{"protocolSection":{"identificationModule":{"nctId":"NCT01061775","orgStudyIdInfo":{"id":"0903-028"},"organization":{"fullName":"Children's Hospitals and Clinics of Minnesota","class":"OTHER"},"briefTitle":"Effects of Exenatide on Hypothalamic Obesity","officialTitle":"Effects of Exenatide on Hypothalamic Obesity"},"statusModule":{"statusVerifiedDate":"2019-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-01"},"primaryCompletionDateStruct":{"date":"2013-07","type":"ACTUAL"},"completionDateStruct":{"date":"2019-03-15","type":"ACTUAL"},"studyFirstSubmitDate":"2010-02-02","studyFirstSubmitQcDate":"2010-02-02","studyFirstPostDateStruct":{"date":"2010-02-03","type":"ESTIMATED"},"resultsFirstSubmitDate":"2015-02-25","resultsFirstSubmitQcDate":"2016-02-22","resultsFirstPostDateStruct":{"date":"2016-03-21","type":"ESTIMATED"},"lastUpdateSubmitDate":"2019-09-24","lastUpdatePostDateStruct":{"date":"2019-10-08","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Children's Hospitals and Clinics of Minnesota","class":"OTHER"},"collaborators":[{"name":"Amylin Pharmaceuticals, LLC.","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The primary aim of this study is to evaluate the effect of Exenatide on weight status (change in body mass index) of children treated for craniopharyngioma that have developed hypothalamic obesity at Children's Hospitals and Clinics of Minnesota. We hypothesize that Exenatide given to hypothalamic obese children for 6 months will reduce their body mass index significantly from baseline.","detailedDescription":"Hypothalamic obesity is when individuals suffer from acute weight gain after brain tumor treatment, involving secondary damage to the ventromedial nucleus of the hypothalamus, which may lead to obesity. The weight gain is uncontrolled and not receptive to diet and exercise interventions. The rate of long-term obesity in children diagnosed with craniopharyngioma can be as high as 50%. Exenatide, a drug indicated for diabetes, is an incretin mimicking agent that mimics the enhancement of glucose-dependent insulin secretion and several other antihyperglycemic actions of incretins has resulted in weight loss when given to diabetics. Exenatide shows potential to benefit patients suffering from hypothalamic obesity by slowing gastric emptying and therefore reducing food intake. Also increasing the glucagon-like peptide 1 (GLP-1) circulation, decreased due to obesity, at the already compromised GLP-1 receptor site of the hypothalamus could potentially help with regulation of appetite."},"conditionsModule":{"conditions":["Hypothalamic Obesity"],"keywords":["Hypothalamic Obesity","Exenatide","Byetta","Craniopharyngioma"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1","PHASE2"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":19,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide","type":"EXPERIMENTAL","description":"5mcg of exenatide will be given twice a day for 4 weeks and increased to 10 mcg twice a day for 20 weeks.","interventionNames":["Drug: Exenatide"]}],"interventions":[{"type":"DRUG","name":"Exenatide","description":"5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.","armGroupLabels":["Exenatide"],"otherNames":["Byetta"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"BMI Change","description":"BMI was collected at baseline and 24 weeks","timeFrame":"24 weeks"},{"measure":"Waist to Height Ratio (WHtR)","description":"Waist circumference was measured at the natural waist level (midway between the lowest rib margin and the iliac crest) at baseline and 24 weeks","timeFrame":"24 weeks"}],"secondaryOutcomes":[{"measure":"Childhood Eating Behavior Questionnaire (CEBQ)","description":"The Child Eating Behaviour Questionnaire (CEBQ) was designed as parent-report measure comprised of 35 items, each rated on a five-point likert scale that ranges from never to always. We utilized the CEBQ as a self-report measure during this study; it has not been validated for such use. For the purposes of this study, we looked at the Satiety Responsiveness Subscale Scores (5 questions; total scores could range from 5-25 with lower scores denoting a lower level of satiety). The results reported show the change between baseline and week 24 scores.","timeFrame":"24 weeks"},{"measure":"Calorie Intake Based on 3-day Diet Records","description":"Dietary data were collected via 3-day diet records (Crawford et al. 1994) twice during the study, at baseline and week 24. Three-day diet records were collected on consecutive days including one weekend day. A registered dietitian (RD) instructed subjects on dietary data collection at baseline appointment. Depending on the age and capacity of the subject, the patient, parent or a collaboration of both recorded dietary intake. A RD entered dietary data into Nutritionist Pro software (First DataBank, SanBruno, CA) and the mean difference was analyzed.","timeFrame":"24 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* \\>/=6 months post surgical or radiation or chemotherapy treatment for 1° craniopharyngiomas or other suprasellar tumors\n* 10-21 years old\n* Age-and sex-adjusted BMI \\>/=95%\n* Parent sign consent and patient sign assent\n\nExclusion Criteria:\n\n* \\< 6 months post surgical or radiation or chemotherapy treatment for 1° craniopharyngiomas or other suprasellar tumors\n* Pregnant or breastfeeding, or those women who plan to get pregnant\n* Renal impairment\n* Gastroparesis\n* Pancreatitis\n* Diabetes\n* \\<1 month post initiation of Metformin treatment\n* Prescription or over-the-counter weight loss medications within 3 months of screening\n* Are actively participating in, or have participated in a formal weight loss program within the last 3 months\n* Have had bariatric surgery","healthyVolunteers":false,"sex":"ALL","minimumAge":"10 Years","maximumAge":"21 Years","stdAges":["CHILD","ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"M. Jennifer Abuzzahab, MD","affiliation":"Children's Hospitals & Clinics of Minnesota","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Children's Hospital of Orange County","city":"Orange","state":"California","zip":"92868","country":"United States","geoPoint":{"lat":33.78779,"lon":-117.85311}},{"facility":"Children's Hospitals & Clincis of Minnesota","city":"Saint Paul","state":"Minnesota","zip":"55102","country":"United States","geoPoint":{"lat":44.94441,"lon":-93.09327}}]},"referencesModule":{"seeAlsoLinks":[{"label":"Hospital website","url":"http://www.childrensmn.org/"}]},"ipdSharingStatementModule":{"ipdSharing":"NO","description":"We do not plan to share individual participant data."}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Exenatide","description":"Participants received 5mcg of exenatide twice a day for 4 weeks and increased to 10 mcg twice a day for 20 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"19"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"16"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"2"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Exenatide","description":"Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"19"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"16"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"3"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEDIAN","dispersionType":"FULL_RANGE","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"15","lowerLimit":"10","upperLimit":"21"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"8"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"11"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"19"}]}]}]},{"title":"Tumor Type","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Craniopharyngioma","categories":[{"measurements":[{"groupId":"BG000","value":"14"}]}]},{"title":"Optic chiasm-hypothalamic glioma","categories":[{"measurements":[{"groupId":"BG000","value":"2"}]}]},{"title":"Suprarasellar germinoma","categories":[{"measurements":[{"groupId":"BG000","value":"2"}]}]},{"title":"Thalamic astrocytoma","categories":[{"measurements":[{"groupId":"BG000","value":"1"}]}]}]},{"title":"BMI","paramType":"MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"kg/m^2","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"35","lowerLimit":"26.9","upperLimit":"45.8"}]}]}]},{"title":"Height","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"cm","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"160.8","spread":"14.3"}]}]}]},{"title":"Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"89","spread":"28.2"}]}]}]},{"title":"Waist Circumference","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"cm","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"111.6","spread":"19.5"}]}]}]},{"title":"Hip Circumference","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"cm","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"113.5","spread":"16"}]}]}]},{"title":"Waist to Height Ratio","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"cm","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0.98","spread":"0.08"}]}]}]},{"title":"Child Eating Behaviour Questionnaire","description":"The Child Eating Behaviour Questionnaire (CEBQ) was designed as parent-report measure comprised of 35 items, each rated on a five-point likert scale that ranges from never to always. We utilized the CEBQ as a self-report measure during this study; it has not been validated for such use. For the purposes of this study, we looked at the Satiety Responsiveness Subscale Scores (5 questions; total scores could range from 5-25 with lower scores denoting a lower level of satiety).","paramType":"MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"11.47","lowerLimit":"5.0","upperLimit":"16.0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"BMI Change","description":"BMI was collected at baseline and 24 weeks","populationDescription":"The effects of exenatide on BMI were analyzed using a paired t-test comparing BMI at baseline with BMI after six months of treatment with each patient serving as his or her own control.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"kg/m^2","timeFrame":"24 weeks","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.77","lowerLimit":"-1.97","upperLimit":"0.43"}]}]}],"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":".05","statisticalMethod":"t-test, 2 sided","ciPctValue":"95","ciNumSides":"TWO_SIDED"}]},{"type":"PRIMARY","title":"Waist to Height Ratio (WHtR)","description":"Waist circumference was measured at the natural waist level (midway between the lowest rib margin and the iliac crest) at baseline and 24 weeks","populationDescription":"All analyses were performed using SPSS (version 20.0.0, SPSS Inc, Chicago, IL).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage","timeFrame":"24 weeks","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.06","spread":"0.08"}]}]}],"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.05","statisticalMethod":"t-test, 2 sided","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Childhood Eating Behavior Questionnaire (CEBQ)","description":"The Child Eating Behaviour Questionnaire (CEBQ) was designed as parent-report measure comprised of 35 items, each rated on a five-point likert scale that ranges from never to always. We utilized the CEBQ as a self-report measure during this study; it has not been validated for such use. For the purposes of this study, we looked at the Satiety Responsiveness Subscale Scores (5 questions; total scores could range from 5-25 with lower scores denoting a lower level of satiety). The results reported show the change between baseline and week 24 scores.","populationDescription":"Paired t-tests were performed to compare the satiety survey (continuous). Three subjects discontinued prior to completing the Week 24 CEBQ.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"units on a scale","timeFrame":"24 weeks","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14","lowerLimit":"12.2167","upperLimit":"15.7833"}]}]}],"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.05","statisticalMethod":"t-test, 2 sided","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Calorie Intake Based on 3-day Diet Records","description":"Dietary data were collected via 3-day diet records (Crawford et al. 1994) twice during the study, at baseline and week 24. Three-day diet records were collected on consecutive days including one weekend day. A registered dietitian (RD) instructed subjects on dietary data collection at baseline appointment. Depending on the age and capacity of the subject, the patient, parent or a collaboration of both recorded dietary intake. A RD entered dietary data into Nutritionist Pro software (First DataBank, SanBruno, CA) and the mean difference was analyzed.","populationDescription":"The sample size was small due to missing data","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"kcals","timeFrame":"24 weeks","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.\n\nOf 55 potential participants screened, 19 agreed to participate. Reasons for decline included reluctance to add another medication to their current regimens, travel distance, and aversion to an injectable medication. Sixteen patients completed the study. Of the three who failed to complete the study, one was lost to follow up, and two dropped out due to difficulty adhering to the twice daily injections, but none experienced significant side effects from therapy. Three of the 19 patients were on chronic metformin therapy."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"406.700","lowerLimit":"-117.088","upperLimit":"930.488"}]}]}],"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.05","statisticalMethod":"t-test, 2 sided","ciNumSides":"TWO_SIDED"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","eventGroups":[{"id":"EG000","title":"Exenatide","description":"Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.","seriousNumAffected":2,"seriousNumAtRisk":19,"otherNumAffected":17,"otherNumAtRisk":19}],"seriousEvents":[{"term":"cholecystitis","organSystem":"Endocrine disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"2 developed cholecystitis requiring cholecystectomy. Both super-responders, with 1 losing 18 lbs in six months and the other remaining on medication for a full year losing nearly 40 lbs. Both developed symptoms well after last dose of study drug.","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":19}]}],"otherEvents":[{"term":"Nausea and stomachache","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":20,"numAffected":14,"numAtRisk":19}]},{"term":"vomiting","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":20,"numAffected":10,"numAtRisk":19}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":3,"numAtRisk":19}]},{"term":"Abdominal Pain","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":8,"numAffected":4,"numAtRisk":19}]},{"term":"Blood in Stool","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":19}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":19}]},{"term":"Reflux Gastritis","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":19}]},{"term":"Absomen Sore to Touch","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":19}]},{"term":"Pyrexia","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":19}]},{"term":"Fatigue","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":19}]},{"term":"Injection Site Pain","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":19}]},{"term":"Body Aches","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":19}]},{"term":"Seasonal Allergies","organSystem":"Immune system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":19}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":19}]},{"term":"Ear Infection","organSystem":"Immune system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":2,"numAtRisk":19}]},{"term":"Pharyngitis","organSystem":"Immune system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":19}]},{"term":"Sinusitis","organSystem":"Immune system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":19}]},{"term":"Upper Respiratory Infection","organSystem":"Infections and infestations","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":19}]},{"term":"Blood in Urine Present","organSystem":"Investigations","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":19}]},{"term":"Decreased Appetite","organSystem":"Metabolism and nutrition disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":19}]},{"term":"Back Pain","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":19}]},{"term":"Headache","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":19}]},{"term":"Dizziness","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":19}]},{"term":"Cough","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":19}]},{"term":"Rhinorrhoea","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":19}]},{"term":"Tonsillar Hypertrophy","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":19}]},{"term":"Alopecia","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":19}]},{"term":"Rash","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":19}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Dr. Jennifer Abuzzahab","organization":"Children's Hospitals and Clinics of Minnesota","email":"jennifer.abuzzahab@childrensmn.org","phone":"651-220-6867"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D050035","term":"Sexual Infantilism"},{"id":"D003397","term":"Craniopharyngioma"}],"ancestors":[{"id":"D006059","term":"Gonadal Dysgenesis"},{"id":"D012734","term":"Disorders of Sex Development"},{"id":"D014564","term":"Urogenital Abnormalities"},{"id":"D052776","term":"Female Urogenital Diseases"},{"id":"D005261","term":"Female Urogenital Diseases and Pregnancy Complications"},{"id":"D000091642","term":"Urogenital Diseases"},{"id":"D052801","term":"Male Urogenital Diseases"},{"id":"D000013","term":"Congenital Abnormalities"},{"id":"D009358","term":"Congenital, Hereditary, and Neonatal Diseases and Abnormalities"},{"id":"D006058","term":"Gonadal Disorders"},{"id":"D004700","term":"Endocrine System Diseases"},{"id":"D007006","term":"Hypogonadism"},{"id":"D017599","term":"Neuroectodermal Tumors"},{"id":"D009373","term":"Neoplasms, Germ Cell and Embryonal"},{"id":"D009370","term":"Neoplasms by Histologic Type"},{"id":"D009369","term":"Neoplasms"},{"id":"D009380","term":"Neoplasms, Nerve Tissue"}]},"interventionBrowseModule":{"meshes":[{"id":"D000077270","term":"Exenatide"}],"ancestors":[{"id":"D010455","term":"Peptides"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"},{"id":"D014688","term":"Venoms"},{"id":"D045424","term":"Complex Mixtures"},{"id":"D014118","term":"Toxins, Biological"},{"id":"D001685","term":"Biological Factors"}]}},"hasResults":true}