{"protocolSection":{"identificationModule":{"nctId":"NCT03861039","orgStudyIdInfo":{"id":"17078"},"secondaryIdInfos":[{"id":"I8F-JE-GPGP","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes","officialTitle":"A Phase 3, Long-Term Safety Study of Tirzepatide in Combination With Monotherapy of Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus (SURPASS J-combo)"},"statusModule":{"statusVerifiedDate":"2022-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-03-30","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-01-26","type":"ACTUAL"},"completionDateStruct":{"date":"2021-02-16","type":"ACTUAL"},"studyFirstSubmitDate":"2019-03-01","studyFirstSubmitQcDate":"2019-03-01","studyFirstPostDateStruct":{"date":"2019-03-04","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-01-21","resultsFirstSubmitQcDate":"2022-01-21","resultsFirstPostDateStruct":{"date":"2022-02-14","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-01-21","lastUpdatePostDateStruct":{"date":"2022-02-14","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"The purpose of this study is to determine the long-term safety of the study drug tirzepatide in combination with oral antihyperglycemic medications in participants with type 2 diabetes."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":443,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"5 mg Tirzepatide","type":"EXPERIMENTAL","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.","interventionNames":["Drug: Tirzepatide","Drug: Oral antihyperglycemic medication (OAM)"]},{"label":"10 mg Tirzepatide","type":"EXPERIMENTAL","description":"10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.","interventionNames":["Drug: Tirzepatide","Drug: Oral antihyperglycemic medication (OAM)"]},{"label":"15 mg Tirzepatide","type":"EXPERIMENTAL","description":"15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.","interventionNames":["Drug: Tirzepatide","Drug: Oral antihyperglycemic medication (OAM)"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC","armGroupLabels":["10 mg Tirzepatide","15 mg Tirzepatide","5 mg Tirzepatide"],"otherNames":["LY3298176"]},{"type":"DRUG","name":"Oral antihyperglycemic medication (OAM)","description":"Oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.","armGroupLabels":["10 mg Tirzepatide","15 mg Tirzepatide","5 mg Tirzepatide"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration","description":"An SAE is any AE from this study that results in one of the following outcomes:\n\n* Death\n* Initial or prolonged inpatient hospitalization\n* A life-threatening experience (that is, immediate risk of dying)\n* Persistent or significant disability/incapacity\n* Congenital anomaly/birth defect.\n* Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require.\n\nA summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.","timeFrame":"Baseline through Week 52"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Hemoglobin A1c (HbA1c)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + oral antihyperglycemic medication (OAM) Group 1 + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Percentage of Participants Who Achieve HbA1c <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.","timeFrame":"Week 52"},{"measure":"Change From Baseline in Fasting Serum Glucose","description":"Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + OAM Group 1 + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, 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 analysis of covariance (ANCOVA) model for endpoint measures: Variable = Baseline + OAM Group 1 + Treatment (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline in Body Weight","description":"LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + OAM Group 1 + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Percentage of Participants Who Achieve Weight Loss of ≥5% From Baseline","description":"Percentage of Participants who Achieve Weight Loss of ≥5% from Baseline","timeFrame":"Week 52"},{"measure":"Change From Baseline in Fasting Insulin","description":"LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline in Fasting C-Peptide","description":"LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline in Homeostasis Model Assessment B (HOMA-2B) (Insulin)","description":"The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S).\n\nLS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline in HOMA-2S (Insulin)","description":"The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S).\n\nLS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Number of Participants With Hypoglycemia Incidence and Rate With Blood Glucose <54 mg/dL or Severe Hypoglycemia, Exclude Hypoglycemic Events Occurring After Initiation of a New Antihyperglycemic Therapy","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.","timeFrame":"Baseline through Week 56"},{"measure":"Number of Participants With Anti-Tirzepatide Antibodies","description":"Number of Participants with Anti-Tirzepatide Antibodies","timeFrame":"Baseline through Week 52"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\nParticipant must:\n\n* Have been diagnosed with type 2 diabetes mellitus based on the World Health Organization classification before the screening visit.\n* Have HbA1c ≥7.0% to \\<11.0%, as determined by the central laboratory at screening.\n* Have been taking sulfonylureas, biguanides, thiazolidinedione, alpha-glucosidase inhibitor, glinides, or sodium-glucose cotransporter type 2 inhibitor monotherapy for at least 3 months before screening and have been on the following dose for at least 8 weeks before screening.\n* Have body mass index (BMI) of ≥23 kilograms per meter squared at screening.\n* Be of stable weight (±5%) during 3 months preceding screening; and agree to not initiate an intensive diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment.\n\nExclusion Criteria:\n\nParticipant 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 immediate or urgent 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 there ALT level is ≤3.0 the ULN for the reference range.\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 weight loss drugs, including over-the-counter medications during the last 3 months.","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Akaicho Clinic","city":"Chiba","state":"Chiba","zip":"260 0804","country":"Japan","geoPoint":{"lat":35.6,"lon":140.11667}},{"facility":"Kashiwa hospital","city":"Kashiwa","state":"Chiba","zip":"277-0825","country":"Japan","geoPoint":{"lat":35.86224,"lon":139.97732}},{"facility":"Yuri Ono Clinic","city":"Sapporo","state":"Hokkaido","zip":"060-0001","country":"Japan","geoPoint":{"lat":43.06667,"lon":141.35}},{"facility":"Manda Hospital","city":"Sapporo","state":"Hokkaido","zip":"060-0062","country":"Japan","geoPoint":{"lat":43.06667,"lon":141.35}},{"facility":"Miyanomori Hospital","city":"Sapporo","state":"Hokkaido","zip":"064-8570","country":"Japan","geoPoint":{"lat":43.06667,"lon":141.35}},{"facility":"Ikeda Hospital","city":"Amagasaki","state":"Hyōgo","zip":"661-0002","country":"Japan","geoPoint":{"lat":34.71667,"lon":135.41667}},{"facility":"Nakamoto Naika Clinic","city":"Mito","state":"Ibaraki","zip":"310 0826","country":"Japan","geoPoint":{"lat":36.35,"lon":140.45}},{"facility":"Naka Memorial Clinic","city":"Naka","state":"Ibaraki","zip":"311-0113","country":"Japan","geoPoint":{"lat":36.05,"lon":140.16667}},{"facility":"Ohishi Naika Clinic","city":"Tsuchiura","state":"Ibaraki","zip":"300-0835","country":"Japan","geoPoint":{"lat":36.09047,"lon":140.21047}},{"facility":"Takai Naika Clinic","city":"Kamakura","state":"Kanagawa","zip":"247-0056","country":"Japan","geoPoint":{"lat":35.31085,"lon":139.54698}},{"facility":"Tsuruma Kaneshiro Diabetes Clinic","city":"Yamato","state":"Kanagawa","zip":"242-0004","country":"Japan","geoPoint":{"lat":35.47276,"lon":139.45101}},{"facility":"Yokohama Minoru Clinic","city":"Yokohama","state":"Kanagawa","zip":"232-0064","country":"Japan","geoPoint":{"lat":35.43333,"lon":139.65}},{"facility":"H.E.C. Science Clinic","city":"Yokohama","state":"Kanagawa","zip":"235-0045","country":"Japan","geoPoint":{"lat":35.43333,"lon":139.65}},{"facility":"Takatsuki Red Cross Hospital","city":"Takatsuki","state":"Osaka","zip":"569-1096","country":"Japan","geoPoint":{"lat":34.84833,"lon":135.61678}},{"facility":"Otsu City Hospital","city":"Ōtsu","state":"Shiga","zip":"520-0804","country":"Japan","geoPoint":{"lat":35.0,"lon":135.86667}},{"facility":"Wakakusa Clinic","city":"Shimotsuke","state":"Tochigi","zip":"329-0433","country":"Japan","geoPoint":{"lat":36.41323,"lon":139.86622}},{"facility":"Seiwa Clinic","city":"Adachi-ku","state":"Tokyo","zip":"123 0845","country":"Japan"},{"facility":"HDC Atlas Clinic","city":"Chiyoda City","state":"Tokyo","zip":"102-0082","country":"Japan","geoPoint":{"lat":35.68449,"lon":139.75056}},{"facility":"Asahi Life Foundation Adult Disease Research Center","city":"Chuo-ku","state":"Tokyo","zip":"103 0002","country":"Japan"},{"facility":"Nihonbashi Sakura Clinic","city":"Chuo-ku","state":"Tokyo","zip":"103-0025","country":"Japan"},{"facility":"Tokyo-Eki Center-building Clinic","city":"Chuo-ku","state":"Tokyo","zip":"103-0027","country":"Japan"},{"facility":"Tokyo Center Clinic","city":"Chuo-ku","state":"Tokyo","zip":"103-0028","country":"Japan"},{"facility":"Tokyo Clinical Trial Centre Fukuwa Clinic","city":"Chuo-ku","state":"Tokyo","zip":"104-0031","country":"Japan"},{"facility":"Kanno Naika","city":"Mitaka","state":"Tokyo","zip":"181 0013","country":"Japan","geoPoint":{"lat":35.68361,"lon":139.56002}},{"facility":"Shinjuku Research Park Clinic","city":"Shinjuku-Ku","state":"Tokyo","zip":"169-0073","country":"Japan"},{"facility":"Futata Tetsuhiro Clinic","city":"Fukuoka","zip":"819 0006","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"facility":"Morinaga Ueno Clinic","city":"Kumamoto","zip":"860 0863","country":"Japan","geoPoint":{"lat":32.80589,"lon":130.69181}},{"facility":"Jinnouchi Hospital","city":"Kumamoto","zip":"862-0976","country":"Japan","geoPoint":{"lat":32.80589,"lon":130.69181}},{"facility":"Saiseikai Noe Hospital","city":"Osaka","zip":"536 0001","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"Kitada Clinic","city":"Osaka","zip":"538 0044","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"Kansai Denryoku Hospital","city":"Osaka","zip":"553-0003","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"Abe Diabetes Clinic","city":"Ōita","zip":"870-0039","country":"Japan","geoPoint":{"lat":33.23333,"lon":131.6}},{"facility":"Shizuoka City Shizuoka Hospital","city":"Shizuoka","zip":"420-8630","country":"Japan","geoPoint":{"lat":34.98333,"lon":138.38333}},{"facility":"Suruga Clinic","city":"Shizuoka","zip":"424-0855","country":"Japan","geoPoint":{"lat":34.98333,"lon":138.38333}}]},"referencesModule":{"references":[{"pmid":"40711720","type":"DERIVED","citation":"Mimura H, Oura T, Chin R, Hirase T, Shimono D. Association Between Early Weight Loss and Metabolic Outcomes with Tirzepatide in Japanese Patients with Type 2 Diabetes: A SURPASS J Post Hoc Analysis. Diabetes Ther. 2025 Sep;16(9):1871-1885. doi: 10.1007/s13300-025-01775-y. Epub 2025 Jul 25."},{"pmid":"35914542","type":"DERIVED","citation":"Kadowaki T, Chin R, Ozeki A, Imaoka T, Ogawa Y. Safety and efficacy of tirzepatide as an add-on to single oral antihyperglycaemic medication in patients with type 2 diabetes in Japan (SURPASS J-combo): a multicentre, randomised, open-label, parallel-group, phase 3 trial. Lancet Diabetes Endocrinol. 2022 Sep;10(9):634-644. doi: 10.1016/S2213-8587(22)00187-5. Epub 2022 Jul 30."}],"seeAlsoLinks":[{"label":"A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes","url":"https://trials.lillytrialguide.com/en-US/trial/2qJ9f49B7nrO6hGapNnDZD"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.","infoTypes":["STUDY_PROTOCOL","SAP","CSR"],"timeFrame":"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.","accessCriteria":"A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.","url":"https://vivli.org/"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"FG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"FG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"148"},{"groupId":"FG001","numSubjects":"147"},{"groupId":"FG002","numSubjects":"148"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"148"},{"groupId":"FG001","numSubjects":"147"},{"groupId":"FG002","numSubjects":"148"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"145"},{"groupId":"FG001","numSubjects":"139"},{"groupId":"FG002","numSubjects":"133"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"15"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"11"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"4"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants.","groups":[{"id":"BG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"BG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"BG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"148"},{"groupId":"BG001","value":"147"},{"groupId":"BG002","value":"148"},{"groupId":"BG003","value":"443"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"57.7","spread":"11.0"},{"groupId":"BG001","value":"56.9","spread":"11.2"},{"groupId":"BG002","value":"56.5","spread":"10.4"},{"groupId":"BG003","value":"57.0","spread":"10.8"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"34"},{"groupId":"BG002","value":"44"},{"groupId":"BG003","value":"107"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"119"},{"groupId":"BG001","value":"113"},{"groupId":"BG002","value":"104"},{"groupId":"BG003","value":"336"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"148"},{"groupId":"BG001","value":"147"},{"groupId":"BG002","value":"148"},{"groupId":"BG003","value":"443"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"148"},{"groupId":"BG001","value":"147"},{"groupId":"BG002","value":"148"},{"groupId":"BG003","value":"443"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"Japan","categories":[{"measurements":[{"groupId":"BG000","value":"148"},{"groupId":"BG001","value":"147"},{"groupId":"BG002","value":"148"},{"groupId":"BG003","value":"443"}]}]}]},{"title":"Hemoglobin A1c","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":": Percentage of HbA1c","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.53","spread":"1.15"},{"groupId":"BG001","value":"8.56","spread":"1.05"},{"groupId":"BG002","value":"8.59","spread":"1.09"},{"groupId":"BG003","value":"8.56","spread":"1.09"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration","description":"An SAE is any AE from this study that results in one of the following outcomes:\n\n* Death\n* Initial or prolonged inpatient hospitalization\n* A life-threatening experience (that is, immediate risk of dying)\n* Persistent or significant disability/incapacity\n* Congenital anomaly/birth defect.\n* Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require.\n\nA summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.","populationDescription":"All randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"timeFrame":"Baseline through Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"147"},{"groupId":"OG002","value":"148"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Hemoglobin A1c (HbA1c)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + oral antihyperglycemic medication (OAM) Group 1 + 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.","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. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"146"},{"groupId":"OG002","value":"145"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.57","spread":"0.075"},{"groupId":"OG001","value":"-2.98","spread":"0.075"},{"groupId":"OG002","value":"-3.02","spread":"0.077"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieve HbA1c <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.","populationDescription":"All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value.","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. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"146"},{"groupId":"OG002","value":"145"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"92.57"},{"groupId":"OG001","value":"97.95"},{"groupId":"OG002","value":"96.55"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Serum Glucose","description":"Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + OAM Group 1 + 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.","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. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"146"},{"groupId":"OG002","value":"145"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-58.6","spread":"1.75"},{"groupId":"OG001","value":"-71.2","spread":"1.75"},{"groupId":"OG002","value":"-74.4","spread":"1.81"}]}]}]},{"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 analysis of covariance (ANCOVA) model for endpoint measures: Variable = Baseline + OAM Group 1 + 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.","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. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"136"},{"groupId":"OG001","value":"135"},{"groupId":"OG002","value":"125"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-80.0","spread":"1.91"},{"groupId":"OG001","value":"-94.1","spread":"1.92"},{"groupId":"OG002","value":"-96.3","spread":"1.99"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight","description":"LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + OAM Group 1 + 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.","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. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"146"},{"groupId":"OG002","value":"145"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.8","spread":"0.51"},{"groupId":"OG001","value":"-7.5","spread":"0.51"},{"groupId":"OG002","value":"-10.2","spread":"0.52"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieve Weight Loss of ≥5% From Baseline","description":"Percentage of Participants who Achieve Weight Loss of ≥5% from Baseline","populationDescription":"All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value.","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. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"146"},{"groupId":"OG002","value":"145"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"43.92"},{"groupId":"OG001","value":"70.55"},{"groupId":"OG002","value":"84.14"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Insulin","description":"LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + 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.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"picomol per liter (pmol/L)","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"143"},{"groupId":"OG001","value":"144"},{"groupId":"OG002","value":"134"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.2","spread":"2.68"},{"groupId":"OG001","value":"-4.8","spread":"2.21"},{"groupId":"OG002","value":"-7.7","spread":"2.16"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting C-Peptide","description":"LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + 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.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"micrograms/litre (ug/L)","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"143"},{"groupId":"OG001","value":"144"},{"groupId":"OG002","value":"134"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.12","spread":"0.044"},{"groupId":"OG001","value":"-0.28","spread":"0.040"},{"groupId":"OG002","value":"-0.34","spread":"0.040"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Homeostasis Model Assessment B (HOMA-2B) (Insulin)","description":"The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S).\n\nLS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + 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.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HOMA-2B","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"135"},{"groupId":"OG002","value":"128"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"39.7","spread":"2.16"},{"groupId":"OG001","value":"44.9","spread":"2.40"},{"groupId":"OG002","value":"49.2","spread":"2.60"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in HOMA-2S (Insulin)","description":"The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S).\n\nLS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + 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.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage of HOMA-2S","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"135"},{"groupId":"OG002","value":"128"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.1","spread":"3.37"},{"groupId":"OG001","value":"16.7","spread":"4.23"},{"groupId":"OG002","value":"24.1","spread":"4.66"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Hypoglycemia Incidence and Rate With Blood Glucose <54 mg/dL or Severe Hypoglycemia, Exclude Hypoglycemic Events Occurring After Initiation of a New Antihyperglycemic Therapy","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.","populationDescription":"All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline through Week 56","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"147"},{"groupId":"OG002","value":"148"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"3"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Anti-Tirzepatide Antibodies","description":"Number of Participants with Anti-Tirzepatide Antibodies","populationDescription":"All randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"timeFrame":"Baseline through Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"147"},{"groupId":"OG002","value":"148"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"87"},{"groupId":"OG001","value":"82"},{"groupId":"OG002","value":"88"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Baseline through Week 56","description":"All randomized 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.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.","deathsNumAffected":0,"deathsNumAtRisk":148,"seriousNumAffected":2,"seriousNumAtRisk":148,"otherNumAffected":109,"otherNumAtRisk":148},{"id":"EG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.","deathsNumAffected":0,"deathsNumAtRisk":147,"seriousNumAffected":11,"seriousNumAtRisk":147,"otherNumAffected":108,"otherNumAtRisk":147},{"id":"EG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.","deathsNumAffected":0,"deathsNumAtRisk":148,"seriousNumAffected":11,"seriousNumAtRisk":148,"otherNumAffected":124,"otherNumAtRisk":148}],"seriousEvents":[{"term":"Angina pectoris","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Atrioventricular block complete","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Vertigo positional","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Cataract","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Eyelid ptosis","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Macular fibrosis","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Colitis ulcerative","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Cholelithiasis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Appendicitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Diabetic gangrene","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Pneumonia legionella","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Clavicle fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Radius fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Joint contracture","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Spinal ligament ossification","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Basal cell carcinoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Bladder cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Bladder papilloma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Colon cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Renal neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Facial paralysis","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Nephrolithiasis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Ureterolithiasis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Coronary artery bypass","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Intra-cerebral aneurysm operation","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]}],"otherEvents":[{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":148}]},{"term":"Leukopenia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Angina pectoris","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Atrioventricular block complete","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Bundle branch block right","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Palpitations","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":148}]},{"term":"Tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Ventricular extrasystoles","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Ventricular tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Deafness neurosensory","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Meniere's disease","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Vertigo","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Blepharitis","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Cataract","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Conjunctival haemorrhage","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":148}]},{"term":"Conjunctivitis allergic","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":148}]},{"term":"Corneal leukoma","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Diabetic retinopathy","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Dry eye","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Eczema eyelids","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Glaucoma","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Iridocyclitis","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Maculopathy","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":2,"numAffected":1,"numAtRisk":148}]},{"term":"Ocular hypertension","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Swelling of eyelid","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Vitreous floaters","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Abdominal discomfort","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":10,"numAffected":9,"numAtRisk":148},{"groupId":"EG001","numEvents":9,"numAffected":7,"numAtRisk":147},{"groupId":"EG002","numEvents":10,"numAffected":8,"numAtRisk":148}]},{"term":"Abdominal distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":5,"numAtRisk":148},{"groupId":"EG001","numEvents":7,"numAffected":6,"numAtRisk":147},{"groupId":"EG002","numEvents":7,"numAffected":6,"numAtRisk":148}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":3,"numAffected":2,"numAtRisk":147},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":148}]},{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":147},{"groupId":"EG002","numEvents":5,"numAffected":5,"numAtRisk":148}]},{"term":"Anal fissure","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Anal pruritus","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Aphthous ulcer","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Barrett's oesophagus","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Chronic gastritis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":12,"numAffected":12,"numAtRisk":148},{"groupId":"EG001","numEvents":21,"numAffected":20,"numAtRisk":147},{"groupId":"EG002","numEvents":24,"numAffected":22,"numAtRisk":148}]},{"term":"Dental caries","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":148},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":24,"numAffected":11,"numAtRisk":148},{"groupId":"EG001","numEvents":40,"numAffected":20,"numAtRisk":147},{"groupId":"EG002","numEvents":28,"numAffected":20,"numAtRisk":148}]},{"term":"Dry mouth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":6,"numAtRisk":148},{"groupId":"EG001","numEvents":19,"numAffected":11,"numAtRisk":147},{"groupId":"EG002","numEvents":6,"numAffected":5,"numAtRisk":148}]},{"term":"Enterocolitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Eructation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Faeces soft","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":147},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":148}]},{"term":"Flatulence","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Functional gastrointestinal disorder","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Gastric disorder","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Gastric ulcer","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Gastritis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Gastritis erosive","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Gastrointestinal disorder","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":148}]},{"term":"Gastrooesophageal reflux disease","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":148},{"groupId":"EG001","numEvents":6,"numAffected":6,"numAtRisk":147},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":148}]},{"term":"Haematochezia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Haemorrhoids","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Hiatus hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Inguinal hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Irritable bowel syndrome","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Large intestine polyp","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":60,"numAffected":14,"numAtRisk":148},{"groupId":"EG001","numEvents":35,"numAffected":20,"numAtRisk":147},{"groupId":"EG002","numEvents":51,"numAffected":40,"numAtRisk":148}]},{"term":"Oesophagitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Parotid gland enlargement","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Stomatitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Toothache","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":4,"numAtRisk":148},{"groupId":"EG001","numEvents":13,"numAffected":11,"numAtRisk":147},{"groupId":"EG002","numEvents":23,"numAffected":15,"numAtRisk":148}]},{"term":"Asthenia","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Chest discomfort","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":4,"numAffected":2,"numAtRisk":148}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":147},{"groupId":"EG002","numEvents":4,"numAffected":3,"numAtRisk":148}]},{"term":"Injection site haemorrhage","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Injection site pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":2,"numAffected":1,"numAtRisk":148}]},{"term":"Injection site reaction","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":4,"numAtRisk":148},{"groupId":"EG001","numEvents":25,"numAffected":3,"numAtRisk":147},{"groupId":"EG002","numEvents":72,"numAffected":4,"numAtRisk":148}]},{"term":"Malaise","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":4,"numAffected":3,"numAtRisk":147},{"groupId":"EG002","numEvents":6,"numAffected":6,"numAtRisk":148}]},{"term":"Oedema peripheral","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Pyrexia","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Cholelithiasis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Fatty liver alcoholic","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Gallbladder polyp","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":148}]},{"term":"Hepatic cyst","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":148}]},{"term":"Hepatic function abnormal","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Hepatic steatosis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Hepatomegaly","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Seasonal allergy","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Acute sinusitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Adenoviral conjunctivitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Bronchitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Campylobacter gastroenteritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Cellulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Conjunctivitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Cystitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":147},{"groupId":"EG002","numEvents":6,"numAffected":2,"numAtRisk":148}]},{"term":"Dermatitis infected","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Empyema","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Enterocolitis viral","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Folliculitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Furuncle","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Gastroenteritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":9,"numAffected":7,"numAtRisk":148},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":147},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":148}]},{"term":"Gastroenteritis viral","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Gingivitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Helicobacter infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Hepatitis e","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Herpes simplex","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Herpes virus infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Herpes zoster","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":147},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":148}]},{"term":"Hordeolum","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":3,"numAffected":2,"numAtRisk":148}]},{"term":"Infected dermal cyst","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Influenza","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":148}]},{"term":"Nasal vestibulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":34,"numAffected":28,"numAtRisk":148},{"groupId":"EG001","numEvents":26,"numAffected":20,"numAtRisk":147},{"groupId":"EG002","numEvents":37,"numAffected":27,"numAtRisk":148}]},{"term":"Oral herpes","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Otitis media","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Paronychia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Parotitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Periodontitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":148}]},{"term":"Pharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":147},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":148}]},{"term":"Rhinitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Sinusitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Tinea pedis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Tonsillitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Tracheobronchitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Upper respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Varicella","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Vulvovaginal candidiasis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":29},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":34},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":44}]},{"term":"Animal bite","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Ankle fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Arthropod sting","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Compression fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Contusion","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Epicondylitis","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Foot fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Heat illness","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Ligament sprain","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":3,"numAffected":2,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Post-traumatic neck syndrome","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Procedural pain","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Radius fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Rib fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Skin abrasion","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Skin laceration","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Spinal compression fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Thermal burn","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Upper limb fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Wound","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Alanine aminotransferase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":148}]},{"term":"Amylase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":147},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":148}]},{"term":"Aspartate aminotransferase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":148}]},{"term":"Blood alkaline phosphatase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Blood calcitonin increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Blood creatine phosphokinase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Blood creatinine increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Blood pressure decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Electrocardiogram st segment depression","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Gamma-glutamyltransferase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Heart rate increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Helicobacter test positive","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Hepatic enzyme increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":3,"numAffected":1,"numAtRisk":148}]},{"term":"Lipase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":4,"numAtRisk":148},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":147},{"groupId":"EG002","numEvents":9,"numAffected":9,"numAtRisk":148}]},{"term":"Occult blood","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Occult blood positive","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Salmonella test positive","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Urine albumin/creatinine ratio increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Weight decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":8,"numAffected":8,"numAtRisk":147},{"groupId":"EG002","numEvents":6,"numAffected":6,"numAtRisk":148}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":11,"numAffected":11,"numAtRisk":148},{"groupId":"EG001","numEvents":18,"numAffected":15,"numAtRisk":147},{"groupId":"EG002","numEvents":19,"numAffected":18,"numAtRisk":148}]},{"term":"Dehydration","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Gout","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Hyperamylasaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Hypercalcitoninaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Hyperglycaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Hyperlipasaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Hyperlipidaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Hyperuricaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Arthralgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":147},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":148}]},{"term":"Arthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Back pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":148},{"groupId":"EG001","numEvents":8,"numAffected":8,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Coccydynia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Intervertebral disc protrusion","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Lumbar spinal stenosis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Muscle spasms","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Musculoskeletal stiffness","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Myalgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Myositis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Neck pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Nodal osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":148}]},{"term":"Osteoporosis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Pain in extremity","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Periarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":147},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":148}]},{"term":"Rotator cuff syndrome","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Spinal osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Spinal stenosis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Synovial cyst","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Tendon pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Tenosynovitis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Tenosynovitis stenosans","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Trigger finger","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Neoplasm skin","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Renal neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Skin papilloma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Uterine leiomyoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":29},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":34},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":44}]},{"term":"Autonomic nervous system imbalance","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":3,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Cervical radiculopathy","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":147},{"groupId":"EG002","numEvents":8,"numAffected":8,"numAtRisk":148}]},{"term":"Dizziness postural","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":6,"numAffected":3,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Dysaesthesia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Dysgeusia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Facial paralysis","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":148}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":148},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":147},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":148}]},{"term":"Hypoaesthesia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Intercostal neuralgia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Somnolence","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Syncope","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Tremor","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Trigeminal neuralgia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Adjustment disorder with depressed mood","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Panic disorder","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Calculus urinary","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Diabetic nephropathy","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Haematuria","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Hydronephrosis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Nephrocalcinosis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Nephrolithiasis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Pollakiuria","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Renal cyst","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":148}]},{"term":"Renal impairment","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Ureterolithiasis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":3,"numAffected":2,"numAtRisk":148}]},{"term":"Benign prostatic hyperplasia","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":113},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":104}]},{"term":"Breast calcifications","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Menorrhagia","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":29},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":34},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":44}]},{"term":"Vulvovaginal inflammation","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":29},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":34},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":44}]},{"term":"Asthma","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Cough","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Cystic lung disease","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Dysphonia","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Dyspnoea","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Epistaxis","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Hiccups","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":2,"numAffected":1,"numAtRisk":148}]},{"term":"Oropharyngeal discomfort","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Oropharyngeal pain","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Rhinitis allergic","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":148}]},{"term":"Rhinorrhoea","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Upper respiratory tract inflammation","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Asteatosis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Decubitus ulcer","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Dermal cyst","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Dermatitis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Dermatitis contact","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Drug eruption","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Dry skin","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":148}]},{"term":"Dyshidrotic eczema","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Eczema","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":148}]},{"term":"Eczema asteatotic","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Haemorrhage subcutaneous","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Ingrowing nail","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Miliaria","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Pain of skin","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Pruritus","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Psoriasis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Rash","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Urticaria","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Cataract operation","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Intraocular lens implant","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Skin lesion removal","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Transurethral bladder resection","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Ureteric calculus removal","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Urethral stent insertion","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Arteriosclerosis","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":148}]},{"term":"Hypertension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":148},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]},{"term":"Orthostatic hypotension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":148},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":147},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":148}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"LTE60","restrictiveAgreement":true},"pointOfContact":{"title":"Chief Medical Officer","organization":"Eli Lilly and Company","email":"ClinicalTrials.gov@lilly.com","phone":"800-545-5979"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2019-01-17","uploadDate":"2021-12-09T23:34","filename":"Prot_000.pdf","size":1111961},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2021-02-17","uploadDate":"2021-12-09T23:35","filename":"SAP_001.pdf","size":701767}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"}],"ancestors":[{"id":"D003920","term":"Diabetes Mellitus"},{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D000098860","term":"Tirzepatide"}],"ancestors":[{"id":"D000067757","term":"Glucagon-Like Peptide-1 Receptor"},{"id":"D000067756","term":"Glucagon-Like Peptide Receptors"},{"id":"D043562","term":"Receptors, G-Protein-Coupled"},{"id":"D011956","term":"Receptors, Cell Surface"},{"id":"D008565","term":"Membrane Proteins"},{"id":"D011506","term":"Proteins"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"},{"id":"D011964","term":"Receptors, Gastrointestinal Hormone"},{"id":"D018000","term":"Receptors, Peptide"}]}},"hasResults":true}