.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"26.4","ciUpperLimit":"67.7"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"45.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"26.3","ciUpperLimit":"64.1"}]},{"type":"SECONDARY","title":"Percent Change From Baseline for Serum Lipid Levels","description":"Geometric LS mean was determined by the MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Baseline Antihyperglycemic medication + Baseline Age group + Treatment + Time + Treatment\\*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percent change of Serum Lipid Levels","timeFrame":"Baseline, Week 30","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period."},{"id":"OG002","title":"Pooled Doses of Tirzepatide (5mg,10mg)","description":"Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period."},{"id":"OG003","title":"Placebo","description":"Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"28"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"32"}]}],"classes":[{"title":"Serum Cholesterol","categories":[{"measurements":[{"groupId":"OG000","value":"-8.07","spread":"2.319"},{"groupId":"OG001","value":"-13.82","spread":"2.115"},{"groupId":"OG002","value":"-10.99","spread":"1.564"},{"groupId":"OG003","value":"5.07","spread":"2.456"}]}]},{"title":"Serum High-density lipoprotein (HDL) Cholesterol 3RD generation, enzymatic","categories":[{"measurements":[{"groupId":"OG000","value":"5.56","spread":"3.269"},{"groupId":"OG001","value":"1.72","spread":"3.087"},{"groupId":"OG002","value":"3.62","spread":"2.247"},{"groupId":"OG003","value":"0.92","spread":"2.887"}]}]},{"title":"Serum Triglycerides","categories":[{"measurements":[{"groupId":"OG000","value":"-27.6","spread":"4.816"},{"groupId":"OG001","value":"-35.8","spread":"4.165"},{"groupId":"OG002","value":"-31.8","spread":"3.165"},{"groupId":"OG003","value":"-1.74","spread":"6.022"}]}]},{"title":"Serum low-density lipoprotein (LDL) Cholesterol Combined","categories":[{"measurements":[{"groupId":"OG000","value":"-6.08","spread":"3.870"},{"groupId":"OG001","value":"-11.97","spread":"3.540"},{"groupId":"OG002","value":"-9.07","spread":"2.618"},{"groupId":"OG003","value":"9.84","spread":"4.185"}]}]},{"title":"Serum very low-density lipoprotein (VLDL) Cholesterol Combined","categories":[{"measurements":[{"groupId":"OG000","value":"-25.9","spread":"5.005"},{"groupId":"OG001","value":"-34.8","spread":"4.293"},{"groupId":"OG002","value":"-30.5","spread":"3.276"},{"groupId":"OG003","value":"-0.26","spread":"6.211"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Height Standard Deviation Score (SDS)","description":"Height SDS (age and sex-matched), calculated using the World Health Organization (WHO) growth reference standards. Height SDS is derived by comparing a child's height to the median height for their age and sex in the WHO reference population, then expressing the difference in standard deviation units (Z-scores). A Z-score of 0 represents the population mean. A Height SDS below -2 indicates short stature. Positive changes in Height SDS from baseline reflect improvement in growth velocity or catch-up growth.\n\nLS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Baseline Age group + Baseline Antihyperglycemic medication + Treatment + Time + Treatment\\*Time(Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Z-score","timeFrame":"Baseline, Week 30","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period."},{"id":"OG002","title":"Pooled Doses of Tirzepatide (5mg,10mg)","description":"Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period."},{"id":"OG003","title":"Placebo","description":"Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"29"},{"groupId":"OG002","value":"58"},{"groupId":"OG003","value":"34"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.092","spread":"0.0275"},{"groupId":"OG001","value":"-0.11","spread":"0.0274"},{"groupId":"OG002","value":"-0.100","spread":"0.0194"},{"groupId":"OG003","value":"-0.11","spread":"0.0259"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.708","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference (Final Values)","paramValue":"0.014","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.061","ciUpperLimit":"0.089"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.976","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference (Final Values)","paramValue":"-0.001","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.076","ciUpperLimit":"0.074"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.841","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference (Final Values)","paramValue":"0.007","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.058","ciUpperLimit":"0.071"}]},{"type":"SECONDARY","title":"Change From Baseline in Weight SDS","description":"Weight SDS, calculated using Centers for Disease Control and Prevention (CDC) growth reference standards. Weight SDS is derived by comparing a child's weight to median weight for their age and sex in the CDC reference population, then expressing the difference in standard deviation units (Z-scores). A Z-score of 0 represents the population mean for a given age and sex. A Weight SDS below -2 may indicate underweight status, while a Weight SDS above +2 may indicate overweight or obesity. Change from baseline Weight SDS reflects shifts in growth trajectory, with positive changes indicating weight gain and negative changes indicating weight reduction.\n\nLS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Baseline Age group + Baseline Antihyperglycemic medication + Treatment + Time + Treatment\\*Time(Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Z-score","timeFrame":"Baseline, Week 30","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period."},{"id":"OG002","title":"Pooled Doses of Tirzepatide (5mg,10mg)","description":"Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period."},{"id":"OG003","title":"Placebo","description":"Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"29"},{"groupId":"OG002","value":"58"},{"groupId":"OG003","value":"34"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.38","spread":"0.0600"},{"groupId":"OG001","value":"-0.50","spread":"0.0594"},{"groupId":"OG002","value":"-0.44","spread":"0.0422"},{"groupId":"OG003","value":"-0.099","spread":"0.0570"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference (Final Values)","paramValue":"-0.29","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.45","ciUpperLimit":"-0.12"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference (Final Values)","paramValue":"-0.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.57","ciUpperLimit":"-0.24"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference (Final Values)","paramValue":"-0.34","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.49","ciUpperLimit":"-0.2"}]},{"type":"SECONDARY","title":"Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale","description":"The PedsQL Measurement Model measures health-related quality of life (HRQOL) in children (ages 8 to 12) and teenagers (ages 13 to 18). The 23-item PedsQL Generic Core Scale includes physical, emotional, social, and school functioning dimensions. The PedsQL Generic Core yields two summary scores: Physical Summary and Psychosocial Summary. Scores are transformed on a 0-100 scale, with higher scores indicating better functioning. Each item is scored from 0 (never) to 4 (almost always). Items are reverse scored and linearly transformed to a 0-100 scale so that higher scores indicate better HRQOL; the total score therefore ranges from 0 (worst) to 100 (best). Higher scores indicate better health-related quality of life. LS mean was determined by the MMRM model for post-baseline measures: Variable = Baseline + Baseline Antihyperglycemic Medication + Baseline Age Group + Treatment + Time + Treatment\\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind, open-label, and safety follow-up periods regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg Tirzepatide once weekly (QW) administered as subcutaneous (SC) injection via single-dose pen (SDP) for 30 weeks in double-blind period and 22 weeks in open-label period"},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period and 22 weeks in open-label period"},{"id":"OG002","title":"Placebo/5 mg Tirzepatide","description":"Participants who received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period were administered with 5 mg Tirzepatide QW administered as SC injection via SDP for 22 weeks in open-label period."},{"id":"OG003","title":"Pooled Doses of Tirzepatide (5mg,10mg)","description":"Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"27"},{"groupId":"OG002","value":"25"},{"groupId":"OG003","value":"56"}]}],"classes":[{"title":"Physical Functioning Score","categories":[{"measurements":[{"groupId":"OG000","value":"4.26","spread":"2.034"},{"groupId":"OG001","value":"3.06","spread":"2.092"},{"groupId":"OG002","value":"5.03","spread":"2.142"},{"groupId":"OG003","value":"3.66","spread":"1.456"}]}]},{"title":"Emotional Functioning Score","categories":[{"measurements":[{"groupId":"OG000","value":"4.35","spread":"3.506"},{"groupId":"OG001","value":"4.11","spread":"3.601"},{"groupId":"OG002","value":"6.78","spread":"3.705"},{"groupId":"OG003","value":"4.23","spread":"2.514"}]}]},{"title":"Social Functioning Score","categories":[{"measurements":[{"groupId":"OG000","value":"4.16","spread":"2.628"},{"groupId":"OG001","value":"3.00","spread":"2.696"},{"groupId":"OG002","value":"4.54","spread":"2.764"},{"groupId":"OG003","value":"3.58","spread":"1.878"}]}]},{"title":"School Functioning Score","categories":[{"measurements":[{"groupId":"OG000","value":"13.30","spread":"3.095"},{"groupId":"OG001","value":"0.18","spread":"3.152"},{"groupId":"OG002","value":"12.03","spread":"3.239"},{"groupId":"OG003","value":"6.74","spread":"2.197"}]}]},{"title":"Psychosocial Health Summary Score","categories":[{"measurements":[{"groupId":"OG000","value":"7.82","spread":"2.482"},{"groupId":"OG001","value":"2.20","spread":"2.533"},{"groupId":"OG002","value":"7.47","spread":"2.605"},{"groupId":"OG003","value":"5.01","spread":"1.767"}]}]},{"title":"Physical Health Summary Score","categories":[{"measurements":[{"groupId":"OG000","value":"4.26","spread":"2.034"},{"groupId":"OG001","value":"3.06","spread":"2.092"},{"groupId":"OG002","value":"5.03","spread":"2.142"},{"groupId":"OG003","value":"3.66","spread":"1.456"}]}]},{"title":"Total Score","categories":[{"measurements":[{"groupId":"OG000","value":"6.65","spread":"2.114"},{"groupId":"OG001","value":"2.45","spread":"2.163"},{"groupId":"OG002","value":"6.61","spread":"2.220"},{"groupId":"OG003","value":"4.55","spread":"1.507"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline PedsQL (3.2) Diabetic Module","description":"The PedsQL 3.2 Diabetes Module has 33 items for ages 13 years and older, and 32 items (1 less item for the Worry Scale) for ages 2 to 12 years. The 5 dimensions consist of diabetes symptoms (15 items), treatment barriers (5 items), treatment adherence (6 items), worry \\[2 items (3 for teens and adults)\\] and communication (4 items). Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores reflect fewer problems and better functioning. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment + Time + Treatment\\*Time(Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance- Covariance structure (Change from Baseline) = Unstructured.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind, open-label, and safety follow-up periods regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg Tirzepatide once weekly (QW) administered as subcutaneous (SC) injection via single-dose pen (SDP) for 30 weeks in double-blind period and 22 weeks in open-label period"},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period and 22 weeks in open-label period"},{"id":"OG002","title":"Placebo/5 mg Tirzepatide","description":"Participants who received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period were administered with 5 mg Tirzepatide QW administered as SC injection via SDP for 22 weeks in open-label period."},{"id":"OG003","title":"Pooled Doses of Tirzepatide (5mg,10mg)","description":"Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"27"},{"groupId":"OG002","value":"25"},{"groupId":"OG003","value":"56"}]}],"classes":[{"title":"Diabetes Management Summary Score","categories":[{"measurements":[{"groupId":"OG000","value":"7.21","spread":"2.669"},{"groupId":"OG001","value":"8.60","spread":"2.733"},{"groupId":"OG002","value":"5.25","spread":"2.872"},{"groupId":"OG003","value":"7.90","spread":"1.907"}]}]},{"title":"Total Score","categories":[{"measurements":[{"groupId":"OG000","value":"8.79","spread":"2.310"},{"groupId":"OG001","value":"8.74","spread":"2.374"},{"groupId":"OG002","value":"6.03","spread":"2.489"},{"groupId":"OG003","value":"8.76","spread":"1.657"}]}]}]},{"type":"SECONDARY","title":"Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide","description":"The steady-state AUCs were estimated from Tirzepatide concentrations at Weeks 0, 7, 16, and 29 using the population PK model by treatment group.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable PK data obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"nanogram*hour per milliliter (ng*hr/mL)","timeFrame":"Week 0: after the first dose anytime on the same day. Weeks 7, 16, and 29: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours post-dose, as assigned by IWRS.","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"31"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"92100","lowerLimit":"85700","upperLimit":"98600"},{"groupId":"OG001","value":"184000","lowerLimit":"171000","upperLimit":"197000"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline Up to Week 56","description":"All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts.\n\nPer analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.","eventGroups":[{"id":"EG000","title":"5 mg Tirzepatide / Double-Blind Period","description":"Participants received 5 mg of tirzepatide QW administered as SC injection via SDP for 30 weeks in a double-blind period.","deathsNumAffected":0,"deathsNumAtRisk":32,"seriousNumAffected":1,"seriousNumAtRisk":32,"otherNumAffected":17,"otherNumAtRisk":32},{"id":"EG001","title":"TZP 10mg / Double-Blind Period","description":"Participants received 10 mg of tirzepatide QW administered as SC injection via SDP for 30 weeks in a double-blind period.","deathsNumAffected":0,"deathsNumAtRisk":33,"seriousNumAffected":1,"seriousNumAtRisk":33,"otherNumAffected":19,"otherNumAtRisk":33},{"id":"EG002","title":"Placebo / Double-Blind Period","description":"Participants received placebo QW administered as SC injection via SDP for 30 weeks in a double-blind period.","deathsNumAffected":0,"deathsNumAtRisk":34,"seriousNumAffected":1,"seriousNumAtRisk":34,"otherNumAffected":11,"otherNumAtRisk":34},{"id":"EG003","title":"TZP 5mg / 5mg Open-Label and Safety Follow-Up Period","description":"Participants who received 5 mg tirzepatide during the double-blind period continued to receive 5 mg of tirzepatide QW administered as SC injection via SDP for 22 weeks in the open-label period and 4 weeks in the safety follow-up period.","deathsNumAffected":0,"deathsNumAtRisk":32,"seriousNumAffected":1,"seriousNumAtRisk":32,"otherNumAffected":10,"otherNumAtRisk":32},{"id":"EG004","title":"TZP 10mg / 10mg Open-Label and Safety Follow-Up Period","description":"Participants who received 10 mg of tirzepatide during the double-blind period continued to receive 10 mg of tirzepatide QW administered as SC injection via SDP for 22 weeks in the open-label period and 4 weeks in the safety follow-up period.","deathsNumAffected":0,"deathsNumAtRisk":33,"seriousNumAffected":1,"seriousNumAtRisk":33,"otherNumAffected":7,"otherNumAtRisk":33},{"id":"EG005","title":"Placebo/TZP 5mg Open-Label and Safety Follow-Up Period","description":"Participants who received placebo QW during the double-blind period were switched to 5 mg tirzepatide QW administered as SC injection via SDP for 22 weeks in the open-label period and 4 weeks in the safety follow-up period.","deathsNumAffected":0,"deathsNumAtRisk":32,"seriousNumAffected":0,"seriousNumAtRisk":32,"otherNumAffected":8,"otherNumAtRisk":32}],"seriousEvents":[{"term":"Appendicitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":32},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":33},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":34},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":33},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":32}]},{"term":"Mastoiditis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":33},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":34},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":33},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":32}]},{"term":"Borderline personality disorder","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":33},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":34},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":33},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":32}]},{"term":"Suicidal ideation","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":33},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":34},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":33},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":32}]},{"term":"Suicide attempt","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":33},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":34},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":33},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":32}]},{"term":"Cholecystitis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 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