{"protocolSection":{"identificationModule":{"nctId":"NCT05341089","orgStudyIdInfo":{"id":"17785"},"secondaryIdInfos":[{"id":"J2A-MC-GZGH","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Two Different Formulations of LY3502970 in Healthy Participants","officialTitle":"A Phase 1 Multiple-Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of 2 Different Formulations of LY3502970 in Healthy Participants"},"statusModule":{"statusVerifiedDate":"2026-04-15","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-05-17","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-09-01","type":"ACTUAL"},"completionDateStruct":{"date":"2022-09-01","type":"ACTUAL"},"studyFirstSubmitDate":"2022-04-18","studyFirstSubmitQcDate":"2022-04-18","studyFirstPostDateStruct":{"date":"2022-04-22","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-04-30","resultsFirstSubmitQcDate":"2026-04-30","resultsFirstPostDateStruct":{"date":"2026-05-27","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-04-30","lastUpdatePostDateStruct":{"date":"2026-05-27","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The main purpose of this study is to conduct blood tests to measure how much LY3502970 is in the bloodstream when administered as two different formulations in healthy participants. The study will also evaluate the safety and tolerability of LY3502970. The study will last up to 13 weeks excluding the screening period."},"conditionsModule":{"conditions":["Healthy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":39,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"2 mg/4mg/8mg LY3502970 - Dose Titration Period","type":"EXPERIMENTAL","description":"Participants received escalating oral doses of LY3502970 according to the following dosing schedule:\n\n* Days 1-7: 2 milligrams (mg) once daily (QD)\n* Days 8-14: 4 mg QD\n* Days 15-21: 8 mg QD","interventionNames":["Drug: LY3502970"]},{"label":"16 mg LY3502970 (Formulation 1/Formulation 2) - Test Period","type":"EXPERIMENTAL","description":"Participants received 16 mg LY3502970 Formulation 1 orally QD from Days 22-28 in test period 1, followed by 16 mg LY3502970 Formulation 2 orally QD from Days 29-35 in test period 2.","interventionNames":["Drug: LY3502970"]},{"label":"16 mg LY3502970 (Formulation 2/Formulation 1) - Test Period","type":"EXPERIMENTAL","description":"Participants received 16 mg LY3502970 Formulation 2 orally QD from Days 22-28 in test period 1, followed by 16 mg LY3502970 Formulation 1 orally QD from Days 29-35 in test period 2.","interventionNames":["Drug: LY3502970"]}],"interventions":[{"type":"DRUG","name":"LY3502970","description":"Administered orally.","armGroupLabels":["16 mg LY3502970 (Formulation 1/Formulation 2) - Test Period","16 mg LY3502970 (Formulation 2/Formulation 1) - Test Period","2 mg/4mg/8mg LY3502970 - Dose Titration Period"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 in Formulation 1 and Formulation 2","description":"PK: Cmax of LY3502970 in Formulation 1 and Formulation 2","timeFrame":"Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose"},{"measure":"PK: Area Under the Plasma Concentration-Time Curve (AUC) From 0 to 24 Hours (AUC (0-24)) of LY3502970 in Formulation 1 and Formulation 2","description":"PK:(AUC (0-24)) of LY3502970 in Formulation 1 and Formulation 2","timeFrame":"Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose"},{"measure":"PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Formulation 1 and Formulation 2","description":"PK: Tmax of LY3502970 in Formulation 1 and Formulation 2","timeFrame":"Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Are overtly healthy as determined by medical evaluation\n* Participants who have a hemoglobin level of at least 11.4 grams per deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants\n* Participants with a body weight of at least 45 kilograms (kg) and body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m²)\n* Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential\n\nExclusion Criteria:\n\n* Participants who have any abnormality in the 12-lead electrocardiogram (ECG) at screening\n* Participants who have an abnormal blood pressure, pulse rate, or both, which are deemed to be clinically significant by the investigator, at screening\n* Participants who have known allergies to LY3502970, related compounds, or any components of the formulation\n* Participants who have used or intend to use over-the-counter or prescription medication including herbal medications or traditional medications within 14 days prior to dosing\n* Participants who show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies, or both. A negative test within 6 months of screening would not need to be repeated.\n* Participants who show evidence of hepatitis C and/or positive hepatitis C antibody, or both. A negative test within 6 months of screening would not need to be repeated.\n* Participants who show evidence of hepatitis B, positive hepatitis B surface antigen, and/or positive hepatitis B core antibody, or all. A negative test within 6 months of screening would not need to be repeated.","healthyVolunteers":true,"sex":"ALL","minimumAge":"21 Years","maximumAge":"70 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":"Lilly Centre for Clinical Pharmacology","city":"Singapore","zip":"138623","country":"Singapore","geoPoint":{"lat":1.28967,"lon":103.85007}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"2 mg/4mg/8mg LY3502970 - Dose Titration Period","description":"Participants received escalating oral doses of LY3502970 according to the following dosing schedule:\n\n* Days 1-7: 2 milligrams (mg) once daily (QD)\n* Days 8-14: 4 mg QD\n* Days 15-21: 8 mg QD"},{"id":"FG001","title":"16 mg LY3502970 (Formulation 1/Formulation 2) - Test Period","description":"Participants received 16 mg LY3502970 Formulation 1 orally QD from Days 22-28 in test period 1, followed by 16 mg LY3502970 Formulation 2 orally QD from Days 29-35 in test period 2."},{"id":"FG002","title":"16 mg LY3502970 (Formulation 2/Formulation 1) -Test Period","description":"Participants received 16 mg LY3502970 Formulation 2 orally QD from Days 22-28 in test period 1, followed by 16 mg LY3502970 Formulation 1 orally QD from Days 29-35 in test period 2."}],"periods":[{"title":"Dose Titration Period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"39"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Received at Least One Dose of LY3502970","achievements":[{"groupId":"FG000","comment":"Received at least one dose of 2 mg LY3502970 = 38; received at least one dose of 4 mg LY3502970 = 37; and received at least one dose of 8 mg LY3502970 = 34.","numSubjects":"38"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"Participants who had completed the dose titration period were eligible to enter the test period. On Day 21, they were randomized to receive 16 mg of Formulation 1 or 16 mg of Formulation 2 of LY3502970 QD, with each participant receiving both formulations during the test period.","numSubjects":"34"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]},{"title":"Test Period 1","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"17"}]},{"type":"Received at Least One Dose of LY3502970","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"17"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"16"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]}]},{"title":"Test Period 2","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"16"}]},{"type":"Received at Least One Dose of LY3502970","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"16"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"15"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All participants who received at least one dose of LY3502970.","groups":[{"id":"BG000","title":"2 mg/4mg/8mg LY3502970 - Dose Titration Period","description":"Participants received escalating oral doses of LY3502970 according to the following dosing schedule:\n\n* Days 1-7: 2 milligrams (mg) once daily (QD)\n* Days 8-14: 4 mg QD\n* Days 15-21: 8 mg QD"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"38"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"40.4","spread":"10.5"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"4"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"34"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"38"}]},{"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":"38"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"Singapore","categories":[{"measurements":[{"groupId":"BG000","value":"38"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 in Formulation 1 and Formulation 2","description":"PK: Cmax of LY3502970 in Formulation 1 and Formulation 2","populationDescription":"The pharmacokinetic population consisted of participants from the test period who received at least one dose of LY3502970 and had evaluable PK samples.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram per milliliter (ng/mL)","timeFrame":"Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose","groups":[{"id":"OG000","title":"16 mg LY3502970 (Formulation 1)","description":"Participants from test periods 1 and 2 who received 16 mg LY3502970 (Formulation 1) were included in this arm."},{"id":"OG001","title":"16 mg LY3502970 (Formulation 2)","description":"Participants from test periods 1 and 2 who received 16 mg LY3502970 (Formulation 2) were included in this arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"33"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"86.5","spread":"40"},{"groupId":"OG001","value":"86.5","spread":"43"}]}]}]},{"type":"PRIMARY","title":"PK: Area Under the Plasma Concentration-Time Curve (AUC) From 0 to 24 Hours (AUC (0-24)) of LY3502970 in Formulation 1 and Formulation 2","description":"PK:(AUC (0-24)) of LY3502970 in Formulation 1 and Formulation 2","populationDescription":"The pharmacokinetic population consisted of participants from the test period who received at least one dose of LY3502970 and had evaluable PK samples.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Nanogram*hour per milliliter (ng*h/mL)","timeFrame":"Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose","groups":[{"id":"OG000","title":"16 mg LY3502970 (Formulation 1)","description":"Participants from test periods 1 and 2 who received 16 mg LY3502970 (Formulation 1) were included in this arm."},{"id":"OG001","title":"16 mg LY3502970 (Formulation 2)","description":"Participants from test periods 1 and 2 who received 16 mg LY3502970 (Formulation 2) were included in this arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"33"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1260","spread":"38"},{"groupId":"OG001","value":"1240","spread":"40"}]}]}]},{"type":"PRIMARY","title":"PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Formulation 1 and Formulation 2","description":"PK: Tmax of LY3502970 in Formulation 1 and Formulation 2","populationDescription":"The pharmacokinetic population consisted of participants from the test period who received at least one dose of LY3502970 and had evaluable PK samples.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"Hours (h)","timeFrame":"Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose","groups":[{"id":"OG000","title":"16 mg LY3502970 (Formulation 1)","description":"Participants from test periods 1 and 2 who received 16 mg LY3502970 (Formulation 1) were included in this arm."},{"id":"OG001","title":"16 mg LY3502970 (Formulation 2)","description":"Participants from test periods 1 and 2 who received 16 mg LY3502970 (Formulation 2) were included in this arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"33"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.00","lowerLimit":"4.00","upperLimit":"23.92"},{"groupId":"OG001","value":"6.00","lowerLimit":"2.00","upperLimit":"12.00"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From baseline until end of follow-up (up to 49 days)","description":"All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.","eventGroups":[{"id":"EG000","title":"2 mg LY3502970 - Dose Titration Period","description":"Participants from the dose titration period who received 2 mg LY3502970 were included in this arm.","deathsNumAffected":0,"deathsNumAtRisk":38,"seriousNumAffected":0,"seriousNumAtRisk":38,"otherNumAffected":23,"otherNumAtRisk":38},{"id":"EG001","title":"4 mg LY3502970 - Dose Titration Period","description":"Participants from the dose titration period who received 4 mg LY3502970 were included in this arm.","deathsNumAffected":0,"deathsNumAtRisk":37,"seriousNumAffected":0,"seriousNumAtRisk":37,"otherNumAffected":8,"otherNumAtRisk":37},{"id":"EG002","title":"8 mg LY3502970 - Dose Titration Period","description":"Participants from the dose titration period who received 8 mg LY3502970 were included in this arm.","deathsNumAffected":0,"deathsNumAtRisk":34,"seriousNumAffected":0,"seriousNumAtRisk":34,"otherNumAffected":17,"otherNumAtRisk":34},{"id":"EG003","title":"16 mg LY3502970 (Formulation 1)","description":"Participants from test periods 1 and 2 who received 16 mg LY3502970 (Formulation 1) were included in this arm.","deathsNumAffected":0,"deathsNumAtRisk":33,"seriousNumAffected":0,"seriousNumAtRisk":33,"otherNumAffected":24,"otherNumAtRisk":33},{"id":"EG004","title":"16 mg LY3502970 (Formulation 2)","description":"Participants from test periods 1 and 2 who received 16 mg LY3502970 (Formulation 2) were included in this arm.","deathsNumAffected":0,"deathsNumAtRisk":34,"seriousNumAffected":0,"seriousNumAtRisk":34,"otherNumAffected":24,"otherNumAtRisk":34}],"otherEvents":[{"term":"Abdominal discomfort","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":38},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":37},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":34},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":33},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":34}]},{"term":"Abdominal distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":13,"numAffected":10,"numAtRisk":38},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":37},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":34},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":33},{"groupId":"EG004","numEvents":2,"numAffected":1,"numAtRisk":34}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":38},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":37},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":34},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":33},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":34}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":38},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":37},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":34},{"groupId":"EG003","numEvents":8,"numAffected":3,"numAtRisk":33},{"groupId":"EG004","numEvents":3,"numAffected":2,"numAtRisk":34}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":11,"numAffected":9,"numAtRisk":38},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":37},{"groupId":"EG002","numEvents":6,"numAffected":6,"numAtRisk":34},{"groupId":"EG003","numEvents":4,"numAffected":2,"numAtRisk":33},{"groupId":"EG004","numEvents":5,"numAffected":5,"numAtRisk":34}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":38,"numAffected":13,"numAtRisk":38},{"groupId":"EG001","numEvents":8,"numAffected":3,"numAtRisk":37},{"groupId":"EG002","numEvents":13,"numAffected":6,"numAtRisk":34},{"groupId":"EG003","numEvents":13,"numAffected":6,"numAtRisk":33},{"groupId":"EG004","numEvents":19,"numAffected":4,"numAtRisk":34}]},{"term":"Catheter site bruise","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":38},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":37},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":34},{"groupId":"EG003","numEvents":12,"numAffected":9,"numAtRisk":33},{"groupId":"EG004","numEvents":3,"numAffected":3,"numAtRisk":34}]},{"term":"Catheter site erythema","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":38},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":37},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":34},{"groupId":"EG003","numEvents":10,"numAffected":10,"numAtRisk":33},{"groupId":"EG004","numEvents":12,"numAffected":10,"numAtRisk":34}]},{"term":"Catheter site pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":38},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":37},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":34},{"groupId":"EG003","numEvents":4,"numAffected":4,"numAtRisk":33},{"groupId":"EG004","numEvents":5,"numAffected":4,"numAtRisk":34}]},{"term":"Catheter site phlebitis","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":38},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":37},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":34},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":33},{"groupId":"EG004","numEvents":4,"numAffected":4,"numAtRisk":34}]},{"term":"Catheter site swelling","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":38},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":37},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":34},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":33},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":34}]},{"term":"Early satiety","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":38},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":37},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":34},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":33},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":34}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 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