{"protocolSection":{"identificationModule":{"nctId":"NCT01272219","orgStudyIdInfo":{"id":"NN8022-1839"},"secondaryIdInfos":[{"id":"2008-001049-24","type":"EUDRACT_NUMBER"},{"id":"U1111-1118-7871","type":"OTHER","domain":"WHO"},{"id":"2008","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2008"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes","officialTitle":"Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Trial With Stratification of Subject to Either 56 or 160 Weeks of Treatment Based on Pre-diabetes Status at Randomisation"},"statusModule":{"statusVerifiedDate":"2017-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-06-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2013-03-18","type":"ACTUAL"},"completionDateStruct":{"date":"2015-03-02","type":"ACTUAL"},"studyFirstSubmitDate":"2011-01-06","studyFirstSubmitQcDate":"2011-01-06","studyFirstPostDateStruct":{"date":"2011-01-07","type":"ESTIMATED"},"resultsFirstSubmitDate":"2015-01-22","resultsFirstSubmitQcDate":"2015-01-22","resultsFirstPostDateStruct":{"date":"2015-02-09","type":"ESTIMATED"},"dispFirstSubmitDate":"2014-03-04","dispFirstSubmitQcDate":"2014-03-12","dispFirstPostDateStruct":{"date":"2014-04-09","type":"ESTIMATED"},"lastUpdateSubmitDate":"2017-12-20","lastUpdatePostDateStruct":{"date":"2018-01-19","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America.\n\nThe aim of this clinical trial is to evaluate the potential of liraglutide to induce and maintain weight loss over 56 weeks in obese subjects or overweight subjects with co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline.\n\nBased on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either 68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects with pre-diabetes status at baseline)."},"conditionsModule":{"conditions":["Metabolism and Nutrition Disorder","Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":3731,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)","type":"EXPERIMENTAL","interventionNames":["Drug: liraglutide"]},{"label":"Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)","type":"EXPERIMENTAL","interventionNames":["Drug: placebo"]},{"label":"Liraglutide Placebo, no Pre-diabetes","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo"]},{"label":"Liraglutide 3.0mg, Pre-diabetes","type":"EXPERIMENTAL","interventionNames":["Drug: liraglutide"]},{"label":"Liraglutide Placebo, Pre-diabetes","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"liraglutide","description":"Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide 3.0 mg for 12 weeks (until week 68).","armGroupLabels":["Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)"]},{"type":"DRUG","name":"placebo","description":"Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide placebo for 12 weeks (until week 68).","armGroupLabels":["Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)","Liraglutide Placebo, no Pre-diabetes"]},{"type":"DRUG","name":"liraglutide","description":"Liraglutide 3.0 mg, subcutaneous (under the skin) injection once daily for 160 weeks.","armGroupLabels":["Liraglutide 3.0mg, Pre-diabetes"]},{"type":"DRUG","name":"placebo","description":"Liraglutide placebo, subcutaneous (under the skin) injection once daily for 160 weeks.","armGroupLabels":["Liraglutide Placebo, Pre-diabetes"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Fasting Body Weight","description":"The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).","timeFrame":"Week 0, Week 56"},{"measure":"Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.","description":"Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period).","timeFrame":"At Week 56"},{"measure":"Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight","description":"Percentage of subjects losing \\>10% of baseline fasting body weight after 56-weeks of treatment (main treatment period).","timeFrame":"At 56 weeks"},{"measure":"Proportion of Subjects With Onset of Type 2 Diabetes","description":"Proportion of subjects with onset of Type 2 diabetes mellitus (T2DM) at week 160 (main + extension treatment period) among subjects with pre-diabetes at baseline - evaluated as time to onset of T2DM. Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).","timeFrame":"At 160 weeks"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Waist Circumference (cm)","description":"The observed mean change from baseline in waist circumference (cm) after 56-weeks of treatment (main treatment period).","timeFrame":"Week 0, Week 56"},{"measure":"Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)","description":"The observed mean change from baseline in waist circumference (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).","timeFrame":"Week 0, week 160"},{"measure":"Pre-diabetes Status After 56 Weeks of Treatment","description":"Observed percentage of subjects with pre-diabetes status after 56 weeks of treatment (main treatment period).","timeFrame":"Week 0, Week 56"},{"measure":"Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment","description":"Observed percentage of subjects (subjects with pre-diabetes at baseline) with pre-diabetes status after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).","timeFrame":"Week 0, week 160"},{"measure":"Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)","description":"The observed mean change from baseline in fasting body weight (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).","timeFrame":"Week 0, week 160"},{"measure":"Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline)","description":"Percentage of subjects losing \\>=5% and percentage of subjects losing \\>10% of baseline fasting body weight (pre-diabetic subjects at baseline) after 160-weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).","timeFrame":"At 160 weeks"},{"measure":"Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)","description":"The observed mean change in fasting body weight (%) from week 56 to week 68 in re-randomised subjects (with no pre-diabetes at baseline) after 12-weeks of treatment (re-randomised treatment period).","timeFrame":"Week 56, Week 68"},{"measure":"Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)","description":"The observed mean change from baseline in fasting body weight (%) in re-randomised subjects (with no pre-diabetes at baseline) after 68 weeks of treatment (main + re-randomised treatment period).","timeFrame":"Week 0, Week 68"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Informed consent obtained\n* Body Mass Index (BMI) of 30.0 kg/m\\^2 or above\n* Body Mass Index (BMI) of 27 kg/m\\^2 or above in the presence of co-morbidities of treated or untreated dyslipidemia and/or hypertension\n* Stable body weight\n* Preceding failed dietary effort\n\nExclusion Criteria:\n\n* Known type 1 or type 2 diabetes\n* Glycosylated haemoglobin (HbA1c) of 6.5 % or above (Screening visit 1) or FPG of 126 mg/dL (7 mmol/L) or above (Screening visit 2) or 2 hour post-challenge (OGTT) plasma glucose of 200 mg/dL (11.1 mmol/L) or above (Screening visit 2)\n* Screening calcitonin of 50 ng/L or above\n* Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)\n* Personal history of non-familial medullary thyroid carcinoma\n* History of acute or chronic pancreatitis\n* Obesity induced by drug treatment\n* Use of approved weight lowering pharmacotherapy\n* Previous surgical treatment of obesity\n* History of major depressive disorder or suicide attempt\n* Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Global Clinical Registry GCR, 1452","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Birmingham","state":"Alabama","zip":"35205-4731","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Novo Nordisk Investigational Site","city":"Phoenix","state":"Arizona","zip":"85027","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"Novo Nordisk Investigational Site","city":"Anaheim","state":"California","zip":"92801","country":"United States","geoPoint":{"lat":33.83529,"lon":-117.9145}},{"facility":"Novo Nordisk Investigational Site","city":"Concord","state":"California","zip":"94520","country":"United States","geoPoint":{"lat":37.97798,"lon":-122.03107}},{"facility":"Novo Nordisk Investigational Site","city":"Huntington Beach","state":"California","zip":"92646","country":"United States","geoPoint":{"lat":33.6603,"lon":-117.99923}},{"facility":"Novo Nordisk Investigational Site","city":"La Jolla","state":"California","zip":"92037","country":"United States","geoPoint":{"lat":32.84727,"lon":-117.2742}},{"facility":"Novo Nordisk Investigational Site","city":"San Diego","state":"California","zip":"92103-4140","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"Novo Nordisk Investigational Site","city":"San Diego","state":"California","zip":"92108","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"Novo Nordisk Investigational Site","city":"Santa Monica","state":"California","zip":"90404","country":"United States","geoPoint":{"lat":34.01949,"lon":-118.49138}},{"facility":"Novo Nordisk Investigational Site","city":"Aurora","state":"Colorado","zip":"80045","country":"United States","geoPoint":{"lat":39.72943,"lon":-104.83192}},{"facility":"Novo Nordisk Investigational Site","city":"Colorado Springs","state":"Colorado","zip":"80904","country":"United States","geoPoint":{"lat":38.83388,"lon":-104.82136}},{"facility":"Novo Nordisk Investigational Site","city":"Golden","state":"Colorado","zip":"80401","country":"United States","geoPoint":{"lat":39.75554,"lon":-105.2211}},{"facility":"Novo Nordisk Investigational Site","city":"New London","state":"Connecticut","zip":"06320","country":"United States","geoPoint":{"lat":41.35565,"lon":-72.09952}},{"facility":"Novo Nordisk Investigational Site","city":"Waterbury","state":"Connecticut","zip":"06708","country":"United States","geoPoint":{"lat":41.55815,"lon":-73.0515}},{"facility":"Novo Nordisk Investigational Site","city":"Washington D.C.","state":"District of Columbia","zip":"20036-5847","country":"United States","geoPoint":{"lat":38.89511,"lon":-77.03637}},{"facility":"Novo Nordisk Investigational Site","city":"Boynton Beach","state":"Florida","zip":"33437","country":"United States","geoPoint":{"lat":26.52535,"lon":-80.06643}},{"facility":"Novo Nordisk Investigational Site","city":"Bradenton","state":"Florida","zip":"34201","country":"United States","geoPoint":{"lat":27.49893,"lon":-82.57482}},{"facility":"Novo Nordisk Investigational Site","city":"Crystal River","state":"Florida","zip":"34429","country":"United States","geoPoint":{"lat":28.90248,"lon":-82.5926}},{"facility":"Novo Nordisk Investigational Site","city":"Daytona Beach","state":"Florida","zip":"32117","country":"United States","geoPoint":{"lat":29.21081,"lon":-81.02283}},{"facility":"Novo Nordisk Investigational Site","city":"Jacksonville","state":"Florida","zip":"32205","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Novo Nordisk Investigational Site","city":"Jacksonville","state":"Florida","zip":"32216","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Novo Nordisk Investigational Site","city":"Ocala","state":"Florida","zip":"34471","country":"United States","geoPoint":{"lat":29.1872,"lon":-82.14009}},{"facility":"Novo Nordisk Investigational Site","city":"Ponte Vedra","state":"Florida","zip":"32081","country":"United States","geoPoint":{"lat":30.22746,"lon":-81.38008}},{"facility":"Novo Nordisk Investigational Site","city":"South Miami","state":"Florida","zip":"33143","country":"United States","geoPoint":{"lat":25.7076,"lon":-80.29338}},{"facility":"Novo Nordisk Investigational Site","city":"Athens","state":"Georgia","zip":"30606","country":"United States","geoPoint":{"lat":33.96095,"lon":-83.37794}},{"facility":"Novo Nordisk Investigational Site","city":"Dunwoody","state":"Georgia","zip":"30338","country":"United States","geoPoint":{"lat":33.94621,"lon":-84.33465}},{"facility":"Novo Nordisk Investigational Site","city":"Sandy Springs","state":"Georgia","zip":"30328","country":"United States","geoPoint":{"lat":33.92427,"lon":-84.37854}},{"facility":"Novo Nordisk Investigational Site","city":"Suwanee","state":"Georgia","zip":"30024","country":"United States","geoPoint":{"lat":34.05149,"lon":-84.0713}},{"facility":"Novo Nordisk Investigational Site","city":"Aurora","state":"Illinois","zip":"60504","country":"United States","geoPoint":{"lat":41.76058,"lon":-88.32007}},{"facility":"Novo Nordisk Investigational Site","city":"Topeka","state":"Kansas","zip":"66606","country":"United States","geoPoint":{"lat":39.04833,"lon":-95.67804}},{"facility":"Novo Nordisk Investigational Site","city":"Baton Rouge","state":"Louisiana","zip":"70808-4124","country":"United States","geoPoint":{"lat":30.44332,"lon":-91.18747}},{"facility":"Novo Nordisk Investigational Site","city":"Baltimore","state":"Maryland","zip":"21209","country":"United States","geoPoint":{"lat":39.29038,"lon":-76.61219}},{"facility":"Novo Nordisk Investigational Site","city":"Elkridge","state":"Maryland","zip":"21075-6437","country":"United States","geoPoint":{"lat":39.21261,"lon":-76.71358}},{"facility":"Novo Nordisk Investigational Site","city":"North Dartmouth","state":"Massachusetts","zip":"02747","country":"United States","geoPoint":{"lat":41.63899,"lon":-70.97032}},{"facility":"Novo Nordisk Investigational Site","city":"City of Saint Peters","state":"Missouri","zip":"63376","country":"United States","geoPoint":{"lat":38.80033,"lon":-90.62651}},{"facility":"Novo Nordisk Investigational Site","city":"Kansas City","state":"Missouri","zip":"64111","country":"United States","geoPoint":{"lat":39.09973,"lon":-94.57857}},{"facility":"Novo Nordisk Investigational Site","city":"St Louis","state":"Missouri","zip":"63104","country":"United States","geoPoint":{"lat":38.62727,"lon":-90.19789}},{"facility":"Novo Nordisk Investigational Site","city":"St Louis","state":"Missouri","zip":"63141","country":"United States","geoPoint":{"lat":38.62727,"lon":-90.19789}},{"facility":"Novo Nordisk Investigational Site","city":"New York","state":"New York","zip":"10025","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"Novo Nordisk Investigational Site","city":"Rochester","state":"New York","zip":"14609","country":"United States","geoPoint":{"lat":43.15478,"lon":-77.61556}},{"facility":"Novo Nordisk Investigational Site","city":"Staten Island","state":"New York","zip":"10301","country":"United States","geoPoint":{"lat":40.56233,"lon":-74.13986}},{"facility":"Novo Nordisk Investigational Site","city":"Syracuse","state":"New York","zip":"13210","country":"United States","geoPoint":{"lat":43.04812,"lon":-76.14742}},{"facility":"Novo Nordisk Investigational Site","city":"Cary","state":"North Carolina","zip":"27518","country":"United States","geoPoint":{"lat":35.79154,"lon":-78.78112}},{"facility":"Novo Nordisk Investigational Site","city":"Raleigh","state":"North Carolina","zip":"27612","country":"United States","geoPoint":{"lat":35.7721,"lon":-78.63861}},{"facility":"Novo Nordisk Investigational Site","city":"Canal Fulton","state":"Ohio","zip":"44614","country":"United States","geoPoint":{"lat":40.88978,"lon":-81.59762}},{"facility":"Novo Nordisk Investigational Site","city":"Cincinnati","state":"Ohio","zip":"45219","country":"United States","geoPoint":{"lat":39.12711,"lon":-84.51439}},{"facility":"Novo Nordisk Investigational Site","city":"Franklin","state":"Ohio","zip":"45005","country":"United States","geoPoint":{"lat":39.55895,"lon":-84.30411}},{"facility":"Novo Nordisk Investigational Site","city":"Wadsworth","state":"Ohio","zip":"44281-9236","country":"United States","geoPoint":{"lat":41.02561,"lon":-81.72985}},{"facility":"Novo Nordisk Investigational Site","city":"Tulsa","state":"Oklahoma","zip":"74136","country":"United States","geoPoint":{"lat":36.15398,"lon":-95.99277}},{"facility":"Novo Nordisk Investigational Site","city":"Eugene","state":"Oregon","zip":"97401","country":"United States","geoPoint":{"lat":44.05207,"lon":-123.08675}},{"facility":"Novo Nordisk Investigational Site","city":"Beaver","state":"Pennsylvania","zip":"15009","country":"United States","geoPoint":{"lat":40.69534,"lon":-80.30478}},{"facility":"Novo Nordisk Investigational Site","city":"Philadelphia","state":"Pennsylvania","zip":"19107","country":"United States","geoPoint":{"lat":39.95238,"lon":-75.16362}},{"facility":"Novo Nordisk Investigational Site","city":"Pittsburgh","state":"Pennsylvania","zip":"15206","country":"United States","geoPoint":{"lat":40.44062,"lon":-79.99589}},{"facility":"Novo Nordisk Investigational Site","city":"West Reading","state":"Pennsylvania","zip":"19611","country":"United States","geoPoint":{"lat":40.3337,"lon":-75.94743}},{"facility":"Novo Nordisk Investigational Site","city":"Charleston","state":"South Carolina","zip":"29425","country":"United States","geoPoint":{"lat":32.77632,"lon":-79.93275}},{"facility":"Novo Nordisk Investigational Site","city":"Greer","state":"South Carolina","zip":"29651","country":"United States","geoPoint":{"lat":34.93873,"lon":-82.22706}},{"facility":"Novo Nordisk Investigational Site","city":"Bristol","state":"Tennessee","zip":"37620-7352","country":"United States","geoPoint":{"lat":36.59511,"lon":-82.18874}},{"facility":"Novo Nordisk Investigational Site","city":"Austin","state":"Texas","zip":"78731","country":"United States","geoPoint":{"lat":30.26715,"lon":-97.74306}},{"facility":"Novo Nordisk Investigational Site","city":"Dallas","state":"Texas","zip":"75231","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"Novo Nordisk Investigational Site","city":"Dallas","state":"Texas","zip":"75234","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"Novo Nordisk Investigational Site","city":"Dallas","state":"Texas","zip":"75251","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"Novo Nordisk Investigational Site","city":"Dallas","state":"Texas","zip":"75390-8858","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"Novo Nordisk Investigational Site","city":"San Antonio","state":"Texas","zip":"78229-4801","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Novo Nordisk Investigational Site","city":"Sugar Land","state":"Texas","zip":"77479","country":"United States","geoPoint":{"lat":29.61968,"lon":-95.63495}},{"facility":"Novo Nordisk Investigational Site","city":"Salt Lake City","state":"Utah","zip":"84107","country":"United States","geoPoint":{"lat":40.76078,"lon":-111.89105}},{"facility":"Novo Nordisk Investigational Site","city":"West Jordan","state":"Utah","zip":"84088-8871","country":"United States","geoPoint":{"lat":40.60967,"lon":-111.9391}},{"facility":"Novo Nordisk Investigational Site","city":"Arlington","state":"Virginia","zip":"22206","country":"United States","geoPoint":{"lat":38.88101,"lon":-77.10428}},{"facility":"Novo Nordisk Investigational Site","city":"Henrico","state":"Virginia","zip":"23233","country":"United States","geoPoint":{"lat":36.59264,"lon":-78.61611}},{"facility":"Novo Nordisk Investigational Site","city":"Richmond","state":"Virginia","zip":"23294","country":"United States","geoPoint":{"lat":37.55376,"lon":-77.46026}},{"facility":"Novo Nordisk Investigational Site","city":"Virginia Beach","state":"Virginia","zip":"23454","country":"United States","geoPoint":{"lat":36.85293,"lon":-75.97799}},{"facility":"Novo Nordisk Investigational Site","city":"Renton","state":"Washington","zip":"98057","country":"United States","geoPoint":{"lat":47.48288,"lon":-122.21707}},{"facility":"Novo Nordisk Investigational Site","city":"Wenatchee","state":"Washington","zip":"98801-2028","country":"United States","geoPoint":{"lat":47.42346,"lon":-120.31035}},{"facility":"Novo Nordisk Investigational Site","city":"Milwaukee","state":"Wisconsin","zip":"53209","country":"United States","geoPoint":{"lat":43.0389,"lon":-87.90647}},{"facility":"Novo Nordisk Investigational Site","city":"Ciudad Autónoma de Bs As","zip":"C1426ABP","country":"Argentina"},{"facility":"Novo Nordisk Investigational Site","city":"Ciudad Autónoma de BsAs","zip":"C1406FWY","country":"Argentina"},{"facility":"Novo Nordisk Investigational Site","city":"Ciudad de Buenos Aires","zip":"C1405CWB","country":"Argentina"},{"facility":"Novo Nordisk Investigational Site","city":"Mar del Plata","zip":"B7600FZN","country":"Argentina","geoPoint":{"lat":-38.00042,"lon":-57.5562}},{"facility":"Novo Nordisk Investigational Site","city":"University of Sydney","state":"New South Wales","zip":"2006","country":"Australia"},{"facility":"Novo Nordisk Investigational Site","city":"Woolloongabba","state":"Queensland","zip":"4102","country":"Australia","geoPoint":{"lat":-27.48855,"lon":153.03655}},{"facility":"Novo Nordisk Investigational Site","city":"Adelaide","state":"South Australia","zip":"5005","country":"Australia","geoPoint":{"lat":-34.92866,"lon":138.59863}},{"facility":"Novo Nordisk Investigational Site","city":"Heidelberg West","state":"Victoria","zip":"3081","country":"Australia","geoPoint":{"lat":-37.73922,"lon":145.04034}},{"facility":"Novo Nordisk Investigational Site","city":"Graz","zip":"8036","country":"Austria","geoPoint":{"lat":47.06733,"lon":15.44197}},{"facility":"Novo Nordisk Investigational Site","city":"Salzburg","zip":"5020","country":"Austria","geoPoint":{"lat":47.79941,"lon":13.04399}},{"facility":"Novo Nordisk Investigational Site","city":"Vienna","zip":"1090","country":"Austria","geoPoint":{"lat":48.20849,"lon":16.37208}},{"facility":"Novo Nordisk Investigational Site","city":"Vienna","zip":"1130","country":"Austria","geoPoint":{"lat":48.20849,"lon":16.37208}},{"facility":"Novo Nordisk Investigational Site","city":"Boussu","zip":"7300","country":"Belgium","geoPoint":{"lat":50.43417,"lon":3.7944}},{"facility":"Novo Nordisk Investigational Site","city":"Edegem","zip":"2650","country":"Belgium","geoPoint":{"lat":51.15662,"lon":4.44504}},{"facility":"Novo Nordisk Investigational Site","city":"Liège","zip":"4000","country":"Belgium","geoPoint":{"lat":50.63373,"lon":5.56749}},{"facility":"Novo Nordisk Investigational Site","city":"Porto Alegre","state":"Rio Grande do Sul","zip":"90035-170","country":"Brazil","geoPoint":{"lat":-30.03283,"lon":-51.23019}},{"facility":"Novo Nordisk Investigational Site","city":"Campinas","state":"São Paulo","zip":"13073-350","country":"Brazil","geoPoint":{"lat":-22.90556,"lon":-47.06083}},{"facility":"Novo Nordisk Investigational Site","city":"São Paulo","state":"São Paulo","zip":"05403-000","country":"Brazil","geoPoint":{"lat":-23.5475,"lon":-46.63611}},{"facility":"Novo Nordisk Investigational Site","city":"Curitiba","zip":"80030-110","country":"Brazil","geoPoint":{"lat":-25.42778,"lon":-49.27306}},{"facility":"Novo Nordisk Investigational Site","city":"São Paulo","zip":"04022-002","country":"Brazil","geoPoint":{"lat":-23.5475,"lon":-46.63611}},{"facility":"Novo Nordisk Investigational Site","city":"Calgary","state":"Alberta","zip":"T2T 5C7","country":"Canada","geoPoint":{"lat":51.05011,"lon":-114.08529}},{"facility":"Novo Nordisk Investigational Site","city":"Edmonton","state":"Alberta","zip":"T6G 2E1","country":"Canada","geoPoint":{"lat":53.55014,"lon":-113.46871}},{"facility":"Novo Nordisk Investigational Site","city":"Mount Pearl","state":"Newfoundland and Labrador","zip":"A1N 1W7","country":"Canada","geoPoint":{"lat":47.51659,"lon":-52.78135}},{"facility":"Novo Nordisk Investigational Site","city":"St. John's","state":"Newfoundland and Labrador","zip":"A1A 3R5","country":"Canada","geoPoint":{"lat":47.56494,"lon":-52.70931}},{"facility":"Novo Nordisk Investigational Site","city":"Halifax","state":"Nova Scotia","zip":"B3H 2Y9","country":"Canada","geoPoint":{"lat":44.64269,"lon":-63.57688}},{"facility":"Novo Nordisk Investigational Site","city":"Cambridge","state":"Ontario","zip":"N1R 7L6","country":"Canada","geoPoint":{"lat":43.3601,"lon":-80.31269}},{"facility":"Novo Nordisk Investigational Site","city":"Hamilton","state":"Ontario","zip":"L8L 2X2","country":"Canada","geoPoint":{"lat":43.25011,"lon":-79.84963}},{"facility":"Novo Nordisk Investigational Site","city":"Hamilton","state":"Ontario","zip":"L8M 1K7","country":"Canada","geoPoint":{"lat":43.25011,"lon":-79.84963}},{"facility":"Novo Nordisk Investigational Site","city":"Ottawa","state":"Ontario","zip":"K1H 1A2","country":"Canada","geoPoint":{"lat":45.41117,"lon":-75.69812}},{"facility":"Novo Nordisk Investigational Site","city":"Pointe-Claire","state":"Quebec","zip":"H9R 4S3","country":"Canada","geoPoint":{"lat":45.44868,"lon":-73.81669}},{"facility":"Novo Nordisk Investigational Site","city":"Québec","zip":"G1V 4G2","country":"Canada","geoPoint":{"lat":46.81228,"lon":-71.21454}},{"facility":"Novo Nordisk Investigational Site","city":"Québec","zip":"G1V 4G5","country":"Canada","geoPoint":{"lat":46.81228,"lon":-71.21454}},{"facility":"Novo Nordisk Investigational Site","city":"Århus C","zip":"8000","country":"Denmark"},{"facility":"Novo Nordisk Investigational Site","city":"Frederiksberg C","zip":"1958","country":"Denmark"},{"facility":"Novo Nordisk Investigational Site","city":"Hvidovre","zip":"2650","country":"Denmark","geoPoint":{"lat":55.64297,"lon":12.47708}},{"facility":"Novo Nordisk Investigational Site","city":"Kuopio","zip":"07100","country":"Finland","geoPoint":{"lat":62.89238,"lon":27.67703}},{"facility":"Novo Nordisk Investigational Site","city":"Oulu","zip":"90220","country":"Finland","geoPoint":{"lat":65.01236,"lon":25.46816}},{"facility":"Novo Nordisk Investigational Site","city":"University of Helsinki","zip":"00014","country":"Finland"},{"facility":"Novo Nordisk Investigational Site","city":"Antibes","zip":"06600","country":"France","geoPoint":{"lat":43.58127,"lon":7.12487}},{"facility":"Novo Nordisk Investigational Site","city":"Lille","zip":"59037","country":"France","geoPoint":{"lat":50.63391,"lon":3.05512}},{"facility":"Novo Nordisk Investigational Site","city":"Paris","zip":"75651","country":"France","geoPoint":{"lat":48.85341,"lon":2.3488}},{"facility":"Novo Nordisk Investigational Site","city":"Paris","zip":"75877","country":"France","geoPoint":{"lat":48.85341,"lon":2.3488}},{"facility":"Novo Nordisk Investigational Site","city":"Pierre-Bénite","zip":"69495","country":"France","geoPoint":{"lat":45.70359,"lon":4.82424}},{"facility":"Novo Nordisk Investigational Site","city":"Saint-Herblain","zip":"44800","country":"France","geoPoint":{"lat":47.21154,"lon":-1.651}},{"facility":"Novo Nordisk Investigational Site","city":"Bad Nauheim","zip":"61231","country":"Germany","geoPoint":{"lat":50.36463,"lon":8.73859}},{"facility":"Novo Nordisk Investigational Site","city":"Berlin","zip":"13055","country":"Germany","geoPoint":{"lat":52.52437,"lon":13.41053}},{"facility":"Novo Nordisk Investigational Site","city":"Dresden","zip":"01219","country":"Germany","geoPoint":{"lat":51.05089,"lon":13.73832}},{"facility":"Novo Nordisk Investigational Site","city":"Duisburg","zip":"47051","country":"Germany","geoPoint":{"lat":51.43247,"lon":6.76516}},{"facility":"Novo Nordisk Investigational Site","city":"Freiburg im Breisgau","zip":"79106","country":"Germany","geoPoint":{"lat":47.9959,"lon":7.85222}},{"facility":"Novo Nordisk Investigational Site","city":"Giessen","zip":"35392","country":"Germany","geoPoint":{"lat":50.58727,"lon":8.67554}},{"facility":"Novo Nordisk Investigational Site","city":"Gifhorn","zip":"38518","country":"Germany","geoPoint":{"lat":52.47944,"lon":10.55223}},{"facility":"Novo Nordisk Investigational Site","city":"Leipzig","zip":"04103","country":"Germany","geoPoint":{"lat":51.33962,"lon":12.37129}},{"facility":"Novo Nordisk Investigational Site","city":"Mannheim","zip":"68163","country":"Germany","geoPoint":{"lat":49.4891,"lon":8.46694}},{"facility":"Novo Nordisk Investigational Site","city":"Saint Ingbert","zip":"66386","country":"Germany"},{"facility":"Novo Nordisk Investigational Site","city":"Shatin, New Territories","country":"Hong Kong"},{"facility":"Novo Nordisk Investigational Site","city":"Budapest","zip":"H-1115","country":"Hungary","geoPoint":{"lat":47.49835,"lon":19.04045}},{"facility":"Novo Nordisk Investigational Site","city":"Budapest","zip":"H-1134","country":"Hungary","geoPoint":{"lat":47.49835,"lon":19.04045}},{"facility":"Novo Nordisk Investigational Site","city":"Debrecen","zip":"H-4012","country":"Hungary","geoPoint":{"lat":47.53167,"lon":21.62444}},{"facility":"Novo Nordisk Investigational Site","city":"Bangalore","state":"Karnataka","zip":"560 017","country":"India","geoPoint":{"lat":12.97194,"lon":77.59369}},{"facility":"Novo Nordisk Investigational Site","city":"Belagavi","state":"Karnataka","zip":"590001","country":"India","geoPoint":{"lat":15.85212,"lon":74.50447}},{"facility":"Novo Nordisk Investigational Site","city":"Mumbai","state":"Maharashtra","zip":"4000021","country":"India","geoPoint":{"lat":19.07283,"lon":72.88261}},{"facility":"Novo Nordisk Investigational Site","city":"Mumbai","state":"Maharashtra","zip":"400007","country":"India","geoPoint":{"lat":19.07283,"lon":72.88261}},{"facility":"Novo Nordisk Investigational Site","city":"Mumbai","state":"Maharashtra","zip":"400703","country":"India","geoPoint":{"lat":19.07283,"lon":72.88261}},{"facility":"Novo Nordisk Investigational Site","city":"Pune","state":"Maharashtra","zip":"411030","country":"India","geoPoint":{"lat":18.51957,"lon":73.85535}},{"facility":"Novo Nordisk Investigational Site","city":"Trichy","state":"Tamil Nadu","zip":"620018","country":"India","geoPoint":{"lat":10.80289,"lon":78.69875}},{"facility":"Novo Nordisk Investigational Site","city":"Karnāl","zip":"132001","country":"India","geoPoint":{"lat":29.69197,"lon":76.98448}},{"facility":"Novo Nordisk Investigational Site","city":"Kerala","zip":"682026","country":"India"},{"facility":"Novo Nordisk Investigational Site","city":"Dublin","zip":"DUBLIN 4","country":"Ireland","geoPoint":{"lat":53.33306,"lon":-6.24889}},{"facility":"Novo Nordisk Investigational Site","city":"Dublin","zip":"DUBLIN 8","country":"Ireland","geoPoint":{"lat":53.33306,"lon":-6.24889}},{"facility":"Novo Nordisk Investigational Site","city":"Dublin","country":"Ireland","geoPoint":{"lat":53.33306,"lon":-6.24889}},{"facility":"Novo Nordisk Investigational Site","city":"Galway","zip":"H91 YR71","country":"Ireland","geoPoint":{"lat":53.27245,"lon":-9.05095}},{"facility":"Novo Nordisk Investigational Site","city":"Haifa","zip":"31096","country":"Israel","geoPoint":{"lat":32.81303,"lon":34.99928}},{"facility":"Novo Nordisk Investigational Site","city":"Jerusalem","zip":"91120","country":"Israel","geoPoint":{"lat":31.76904,"lon":35.21633}},{"facility":"Novo Nordisk Investigational Site","city":"Kfar Saba","zip":"44281","country":"Israel","geoPoint":{"lat":32.175,"lon":34.90694}},{"facility":"Novo Nordisk Investigational Site","city":"Ofakim","zip":"87520","country":"Israel","geoPoint":{"lat":31.3141,"lon":34.62025}},{"facility":"Novo Nordisk Investigational Site","city":"Petah Tikva","zip":"49100","country":"Israel","geoPoint":{"lat":32.0888,"lon":34.88666}},{"facility":"Novo Nordisk Investigational Site","city":"Petah Tikva","zip":"49372","country":"Israel","geoPoint":{"lat":32.0888,"lon":34.88666}},{"facility":"Novo Nordisk Investigational Site","city":"Tel Aviv","zip":"64239","country":"Israel","geoPoint":{"lat":32.08088,"lon":34.78057}},{"facility":"Novo Nordisk Investigational Site","city":"Tel Litwinsky","zip":"52621","country":"Israel","geoPoint":{"lat":32.05096,"lon":34.84588}},{"facility":"Novo Nordisk Investigational Site","city":"Bologna","zip":"40138","country":"Italy","geoPoint":{"lat":44.49381,"lon":11.33875}},{"facility":"Novo Nordisk Investigational Site","city":"Florence","zip":"50139","country":"Italy","geoPoint":{"lat":43.77925,"lon":11.24626}},{"facility":"Novo Nordisk Investigational Site","city":"Milan","zip":"20145","country":"Italy","geoPoint":{"lat":42.78235,"lon":12.59836}},{"facility":"Novo Nordisk Investigational Site","city":"Padova","zip":"35128","country":"Italy","geoPoint":{"lat":44.38225,"lon":11.14261}},{"facility":"Novo Nordisk Investigational Site","city":"Palermo","zip":"90127","country":"Italy","geoPoint":{"lat":38.1166,"lon":13.3636}},{"facility":"Novo Nordisk Investigational Site","city":"Pisa","zip":"56124","country":"Italy","geoPoint":{"lat":43.70853,"lon":10.4036}},{"facility":"Novo Nordisk Investigational Site","city":"Roma","zip":"00168","country":"Italy","geoPoint":{"lat":44.99364,"lon":11.10642}},{"facility":"Novo Nordisk Investigational Site","city":"Siena","zip":"53100","country":"Italy","geoPoint":{"lat":43.31822,"lon":11.33064}},{"facility":"Novo Nordisk Investigational Site","city":"Pachuca","state":"Hidalgo","zip":"42084","country":"Mexico","geoPoint":{"lat":20.11697,"lon":-98.73329}},{"facility":"Novo Nordisk Investigational Site","city":"Guadalajara","state":"Jalisco","zip":"44600","country":"Mexico","geoPoint":{"lat":20.67738,"lon":-103.34749}},{"facility":"Novo Nordisk Investigational Site","city":"Guadalajara","state":"Jalisco","zip":"44650","country":"Mexico","geoPoint":{"lat":20.67738,"lon":-103.34749}},{"facility":"Novo Nordisk Investigational Site","city":"Mexico City","state":"México, D.F.","zip":"03300","country":"Mexico","geoPoint":{"lat":19.42847,"lon":-99.12766}},{"facility":"Novo Nordisk Investigational Site","city":"Mexico City","state":"México, D.F.","zip":"14000","country":"Mexico","geoPoint":{"lat":19.42847,"lon":-99.12766}},{"facility":"Novo Nordisk Investigational Site","city":"Tampico","state":"Tamaulipas","zip":"89000","country":"Mexico","geoPoint":{"lat":22.28519,"lon":-97.87777}},{"facility":"Novo Nordisk Investigational Site","city":"Durango","zip":"34000","country":"Mexico","geoPoint":{"lat":24.02032,"lon":-104.65756}},{"facility":"Novo Nordisk Investigational Site","city":"Monterrey","zip":"64700","country":"Mexico","geoPoint":{"lat":25.68435,"lon":-100.31721}},{"facility":"Novo Nordisk Investigational Site","city":"Almere Stad","zip":"1311RL","country":"Netherlands","geoPoint":{"lat":52.37025,"lon":5.21413}},{"facility":"Novo Nordisk Investigational Site","city":"Amsterdam","zip":"1066 EC","country":"Netherlands","geoPoint":{"lat":52.37403,"lon":4.88969}},{"facility":"Novo Nordisk Investigational Site","city":"Beek","zip":"6191JW","country":"Netherlands","geoPoint":{"lat":50.94083,"lon":5.79722}},{"facility":"Novo Nordisk Investigational Site","city":"Hengelo OV","zip":"7555 DL","country":"Netherlands"},{"facility":"Novo Nordisk Investigational Site","city":"Hilversum","zip":"1213 RH","country":"Netherlands","geoPoint":{"lat":52.22333,"lon":5.17639}},{"facility":"Novo Nordisk Investigational Site","city":"Leidschendam","zip":"2262 BA","country":"Netherlands","geoPoint":{"lat":52.08167,"lon":4.39281}},{"facility":"Novo Nordisk Investigational Site","city":"Zwijndrecht","zip":"3331 LZ","country":"Netherlands","geoPoint":{"lat":51.8175,"lon":4.63333}},{"facility":"Novo Nordisk Investigational Site","city":"Bergen","zip":"NO-5012","country":"Norway","geoPoint":{"lat":60.39299,"lon":5.32415}},{"facility":"Novo Nordisk Investigational Site","city":"Oslo","zip":"0424","country":"Norway","geoPoint":{"lat":59.91273,"lon":10.74609}},{"facility":"Novo Nordisk Investigational Site","city":"Trondheim","zip":"7030","country":"Norway","geoPoint":{"lat":63.43049,"lon":10.39506}},{"facility":"Novo Nordisk Investigational Site","city":"Tønsberg","zip":"3117","country":"Norway","geoPoint":{"lat":59.26754,"lon":10.40762}},{"facility":"Novo Nordisk Investigational Site","city":"Bialystok","zip":"15-381","country":"Poland","geoPoint":{"lat":53.13333,"lon":23.16433}},{"facility":"Novo Nordisk Investigational Site","city":"Katowice","zip":"40-662","country":"Poland","geoPoint":{"lat":50.2597,"lon":19.02173}},{"facility":"Novo Nordisk Investigational Site","city":"Katowice","zip":"40-767","country":"Poland","geoPoint":{"lat":50.2597,"lon":19.02173}},{"facility":"Novo Nordisk Investigational Site","city":"Poznan","zip":"60-569","country":"Poland","geoPoint":{"lat":52.40692,"lon":16.92993}},{"facility":"Novo Nordisk Investigational Site","city":"Szczecin","zip":"70-483","country":"Poland","geoPoint":{"lat":53.42894,"lon":14.55302}},{"facility":"Novo Nordisk Investigational Site","city":"Szczecin","zip":"71-455","country":"Poland","geoPoint":{"lat":53.42894,"lon":14.55302}},{"facility":"Novo Nordisk Investigational Site","city":"Warsaw","zip":"02-507","country":"Poland","geoPoint":{"lat":52.22977,"lon":21.01178}},{"facility":"Novo Nordisk Investigational Site","city":"Arkhangelsk","zip":"163045","country":"Russia","geoPoint":{"lat":64.5461,"lon":40.55183}},{"facility":"Novo Nordisk Investigational Site","city":"Moscow","zip":"101990","country":"Russia","geoPoint":{"lat":55.75204,"lon":37.61781}},{"facility":"Novo Nordisk Investigational Site","city":"Moscow","zip":"115093","country":"Russia","geoPoint":{"lat":55.75204,"lon":37.61781}},{"facility":"Novo Nordisk Investigational Site","city":"Moscow","zip":"117036","country":"Russia","geoPoint":{"lat":55.75204,"lon":37.61781}},{"facility":"Novo Nordisk Investigational Site","city":"Moscow","zip":"121356","country":"Russia","geoPoint":{"lat":55.75204,"lon":37.61781}},{"facility":"Novo Nordisk Investigational Site","city":"Moscow","zip":"125367","country":"Russia","geoPoint":{"lat":55.75204,"lon":37.61781}},{"facility":"Novo Nordisk Investigational Site","city":"Moscow","zip":"127486","country":"Russia","geoPoint":{"lat":55.75204,"lon":37.61781}},{"facility":"Novo Nordisk Investigational Site","city":"Novosibirsk","zip":"630047","country":"Russia","geoPoint":{"lat":55.02259,"lon":82.93175}},{"facility":"Novo Nordisk Investigational Site","city":"Tyumen","zip":"625023","country":"Russia","geoPoint":{"lat":57.15222,"lon":65.52722}},{"facility":"Novo Nordisk Investigational Site","city":"Belgrade","zip":"11000","country":"Serbia and Montenegro"},{"facility":"Novo Nordisk Investigational Site","city":"Belgrade","zip":"11000","country":"Serbia","geoPoint":{"lat":44.80401,"lon":20.46513}},{"facility":"Novo Nordisk Investigational Site","city":"Johannesburg","state":"Gauteng","zip":"2193","country":"South Africa","geoPoint":{"lat":-26.20227,"lon":28.04363}},{"facility":"Novo Nordisk Investigational Site","city":"Pretoria","state":"Gauteng","zip":"0083","country":"South Africa","geoPoint":{"lat":-25.74486,"lon":28.18783}},{"facility":"Novo Nordisk Investigational Site","city":"Cape Town","state":"Western Cape","zip":"7130","country":"South Africa","geoPoint":{"lat":-33.92584,"lon":18.42322}},{"facility":"Novo Nordisk Investigational Site","city":"Almería","zip":"04001","country":"Spain","geoPoint":{"lat":36.83814,"lon":-2.45974}},{"facility":"Novo Nordisk Investigational Site","city":"Barcelona","zip":"08036","country":"Spain","geoPoint":{"lat":41.38879,"lon":2.15899}},{"facility":"Novo Nordisk Investigational Site","city":"Madrid","zip":"28006","country":"Spain","geoPoint":{"lat":40.4165,"lon":-3.70256}},{"facility":"Novo Nordisk Investigational Site","city":"Santiago de Compostela","zip":"15706","country":"Spain","geoPoint":{"lat":42.88052,"lon":-8.54569}},{"facility":"Novo Nordisk Investigational Site","city":"Seville","zip":"41003","country":"Spain","geoPoint":{"lat":37.38283,"lon":-5.97317}},{"facility":"Novo Nordisk Investigational Site","city":"Valladolid","zip":"47005","country":"Spain","geoPoint":{"lat":41.65541,"lon":-4.72353}},{"facility":"Novo Nordisk Investigational Site","city":"Bern","zip":"3010","country":"Switzerland","geoPoint":{"lat":46.94809,"lon":7.44744}},{"facility":"Novo Nordisk Investigational Site","city":"Dättwil","zip":"5405","country":"Switzerland","geoPoint":{"lat":47.45506,"lon":8.28474}},{"facility":"Novo Nordisk Investigational Site","city":"Geneva","zip":"1211","country":"Switzerland","geoPoint":{"lat":46.20222,"lon":6.14569}},{"facility":"Novo Nordisk Investigational Site","city":"Sankt Gallen","zip":"9016","country":"Switzerland","geoPoint":{"lat":47.42391,"lon":9.37477}},{"facility":"Novo Nordisk Investigational Site","city":"Zollikerberg","zip":"8125","country":"Switzerland","geoPoint":{"lat":47.3451,"lon":8.60088}},{"facility":"Novo Nordisk Investigational Site","city":"Ankara","zip":"06100","country":"Turkey (Türkiye)","geoPoint":{"lat":39.91987,"lon":32.85427}},{"facility":"Novo Nordisk Investigational Site","city":"Ankara","zip":"06110","country":"Turkey (Türkiye)","geoPoint":{"lat":39.91987,"lon":32.85427}},{"facility":"Novo Nordisk Investigational Site","city":"Istanbul","zip":"34098","country":"Turkey (Türkiye)","geoPoint":{"lat":41.01384,"lon":28.94966}},{"facility":"Novo Nordisk Investigational Site","city":"Istanbul","zip":"34371","country":"Turkey (Türkiye)","geoPoint":{"lat":41.01384,"lon":28.94966}},{"facility":"Novo Nordisk Investigational Site","city":"Istanbul","zip":"34668","country":"Turkey (Türkiye)","geoPoint":{"lat":41.01384,"lon":28.94966}},{"facility":"Novo Nordisk Investigational Site","city":"Istanbul","zip":"34760","country":"Turkey (Türkiye)","geoPoint":{"lat":41.01384,"lon":28.94966}},{"facility":"Novo Nordisk Investigational Site","city":"Coventry","zip":"CV2 2DX","country":"United Kingdom","geoPoint":{"lat":52.40656,"lon":-1.51217}},{"facility":"Novo Nordisk Investigational Site","city":"Glasgow","zip":"G11 6NT","country":"United Kingdom","geoPoint":{"lat":55.86515,"lon":-4.25763}},{"facility":"Novo Nordisk Investigational Site","city":"Hull","zip":"HU3 2RW","country":"United Kingdom","geoPoint":{"lat":53.7446,"lon":-0.33525}},{"facility":"Novo Nordisk Investigational Site","city":"Liverpool","zip":"L9 7AL","country":"United Kingdom","geoPoint":{"lat":53.41058,"lon":-2.97794}},{"facility":"Novo Nordisk Investigational Site","city":"London","zip":"SE1 9RT","country":"United Kingdom","geoPoint":{"lat":51.50853,"lon":-0.12574}},{"facility":"Novo Nordisk Investigational Site","city":"London","zip":"W1T 7DN","country":"United Kingdom","geoPoint":{"lat":51.50853,"lon":-0.12574}},{"facility":"Novo Nordisk Investigational Site","city":"London","zip":"W6 8RF","country":"United Kingdom","geoPoint":{"lat":51.50853,"lon":-0.12574}},{"facility":"Novo Nordisk Investigational Site","city":"Luton","zip":"LU4 0DZ","country":"United Kingdom","geoPoint":{"lat":51.87967,"lon":-0.41748}},{"facility":"Novo Nordisk Investigational Site","city":"Swansea","zip":"SA6 6NL","country":"United Kingdom","geoPoint":{"lat":51.62079,"lon":-3.94323}}]},"referencesModule":{"references":[{"pmid":"27198973","type":"RESULT","citation":"Kolotkin RL, Fujioka K, Wolden ML, Brett JH, Bjorner JB. Improvements in health-related quality of life with liraglutide 3.0 mg compared with placebo in weight management. Clin Obes. 2016 Aug;6(4):233-42. doi: 10.1111/cob.12146. Epub 2016 May 19."},{"pmid":"27193270","type":"RESULT","citation":"Overgaard RV, Petri KC, Jacobsen LV, Jensen CB. Liraglutide 3.0 mg for Weight Management: A Population Pharmacokinetic Analysis. Clin Pharmacokinet. 2016 Nov;55(11):1413-1422. doi: 10.1007/s40262-016-0410-7."},{"pmid":"27482610","type":"RESULT","citation":"O'Neil PM, Garvey WT, Gonzalez-Campoy JM, Mora P, Ortiz RV, Guerrero G, Claudius B, Pi-Sunyer X; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS. Endocr Pract. 2016 Nov;22(11):1277-1287. doi: 10.4158/EP151181.OR. Epub 2016 Aug 2."},{"pmid":"27804269","type":"RESULT","citation":"Fujioka K, O'Neil PM, Davies M, Greenway F, C W Lau D, Claudius B, Skjoth TV, Bjorn Jensen C, P H Wilding J. Early Weight Loss with Liraglutide 3.0 mg Predicts 1-Year Weight Loss and is Associated with Improvements in Clinical Markers. Obesity (Silver Spring). 2016 Nov;24(11):2278-2288. doi: 10.1002/oby.21629."},{"pmid":"27817208","type":"RESULT","citation":"Bays H, Pi-Sunyer X, Hemmingsson JU, Claudius B, Jensen CB, Van Gaal L. Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects. Curr Med Res Opin. 2017 Feb;33(2):225-229. doi: 10.1080/03007995.2016.1251892. Epub 2016 Nov 6."},{"pmid":"26833744","type":"RESULT","citation":"Wilding JP, Overgaard RV, Jacobsen LV, Jensen CB, le Roux CW. Exposure-response analyses of liraglutide 3.0 mg for weight management. Diabetes Obes Metab. 2016 May;18(5):491-9. doi: 10.1111/dom.12639. Epub 2016 Mar 1."},{"pmid":"26132939","type":"RESULT","citation":"Pi-Sunyer X, Astrup A, Fujioka K, Greenway F, Halpern A, Krempf M, Lau DC, le Roux CW, Violante Ortiz R, Jensen CB, Wilding JP; SCALE Obesity and Prediabetes NN8022-1839 Study Group. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J Med. 2015 Jul 2;373(1):11-22. doi: 10.1056/NEJMoa1411892."},{"pmid":"26418188","type":"RESULT","citation":"McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814."},{"pmid":"26744025","type":"RESULT","citation":"Ard J, Cannon A, Lewis CE, Lofton H, Vang Skjoth T, Stevenin B, Pi-Sunyer X. Efficacy and safety of liraglutide 3.0 mg for weight management are similar across races: subgroup analysis across the SCALE and phase II randomized trials. Diabetes Obes Metab. 2016 Apr;18(4):430-5. doi: 10.1111/dom.12632. Epub 2016 Feb 11."},{"pmid":"28237263","type":"RESULT","citation":"le Roux CW, Astrup A, Fujioka K, Greenway F, Lau DCW, Van Gaal L, Ortiz RV, Wilding JPH, Skjoth TV, Manning LS, Pi-Sunyer X; SCALE Obesity Prediabetes NN8022-1839 Study Group. 3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial. Lancet. 2017 Apr 8;389(10077):1399-1409. doi: 10.1016/S0140-6736(17)30069-7. Epub 2017 Feb 23."},{"pmid":"28462892","type":"RESULT","citation":"von Scholten BJ, Davies MJ, Persson F, Hansen TW, Madsbad S, Endahl L, Jepsen CH, Rossing P. Effect of weight reductions on estimated kidney function: Post-hoc analysis of two randomized trials. J Diabetes Complications. 2017 Jul;31(7):1164-1168. doi: 10.1016/j.jdiacomp.2017.04.003. Epub 2017 Apr 11."},{"pmid":"28386912","type":"RESULT","citation":"O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW, Wadden TA, Brett J, Cancino AP, Wilding JPH; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 Nov;19(11):1529-1536. doi: 10.1111/dom.12963. Epub 2017 Jul 21."},{"pmid":"28950422","type":"RESULT","citation":"Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jacobsen PB, Marso SP; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018 Mar;20(3):734-739. doi: 10.1111/dom.13125. Epub 2017 Nov 1."},{"pmid":"29045079","type":"RESULT","citation":"Kolotkin RL, Gabriel Smolarz B, Meincke HH, Fujioka K. Improvements in health-related quality of life over 3 years with liraglutide 3.0 mg compared with placebo in participants with overweight or obesity. Clin Obes. 2018 Feb;8(1):1-10. doi: 10.1111/cob.12226. Epub 2017 Oct 16."},{"pmid":"29145215","type":"RESULT","citation":"le Roux C, Aroda V, Hemmingsson J, Cancino AP, Christensen R, Pi-Sunyer X. Comparison of Efficacy and Safety of Liraglutide 3.0 mg in Individuals with BMI above and below 35 kg/m(2): A Post-hoc Analysis. Obes Facts. 2017;10(6):531-544. doi: 10.1159/000478099. Epub 2017 Nov 17."},{"pmid":"39316288","type":"DERIVED","citation":"Kral P, Holst-Hansen T, Olivieri AV, Ivanescu C, Lamotte M, Larsen S. The Correlation Between Body Mass Index and Health-Related Quality of Life: Data from Two Weight Loss Intervention Studies. Adv Ther. 2024 Nov;41(11):4228-4247. doi: 10.1007/s12325-024-02932-8. Epub 2024 Sep 24."},{"pmid":"35975210","type":"DERIVED","citation":"Williams DM, Staff M, Bain SC, Min T. Glucagon-like Peptide-1 Receptor Analogues for the Treatment of Obesity. touchREV Endocrinol. 2022 Mar;18(1):43-48. doi: 10.17925/EE.2022.18.1.43. Epub 2022 Mar 18."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Subjects were stratified based on pre-diabetes status and BMI at screening. The Main Period table, below, reflects the stratification that should have occurred at baseline. The Re-randomized Period and Main + Extension Period tables reflect the actual distribution of subjects, factoring in an incorrect stratification of 43 subjects at screening.","recruitmentDetails":"The trial was conducted at 191 sites in 27 countries: Australia:4,Austria:3,Belgium:2, Brazil:5,Canada:11, Denmark:3,Finland:3, France:5, Germany:8,Hong Kong:1, Hungary:2, India:8, Ireland:1,Israel:7, Italy:7, Mexico:4, Netherlands:5, Norway:3, Poland:5, Russian:7, Serbia:2, South Africa:3, Spain:6, Switzerland:5,Turkey:4, UK:8, US:69.","groups":[{"id":"FG000","title":"Liraglutide 3.0 mg, no Pre-diabetes","description":"Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks."},{"id":"FG001","title":"Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)","description":"Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period."},{"id":"FG002","title":"Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)","description":"Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period."},{"id":"FG003","title":"Liraglutide Placebo, no Pre-diabetes","description":"Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks."},{"id":"FG004","title":"Liraglutide 3.0 mg, Pre-diabetes","description":"Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks."},{"id":"FG005","title":"Liraglutide Placebo, Pre-diabetes","description":"Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks."}],"periods":[{"title":"Main Period: Week 0 to Week 56","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"959"},{"groupId":"FG001","comment":"This arm is not considered for main period as these subjects belong to re-randomised period","numSubjects":"0"},{"groupId":"FG002","comment":"This arm is not considered for main period as these subjects belong to re-randomised period","numSubjects":"0"},{"groupId":"FG003","numSubjects":"487"},{"groupId":"FG004","numSubjects":"1528"},{"groupId":"FG005","numSubjects":"757"}]},{"type":"Exposed","achievements":[{"groupId":"FG000","numSubjects":"957"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"487"},{"groupId":"FG004","numSubjects":"1524"},{"groupId":"FG005","numSubjects":"755"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"679"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"296"},{"groupId":"FG004","numSubjects":"1110"},{"groupId":"FG005","numSubjects":"505"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"280"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"191"},{"groupId":"FG004","numSubjects":"418"},{"groupId":"FG005","numSubjects":"252"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"86"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"16"},{"groupId":"FG004","numSubjects":"152"},{"groupId":"FG005","numSubjects":"29"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"14"},{"groupId":"FG004","numSubjects":"12"},{"groupId":"FG005","numSubjects":"22"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"18"},{"groupId":"FG004","numSubjects":"40"},{"groupId":"FG005","numSubjects":"20"}]},{"type":"Withdrawal criteria","reasons":[{"groupId":"FG000","numSubjects":"122"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"114"},{"groupId":"FG004","numSubjects":"172"},{"groupId":"FG005","numSubjects":"147"}]},{"type":"Unclassified","reasons":[{"groupId":"FG000","numSubjects":"36"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"29"},{"groupId":"FG004","numSubjects":"42"},{"groupId":"FG005","numSubjects":"34"}]}]},{"title":"Re-randomised Period: Week 56 to Week 68","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"This arm is not considered for re-randomised period as these subjects belong to main period","numSubjects":"0"},{"groupId":"FG001","comment":"Incorrect stratification: In this period, overall 37 pre-diabetic subjects were included by error.","numSubjects":"351"},{"groupId":"FG002","comment":"Incorrect stratification: In this period, overall 37 pre-diabetic subjects were included by error.","numSubjects":"350"},{"groupId":"FG003","comment":"Incorrect stratification: In this period, overall 37 pre-diabetic subjects were included by error.","numSubjects":"304"},{"groupId":"FG004","comment":"This arm is not considered for re-randomised period as these subjects belong to main period","numSubjects":"0"},{"groupId":"FG005","comment":"This arm is not considered for re-randomised period as these subjects belong to main period","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"342"},{"groupId":"FG002","numSubjects":"343"},{"groupId":"FG003","numSubjects":"289"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"15"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}]},{"type":"Withdrawal criteria","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"7"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}]},{"type":"Unclassified","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}]}]},{"title":"Main + Extension Period: Week 0-172","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"This arm is not considered for this period as these subjects belong to main period","numSubjects":"0"},{"groupId":"FG001","comment":"This arm is not considered for this period as these subjects belong to re-randomised period","numSubjects":"0"},{"groupId":"FG002","comment":"This arm is not considered for this period as these subjects belong to re-randomised period","numSubjects":"0"},{"groupId":"FG003","comment":"This arm is not considered for this period as these subjects belong to main and re-randomised period","numSubjects":"0"},{"groupId":"FG004","comment":"Incorrect stratification: In this period, overall 6 subjects with no pre-diabetes included by error.","numSubjects":"1505"},{"groupId":"FG005","comment":"Incorrect stratification: In this period, overall 6 subjects with no pre-diabetes included by error.","numSubjects":"749"}]},{"type":"Exposed","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1501"},{"groupId":"FG005","numSubjects":"747"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"783"},{"groupId":"FG005","numSubjects":"327"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"722"},{"groupId":"FG005","numSubjects":"422"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"191"},{"groupId":"FG005","numSubjects":"43"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"29"},{"groupId":"FG005","numSubjects":"36"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"76"},{"groupId":"FG005","numSubjects":"36"}]},{"type":"Withdrawal criteria","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"364"},{"groupId":"FG005","numSubjects":"256"}]},{"type":"Missing reason","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"0"}]},{"type":"Unclassified","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"61"},{"groupId":"FG005","numSubjects":"51"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Liraglutide 3.0 mg, no Pre-diabetes","description":"Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks."},{"id":"BG001","title":"Liraglutide Placebo, no Pre-diabetes","description":"Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks."},{"id":"BG002","title":"Liraglutide 3.0 mg, Pre-diabetes","description":"Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks."},{"id":"BG003","title":"Liraglutide Placebo, Pre-diabetes","description":"Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"959"},{"groupId":"BG001","value":"487"},{"groupId":"BG002","value":"1528"},{"groupId":"BG003","value":"757"},{"groupId":"BG004","value":"3731"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"41.6","spread":"11.7"},{"groupId":"BG001","value":"41.5","spread":"11.5"},{"groupId":"BG002","value":"47.4","spread":"11.8"},{"groupId":"BG003","value":"47.2","spread":"11.8"},{"groupId":"BG004","value":"45.1","spread":"12.0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"801"},{"groupId":"BG001","value":"390"},{"groupId":"BG002","value":"1156"},{"groupId":"BG003","value":"581"},{"groupId":"BG004","value":"2928"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"158"},{"groupId":"BG001","value":"97"},{"groupId":"BG002","value":"372"},{"groupId":"BG003","value":"176"},{"groupId":"BG004","value":"803"}]}]}]},{"title":"Fasting Body Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"104.0","spread":"20.1"},{"groupId":"BG001","value":"103.6","spread":"21.2"},{"groupId":"BG002","value":"107.6","spread":"21.8"},{"groupId":"BG003","value":"107.9","spread":"21.8"},{"groupId":"BG004","value":"106.2","spread":"21.4"}]}]}]},{"title":"Body Mass Index (BMI)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg/m^2","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"37.5","spread":"6.2"},{"groupId":"BG001","value":"37.4","spread":"6.2"},{"groupId":"BG002","value":"38.8","spread":"6.4"},{"groupId":"BG003","value":"39.0","spread":"6.3"},{"groupId":"BG004","value":"38.3","spread":"6.4"}]}]}]},{"title":"Glycosylated Haemoglobin (HbA1c)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage of glycosylated haemoglobin","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5.3","spread":"0.3"},{"groupId":"BG001","value":"5.3","spread":"0.3"},{"groupId":"BG002","value":"5.8","spread":"0.3"},{"groupId":"BG003","value":"5.7","spread":"0.3"},{"groupId":"BG004","value":"5.6","spread":"0.4"}]}]}]},{"title":"Fasting Plasma Glucose (FPG)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/L","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5.0","spread":"0.4"},{"groupId":"BG001","value":"5.1","spread":"0.5"},{"groupId":"BG002","value":"5.5","spread":"0.6"},{"groupId":"BG003","value":"5.5","spread":"0.5"},{"groupId":"BG004","value":"5.3","spread":"0.6"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Fasting Body Weight","description":"The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).","populationDescription":"The full analysis set (FAS) included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using last observation carried forward (LOCF).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percent change","timeFrame":"Week 0, Week 56","groups":[{"id":"OG000","title":"Liraglutide 3.0 mg (56-Week)","description":"Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation."},{"id":"OG001","title":"Liraglutide Placebo (56-Week)","description":"Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2432"},{"groupId":"OG001","value":"1220"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-7.98","spread":"6.67"},{"groupId":"OG001","value":"-2.62","spread":"5.74"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss, if the estimated treatment effect (liraglutide 3.0 mg - liraglutide placebo) was statistically significantly smaller than zero.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Estimated mean difference","paramValue":"-5.39","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.82","ciUpperLimit":"-4.95","estimateComment":"ANCOVA model with treatment, country, sex, pre-diabetes status at screening, baseline BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate."}]},{"type":"PRIMARY","title":"Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.","description":"Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period).","populationDescription":"The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"At Week 56","groups":[{"id":"OG000","title":"Liraglutide 3.0 mg (56-Week)","description":"Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation."},{"id":"OG001","title":"Liraglutide Placebo (56-Week)","description":"Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2432"},{"groupId":"OG001","value":"1220"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"63.2"},{"groupId":"OG001","value":"27.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss as assessed by the proportion of subjects losing ≥5% of their fasting baseline weight, if the estimated odds ratio (liraglutide 3.0 mg/liraglutide placebo) was statistically significantly greater than one.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"4.80","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"4.12","ciUpperLimit":"5.60","estimateComment":"The model included treatment, country, sex, pre-diabetes status at screening, BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate."}]},{"type":"PRIMARY","title":"Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight","description":"Percentage of subjects losing \\>10% of baseline fasting body weight after 56-weeks of treatment (main treatment period).","populationDescription":"The FAS) included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"At 56 weeks","groups":[{"id":"OG000","title":"Liraglutide 3.0 mg (56-Week)","description":"Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation."},{"id":"OG001","title":"Liraglutide Placebo (56-Week)","description":"Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2432"},{"groupId":"OG001","value":"1220"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"33.1"},{"groupId":"OG001","value":"10.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss as assessed by the proportion of subjects losing \\>10% of their fasting baseline weight, if the estimated odds ratio (liraglutide 3.0 mg/liraglutide placebo) was statistically significantly greater than one.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"4.34","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.54","ciUpperLimit":"5.32","estimateComment":"The model included treatment, country, sex, pre-diabetes status at screening, BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate."}]},{"type":"PRIMARY","title":"Proportion of Subjects With Onset of Type 2 Diabetes","description":"Proportion of subjects with onset of Type 2 diabetes mellitus (T2DM) at week 160 (main + extension treatment period) among subjects with pre-diabetes at baseline - evaluated as time to onset of T2DM. Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).","populationDescription":"Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Subject","timeFrame":"At 160 weeks","groups":[{"id":"OG000","title":"Liraglutide 3.0 mg (160-Week)","description":"Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation."},{"id":"OG001","title":"Liraglutide Placebo (160-Week)","description":"Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1472"},{"groupId":"OG001","value":"738"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"46"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"If the estimated time-to-event ratio (liraglutide 3.0 mg/ placebo), as assessed by the survival endpoint describing the time until onset of T2DM ('diabetes-free time'), is statistically significantly \\>1, then liraglutide 3.0 mg was to be considered superior to placebo in delaying the onset of T2DM in subjects with pre-diabetes at baseline. Weibull model was used; included treatment, sex and BMI stratification factor as fixed factors and baseline FPG as a covariate.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.0001","statisticalMethod":"Weibull analysis","paramType":"Treatment estimate","paramValue":"2.681","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.856","ciUpperLimit":"3.872","estimateComment":"The treatment estimate was the factor that the time to event is multiplied with for liraglutide 3.0 mg compared to placebo."}]},{"type":"SECONDARY","title":"Change From Baseline in Waist Circumference (cm)","description":"The observed mean change from baseline in waist circumference (cm) after 56-weeks of treatment (main treatment period).","populationDescription":"The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cm","timeFrame":"Week 0, Week 56","groups":[{"id":"OG000","title":"Liraglutide 3.0 mg (56-Week)","description":"Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation."},{"id":"OG001","title":"Liraglutide Placebo (56-Week)","description":"Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2437"},{"groupId":"OG001","value":"1225"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-8.19","spread":"7.31"},{"groupId":"OG001","value":"-3.94","spread":"6.58"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)","description":"The observed mean change from baseline in waist circumference (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).","populationDescription":"Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cm","timeFrame":"Week 0, week 160","groups":[{"id":"OG000","title":"Liraglutide 3.0 mg (160-Week)","description":"Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation."},{"id":"OG001","title":"Liraglutide Placebo (160-Week)","description":"Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1472"},{"groupId":"OG001","value":"738"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.87","spread":"8.28"},{"groupId":"OG001","value":"-3.37","spread":"7.47"}]}]}]},{"type":"SECONDARY","title":"Pre-diabetes Status After 56 Weeks of Treatment","description":"Observed percentage of subjects with pre-diabetes status after 56 weeks of treatment (main treatment period).","populationDescription":"The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Week 0, Week 56","groups":[{"id":"OG000","title":"Liraglutide 3.0 mg (56-Week)","description":"Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation."},{"id":"OG001","title":"Liraglutide Placebo (56-Week)","description":"Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2437"},{"groupId":"OG001","value":"1225"}]}],"classes":[{"title":"With No Pre-diabetes","categories":[{"measurements":[{"groupId":"OG000","value":"78.3"},{"groupId":"OG001","value":"50.9"}]}]},{"title":"With Pre-diabetes","categories":[{"measurements":[{"groupId":"OG000","value":"20.6"},{"groupId":"OG001","value":"46.1"}]}]},{"title":"With Transient Type 2 Diabetes","categories":[{"measurements":[{"groupId":"OG000","value":"0.9"},{"groupId":"OG001","value":"1.8"}]}]},{"title":"With Confirmed Type 2 Diabetes","categories":[{"measurements":[{"groupId":"OG000","value":"0.2"},{"groupId":"OG001","value":"1.1"}]}]}]},{"type":"SECONDARY","title":"Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment","description":"Observed percentage of subjects (subjects with pre-diabetes at baseline) with pre-diabetes status after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).","populationDescription":"Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Week 0, week 160","groups":[{"id":"OG000","title":"Liraglutide 3.0 mg (160-Week)","description":"Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation."},{"id":"OG001","title":"Liraglutide Placebo (160-Week)","description":"Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1472"},{"groupId":"OG001","value":"738"}]}],"classes":[{"title":"With No Pre-diabetes","categories":[{"measurements":[{"groupId":"OG000","value":"65.9"},{"groupId":"OG001","value":"36.3"}]}]},{"title":"With Pre-diabetes","categories":[{"measurements":[{"groupId":"OG000","value":"31.3"},{"groupId":"OG001","value":"54.9"}]}]},{"title":"With Transient Type 2 Diabetes","categories":[{"measurements":[{"groupId":"OG000","value":"1.1"},{"groupId":"OG001","value":"2.6"}]}]},{"title":"With Confirmed Type 2 Diabetes","categories":[{"measurements":[{"groupId":"OG000","value":"1.8"},{"groupId":"OG001","value":"6.2"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)","description":"The observed mean change from baseline in fasting body weight (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).","populationDescription":"Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percent change","timeFrame":"Week 0, week 160","groups":[{"id":"OG000","title":"Liraglutide 3.0 mg (160-Week)","description":"Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation."},{"id":"OG001","title":"Liraglutide Placebo (160-Week)","description":"Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1467"},{"groupId":"OG001","value":"734"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.14","spread":"7.34"},{"groupId":"OG001","value":"-1.89","spread":"6.27"}]}]}]},{"type":"SECONDARY","title":"Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline)","description":"Percentage of subjects losing \\>=5% and percentage of subjects losing \\>10% of baseline fasting body weight (pre-diabetic subjects at baseline) after 160-weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).","populationDescription":"Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"At 160 weeks","groups":[{"id":"OG000","title":"Liraglutide 3.0 mg (160-Week)","description":"Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation."},{"id":"OG001","title":"Liraglutide Placebo (160-Week)","description":"Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1467"},{"groupId":"OG001","value":"734"}]}],"classes":[{"title":"Losing >=5% of baseline body weight","categories":[{"measurements":[{"groupId":"OG000","value":"49.6"},{"groupId":"OG001","value":"23.7"}]}]},{"title":"Losing >10% of baseline body weight","categories":[{"measurements":[{"groupId":"OG000","value":"24.8"},{"groupId":"OG001","value":"9.9"}]}]}]},{"type":"SECONDARY","title":"Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)","description":"The observed mean change in fasting body weight (%) from week 56 to week 68 in re-randomised subjects (with no pre-diabetes at baseline) after 12-weeks of treatment (re-randomised treatment period).","populationDescription":"The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percent change","timeFrame":"Week 56, Week 68","groups":[{"id":"OG000","title":"Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)","description":"Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period."},{"id":"OG001","title":"Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)","description":"Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period."},{"id":"OG002","title":"Liraglutide Placebo, no Pre-diabetes","description":"Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"349"},{"groupId":"OG001","value":"346"},{"groupId":"OG002","value":"299"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.69","spread":"2.58"},{"groupId":"OG001","value":"2.91","spread":"3.01"},{"groupId":"OG002","value":"0.28","spread":"2.39"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)","description":"The observed mean change from baseline in fasting body weight (%) in re-randomised subjects (with no pre-diabetes at baseline) after 68 weeks of treatment (main + re-randomised treatment period).","populationDescription":"The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percent change","timeFrame":"Week 0, Week 68","groups":[{"id":"OG000","title":"Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)","description":"Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period."},{"id":"OG001","title":"Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)","description":"Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period."},{"id":"OG002","title":"Liraglutide Placebo, no Pre-diabetes","description":"Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"349"},{"groupId":"OG001","value":"347"},{"groupId":"OG002","value":"298"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-8.44","spread":"7.23"},{"groupId":"OG001","value":"-6.77","spread":"7.67"},{"groupId":"OG002","value":"-3.11","spread":"7.52"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).","description":"A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the \"pre-diabetic arms\" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the \"no pre-diabetes arms\" (Arm 1 and Arm 2)","eventGroups":[{"id":"EG000","title":"Liraglutide 3.0 mg, Pre-diabetes","description":"Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.","seriousNumAffected":230,"seriousNumAtRisk":1524,"otherNumAffected":1342,"otherNumAtRisk":1524},{"id":"EG001","title":"Liraglutide Placebo, Pre-diabetes","description":"Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.","seriousNumAffected":96,"seriousNumAtRisk":755,"otherNumAffected":586,"otherNumAtRisk":755},{"id":"EG002","title":"Liraglutide 3.0 mg, no Pre-diabetes","description":"Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.","seriousNumAffected":59,"seriousNumAtRisk":957,"otherNumAffected":843,"otherNumAtRisk":957},{"id":"EG003","title":"Liraglutide Placebo, no Pre-diabetes","description":"Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.","seriousNumAffected":19,"seriousNumAtRisk":487,"otherNumAffected":345,"otherNumAtRisk":487}],"seriousEvents":[{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Bandaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Hypercoagulation","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Leukocytosis","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Acute coronary syndrome","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Angina unstable","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Aortic valve disease mixed","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Aortic valve stenosis","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":1524},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":755},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Atrial flutter","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Cardiac failure","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Cardiac failure chronic","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Cardiac tamponade","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Cardio-respiratory arrest","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Cardiomegaly","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Congestive cardiomyopathy","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Coronary artery disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Coronary artery stenosis","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Hypertensive heart disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Left ventricular dysfunction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Myocardial ischaemia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Palpitations","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Pericarditis","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Supraventricular tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Ventricular fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Ventricular tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Dermoid cyst","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Multiple endocrine adenomatosis Type I","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Vertigo","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Basedow","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Goitre","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Hyperparathyroidism primary","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Hyperthyroidism","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Toxic nodular goitre","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Cataract","organSystem":"Eye disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Retinal detachment","organSystem":"Eye disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Abdominal hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":487}]},{"term":"Anal fissure","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Anal fistula","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Barrett","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Caecitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Colitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Colitis ischaemic","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Colitis ulcerative","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Diverticulum","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Faecal incontinence","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Gastric ulcer haemorrhage","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Gastritis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Gastrointestinal haemorrhage","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Gastrooesophageal reflux disease","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":487}]},{"term":"Haemorrhoids","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Hiatus hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Inguinal hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Intestinal obstruction","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Intestinal perforation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Intestinal prolapse","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Pancreatic cyst","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Pancreatitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Pancreatitis acute","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Rectal haemorrhage","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Umbilical hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Umbilical hernia, obstructive","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Chest discomfort","organSystem":"General disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":487}]},{"term":"Cyst","organSystem":"General disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Device dislocation","organSystem":"General disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Inflammation","organSystem":"General disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Medical device complication","organSystem":"General disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Metaplasia","organSystem":"General disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Non-cardiac chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":487}]},{"term":"Ulcer haemorrhage","organSystem":"General disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Bile duct stone","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Biliary colic","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Cholecystitis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":6,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":957},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":487}]},{"term":"Cholecystitis acute","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":9,"numAffected":9,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Cholecystitis chronic","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Cholelithiasis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":23,"numAffected":22,"numAtRisk":1524},{"groupId":"EG001","numEvents":6,"numAffected":6,"numAtRisk":755},{"groupId":"EG002","numEvents":7,"numAffected":7,"numAtRisk":957},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":487}]},{"term":"Gallbladder polyp","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Hepatic cyst","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Hepatic lesion","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Hepatitis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Hepatitis acute","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Amyloidosis","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Anaphylactic reaction","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Drug hypersensitivity","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":487}]},{"term":"Hypersensitivity","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":487}]},{"term":"Abdominal wall infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Abscess neck","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Alveolar osteitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Anal abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Appendicitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":487}]},{"term":"Arthritis bacterial","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Arthritis infective","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Brain abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Breast abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Bronchitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Bronchopneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Campylobacter gastroenteritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Cellulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":1524},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Clostridium difficile colitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Cytomegalovirus infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Diverticulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Empyema","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Erysipelas","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Gastroenteritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":957},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":487}]},{"term":"Gastroenteritis viral","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Hepatitis A","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Incision site infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Lobar pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Localised infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Meningitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Oophoritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Osteomyelitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Pharyngotonsillitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Post procedural infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Postoperative wound infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Pyelonephritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Sepsis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Septic shock","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Urinary tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Urosepsis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Vulval abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Accident","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Animal bite","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Ankle fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Cartilage injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Clavicle fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Drug dispensing error","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Fall","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Fibula fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Hand fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Humerus fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Incisional hernia","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Joint dislocation","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Limb injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Limb traumatic amputation","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Meniscus lesion","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Muscle injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Muscle strain","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Post laminectomy syndrome","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Post procedural complication","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Post procedural haemorrhage","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Procedural pain","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Rib fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Road traffic accident","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Stab wound","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Tendon injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Tendon rupture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Tibia fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Upper limb fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Ureteric injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Wound","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Wrong drug administered","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Alanine aminotransferase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Amylase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Blood creatine phosphokinase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Catheterisation cardiac","organSystem":"Investigations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Lipase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Weight decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Weight increased","organSystem":"Investigations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Central obesity","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Dehydration","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Hypocalcaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Hypovolaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Obesity","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Arthralgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":755},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Arthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":3,"numAffected":2,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Back pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":1524},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":487}]},{"term":"Bursitis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Cervical spinal stenosis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Chondromalacia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Chondropathy","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Dupuytren","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Intervertebral disc disorder","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Intervertebral disc protrusion","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":6,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Joint laxity","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Lumbar spinal stenosis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Myalgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Neck pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":487}]},{"term":"Osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":14,"numAffected":12,"numAtRisk":1524},{"groupId":"EG001","numEvents":6,"numAffected":5,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Osteonecrosis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Pain in jaw","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":487}]},{"term":"Rheumatoid arthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Spinal osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Synovial cyst","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Adrenal adenoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Benign salivary gland neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Bile duct cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Breast cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":487}]},{"term":"Breast cancer in situ","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Breast cancer metastatic","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Breast cancer stage III","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Carcinoid tumour of the small bowel","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Cholesteatoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Chronic myeloid leukaemia","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Colon adenoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Colon cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Colon cancer metastatic","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Colon cancer stage 0","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Diffuse large B-cell lymphoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Dysplastic naevus","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Fibroadenoma of breast","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Haemangioma of bone","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Hepatic adenoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Laryngeal cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Lentigo maligna","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Lipoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Lymphoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Mantle cell lymphoma stage I","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Melanocytic naevus","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Neoplasm skin","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Pancreatic carcinoma metastatic","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Prostate cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Rectal cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Seborrhoeic keratosis","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Thyroid cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Uterine leiomyoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":1524},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Vaginal cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Brain stem infarction","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Carotid artery aneurysm","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":487}]},{"term":"Cerebrovascular accident","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Cervicobrachial syndrome","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Convulsion","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Hypoaesthesia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":487}]},{"term":"Intercostal neuralgia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Intracranial pressure increased","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Ischaemic stroke","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Migraine","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Presyncope","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Spinal cord herniation","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Syncope","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Transient ischaemic attack","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":3,"numAffected":2,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"VIIth nerve paralysis","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Abortion missed","organSystem":"Pregnancy, puerperium and perinatal conditions","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Abortion spontaneous","organSystem":"Pregnancy, puerperium and perinatal conditions","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Abortion threatened","organSystem":"Pregnancy, puerperium and perinatal conditions","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Ectopic pregnancy","organSystem":"Pregnancy, puerperium and perinatal conditions","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":487}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":487}]},{"term":"Depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Suicidal ideation","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Suicide attempt","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Bladder prolapse","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":487}]},{"term":"Calculus ureteric","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"IgA nephropathy","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Nephrolithiasis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Oliguria","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Renal colic","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Renal cyst","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Renal failure acute","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Renal impairment","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Renal infarct","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Stress urinary incontinence","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Urinary incontinence","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Adnexa uteri cyst","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Cervical dysplasia","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":487}]},{"term":"Dysmenorrhoea","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Endometrial disorder","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Endometrial hyperplasia","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Endometriosis","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Menometrorrhagia","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Menorrhagia","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Metrorrhagia","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Ovarian cyst","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Pelvic adhesions","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Polymenorrhoea","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Rectocele","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":487}]},{"term":"Uterine polyp","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Uterine prolapse","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Asthma","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Chronic obstructive pulmonary disease","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Dyspnoea","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Haemoptysis","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Lung disorder","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Nasal septum deviation","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Nasal turbinate hypertrophy","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Pulmonary embolism","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Pulmonary fibrosis","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":487}]},{"term":"Sleep apnoea syndrome","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Angioedema","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Cutis laxa","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Eczema","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Excessive skin","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Panniculitis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Skin ulcer","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Miscarriage of partner","organSystem":"Social circumstances","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Abdominoplasty","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Abortion induced","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Coronary arterial stent insertion","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Coronary revascularisation","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Gastrectomy","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Gastric bypass","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Heart transplant","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Hip arthroplasty","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Ligament operation","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Lipectomy","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Mammoplasty","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Obesity surgery","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Rectocele repair","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Circulatory collapse","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Deep vein thrombosis","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Embolism venous","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Hypertension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Hypotension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Orthostatic hypotension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Varicophlebitis","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":755},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]},{"term":"Varicose vein","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1524},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":755},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":957},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":487}]}],"otherEvents":[{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":150,"numAffected":112,"numAtRisk":1524},{"groupId":"EG001","numEvents":49,"numAffected":37,"numAtRisk":755},{"groupId":"EG002","numEvents":79,"numAffected":62,"numAtRisk":957},{"groupId":"EG003","numEvents":22,"numAffected":19,"numAtRisk":487}]},{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":137,"numAffected":110,"numAtRisk":1524},{"groupId":"EG001","numEvents":49,"numAffected":40,"numAtRisk":755},{"groupId":"EG002","numEvents":84,"numAffected":63,"numAtRisk":957},{"groupId":"EG003","numEvents":20,"numAffected":18,"numAtRisk":487}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":422,"numAffected":333,"numAtRisk":1524},{"groupId":"EG001","numEvents":100,"numAffected":85,"numAtRisk":755},{"groupId":"EG002","numEvents":255,"numAffected":203,"numAtRisk":957},{"groupId":"EG003","numEvents":52,"numAffected":44,"numAtRisk":487}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":626,"numAffected":388,"numAtRisk":1524},{"groupId":"EG001","numEvents":144,"numAffected":107,"numAtRisk":755},{"groupId":"EG002","numEvents":308,"numAffected":201,"numAtRisk":957},{"groupId":"EG003","numEvents":58,"numAffected":46,"numAtRisk":487}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":196,"numAffected":156,"numAtRisk":1524},{"groupId":"EG001","numEvents":40,"numAffected":35,"numAtRisk":755},{"groupId":"EG002","numEvents":121,"numAffected":102,"numAtRisk":957},{"groupId":"EG003","numEvents":16,"numAffected":14,"numAtRisk":487}]},{"term":"Eructation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":96,"numAffected":86,"numAtRisk":1524},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":755},{"groupId":"EG002","numEvents":52,"numAffected":38,"numAtRisk":957},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":487}]},{"term":"Flatulence","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":94,"numAffected":81,"numAtRisk":1524},{"groupId":"EG001","numEvents":25,"numAffected":22,"numAtRisk":755},{"groupId":"EG002","numEvents":35,"numAffected":29,"numAtRisk":957},{"groupId":"EG003","numEvents":17,"numAffected":15,"numAtRisk":487}]},{"term":"Gastrooesophageal reflux disease","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":112,"numAffected":101,"numAtRisk":1524},{"groupId":"EG001","numEvents":19,"numAffected":18,"numAtRisk":755},{"groupId":"EG002","numEvents":50,"numAffected":47,"numAtRisk":957},{"groupId":"EG003","numEvents":8,"numAffected":8,"numAtRisk":487}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":974,"numAffected":622,"numAtRisk":1524},{"groupId":"EG001","numEvents":170,"numAffected":128,"numAtRisk":755},{"groupId":"EG002","numEvents":616,"numAffected":418,"numAtRisk":957},{"groupId":"EG003","numEvents":96,"numAffected":78,"numAtRisk":487}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":476,"numAffected":300,"numAtRisk":1524},{"groupId":"EG001","numEvents":55,"numAffected":42,"numAtRisk":755},{"groupId":"EG002","numEvents":267,"numAffected":172,"numAtRisk":957},{"groupId":"EG003","numEvents":29,"numAffected":25,"numAtRisk":487}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":190,"numAffected":154,"numAtRisk":1524},{"groupId":"EG001","numEvents":67,"numAffected":58,"numAtRisk":755},{"groupId":"EG002","numEvents":89,"numAffected":79,"numAtRisk":957},{"groupId":"EG003","numEvents":31,"numAffected":27,"numAtRisk":487}]},{"term":"Injection site haematoma","organSystem":"General disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":102,"numAffected":91,"numAtRisk":1524},{"groupId":"EG001","numEvents":69,"numAffected":61,"numAtRisk":755},{"groupId":"EG002","numEvents":68,"numAffected":64,"numAtRisk":957},{"groupId":"EG003","numEvents":45,"numAffected":42,"numAtRisk":487}]},{"term":"Oedema peripheral","organSystem":"General disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":60,"numAffected":53,"numAtRisk":1524},{"groupId":"EG001","numEvents":58,"numAffected":47,"numAtRisk":755},{"groupId":"EG002","numEvents":25,"numAffected":22,"numAtRisk":957},{"groupId":"EG003","numEvents":7,"numAffected":6,"numAtRisk":487}]},{"term":"Bronchitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":139,"numAffected":114,"numAtRisk":1524},{"groupId":"EG001","numEvents":80,"numAffected":62,"numAtRisk":755},{"groupId":"EG002","numEvents":41,"numAffected":35,"numAtRisk":957},{"groupId":"EG003","numEvents":27,"numAffected":26,"numAtRisk":487}]},{"term":"Gastroenteritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":171,"numAffected":138,"numAtRisk":1524},{"groupId":"EG001","numEvents":53,"numAffected":46,"numAtRisk":755},{"groupId":"EG002","numEvents":53,"numAffected":48,"numAtRisk":957},{"groupId":"EG003","numEvents":32,"numAffected":24,"numAtRisk":487}]},{"term":"Influenza","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":249,"numAffected":181,"numAtRisk":1524},{"groupId":"EG001","numEvents":123,"numAffected":80,"numAtRisk":755},{"groupId":"EG002","numEvents":84,"numAffected":65,"numAtRisk":957},{"groupId":"EG003","numEvents":37,"numAffected":26,"numAtRisk":487}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":764,"numAffected":404,"numAtRisk":1524},{"groupId":"EG001","numEvents":408,"numAffected":210,"numAtRisk":755},{"groupId":"EG002","numEvents":290,"numAffected":193,"numAtRisk":957},{"groupId":"EG003","numEvents":166,"numAffected":110,"numAtRisk":487}]},{"term":"Sinusitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":174,"numAffected":129,"numAtRisk":1524},{"groupId":"EG001","numEvents":111,"numAffected":65,"numAtRisk":755},{"groupId":"EG002","numEvents":99,"numAffected":84,"numAtRisk":957},{"groupId":"EG003","numEvents":47,"numAffected":35,"numAtRisk":487}]},{"term":"Upper respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":389,"numAffected":236,"numAtRisk":1524},{"groupId":"EG001","numEvents":213,"numAffected":120,"numAtRisk":755},{"groupId":"EG002","numEvents":122,"numAffected":101,"numAtRisk":957},{"groupId":"EG003","numEvents":68,"numAffected":54,"numAtRisk":487}]},{"term":"Urinary tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":176,"numAffected":123,"numAtRisk":1524},{"groupId":"EG001","numEvents":62,"numAffected":43,"numAtRisk":755},{"groupId":"EG002","numEvents":60,"numAffected":48,"numAtRisk":957},{"groupId":"EG003","numEvents":19,"numAffected":15,"numAtRisk":487}]},{"term":"Lipase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":207,"numAffected":145,"numAtRisk":1524},{"groupId":"EG001","numEvents":26,"numAffected":24,"numAtRisk":755},{"groupId":"EG002","numEvents":41,"numAffected":35,"numAtRisk":957},{"groupId":"EG003","numEvents":10,"numAffected":10,"numAtRisk":487}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":181,"numAffected":169,"numAtRisk":1524},{"groupId":"EG001","numEvents":28,"numAffected":27,"numAtRisk":755},{"groupId":"EG002","numEvents":111,"numAffected":102,"numAtRisk":957},{"groupId":"EG003","numEvents":17,"numAffected":16,"numAtRisk":487}]},{"term":"Hypoglycaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":637,"numAffected":295,"numAtRisk":1524},{"groupId":"EG001","numEvents":52,"numAffected":35,"numAtRisk":755},{"groupId":"EG002","numEvents":302,"numAffected":176,"numAtRisk":957},{"groupId":"EG003","numEvents":37,"numAffected":29,"numAtRisk":487}]},{"term":"Arthralgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":231,"numAffected":186,"numAtRisk":1524},{"groupId":"EG001","numEvents":134,"numAffected":97,"numAtRisk":755},{"groupId":"EG002","numEvents":41,"numAffected":38,"numAtRisk":957},{"groupId":"EG003","numEvents":29,"numAffected":23,"numAtRisk":487}]},{"term":"Back pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":283,"numAffected":198,"numAtRisk":1524},{"groupId":"EG001","numEvents":159,"numAffected":118,"numAtRisk":755},{"groupId":"EG002","numEvents":97,"numAffected":77,"numAtRisk":957},{"groupId":"EG003","numEvents":50,"numAffected":41,"numAtRisk":487}]},{"term":"Pain in extremity","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":127,"numAffected":108,"numAtRisk":1524},{"groupId":"EG001","numEvents":64,"numAffected":54,"numAtRisk":755},{"groupId":"EG002","numEvents":27,"numAffected":25,"numAtRisk":957},{"groupId":"EG003","numEvents":24,"numAffected":22,"numAtRisk":487}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":197,"numAffected":149,"numAtRisk":1524},{"groupId":"EG001","numEvents":73,"numAffected":55,"numAtRisk":755},{"groupId":"EG002","numEvents":81,"numAffected":67,"numAtRisk":957},{"groupId":"EG003","numEvents":20,"numAffected":19,"numAtRisk":487}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":432,"numAffected":273,"numAtRisk":1524},{"groupId":"EG001","numEvents":223,"numAffected":124,"numAtRisk":755},{"groupId":"EG002","numEvents":178,"numAffected":127,"numAtRisk":957},{"groupId":"EG003","numEvents":80,"numAffected":58,"numAtRisk":487}]},{"term":"Cough","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":133,"numAffected":112,"numAtRisk":1524},{"groupId":"EG001","numEvents":87,"numAffected":60,"numAtRisk":755},{"groupId":"EG002","numEvents":35,"numAffected":34,"numAtRisk":957},{"groupId":"EG003","numEvents":23,"numAffected":22,"numAtRisk":487}]},{"term":"Oropharyngeal pain","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":81,"numAffected":74,"numAtRisk":1524},{"groupId":"EG001","numEvents":52,"numAffected":44,"numAtRisk":755},{"groupId":"EG002","numEvents":34,"numAffected":31,"numAtRisk":957},{"groupId":"EG003","numEvents":22,"numAffected":21,"numAtRisk":487}]},{"term":"Hypertension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":86,"numAffected":74,"numAtRisk":1524},{"groupId":"EG001","numEvents":58,"numAffected":48,"numAtRisk":755},{"groupId":"EG002","numEvents":23,"numAffected":22,"numAtRisk":957},{"groupId":"EG003","numEvents":13,"numAffected":13,"numAtRisk":487}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"When the primary results are available, Novo Nordisk plans to discuss the interpretation of these with the principal Investigator, but reserves the right to release results that may impact Novo Nordisk financial expectations (e.g. a press release directly to the public or similar) without prior consultation with the remaining participating Investigators. Novo Nordisk reserves the right not to release data until specified milestones, e.g. a clinical trial report is available."},"pointOfContact":{"title":"Public Access to Clinical Trials","organization":"Novo Nordisk A/S","email":"clinicaltrials@novonordisk.com"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D009748","term":"Nutrition Disorders"},{"id":"D009765","term":"Obesity"}],"ancestors":[{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D050177","term":"Overweight"},{"id":"D044343","term":"Overnutrition"},{"id":"D001835","term":"Body Weight"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"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}