{"protocolSection":{"identificationModule":{"nctId":"NCT06704763","orgStudyIdInfo":{"id":"27312"},"secondaryIdInfos":[{"id":"J2A-MC-GZPP","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Drug-Drug Interaction Study of Orforglipron (LY3502970) With Quinidine in Healthy Participants","officialTitle":"A Drug-Drug Interaction, Single-arm, Open-label Study to Assess the Effect of Quinidine on the Pharmacokinetics of Orforglipron in Healthy Participants"},"statusModule":{"statusVerifiedDate":"2026-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2024-12-06","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2025-02-05","type":"ACTUAL"},"completionDateStruct":{"date":"2025-02-05","type":"ACTUAL"},"studyFirstSubmitDate":"2024-11-22","studyFirstSubmitQcDate":"2024-11-22","studyFirstPostDateStruct":{"date":"2024-11-26","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-04-30","resultsFirstSubmitQcDate":"2026-04-30","resultsFirstPostDateStruct":{"date":"2026-05-26","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-04-30","lastUpdatePostDateStruct":{"date":"2026-05-26","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of this study is to determine the effect of quinidine on the levels of orforglipron in the blood stream and how long it takes the body to eliminate it, when administered orally in healthy participants.\n\nThe study will last up to approximately 8 weeks including screening."},"conditionsModule":{"conditions":["Healthy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":27,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Midazolam + Orforglipron + Quinidine","type":"EXPERIMENTAL","description":"Participants received:\n\n* Day -1: single dose of 0.2 milligram (mg) midazolam.\n* Day 1: single dose of 1 mg orforglipron.\n* Days 5 to 6: 200 mg quinidine twice daily (BID).\n* Day 7: 200 mg quinidine BID plus a single dose of 0.2 mg midazolam.\n* Day 8: 200 mg quinidine BID plus a single dose of 1 mg orforglipron.","interventionNames":["Drug: Orforglipron","Drug: Midazolam","Drug: Quinidine"]}],"interventions":[{"type":"DRUG","name":"Orforglipron","description":"Administered orally","armGroupLabels":["Midazolam + Orforglipron + Quinidine"],"otherNames":["LY3502970"]},{"type":"DRUG","name":"Midazolam","description":"Administered orally","armGroupLabels":["Midazolam + Orforglipron + Quinidine"]},{"type":"DRUG","name":"Quinidine","description":"Administered orally","armGroupLabels":["Midazolam + Orforglipron + Quinidine"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Orforglipron","description":"PK: AUC0-inf of Orforglipron.","timeFrame":"Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours post orforglipron dose on days 1, 8"},{"measure":"PK: Maximum Observed Concentration (Cmax) of Orforglipron","description":"PK: Cmax of Orforglipron.","timeFrame":"Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours post orforglipron dose on days 1, 8"}],"secondaryOutcomes":[{"measure":"PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Midazolam","description":"PK: AUC0-inf of Midazolam.","timeFrame":"Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7"},{"measure":"PK: Maximum Concentration (Cmax) of Midazolam","description":"PK: Cmax of Midazolam.","timeFrame":"Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7"},{"measure":"PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of 1-Hydroxymidazolam","description":"PK: AUC0-inf of 1-Hydroxymidazolam (metabolite of Midazolam).","timeFrame":"Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7"},{"measure":"PK: Maximum Concentration (Cmax) of 1-Hydroxymidazolam","description":"PK: Cmax of 1-Hydroxymidazolam (metabolite of Midazolam).","timeFrame":"Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG)\n* Have a hemoglobin level of:\n\n  * at least 11.4 grams per deciliter (g/dL) for individuals assigned female at birth (AFAB), and\n  * at least 12.5 g/dL for individuals assigned male at birth (AMAB)\n* Have a body weight equal to or greater than 45 kilograms (kg), and a body mass index within the range of 18.5 to 35.0 kilogram per square meter (kg/m²) at screening\n\nExclusion Criteria:\n\n* Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, psychological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting risk when taking orforglipron, midazolam, or quinidine; or interfering with the interpretation of data\n* Have a 12 lead electrocardiogram (ECG) abnormality, including known prolongation of QT/QTc interval, significant bradycardia, significant heart blocks or a history of any risk factors for ventricular arrhythmia, heart failure, hypokalemia or hypomagnesemia, or other factors that, in the opinion of the investigator, increases the risks associated with participating in the study\n* Have an abnormal blood pressure or pulse rate, deemed to be clinically significant by the investigator\n* Have a history of benign ethnic neutropenia\n* Have a GI disease or disorder, such as relevant esophageal reflux or gall bladder disease, which could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or impacts gastric emptying, for example gastric bypass surgery or pyloric stenosis, except for appendectomy\n* Have a history or presence of pancreatitis, including chronic pancreatitis or idiopathic acute pancreatitis\n* Have known allergies to:\n\n  * quinidine\n  * midazolam\n  * orforglipron\n  * related compounds, or\n  * any components of the formulation","healthyVolunteers":true,"sex":"ALL","minimumAge":"21 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Contact Lilly at 1-800-LillyRx (1-800-545-5979)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"ICON","city":"Salt Lake City","state":"Utah","zip":"84124","country":"United States","geoPoint":{"lat":40.76078,"lon":-111.89105}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Midazolam + Orforglipron + Quinidine","description":"Participants received:\n\n* Day -1: single dose of 0.2 milligram (mg) midazolam.\n* Day 1: single dose of 1 mg orforglipron.\n* Days 5 to 6: 200 mg quinidine twice daily (BID).\n* Day 7: 200 mg quinidine BID plus a single dose of 0.2 mg midazolam.\n* Day 8: 200 mg quinidine BID plus a single dose of 1 mg orforglipron."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"27"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"27"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"27"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All enrolled participants.","groups":[{"id":"BG000","title":"Midazolam + Orforglipron + Quinidine","description":"Participants received:\n\n* Day -1: single dose of 0.2 mg midazolam.\n* Day 1: single dose of 1 mg orforglipron.\n* Days 5 to 6: 200 mg quinidine BID.\n* Day 7: 200 mg quinidine BID plus a single dose of 0.2 mg midazolam.\n* Day 8: 200 mg quinidine BID plus a single dose of 1 mg orforglipron."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"27"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"35.3","spread":"9.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"13"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"14"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"4"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"23"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","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"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"3"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"22"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"27"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Orforglipron","description":"PK: AUC0-inf of Orforglipron.","populationDescription":"All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram*hour per milliliter","timeFrame":"Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours post orforglipron dose on days 1, 8","groups":[{"id":"OG000","title":"Midazolam + Orforglipron + Quinidine","description":"Participants received:\n\n* Day -1: single dose of 0.2 mg midazolam.\n* Day 1: single dose of 1 mg orforglipron.\n* Days 5 to 6: 200 mg quinidine BID.\n* Day 7: 200 mg quinidine BID plus a single dose of 0.2 mg midazolam.\n* Day 8: 200 mg quinidine BID plus a single dose of 1 mg orforglipron."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"}]}],"classes":[{"title":"Day 1","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"89.9","spread":"30.4"}]}]},{"title":"Day 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"79.1","spread":"30.2"}]}]}]},{"type":"PRIMARY","title":"PK: Maximum Observed Concentration (Cmax) of Orforglipron","description":"PK: Cmax of Orforglipron.","populationDescription":"All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram per milliliter","timeFrame":"Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours post orforglipron dose on days 1, 8","groups":[{"id":"OG000","title":"Midazolam + Orforglipron + Quinidine","description":"Participants received:\n\n* Day -1: single dose of 0.2 mg midazolam.\n* Day 1: single dose of 1 mg orforglipron.\n* Days 5 to 6: 200 mg quinidine BID.\n* Day 7: 200 mg quinidine BID plus a single dose of 0.2 mg midazolam.\n* Day 8: 200 mg quinidine BID plus a single dose of 1 mg orforglipron."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"}]}],"classes":[{"title":"Day 1","categories":[{"measurements":[{"groupId":"OG000","value":"4.11","spread":"32.2"}]}]},{"title":"Day 8","categories":[{"measurements":[{"groupId":"OG000","value":"3.06","spread":"39.6"}]}]}]},{"type":"SECONDARY","title":"PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Midazolam","description":"PK: AUC0-inf of Midazolam.","populationDescription":"All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram*hour per milliliter","timeFrame":"Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7","groups":[{"id":"OG000","title":"Midazolam + Orforglipron + Quinidine","description":"Participants received:\n\n* Day -1: single dose of 0.2 mg midazolam.\n* Day 1: single dose of 1 mg orforglipron.\n* Days 5 to 6: 200 mg quinidine BID.\n* Day 7: 200 mg quinidine BID plus a single dose of 0.2 mg midazolam.\n* Day 8: 200 mg quinidine BID plus a single dose of 1 mg orforglipron."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"}]}],"classes":[{"title":"Day -1","categories":[{"measurements":[{"groupId":"OG000","value":"2.06","spread":"41.7"}]}]},{"title":"Day 7","categories":[{"measurements":[{"groupId":"OG000","value":"2.73","spread":"42.1"}]}]}]},{"type":"SECONDARY","title":"PK: Maximum Concentration (Cmax) of Midazolam","description":"PK: Cmax of Midazolam.","populationDescription":"All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram per milliliter","timeFrame":"Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7","groups":[{"id":"OG000","title":"Midazolam + Orforglipron + Quinidine","description":"Participants received:\n\n* Day -1: single dose of 0.2 mg midazolam.\n* Day 1: single dose of 1 mg orforglipron.\n* Days 5 to 6: 200 mg quinidine BID.\n* Day 7: 200 mg quinidine BID plus a single dose of 0.2 mg midazolam.\n* Day 8: 200 mg quinidine BID plus a single dose of 1 mg orforglipron."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"}]}],"classes":[{"title":"Day -1","categories":[{"measurements":[{"groupId":"OG000","value":"0.725","spread":"35.2"}]}]},{"title":"Day 7","categories":[{"measurements":[{"groupId":"OG000","value":"0.999","spread":"49.2"}]}]}]},{"type":"SECONDARY","title":"PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of 1-Hydroxymidazolam","description":"PK: AUC0-inf of 1-Hydroxymidazolam (metabolite of Midazolam).","populationDescription":"All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram*hour per milliliter","timeFrame":"Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7","groups":[{"id":"OG000","title":"Midazolam + Orforglipron + Quinidine","description":"Participants received:\n\n* Day -1: single dose of 0.2 mg midazolam.\n* Day 1: single dose of 1 mg orforglipron.\n* Days 5 to 6: 200 mg quinidine BID.\n* Day 7: 200 mg quinidine BID plus a single dose of 0.2 mg midazolam.\n* Day 8: 200 mg quinidine BID plus a single dose of 1 mg orforglipron."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"}]}],"classes":[{"title":"Day -1","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.676","spread":"39.2"}]}]},{"title":"Day 7","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.999","spread":"38"}]}]}]},{"type":"SECONDARY","title":"PK: Maximum Concentration (Cmax) of 1-Hydroxymidazolam","description":"PK: Cmax of 1-Hydroxymidazolam (metabolite of Midazolam).","populationDescription":"All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram per milliliter","timeFrame":"Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7","groups":[{"id":"OG000","title":"Midazolam + Orforglipron + Quinidine","description":"Participants received:\n\n* Day -1: single dose of 0.2 mg midazolam.\n* Day 1: single dose of 1 mg orforglipron.\n* Days 5 to 6: 200 mg quinidine BID.\n* Day 7: 200 mg quinidine BID plus a single dose of 0.2 mg midazolam.\n* Day 8: 200 mg quinidine BID plus a single dose of 1 mg orforglipron."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"}]}],"classes":[{"title":"Day -1","categories":[{"measurements":[{"groupId":"OG000","value":"0.224","spread":"39.6"}]}]},{"title":"Day 7","categories":[{"measurements":[{"groupId":"OG000","value":"0.343","spread":"50.5"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Day -1 through the end of study (Up To 21 days)","description":"* All enrolled participants who received at least one dose of study drug.\n* As per the planned safety analyses, adverse event data were reported by days (i.e) Day -1 = 0.2 mg Midazolam; Days 1 to 4 = 1 mg Orforglipron; Days 5 to 6 = 200 mg Quinidine BID ; Day 7 = 200 mg Quinidine BID + 0.2 mg Midazolam; Day 8 to end of study = 200 mg Quinidine BID + 1 mg Orforglipron .","eventGroups":[{"id":"EG000","title":"0.2 mg Midazolam (Day -1)","description":"Participants observed for adverse events during and after Midazolam on Day -1 and prior to Day 1 dosing were grouped under this arm.","deathsNumAffected":0,"deathsNumAtRisk":27,"seriousNumAffected":0,"seriousNumAtRisk":27,"otherNumAffected":4,"otherNumAtRisk":27},{"id":"EG001","title":"1 mg Orforglipron (Days 1 to 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arm.","deathsNumAffected":0,"deathsNumAtRisk":27,"seriousNumAffected":0,"seriousNumAtRisk":27,"otherNumAffected":1,"otherNumAtRisk":27},{"id":"EG004","title":"200mg Quinidine BID + 1mg Orforglipron (Day 8 to End of Study)","description":"Participants observed for adverse events during and after Quinidine and Orforglipron on Day 8 were grouped under this arm.","deathsNumAffected":0,"deathsNumAtRisk":27,"seriousNumAffected":0,"seriousNumAtRisk":27,"otherNumAffected":7,"otherNumAtRisk":27}],"otherEvents":[{"term":"Palpitations","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":27},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":27}]},{"term":"Dry eye","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":27},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":27}]},{"term":"Vision blurred","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":27},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":27}]},{"term":"Abdominal distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":27},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":27}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":27},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":27}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":27},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":27}]},{"term":"Flatulence","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":27},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":27}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":27},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":27},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":27}]},{"term":"Rectal tenesmus","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":27},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":27}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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