{"protocolSection":{"identificationModule":{"nctId":"NCT02073929","orgStudyIdInfo":{"id":"EudraCT nr 2013-003862-15"},"organization":{"fullName":"Herlev Hospital","class":"OTHER"},"briefTitle":"LIPT - Liraglutide in Polycystic Ovary Syndrome","officialTitle":"A Randomised, Double-blind, Placebo-controlled Study of the Effect of Liraglutide in Polycystic Ovary Syndrome on Risk Markers of Vascular Thrombosis.","acronym":"LIPT"},"statusModule":{"statusVerifiedDate":"2015-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-03"},"primaryCompletionDateStruct":{"date":"2015-12","type":"ACTUAL"},"completionDateStruct":{"date":"2015-12","type":"ACTUAL"},"studyFirstSubmitDate":"2014-02-25","studyFirstSubmitQcDate":"2014-02-25","studyFirstPostDateStruct":{"date":"2014-02-28","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-06-20","resultsFirstSubmitQcDate":"2019-02-27","resultsFirstPostDateStruct":{"date":"2019-02-28","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-02-27","lastUpdatePostDateStruct":{"date":"2019-02-28","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR_INVESTIGATOR","investigatorFullName":"Jens Faber","investigatorTitle":"Professor, DSc, Senior Hospital Physician","investigatorAffiliation":"Herlev Hospital"},"leadSponsor":{"name":"Jens Faber","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"Polycystic ovary syndrome (PCOS) affects 5-10% of women in fertile age. PCOS is associated with metabolic syndrom, diabetes and and increased risk og cardiovascular disease.\n\nThe study investigates the effect af intervention with GLP-1-analog on risk markers of cardiovascular disease in women with PCOS.\n\n70 women will be included in af RCT.\n\nHypothesis: GLP-1-analog treatment in women with PCOS (without diabetes) will result in a beneficial reduction in risk markers of vascular thrombosis and early cardiovascular disease."},"conditionsModule":{"conditions":["Polycystic Ovary Syndrome","Cardiovascular Disease"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":72,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Active","type":"ACTIVE_COMPARATOR","description":"Liraglutide s.c. 1,8mg daily for 26 weeks","interventionNames":["Drug: Liraglutide for 26 weeks"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo s.c. daily for 26 weeks","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"Liraglutide for 26 weeks","description":"GLP-1-analogue Liraglutide s.c. 1,8mg daily for 26 weeks","armGroupLabels":["Active"]},{"type":"DRUG","name":"placebo","description":"Placebo s.c. daily for 26 weeks","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Endogenous Thrombin Potential (ETP)","description":"Area under curve in a Thrombin Generation Test (TGT). Measurements every min for 10 min","timeFrame":"at time 0 and 26 weeks"}],"secondaryOutcomes":[{"measure":"Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1","timeFrame":"at time 0 and 26 weeks"}],"otherOutcomes":[{"measure":"Change in Plasma Level of Adrenomedullin","description":"measured in nmol/l","timeFrame":"at time 0 and 26 weeks"},{"measure":"Change in Plasma Level of Atrial Natriuretic Peptide (ANP)","description":"measured in pmol/l","timeFrame":"at time 0 and 26 weeks"},{"measure":"Change in Plasma Level of Copeptin","timeFrame":"at time 0 and 26 weeks"},{"measure":"Percent Change in Plasma Level of High Sensitivity C-reactive Protein (CRP)","description":"percent change from baseline","timeFrame":"at time 0 and 26 weeks"},{"measure":"Change in Bleeding Pattern (Bleeding Ratio)","description":"Ration between number of bleedings during 3 months before trial and last 3 months of trial","timeFrame":"at time 0 and 26 weeks"},{"measure":"Change in Percent Liver Fat Content","description":"percent liver fat content","timeFrame":"at time 0 and 26 weeks"},{"measure":"Change in Body Composition (VAT)","description":"cubic cm","timeFrame":"at time 0 and 26 weeks"},{"measure":"Change in Ovarian Volume Between Baseline and Follow up (26 Weeks)","description":"measured as ml","timeFrame":"at time 0 and 26 weeks"},{"measure":"Change in Serum Levels of Anti-Müllerian Hormone","description":"measured as pmol/l","timeFrame":"at time 0 and 26 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* PCOS\n* \\>18 years\n* premenopausal\n* BMI \\>25 og 25 and thereunder + insulin resistent\n\nExclusion Criteria (including):\n\n* actualt or intended pregnancy\n* inadeqvat contraception\n* hormonal contraception within 6 weeks\n* metfoomin, GLP-1-analog or DPP IV inhibitor within 3 months\n* medications affectiv hemostatic mechanisme\n* diabetes or other severe comorbidity\n* familar MEN\n* ...","healthyVolunteers":false,"sex":"FEMALE","minimumAge":"18 Years","maximumAge":"60 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Jens Faber, DSc","affiliation":"Dept. of Medicine, Herlev Hospital","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Dept. of Medicine and Dept. of Gyn-Obs, Herlev Hospital","city":"Herlev","zip":"2730","country":"Denmark","geoPoint":{"lat":55.72366,"lon":12.43998}},{"facility":"Herlev Hospital, Dept of Gynecology","city":"Herlev","zip":"2730","country":"Denmark","geoPoint":{"lat":55.72366,"lon":12.43998}},{"facility":"Dept. of Medicine and Dept. of Obstetrics and Gynaecology, Herlev Hospital","city":"Herlev","zip":"DK-2730","country":"Denmark","geoPoint":{"lat":55.72366,"lon":12.43998}}]},"referencesModule":{"references":[{"pmid":"28681988","type":"DERIVED","citation":"Frossing S, Nylander M, Chabanova E, Frystyk J, Holst JJ, Kistorp C, Skouby SO, Faber J. Effect of liraglutide on ectopic fat in polycystic ovary syndrome: A randomized clinical trial. Diabetes Obes Metab. 2018 Jan;20(1):215-218. doi: 10.1111/dom.13053. Epub 2017 Aug 11."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Liraglutide","description":"Liraglutide s.c. 1,8mg daily for 26 weeks\n\nLiraglutide: GLP-1-analogue Liraglutide"},{"id":"FG001","title":"Placebo","description":"Placebo s.c. 1,8mg daily for 26 weeks\n\nplacebo"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"48"},{"groupId":"FG001","numSubjects":"24"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"44"},{"groupId":"FG001","numSubjects":"21"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Liraglutide","description":"Liraglutide"},{"id":"BG001","title":"Placebo","description":"Placebo"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"72"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"31.4","lowerLimit":"24.6","upperLimit":"35.6"},{"groupId":"BG001","value":"26.2","lowerLimit":"24.8","upperLimit":"31.5"},{"groupId":"BG002","value":"29.9","lowerLimit":"24.7","upperLimit":"34.2"}]}]}]},{"title":"Sex/Gender, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"women","categories":[{"measurements":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"72"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"caucasians","categories":[{"measurements":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"67"}]}]},{"title":"other ethnicity","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}]}]}]},{"title":"BMI","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg/m2","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"33.3","spread":"5.1"},{"groupId":"BG001","value":"33.3","spread":"4.6"},{"groupId":"BG002","value":"33.3","spread":"4.9"}]}]}]},{"title":"Waist Circumference","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"cm","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"102.6","spread":"10.8"},{"groupId":"BG001","value":"102.6","spread":"11.1"},{"groupId":"BG002","value":"102.6","spread":"11.0"}]}]}]},{"title":"Total testosterone","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"nmol/l","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1.23","lowerLimit":"0.91","upperLimit":"1.63"},{"groupId":"BG001","value":"1.35","lowerLimit":"0.95","upperLimit":"1.93"},{"groupId":"BG002","value":"1.30","lowerLimit":"0.92","upperLimit":"1.84"}]}]}]},{"title":"Endogenous Thrombin Potential","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"micromol/l x min","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1796","spread":"332"},{"groupId":"BG001","value":"1830","spread":"285"},{"groupId":"BG002","value":"1801","spread":"324"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Endogenous Thrombin Potential (ETP)","description":"Area under curve in a Thrombin Generation Test (TGT). Measurements every min for 10 min","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"nMolar x minutes","timeFrame":"at time 0 and 26 weeks","groups":[{"id":"OG000","title":"Liraglutide","description":"Liraglutide s.c. 1,8mg daily for 26 weeks\n\nLiraglutide: GLP-1-analogue Liraglutide"},{"id":"OG001","title":"Placebo","description":"Placebo s.c. 1,8mg daily for 26 weeks\n\nplacebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-56.7","lowerLimit":"-132.3","upperLimit":"17.2"},{"groupId":"OG001","value":"-8.2","lowerLimit":"-98.7","upperLimit":"82.3"}]}]}]},{"type":"SECONDARY","title":"Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"percent change in plasma PAI-1","timeFrame":"at time 0 and 26 weeks","groups":[{"id":"OG000","title":"Liraglutide","description":"Liraglutide s.c. 1,8mg daily for 26 weeks\n\nLiraglutide: GLP-1-analogue Liraglutide"},{"id":"OG001","title":"Placebo","description":"Placebo s.c. 1,8mg daily for 26 weeks\n\nplacebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-12","lowerLimit":"-23","upperLimit":"0"},{"groupId":"OG001","value":"4","lowerLimit":"-14","upperLimit":"26"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change in Plasma Level of Adrenomedullin","description":"measured in nmol/l","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"nmol/l","timeFrame":"at time 0 and 26 weeks","groups":[{"id":"OG000","title":"Liraglutide","description":"Liraglutide s.c. 1,8mg daily for 26 weeks\n\nLiraglutide: GLP-1-analogue Liraglutide"},{"id":"OG001","title":"Placebo","description":"Placebo s.c. 1,8mg daily for 26 weeks\n\nplacebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.02","lowerLimit":"-0.04","upperLimit":"0.002"},{"groupId":"OG001","value":"0.003","lowerLimit":"-0.02","upperLimit":"0.02"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change in Plasma Level of Atrial Natriuretic Peptide (ANP)","description":"measured in pmol/l","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"pmol/l","timeFrame":"at time 0 and 26 weeks","groups":[{"id":"OG000","title":"Liraglutide","description":"Liraglutide s.c. 1,8mg daily for 26 weeks\n\nLiraglutide: GLP-1-analogue Liraglutide"},{"id":"OG001","title":"Placebo","description":"Placebo s.c. 1,8mg daily for 26 weeks\n\nplacebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-11.5","lowerLimit":"-17.0","upperLimit":"-6.1"},{"groupId":"OG001","value":"1.4","lowerLimit":"-7.5","upperLimit":"10.2"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change in Plasma Level of Copeptin","populationDescription":"measured as pmol/l","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"pmol/l","timeFrame":"at time 0 and 26 weeks","groups":[{"id":"OG000","title":"Liraglutide","description":"Liraglutide s.c. 1,8mg daily for 26 weeks\n\nLiraglutide: GLP-1-analogue Liraglutide"},{"id":"OG001","title":"Placebo","description":"Placebo s.c. 1,8mg daily for 26 weeks\n\nplacebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.48","lowerLimit":"-0.39","upperLimit":"1.34"},{"groupId":"OG001","value":"0.28","lowerLimit":"-0.51","upperLimit":"1.08"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Percent Change in Plasma Level of High Sensitivity C-reactive Protein (CRP)","description":"percent change from baseline","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"percent change in CRP levels","timeFrame":"at time 0 and 26 weeks","groups":[{"id":"OG000","title":"Liraglutide","description":"Liraglutide s.c. 1,8mg daily for 26 weeks\n\nLiraglutide: GLP-1-analogue Liraglutide"},{"id":"OG001","title":"Placebo","description":"Placebo s.c. 1,8mg daily for 26 weeks\n\nplacebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-15","lowerLimit":"-30","upperLimit":"3"},{"groupId":"OG001","value":"-25","lowerLimit":"-57","upperLimit":"30"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change in Bleeding Pattern (Bleeding Ratio)","description":"Ration between number of bleedings during 3 months before trial and last 3 months of trial","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"n of bleedings/n of expected bleedings","timeFrame":"at time 0 and 26 weeks","groups":[{"id":"OG000","title":"Liraglutide","description":"Liraglutide s.c. 1,8mg daily for 26 weeks\n\nLiraglutide: GLP-1-analogue Liraglutide"},{"id":"OG001","title":"Placebo","description":"Placebo s.c. 1,8mg daily for 26 weeks\n\nplacebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.28","lowerLimit":"0.20","upperLimit":"0.36"},{"groupId":"OG001","value":"0.14","lowerLimit":"0.02","upperLimit":"0.26"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change in Percent Liver Fat Content","description":"percent liver fat content","populationDescription":"only participants with measurable i.e. \\>5% liver fat at baseline was included in this analysis","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage of liver fat","timeFrame":"at time 0 and 26 weeks","groups":[{"id":"OG000","title":"Liraglutide","description":"Liraglutide s.c. 1,8mg daily for 26 weeks\n\nLiraglutide: GLP-1-analogue Liraglutide"},{"id":"OG001","title":"Placebo","description":"Placebo s.c. 1,8mg daily for 26 weeks\n\nplacebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.6","spread":"0.4"},{"groupId":"OG001","value":"-0.2","spread":"0.7"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change in Body Composition (VAT)","description":"cubic cm","populationDescription":"not measured on all subjects (missing. 4 in Liraglutide and one in placebo Group)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cubic cm","timeFrame":"at time 0 and 26 weeks","groups":[{"id":"OG000","title":"Liraglutide","description":"Liraglutide s.c. 1,8mg daily for 26 weeks\n\nLiraglutide: GLP-1-analogue Liraglutide"},{"id":"OG001","title":"Placebo","description":"Placebo s.c. 1,8mg daily for 26 weeks\n\nplacebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"23"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-17","spread":"4"},{"groupId":"OG001","value":"5","spread":"7"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change in Ovarian Volume Between Baseline and Follow up (26 Weeks)","description":"measured as ml","populationDescription":"not measured in all participants, one is missing in each group","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"ml","timeFrame":"at time 0 and 26 weeks","groups":[{"id":"OG000","title":"Liraglutide","description":"Liraglutide s.c. 1,8mg daily for 26 weeks\n\nLiraglutide: GLP-1-analogue Liraglutide"},{"id":"OG001","title":"Placebo","description":"Placebo s.c. 1,8mg daily for 26 weeks\n\nplacebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"23"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2","lowerLimit":"-3","upperLimit":"-1"},{"groupId":"OG001","value":"0","lowerLimit":"-2","upperLimit":"1"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change in Serum Levels of Anti-Müllerian Hormone","description":"measured as pmol/l","populationDescription":"missing one participant in placebo group","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"pmol/ml","timeFrame":"at time 0 and 26 weeks","groups":[{"id":"OG000","title":"Liraglutide","description":"Liraglutide s.c. 1,8mg daily for 26 weeks\n\nLiraglutide: GLP-1-analogue Liraglutide"},{"id":"OG001","title":"Placebo","description":"Placebo s.c. 1,8mg daily for 26 weeks\n\nplacebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"23"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-8.7","lowerLimit":"-17.4","upperLimit":"0.6"},{"groupId":"OG001","value":"3.5","lowerLimit":"-13.9","upperLimit":"21.0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"1","eventGroups":[{"id":"EG000","title":"Active","description":"Liraglutide s.c. 1,8mg daily for 26 weeks\n\nLiraglutide: GLP-1-analogue Liraglutide","seriousNumAffected":2,"seriousNumAtRisk":48,"otherNumAffected":37,"otherNumAtRisk":48},{"id":"EG001","title":"Placebo","description":"Placebo s.c. 1,8mg daily for 26 weeks\n\nplacebo","seriousNumAffected":1,"seriousNumAtRisk":24,"otherNumAffected":3,"otherNumAtRisk":24}],"seriousEvents":[{"term":"gallbladder stone attack","organSystem":"Hepatobiliary disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"gallbladder stone attack / gallstone related pain","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":48},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":24}]}],"otherEvents":[{"term":"nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"nausea in up-titrating phase","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":48},{"groupId":"EG001","numAffected":3,"numAtRisk":24}]},{"term":"constipation","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":48},{"groupId":"EG001","numAffected":0,"numAtRisk":24}]},{"term":"vomiting","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":48},{"groupId":"EG001","numAffected":0,"numAtRisk":24}]},{"term":"diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":48},{"groupId":"EG001","numAffected":1,"numAtRisk":24}]},{"term":"hypotension","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48},{"groupId":"EG001","numAffected":0,"numAtRisk":24}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Professor Jens Faber","organization":"Center of Endocrinology and Metabolism, Dept. of Internal Medicine, Herlev Gentofte Hospital, Denmark","email":"jens.faber@regionh.dk","phone":"+4538689016"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D011085","term":"Polycystic Ovary Syndrome"},{"id":"D002318","term":"Cardiovascular Diseases"}],"ancestors":[{"id":"D010048","term":"Ovarian Cysts"},{"id":"D003560","term":"Cysts"},{"id":"D009369","term":"Neoplasms"},{"id":"D010049","term":"Ovarian Diseases"},{"id":"D000291","term":"Adnexal Diseases"},{"id":"D005831","term":"Genital Diseases, Female"},{"id":"D052776","term":"Female Urogenital Diseases"},{"id":"D005261","term":"Female Urogenital Diseases and Pregnancy Complications"},{"id":"D000091642","term":"Urogenital Diseases"},{"id":"D000091662","term":"Genital Diseases"},{"id":"D006058","term":"Gonadal Disorders"},{"id":"D004700","term":"Endocrine System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D000069450","term":"Liraglutide"}],"ancestors":[{"id":"D052216","term":"Glucagon-Like Peptide 1"},{"id":"D004763","term":"Glucagon-Like Peptides"},{"id":"D052336","term":"Proglucagon"},{"id":"D005768","term":"Gastrointestinal Hormones"},{"id":"D006728","term":"Hormones"},{"id":"D006730","term":"Hormones, Hormone Substitutes, and Hormone Antagonists"}]}},"hasResults":true}