{"protocolSection":{"identificationModule":{"nctId":"NCT01928329","orgStudyIdInfo":{"id":"1307012371"},"organization":{"fullName":"Yale University","class":"OTHER"},"briefTitle":"A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes","officialTitle":"A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes"},"statusModule":{"statusVerifiedDate":"2020-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2013-09"},"primaryCompletionDateStruct":{"date":"2018-06","type":"ACTUAL"},"completionDateStruct":{"date":"2019-08","type":"ACTUAL"},"studyFirstSubmitDate":"2013-08-19","studyFirstSubmitQcDate":"2013-08-19","studyFirstPostDateStruct":{"date":"2013-08-23","type":"ESTIMATED"},"resultsFirstSubmitDate":"2019-09-03","resultsFirstSubmitQcDate":"2019-09-30","resultsFirstPostDateStruct":{"date":"2019-10-22","type":"ACTUAL"},"lastUpdateSubmitDate":"2020-03-17","lastUpdatePostDateStruct":{"date":"2020-03-19","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Yale University","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The goal of the proposed pilot study is to determine whether glucose control can be improved with Bydureon treatment in patients with type I diabetes (T1D)","detailedDescription":"This is a multi-site randomized placebo controlled trial of Bydureon in patients with type I diabetes (T1D) of at least 2 years duration who may or may not still have detectable levels of C-peptide during a mixed meal tolerance test (MMTT). Bydureon is a recently approved long acting form of Exenatide. Because of the lack of safety data for Bydureon in children, we propose to conduct the trial in adults (\\>18 yrs.).\n\nBoth the subject and the study personnel will be blinded to treatment assignment. The randomization will be done, 1;1, by the coordinating site (at Yale). As a secondary analysis, we propose to determine whether the presence of residual insulin production modifies the drug effect. To do this, we plan to stratify patients for randomization on the basis of detectable C-peptide levels. We will therefore wait for the results of the C-peptide levels from the enrollment MMTT prior to randomization. The study investigators will not be told in which stratum the patient is being randomized and will be blinded to the C-peptide results of the MMTT until the conclusion of the study.\n\nNote: The primary and study completion dates were changed 4/2016 to reflect an extension of the recruitment and accrual periods."},"conditionsModule":{"conditions":["Type I Diabetes"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR"]}},"enrollmentInfo":{"count":79,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"2 mg, 1 per week via subcutaneous placebo self injection","interventionNames":["Drug: Placebo"]},{"label":"Exenatide (Bydureon)","type":"EXPERIMENTAL","description":"2 mg, of drug administration 1 per week via subcutaneous self injection","interventionNames":["Drug: Exenatide (Bydureon®)"]}],"interventions":[{"type":"DRUG","name":"Exenatide (Bydureon®)","armGroupLabels":["Exenatide (Bydureon)"]},{"type":"DRUG","name":"Placebo","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in HbA1c Levels","timeFrame":"6 months"}],"secondaryOutcomes":[{"measure":"Change From Baseline in HbA1c Levels","timeFrame":"12 months"},{"measure":"Major Hypoglycemic Event Rate On Drug","description":"The hypoglycemic event rate was calculated for patients while on and off study drug. The event rate is calculated using the number of events divided by the number of months either on or off study drug. Major hypoglycemic events are categorized as an event with a blood glucose level \\< 55 mg/dL.","timeFrame":"Up to 6 months"},{"measure":"Major Hypoglycemic Event Rate Off Drug","description":"The hypoglycemic event rate was calculated for patients while on and off study drug. The event rate is calculated using the number of events divided by the number of months either on or off study drug. Major hypoglycemic events are categorized as an event with a blood glucose level \\< 55 mg/dL.","timeFrame":"Up to 12 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria\n\n* Male or female aged 18-65 years who meets the American Diabetes Association standard T1DM criteria.\n* Diagnosis of T1DM at least 2 years from Visit 0\n* Insulin Requirement of ≤ 0.90 units/kg\n* Absence of ketoacidosis in the past 6 months\n* HbA1c of ≥ 6.5% and ≤ 9.5%\n* Menstruating women must have a negative pregnancy test and be willing to avoid pregnancy during the study period\n* Signed informed consent\n\nExclusion Criteria:\n\n* Inability or unwillingness to give informed consent\n* Current or prior use of immunomodulators or systemic steroids in the last 6 months that could potentially affect diabetes or immunologic status.\n* Known hypersensitivity to Exenatide, Liraglutide or any product component.\n* Participation in an investigational treatment trial within the last 6 weeks before enrollment.\n* 1 or more episodes of hypoglycemia (loss of consciousness or requiring the help of others) within the last 6 months.\n* Another condition that would, in the view of the investigator, affect the safety of using Bydureon. This might include, among others a history of MEN 2, a history of medullary carcinoma of the thyroid or pancreatitis.\n* Known severe renal impairment, end-stage renal disease or renal transplantation.\n* Any history of gastroparesis or other severe gastrointestinal disease, pancreatitis, thyroid nodules or malignancy with the exclusion of a history of localized basal cell carcinoma.\n* Uncompensated heart failure, fluid overload, myocardial infarction or liver disease within the last 6 weeks before enrollment.\n* Clinically active serious infection.\n* Positive pregnancy test in menstruating women or lactating females.\n* Concurrent use of Pramlinitide, other Incretin medications, or other anti-diabetes medications other than insulin.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"University of California, San Francisco","city":"San Francisco","state":"California","country":"United States","geoPoint":{"lat":37.77493,"lon":-122.41942}},{"facility":"Barbara Davis Center","city":"Aurora","state":"Colorado","country":"United States","geoPoint":{"lat":39.72943,"lon":-104.83192}},{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","geoPoint":{"lat":41.30815,"lon":-72.92816}},{"facility":"University of Miami","city":"Miami","state":"Florida","zip":"33136","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"University of Chicago","city":"Chicago","state":"Illinois","country":"United States","geoPoint":{"lat":41.85003,"lon":-87.65005}},{"facility":"Joslin Diabetes Center","city":"Boston","state":"Massachusetts","zip":"02215","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}},{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","zip":"48105","country":"United States","geoPoint":{"lat":42.27756,"lon":-83.74088}},{"facility":"SUNY Upstate Medical University","city":"Syracuse","state":"New York","zip":"13210","country":"United States","geoPoint":{"lat":43.04812,"lon":-76.14742}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Exenatide (Bydureon)","description":"2 mg, of drug administration 1 per week via subcutaneous self injection\n\nExenatide (Bydureon®)"},{"id":"FG001","title":"Placebo","description":"2 mg, 1 per week via subcutaneous placebo self injection\n\nPlacebo"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"40"},{"groupId":"FG001","numSubjects":"39"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"25"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"14"}]}],"dropWithdraws":[{"type":"Withdrew Consent Prior to Receiving Drug","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Removed from Study Prior to Receiving Dr","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Stopping Rule: Lost Greater than 5kg","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Exenatide (Bydureon)","description":"2 mg, of drug administration 1 per week via subcutaneous self injection\n\nExenatide (Bydureon®)"},{"id":"BG001","title":"Placebo","description":"2 mg, 1 per week via subcutaneous placebo self injection\n\nPlacebo"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"40"},{"groupId":"BG001","value":"39"},{"groupId":"BG002","value":"79"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"38.55","spread":"12.06"},{"groupId":"BG001","value":"33.49","spread":"11.39"},{"groupId":"BG002","value":"36.05","spread":"11.94"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"54"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"25"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"34"},{"groupId":"BG001","value":"35"},{"groupId":"BG002","value":"69"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"6"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"40"},{"groupId":"BG001","value":"39"},{"groupId":"BG002","value":"79"}]}]}]},{"title":"C-Peptide Production","description":"Participants were stratified in the randomization based on their ability to produce C-Peptide.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Negative (< 0.05 ng/ml)","measurements":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"46"}]},{"title":"Positive (>= 0.05 ng/ml)","measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"33"}]}]}]},{"title":"BMI (kg/m^2)","description":"BMI was calculated as kg/m\\^2","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg/m^2","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"29.31","spread":"6.35"},{"groupId":"BG001","value":"29.41","spread":"6.34"},{"groupId":"BG002","value":"29.36","spread":"6.31"}]}]}]},{"title":"Study Site","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Yale University","categories":[{"measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"30"}]}]},{"title":"University of Michigan","categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"10"}]}]},{"title":"University of Miami","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"}]}]},{"title":"University of Colorado: Denver","categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"13"}]}]},{"title":"University of Chicago","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"}]}]},{"title":"University of California San Francisco","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"8"}]}]},{"title":"SUNY Upstate Medical University","categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"4"}]}]},{"title":"Joslin Diabetes Center at HMS","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in HbA1c Levels","populationDescription":"Intention to treat analysis","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/mol","timeFrame":"6 months","groups":[{"id":"OG000","title":"Exenatide (Bydureon)","description":"2 mg, of drug administration 1 per week via subcutaneous self injection\n\nExenatide (Bydureon®)"},{"id":"OG001","title":"Placebo","description":"2 mg, 1 per week via subcutaneous placebo self injection\n\nPlacebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.12","spread":"0.08"},{"groupId":"OG001","value":"0.11","spread":"0.10"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0816","pValueComment":"The \\<0.05 is the apriori threshold for statistical significance.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"HbA1c Linear Mixed Model Results (adjusts the model for: baseline BMI, gender, study site, race (White/Non White) and Baseline C-Peptide production).","paramType":"Mean Difference (Final Values)","paramValue":"-0.23","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.50","ciUpperLimit":"0.03","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.13"}]},{"type":"SECONDARY","title":"Change From Baseline in HbA1c Levels","populationDescription":"Intention to treat analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/mol","timeFrame":"12 months","groups":[{"id":"OG000","title":"Exenatide (Bydureon)","description":"2 mg, of drug administration 1 per week via subcutaneous self injection\n\nExenatide (Bydureon®)"},{"id":"OG001","title":"Placebo","description":"2 mg, 1 per week via subcutaneous placebo self injection\n\nPlacebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.08","spread":"0.09"},{"groupId":"OG001","value":"0.10","spread":"0.10"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.912","pValueComment":"The \\<0.05 is the apriori threshold for statistical significance.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"HbA1c Linear Mixed Model Results (adjusts the model for: baseline BMI, gender, study site, race (White/Non White) and Baseline C-Peptide production).","paramType":"Mean Difference (Final Values)","paramValue":"-0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.28","ciUpperLimit":"0.25","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.13"}]},{"type":"SECONDARY","title":"Major Hypoglycemic Event Rate On Drug","description":"The hypoglycemic event rate was calculated for patients while on and off study drug. The event rate is calculated using the number of events divided by the number of months either on or off study drug. Major hypoglycemic events are categorized as an event with a blood glucose level \\< 55 mg/dL.","populationDescription":"Only those randomized that received study drug.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"events per month","timeFrame":"Up to 6 months","groups":[{"id":"OG000","title":"Exenatide (Bydureon)","description":"2 mg, of drug administration 1 per week via subcutaneous self injection\n\nExenatide (Bydureon®)"},{"id":"OG001","title":"Placebo","description":"2 mg, 1 per week via subcutaneous placebo self injection\n\nPlacebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"35"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.67","lowerLimit":"0.00","upperLimit":"13.00"},{"groupId":"OG001","value":"0.80","lowerLimit":"0.00","upperLimit":"10.50"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.423","statisticalMethod":"Wilcoxon (Mann-Whitney)","paramType":"Z score","paramValue":"-.801","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Major Hypoglycemic Event Rate Off Drug","description":"The hypoglycemic event rate was calculated for patients while on and off study drug. The event rate is calculated using the number of events divided by the number of months either on or off study drug. Major hypoglycemic events are categorized as an event with a blood glucose level \\< 55 mg/dL.","populationDescription":"Only those randomized that received study drug and were followed through study completion.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"events per month","timeFrame":"Up to 12 months","groups":[{"id":"OG000","title":"Exenatide (Bydureon)","description":"2 mg, of drug administration 1 per week via subcutaneous self injection\n\nExenatide (Bydureon®)"},{"id":"OG001","title":"Placebo","description":"2 mg, 1 per week via subcutaneous placebo self injection\n\nPlacebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"26"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.33","lowerLimit":"0.00","upperLimit":"5.00"},{"groupId":"OG001","value":"0.50","lowerLimit":"0.00","upperLimit":"13.17"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.189","statisticalMethod":"Wilcoxon (Mann-Whitney)","paramType":"Z score","paramValue":"-1.312","ciNumSides":"TWO_SIDED"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Up to 12 months.","description":"Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.","eventGroups":[{"id":"EG000","title":"Exenatide (Bydureon)","description":"2 mg, of drug administration 1 per week via subcutaneous self injection\n\nExenatide (Bydureon®)","deathsNumAffected":0,"deathsNumAtRisk":39,"seriousNumAffected":6,"seriousNumAtRisk":39,"otherNumAffected":39,"otherNumAtRisk":39},{"id":"EG001","title":"Placebo","description":"2 mg, 1 per week via subcutaneous placebo self injection\n\nPlacebo","deathsNumAffected":0,"deathsNumAtRisk":35,"seriousNumAffected":2,"seriousNumAtRisk":35,"otherNumAffected":28,"otherNumAtRisk":35}],"seriousEvents":[{"term":"Infections and infestations - Other","organSystem":"Infections and infestations","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":39},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":35}]},{"term":"Acidosis","organSystem":"Metabolism and nutrition disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":39},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":35}]},{"term":"Hyperglycemia","organSystem":"Metabolism and nutrition disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":39},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":35}]},{"term":"Hypoglycemia","organSystem":"Metabolism and nutrition disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":3,"numAtRisk":39},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":35}]},{"term":"Anaphylaxis","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":39},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":35}]},{"term":"Pelvic infection","organSystem":"Infections and infestations","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":39},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":35}]},{"term":"Urinary tract infection","organSystem":"Infections and infestations","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":39},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":35}]}],"otherEvents":[{"term":"Blood and lymphatic system disorders - Other","organSystem":"Blood and lymphatic system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":39},{"groupId":"EG001","numAffected":0,"numAtRisk":35}]},{"term":"Conjunctivitis","organSystem":"Eye disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":39},{"groupId":"EG001","numAffected":0,"numAtRisk":35}]},{"term":"Abdominal Bloating","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":39},{"groupId":"EG001","numAffected":4,"numAtRisk":35}]},{"term":"Bloating","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":39},{"groupId":"EG001","numAffected":2,"numAtRisk":35}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":39},{"groupId":"EG001","numAffected":3,"numAtRisk":35}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":39},{"groupId":"EG001","numAffected":0,"numAtRisk":35}]},{"term":"Gastrointestinal disorders - Other","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":39},{"groupId":"EG001","numAffected":3,"numAtRisk":35}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":39},{"groupId":"EG001","numAffected":5,"numAtRisk":35}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":39},{"groupId":"EG001","numAffected":1,"numAtRisk":35}]},{"term":"General disorders and administration site conditions - Other","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":39},{"groupId":"EG001","numAffected":7,"numAtRisk":35}]},{"term":"Injection site reaction","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":39},{"groupId":"EG001","numAffected":3,"numAtRisk":35}]},{"term":"Tremors","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":39},{"groupId":"EG001","numAffected":0,"numAtRisk":35}]},{"term":"Infections and infestations - 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