{"protocolSection":{"identificationModule":{"nctId":"NCT04707469","orgStudyIdInfo":{"id":"NN9924-4635"},"secondaryIdInfos":[{"id":"U1111-1247-0210","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"2020-000299-39","type":"REGISTRY","domain":"European Medicines Agency (EudraCT)"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes","officialTitle":"Efficacy and Safety of Once-daily Oral Semaglutide 25 mg and 50 mg Compared With 14 mg in Subjects With Type 2 Diabetes","acronym":"PIONEER PLUS"},"statusModule":{"statusVerifiedDate":"2025-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-01-15","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-03-07","type":"ACTUAL"},"completionDateStruct":{"date":"2023-03-08","type":"ACTUAL"},"studyFirstSubmitDate":"2021-01-12","studyFirstSubmitQcDate":"2021-01-12","studyFirstPostDateStruct":{"date":"2021-01-13","type":"ACTUAL"},"resultsFirstSubmitDate":"2024-03-05","resultsFirstSubmitQcDate":"2024-03-05","resultsFirstPostDateStruct":{"date":"2024-04-03","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-11-24","lastUpdatePostDateStruct":{"date":"2025-12-09","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This study compares three doses of once daily semaglutide tablets in people with type 2 diabetes who were previously treated with other oral anti-diabetic medicines. Participants will be initiated on the lowest starting dose of 3 mg and gradually increased until they reach the final trial dose of 14 mg, 25 mg or 50 mg once daily semaglutide tablets. The final three doses will be randomized (i.e., decided by chance). Participants will be administered one tablet per day for 68 weeks. Women cannot take part if they are pregnant, breast-feeding or planning to become pregnant during the study period. Women who can get pregnant will be checked for pregnancy via urine tests. Once daily semaglutide tablets (3 mg, 7 mg and 14 mg) are approved for the treatment of type 2 diabetes in the US, in the EU and in some other countries, under the brand name Rybelsus®."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","maskingDescription":"Sponsor staff involved in the clinical trial is masked according to company standard procedures.","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":1606,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Oral semaglutide 50 mg","type":"EXPERIMENTAL","description":"Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12), 25 mg (week 13-16) and 50 mg (week 17-68).","interventionNames":["Drug: Oral semaglutide"]},{"label":"Oral semaglutide 25 mg","type":"EXPERIMENTAL","description":"Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12) and 25 mg (week 13-68).","interventionNames":["Drug: Oral semaglutide"]},{"label":"Oral semaglutide 14 mg","type":"ACTIVE_COMPARATOR","description":"Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8) and 14 mg (week 9-68).","interventionNames":["Drug: Oral semaglutide"]}],"interventions":[{"type":"DRUG","name":"Oral semaglutide","description":"Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.","armGroupLabels":["Oral semaglutide 14 mg","Oral semaglutide 25 mg","Oral semaglutide 50 mg"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Glycated Haemoglobin (HbA1c) (Week 52)","description":"Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.","timeFrame":"Baseline (week 0), week 52"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Body Weight (Week 52)","description":"Change from baseline (week 0) in body weight was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"Baseline (week 0), week 52"},{"measure":"Change From Baseline in HbA1c (Week 68)","description":"Change from baseline (week 0) in HbA1c was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change From Week 12 in HbA1c (Week 52)","description":"Change in HbA1c was evaluated from week 12 to week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.","timeFrame":"Week 12, Week 52"},{"measure":"Change From Baseline in Fasting Plasma Glucose (FPG) (Week 52)","description":"Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"Baseline (week 0), week 52"},{"measure":"Change From Baseline in FPG (Week 68)","description":"Change from baseline (week 0) in FPG was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Percentage of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Week 52)","description":"Percentage of participants who achieved HbA1c \\<7.0 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"At week 52"},{"measure":"Percentage of Participants Who Achieved HbA1c < 7.0 % (Week 68)","description":"Percentage of participants who achieved HbA1c \\<7.0 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"At week 68"},{"measure":"Percentage of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 % (Week 52)","description":"Percentage of participants who achieved HbA1c \\<=6.5 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"At week 52"},{"measure":"Percentage of Participants Who Achieved HbA1c <= 6.5 % (Week 68)","description":"Percentage of participants who achieved HbA1c \\<=6.5 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"At week 68"},{"measure":"Time to Event Analyses of Rescue Medication","description":"Time to event analyses of rescue medication was evaluated from baseline (week 0) to week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change From Baseline in Body Weight (Week 68)","description":"Change from baseline (week 0) in body weight was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Percentage Change From Baseline in Body Weight (Week 52)","description":"Percentage change from baseline (week 0) in body weight was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"Baseline (week 0), week 52"},{"measure":"Percentage Change From Baseline in Body Weight (Week 68)","description":"Percentage change from baseline (week 0) in body weight was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Percentage Change From Week 12 in Body Weight (Week 52)","description":"Percentage change in body weight was evaluated from week 12 to week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"Week 12, Week 52"},{"measure":"Change From Baseline in Body Mass Index (BMI) (Week 52)","description":"Change from baseline (week 0) in body mass index (BMI) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"Baseline (week 0), week 52"},{"measure":"Change From Baseline in BMI (Week 68)","description":"Change from baseline (week 0) in BMI was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change From Baseline in Waist Circumference (Week 52)","description":"Change from baseline (week 0) in waist circumference was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"Baseline (week 0), week 52"},{"measure":"Change From Baseline in Waist Circumference (Week 68)","description":"Change from baseline (week 0) in waist circumference was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Percentage of Participants Who Achieved Weight Loss Greater Than or Equal to (>=) 5 % (Week 52)","description":"Percentage of participants who achieved weight loss \\>= 5 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"At week 52"},{"measure":"Percentage of Participants Who Achieved Weight Loss >= 5 % (Week 68)","description":"Percentage of participants who achieved weight loss \\>= 5 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"At week 68"},{"measure":"Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 52)","description":"Percentage of participants who achieved weight loss \\>= 10 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"At week 52"},{"measure":"Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 68)","description":"Percentage of participants who achieved weight loss \\>= 10 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"At week 68"},{"measure":"Change From Baseline in Total Cholesterol (Week 52)","description":"Change from baseline (week 0) in total cholesterol was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline in Total Cholesterol (Week 68)","description":"Change from baseline (week 0) in total cholesterol was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"Baseline, Week 68"},{"measure":"Change From Baseline in Low Density Lipoproteins (LDL) (Week 52)","description":"Change from baseline (week 0) in LDL was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline in LDL (Week 68)","description":"Change from baseline (week 0) in LDL was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"Baseline, Week 68"},{"measure":"Change From Baseline in High Density Lipoproteins (HDL) (Week 52)","description":"Change from baseline (week 0) in HDL was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline in HDL (Week 68)","description":"Change from baseline (week 0) in HDL was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"Baseline, Week 68"},{"measure":"Change From Baseline in Triglycerides (Week 52)","description":"Change from baseline (week 0) in triglycerides was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline in Triglycerides (Week 68)","description":"Change from baseline (week 0) in triglycerides was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","timeFrame":"Baseline, Week 68"},{"measure":"Number of Adverse Events","description":"An adverse event (AE) defined as any unfavourable and unintended sign, including an abnormal laboratory finding, symptom or disease (new or exacerbated) temporally associated with the use of an investigational medicinal products (IMP). Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.","timeFrame":"From baseline (week 0) up to week 73"},{"measure":"Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) or Severe Hypoglycaemic Episodes (Level 3)","description":"Hypoglycaemic episodes were classified according to the American Diabetes Association 2018/ International Hypoglycaemia Study Group 2017, where glycemic criteria for level 2 was \\< 3.0 mmol/L (54 mg/dL) and level 3 had no specific glucose threshold. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.","timeFrame":"From baseline (week 0) up to week 68"},{"measure":"Change From Baseline in Systolic Blood Pressure (Week 52)","description":"Change from baseline (week 0) in systolic blood pressure at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.","timeFrame":"Baseline (week 0), week 52"},{"measure":"Change From Baseline in Systolic Blood Pressure (Week 68)","description":"Change from baseline (week 0) in systolic blood pressure at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change From Baseline in Diastolic Blood Pressure (Week 52)","description":"Change from baseline (week 0) in diastolic blood pressure at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.","timeFrame":"Baseline (week 0), week 52"},{"measure":"Change From Baseline in Diastolic Blood Pressure (Week 68)","description":"Change from baseline (week 0) in diastolic blood pressure at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change From Baseline in Pulse (Week 52)","description":"Change from baseline (week 0) in pulse at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.","timeFrame":"Baseline (week 0), week 52"},{"measure":"Change From Baseline in Pulse (Week 68)","description":"Change from baseline (week 0) in pulse at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.","timeFrame":"Baseline (week 0), week 68"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female, age above or equal to 18 years at the time of signing informed consent.\n* Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.\n* HbA1c of 8.0-10.5% (64-91 mmol/mol) (both inclusive).\n* BMI equal to or above 25 kg/m\\^2\n* Stable daily dose(s) for 90 days prior to the day of screening of any of the following treatment regimens:\n* No more than 3 of the following oral anti-diabetic drugs and at least 1 marked with a \\*:\n\n  * Metformin (equal to or above1500 mg or maximum tolerated or effective dose).\n  * Sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose).\n  * Sodium/glucose cotransporter 2 (SGLT2) inhibitors (maximum tolerated dose).\n* Dipeptidyl peptidase-4 (DPP-4) inhibitors (maximally indicated dose as per local label).\n* Subjects, on treatment with stable dose of DPP-4 inhibitors at inclusion, must be willing to discontinue DPP-4 inhibitor treatment at randomisation (with no wash-out).\n\nExclusion Criteria:\n\n* Treatment with any medication indicated for the treatment of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed.\n* Renal impairment measured as estimated glomerular filtration rate (eGFR) value of below 30 mL/min/1.73 m\\^2 according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by kidney disease improving global outcomes (KDIGO 2012) classification.\n* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Transparency (dept. 1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"American Clinical Trials","city":"Buena Park","state":"California","zip":"90620","country":"United States","geoPoint":{"lat":33.86751,"lon":-117.99812}},{"facility":"Valley Research","city":"Fresno","state":"California","zip":"93720","country":"United States","geoPoint":{"lat":36.74773,"lon":-119.77237}},{"facility":"Velocity Clin Res San Diego","city":"La Mesa","state":"California","zip":"91942","country":"United States","geoPoint":{"lat":32.76783,"lon":-117.02308}},{"facility":"First Valley Medical Group","city":"Lancaster","state":"California","zip":"93534","country":"United States","geoPoint":{"lat":34.69804,"lon":-118.13674}},{"facility":"Pacific Clinical Studies","city":"Los Alamitos","state":"California","zip":"90720","country":"United States","geoPoint":{"lat":33.80307,"lon":-118.07256}},{"facility":"Velocity Clin Res Los Angeles","city":"Los Angeles","state":"California","zip":"90017","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"Diabetes Medical Center Of California","city":"Northridge","state":"California","zip":"91325","country":"United States","geoPoint":{"lat":34.22834,"lon":-118.53675}},{"facility":"Desert Oasis Hlthcr Med Group","city":"Palm Springs","state":"California","zip":"92262","country":"United States","geoPoint":{"lat":33.8303,"lon":-116.54529}},{"facility":"Gateway Research Center","city":"Poway","state":"California","zip":"92064","country":"United States","geoPoint":{"lat":32.96282,"lon":-117.03586}},{"facility":"Encompass Clinical Research_Spring Valley","city":"Spring Valley","state":"California","zip":"91978","country":"United States","geoPoint":{"lat":32.74477,"lon":-116.99892}},{"facility":"Diablo Clinical Research, Inc.","city":"Walnut Creek","state":"California","zip":"94598","country":"United States","geoPoint":{"lat":37.90631,"lon":-122.06496}},{"facility":"San Fernando Valley Hlth Inst, LLC","city":"West Hills","state":"California","zip":"91304","country":"United States","geoPoint":{"lat":34.19731,"lon":-118.64398}},{"facility":"University of Colorado Hospital","city":"Aurora","state":"Colorado","zip":"80045","country":"United States","geoPoint":{"lat":39.72943,"lon":-104.83192}},{"facility":"Optumcare Clinical Trials,LLC-Golden","city":"Colorado Springs","state":"Colorado","zip":"80906","country":"United States","geoPoint":{"lat":38.83388,"lon":-104.82136}},{"facility":"Chase Medical Research LLC","city":"Waterbury","state":"Connecticut","zip":"06708","country":"United States","geoPoint":{"lat":41.55815,"lon":-73.0515}},{"facility":"Alliance for Multispec Res","city":"Coral Gables","state":"Florida","zip":"33134","country":"United States","geoPoint":{"lat":25.72149,"lon":-80.26838}},{"facility":"Northeast Research Institute","city":"Jacksonville","state":"Florida","zip":"32204","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"San Marcus Res Clin Miami Lakes","city":"Miami Lakes","state":"Florida","zip":"33014","country":"United States","geoPoint":{"lat":25.90871,"lon":-80.30866}},{"facility":"Complete Health Research","city":"Ormond Beach","state":"Florida","zip":"32174-6302","country":"United States","geoPoint":{"lat":29.28581,"lon":-81.05589}},{"facility":"Clinical Trial Res Assoc,Inc","city":"Plantation","state":"Florida","zip":"33324","country":"United States","geoPoint":{"lat":26.13421,"lon":-80.23184}},{"facility":"Progressive Medical Research","city":"Port Orange","state":"Florida","zip":"32127","country":"United States","geoPoint":{"lat":29.13832,"lon":-80.99561}},{"facility":"Endo Res Solutions Inc","city":"Roswell","state":"Georgia","zip":"30076","country":"United States","geoPoint":{"lat":34.02316,"lon":-84.36159}},{"facility":"East West Med Res Inst","city":"Honolulu","state":"Hawaii","zip":"96814","country":"United States","geoPoint":{"lat":21.30694,"lon":-157.85833}},{"facility":"Elite Clinical Trials","city":"Blackfoot","state":"Idaho","zip":"83221","country":"United States","geoPoint":{"lat":43.19047,"lon":-112.34498}},{"facility":"Rocky Mt Clin Res, LLC","city":"Idaho Falls","state":"Idaho","zip":"83404-7596","country":"United States","geoPoint":{"lat":43.46658,"lon":-112.03414}},{"facility":"Solaris Clinical Research","city":"Meridian","state":"Idaho","zip":"83646","country":"United States","geoPoint":{"lat":43.61211,"lon":-116.39151}},{"facility":"Cedar-Crosse Research Center","city":"Chicago","state":"Illinois","zip":"60607","country":"United States","geoPoint":{"lat":41.85003,"lon":-87.65005}},{"facility":"Macoupin Research Group","city":"Gillespie","state":"Illinois","zip":"62033","country":"United States","geoPoint":{"lat":39.12977,"lon":-89.81954}},{"facility":"UnityPoint Health-Diabetes Care Center","city":"Peoria","state":"Illinois","zip":"61603","country":"United States","geoPoint":{"lat":40.69365,"lon":-89.58899}},{"facility":"Evanston Premier Hlthcr Res","city":"Skokie","state":"Illinois","zip":"60077","country":"United States","geoPoint":{"lat":42.03336,"lon":-87.73339}},{"facility":"Midwest Inst For Clin Res","city":"Indianapolis","state":"Indiana","zip":"46260","country":"United States","geoPoint":{"lat":39.76838,"lon":-86.15804}},{"facility":"Iowa Diab & Endo Res Center","city":"West Des Moines","state":"Iowa","zip":"50266","country":"United States","geoPoint":{"lat":41.57721,"lon":-93.71133}},{"facility":"Cotton O'Neil Diab & Endo Ctr","city":"Topeka","state":"Kansas","zip":"66606","country":"United States","geoPoint":{"lat":39.04833,"lon":-95.67804}},{"facility":"The Research Group of Lexington LLC","city":"Lexington","state":"Kentucky","zip":"40503","country":"United States","geoPoint":{"lat":37.98869,"lon":-84.47772}},{"facility":"L-MARC Research Center","city":"Louisville","state":"Kentucky","zip":"40213","country":"United States","geoPoint":{"lat":38.25424,"lon":-85.75941}},{"facility":"Pennington Biom Res Ctr","city":"Baton Rouge","state":"Louisiana","zip":"70808","country":"United States","geoPoint":{"lat":30.44332,"lon":-91.18747}},{"facility":"Centex Studies, Inc._Lake Charles","city":"Lake Charles","state":"Louisiana","zip":"70601","country":"United States","geoPoint":{"lat":30.21309,"lon":-93.2044}},{"facility":"MD Medical Research","city":"Oxon Hill","state":"Maryland","zip":"20745","country":"United States","geoPoint":{"lat":38.80345,"lon":-76.9897}},{"facility":"Brigham & Women's Hospital","city":"Boston","state":"Massachusetts","zip":"02115-5804","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}},{"facility":"MassResearch, LLC","city":"Waltham","state":"Massachusetts","zip":"02453","country":"United States","geoPoint":{"lat":42.37649,"lon":-71.23561}},{"facility":"Aa Mrc Llc","city":"Flint","state":"Michigan","zip":"48504","country":"United States","geoPoint":{"lat":43.01253,"lon":-83.68746}},{"facility":"Arcturus Healthcare, PLC.","city":"Troy","state":"Michigan","zip":"48098","country":"United States","geoPoint":{"lat":42.60559,"lon":-83.14993}},{"facility":"Mercury Str Med Grp, PLLC","city":"Butte","state":"Montana","zip":"59701","country":"United States","geoPoint":{"lat":46.00382,"lon":-112.53474}},{"facility":"Univ of Nebraska Medical CTR","city":"Omaha","state":"Nebraska","zip":"68198-3020","country":"United States","geoPoint":{"lat":41.25626,"lon":-95.94043}},{"facility":"University of Nebraska Medical Center-Diabetes Center","city":"Omaha","state":"Nebraska","zip":"68198-4120","country":"United States","geoPoint":{"lat":41.25626,"lon":-95.94043}},{"facility":"Premier Research Inc.","city":"Trenton","state":"New Jersey","zip":"08611","country":"United States","geoPoint":{"lat":40.21705,"lon":-74.74294}},{"facility":"UNC Diabetes Care Center_Chapel Hill","city":"Chapel Hill","state":"North Carolina","zip":"27514","country":"United States","geoPoint":{"lat":35.9132,"lon":-79.05584}},{"facility":"PharmQuest Life Sciences LLC","city":"Greensboro","state":"North Carolina","zip":"27408","country":"United States","geoPoint":{"lat":36.07264,"lon":-79.79198}},{"facility":"Accellacare","city":"Wilmington","state":"North Carolina","zip":"28401","country":"United States","geoPoint":{"lat":34.23556,"lon":-77.94604}},{"facility":"Lillestol Research LLC","city":"Fargo","state":"North Dakota","zip":"58104","country":"United States","geoPoint":{"lat":46.87719,"lon":-96.7898}},{"facility":"Rapid Medical Research Inc","city":"Cleveland","state":"Ohio","zip":"44122","country":"United States","geoPoint":{"lat":41.4995,"lon":-81.69541}},{"facility":"Prestige Clinical Research","city":"Franklin","state":"Ohio","zip":"45005","country":"United States","geoPoint":{"lat":39.55895,"lon":-84.30411}},{"facility":"Albert J Weisbrot","city":"Mason","state":"Ohio","zip":"45040","country":"United States","geoPoint":{"lat":39.36006,"lon":-84.30994}},{"facility":"Intend Research","city":"Norman","state":"Oklahoma","zip":"73069","country":"United States","geoPoint":{"lat":35.22257,"lon":-97.43948}},{"facility":"Corvallis Clinic PC Clinical Research Department","city":"Corvallis","state":"Oregon","zip":"97330-3737","country":"United States","geoPoint":{"lat":44.56457,"lon":-123.26204}},{"facility":"Preferred Primary Care Physicians_Pittsburgh","city":"Pittsburgh","state":"Pennsylvania","zip":"15236","country":"United States","geoPoint":{"lat":40.44062,"lon":-79.99589}},{"facility":"Palmetto Clinical Research","city":"Greenville","state":"South Carolina","zip":"29615","country":"United States","geoPoint":{"lat":34.85262,"lon":-82.39401}},{"facility":"Palmetto Clinical Research","city":"Summerville","state":"South Carolina","zip":"29485","country":"United States","geoPoint":{"lat":33.0185,"lon":-80.17565}},{"facility":"Holston Medical Group Pc","city":"Bristol","state":"Tennessee","zip":"37620-7352","country":"United States","geoPoint":{"lat":36.59511,"lon":-82.18874}},{"facility":"Chattanooga Medical Research, LLC","city":"Chattanooga","state":"Tennessee","zip":"37404","country":"United States","geoPoint":{"lat":35.04563,"lon":-85.30968}},{"facility":"Murphy Research Center","city":"Humboldt","state":"Tennessee","zip":"38343","country":"United States","geoPoint":{"lat":35.81979,"lon":-88.9159}},{"facility":"Clinical Neuroscience Solutions","city":"Memphis","state":"Tennessee","zip":"38119","country":"United States","geoPoint":{"lat":35.14953,"lon":-90.04898}},{"facility":"Arlington Family Res. Ctr Inc","city":"Arlington","state":"Texas","zip":"76012-4637","country":"United States","geoPoint":{"lat":32.73569,"lon":-97.10807}},{"facility":"Velocity Clinical Res-Dallas","city":"Dallas","state":"Texas","zip":"75230","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"Velocity Clinical Research, Dallas","city":"Dallas","state":"Texas","zip":"75230","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"UT Southwestern Med Cntr","city":"Dallas","state":"Texas","zip":"75390-9302","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"Care United Research, LLC","city":"Forney","state":"Texas","zip":"75126","country":"United States","geoPoint":{"lat":32.74818,"lon":-96.47193}},{"facility":"JCCT- Juno NW Houston","city":"Houston","state":"Texas","zip":"77040","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"JCCT- Juno NW Houston","city":"Houston","state":"Texas","zip":"77074","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Southwest Clinical Trials","city":"Houston","state":"Texas","zip":"77074","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Family Practice Care Associates","city":"Humble","state":"Texas","zip":"77338","country":"United States","geoPoint":{"lat":29.99883,"lon":-95.26216}},{"facility":"Research Trials Worldwide LLC","city":"Humble","state":"Texas","zip":"77338","country":"United States","geoPoint":{"lat":29.99883,"lon":-95.26216}},{"facility":"Juno Research, LLC_Cary","city":"Katy","state":"Texas","zip":"77450","country":"United States","geoPoint":{"lat":29.78579,"lon":-95.8244}},{"facility":"DCOL Ctr for Clin Res","city":"Longview","state":"Texas","zip":"75605","country":"United States","geoPoint":{"lat":32.5007,"lon":-94.74049}},{"facility":"Research Institute Of Dallas","city":"Plano","state":"Texas","zip":"75093","country":"United States","geoPoint":{"lat":33.01984,"lon":-96.69889}},{"facility":"VIP Trials","city":"San Antonio","state":"Texas","zip":"78230","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"VIP Trials","city":"San Antonio","state":"Texas","zip":"78231","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Consano Clinical Research, LLC","city":"Shavano Park","state":"Texas","zip":"78231","country":"United States","geoPoint":{"lat":29.58495,"lon":-98.55252}},{"facility":"Simcare Medical Research, LLC","city":"Sugar Land","state":"Texas","zip":"77478","country":"United States","geoPoint":{"lat":29.61968,"lon":-95.63495}},{"facility":"Health Res of Hampton Roads","city":"Newport News","state":"Virginia","zip":"23606","country":"United States","geoPoint":{"lat":36.98038,"lon":-76.42975}},{"facility":"York Clinical Research LLC","city":"Norfolk","state":"Virginia","zip":"23504","country":"United States","geoPoint":{"lat":36.84681,"lon":-76.28522}},{"facility":"Dominion Medical Associates","city":"Richmond","state":"Virginia","zip":"23219","country":"United States","geoPoint":{"lat":37.55376,"lon":-77.46026}},{"facility":"Capital Clin Res Ctr,LLC","city":"Olympia","state":"Washington","zip":"98502","country":"United States","geoPoint":{"lat":47.04491,"lon":-122.90169}},{"facility":"Wenatchee Valley Hospital and Clinics","city":"Wenatchee","state":"Washington","zip":"98801-2028","country":"United States","geoPoint":{"lat":47.42346,"lon":-120.31035}},{"facility":"Liverpool Hospital","city":"Liverpool","state":"New South Wales","zip":"2170","country":"Australia","geoPoint":{"lat":-33.91938,"lon":150.92588}},{"facility":"Royal Brisbane and Women's Hospital","city":"Herston","state":"Queensland","zip":"4029","country":"Australia","geoPoint":{"lat":-27.44453,"lon":153.01852}},{"facility":"Core Research Centre","city":"Milton","state":"Queensland","zip":"4064","country":"Australia","geoPoint":{"lat":-27.47039,"lon":153.00312}},{"facility":"South Australian Endocrine Research","city":"Keswick","state":"South Australia","zip":"5035","country":"Australia","geoPoint":{"lat":-34.94178,"lon":138.57459}},{"facility":"Southern Adelaide Diabetes & Endocrine Services","city":"Oaklands Park","state":"South Australia","zip":"5046","country":"Australia","geoPoint":{"lat":-35.00671,"lon":138.54457}},{"facility":"Barwon Health (The Geelong Hospital)","city":"Geelong","state":"Victoria","zip":"3220","country":"Australia","geoPoint":{"lat":-38.14711,"lon":144.36069}},{"facility":"Fremantle Hospital","city":"Fremantle","state":"Western Australia","zip":"6160","country":"Australia","geoPoint":{"lat":-32.05632,"lon":115.74557}},{"facility":"MHAT - Blagoevgrad AD, Department of Internal Diseases","city":"Blagoevgrad","zip":"2700","country":"Bulgaria","geoPoint":{"lat":42.01457,"lon":23.09804}},{"facility":"Medical Center Zdrave Lom EOOD","city":"Lom","zip":"3600","country":"Bulgaria","geoPoint":{"lat":43.8317,"lon":23.23793}},{"facility":"UMHAT Pulmed OOD - Pazardzhik, Department of Internal Diseases","city":"Pazardzhik","zip":"4400","country":"Bulgaria","geoPoint":{"lat":42.19934,"lon":24.33318}},{"facility":"\"MHAT - Pazardzhik\"","city":"Pazardzhik","zip":"4401","country":"Bulgaria","geoPoint":{"lat":42.19934,"lon":24.33318}},{"facility":"OCSOMCE - Dr. Albena Dinkova EOOD","city":"Pleven","zip":"5800","country":"Bulgaria","geoPoint":{"lat":43.41791,"lon":24.61666}},{"facility":"UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic","city":"Plovdiv","zip":"4001","country":"Bulgaria","geoPoint":{"lat":42.15387,"lon":24.75001}},{"facility":"MHAT Sveta Karidad EAD","city":"Plovdiv","zip":"4004","country":"Bulgaria","geoPoint":{"lat":42.15387,"lon":24.75001}},{"facility":"MHAT Hadzhi Dimitar OOD","city":"Sliven","zip":"8800","country":"Bulgaria","geoPoint":{"lat":42.68607,"lon":26.32558}},{"facility":"Medical center Smolyan clinical research OOD","city":"Smolyan","zip":"4700","country":"Bulgaria","geoPoint":{"lat":41.57439,"lon":24.71204}},{"facility":"UMHAT \"Aleksandrovska\"","city":"Sofia","zip":"1431","country":"Bulgaria","geoPoint":{"lat":42.69751,"lon":23.32415}},{"facility":"USHATE \"Akad. Ivan Penchev\" Second Clinic of Endocrinology","city":"Sofia","zip":"1431","country":"Bulgaria","geoPoint":{"lat":42.69751,"lon":23.32415}},{"facility":"Medical Institute of Ministry of interior","city":"Sofia","zip":"1606","country":"Bulgaria","geoPoint":{"lat":42.69751,"lon":23.32415}},{"facility":"UMHAT Sveta Marina EAD","city":"Varna","zip":"9010","country":"Bulgaria","geoPoint":{"lat":43.21912,"lon":27.91024}},{"facility":"AIPSMC Dr. Artin Magardichyan EOOD","city":"Varna","zip":"9020","country":"Bulgaria","geoPoint":{"lat":43.21912,"lon":27.91024}},{"facility":"MHAT- Hristo Botev AD","city":"Vratsa","zip":"3000","country":"Bulgaria","geoPoint":{"lat":43.21052,"lon":23.56312}},{"facility":"MHAT- Hristo Botev","city":"Vratsa","zip":"3001","country":"Bulgaria","geoPoint":{"lat":43.21052,"lon":23.56312}},{"facility":"MHAT Sveti Panteleimon - Yambol AD","city":"Yambol","zip":"8600","country":"Bulgaria","geoPoint":{"lat":42.48243,"lon":26.50006}},{"facility":"LMC Clin Res Inc. Calgary","city":"Calgary","state":"Alberta","zip":"T2H 2G4","country":"Canada","geoPoint":{"lat":51.05011,"lon":-114.08529}},{"facility":"C-endo Diab Endo Clin Calgery","city":"Calgary","state":"Alberta","zip":"T2V 4J2","country":"Canada","geoPoint":{"lat":51.05011,"lon":-114.08529}},{"facility":"G.A. Research Associates Ltd.","city":"Moncton","state":"New Brunswick","zip":"E1G 1A7","country":"Canada","geoPoint":{"lat":46.09454,"lon":-64.7965}},{"facility":"LMC ClinRsrh Inc.Brampton","city":"Brampton","state":"Ontario","zip":"L6S 0C6","country":"Canada","geoPoint":{"lat":43.68341,"lon":-79.76633}},{"facility":"LMC Clinical Res Thornhill","city":"Concord","state":"Ontario","zip":"L4K 4M2","country":"Canada","geoPoint":{"lat":43.80011,"lon":-79.48291}},{"facility":"LMC Endo Ctr (Etobicoke) Ltd","city":"Etobicoke","state":"Ontario","zip":"M9R 4E1","country":"Canada","geoPoint":{"lat":43.64415,"lon":-79.56985}},{"facility":"Wharton Med Clin Trials","city":"Hamilton","state":"Ontario","zip":"L8L 5G8","country":"Canada","geoPoint":{"lat":43.25011,"lon":-79.84963}},{"facility":"LMC Research Inc. Ottawa","city":"Nepean","state":"Ontario","zip":"K2J 0V2","country":"Canada","geoPoint":{"lat":45.33619,"lon":-75.7225}},{"facility":"LMC Oakville","city":"Oakville","state":"Ontario","zip":"L6M 1M1","country":"Canada","geoPoint":{"lat":43.45011,"lon":-79.68292}},{"facility":"Stayner Medical Clinic","city":"Stayner","state":"Ontario","zip":"L0M 1S0","country":"Canada","geoPoint":{"lat":44.41833,"lon":-80.09598}},{"facility":"Winterberry Family Medicine","city":"Stoney Creek","state":"Ontario","zip":"L8J 0B6","country":"Canada","geoPoint":{"lat":43.21681,"lon":-79.76633}},{"facility":"LMC Endo Centres Ltd.(Bayview)","city":"Toronto","state":"Ontario","zip":"M4G 3E8","country":"Canada","geoPoint":{"lat":43.70643,"lon":-79.39864}},{"facility":"Mount Sinai Hospital","city":"Toronto","state":"Ontario","zip":"M5T 3L9","country":"Canada","geoPoint":{"lat":43.70643,"lon":-79.39864}},{"facility":"Applied Med Inf Res","city":"Montreal","state":"Quebec","zip":"H4A 3T2","country":"Canada","geoPoint":{"lat":45.50884,"lon":-73.58781}},{"facility":"LMC Clin Rsrch Inc. (Montreal)","city":"Saint-Laurent","state":"Quebec","zip":"H4T 1Z9","country":"Canada","geoPoint":{"lat":45.50008,"lon":-73.66585}},{"facility":"Poliklinika Solmed","city":"Zagreb","state":"City of Zagreb","zip":"10000","country":"Croatia","geoPoint":{"lat":45.81444,"lon":15.97798}},{"facility":"KBC Rijeka, Endokrinologija","city":"Rijeka","state":"Primorje-Gorski Kotar County","zip":"51 000","country":"Croatia","geoPoint":{"lat":45.32673,"lon":14.44241}},{"facility":"Opca bolnica Bjelovar","city":"Bjelovar","zip":"43000","country":"Croatia","geoPoint":{"lat":45.89789,"lon":16.85071}},{"facility":"Klinicki bolnicki centar Osijek","city":"Osijek","zip":"31 000","country":"Croatia","geoPoint":{"lat":45.55066,"lon":18.6942}},{"facility":"General Hospital Dr. Josip Bencevic_Diabetic department","city":"Slavonski Brod","zip":"35 000","country":"Croatia","geoPoint":{"lat":45.16158,"lon":18.0163}},{"facility":"KB Dubrava, Zavod za endokrinologiju i dijabetes","city":"Zagreb","zip":"10000","country":"Croatia","geoPoint":{"lat":45.81444,"lon":15.97798}},{"facility":"Klinicka bolnica Sveti Duh","city":"Zagreb","zip":"10000","country":"Croatia","geoPoint":{"lat":45.81444,"lon":15.97798}},{"facility":"Ordinace pro choroby srdce","city":"Chomutov","zip":"430 02","country":"Czechia","geoPoint":{"lat":50.46048,"lon":13.41779}},{"facility":"Diabetologická a endokrinologická ambulance Hlučín","city":"Hlučín","zip":"748 01","country":"Czechia","geoPoint":{"lat":49.89795,"lon":18.19196}},{"facility":"Diahaza s.r.o.","city":"Holešov","zip":"76901","country":"Czechia","geoPoint":{"lat":49.33331,"lon":17.57832}},{"facility":"Diahelp - diabetologie","city":"Pardubice","zip":"530 02","country":"Czechia","geoPoint":{"lat":50.04075,"lon":15.77659}},{"facility":"DIALINE s.r.o.","city":"Plzeň 3","zip":"301 00","country":"Czechia"},{"facility":"Fakultni nemocnice Kralovske Vinohrady","city":"Prague","zip":"100 00","country":"Czechia","geoPoint":{"lat":50.08804,"lon":14.42076}},{"facility":"DiaGolfova spol s.r.o.","city":"Prague","zip":"102 00","country":"Czechia","geoPoint":{"lat":50.08804,"lon":14.42076}},{"facility":"Diabet2 s.r.o.","city":"Prague","zip":"110 00","country":"Czechia","geoPoint":{"lat":50.08804,"lon":14.42076}},{"facility":"Diabetologická a endokrinologická ambulance Praha","city":"Prague","zip":"140 21","country":"Czechia","geoPoint":{"lat":50.08804,"lon":14.42076}},{"facility":"Private Endocrnologist Dr Viitas","city":"Pärnu","zip":"80018","country":"Estonia","geoPoint":{"lat":58.38588,"lon":24.49711}},{"facility":"East Tallinn Central Hospital","city":"Tallinn","zip":"10138","country":"Estonia","geoPoint":{"lat":59.43696,"lon":24.75353}},{"facility":"Merelahe Family Doctors Centre","city":"Tallinn","zip":"10617","country":"Estonia","geoPoint":{"lat":59.43696,"lon":24.75353}},{"facility":"Estonian Diabetes Centre","city":"Tallinn","zip":"13419","country":"Estonia","geoPoint":{"lat":59.43696,"lon":24.75353}},{"facility":"Tartu University Hospital Internal Medicine Clinic","city":"Tartu","zip":"50406","country":"Estonia","geoPoint":{"lat":58.38062,"lon":26.72509}},{"facility":"SA Viljandi Haigla","city":"Viljandi","zip":"71024","country":"Estonia","geoPoint":{"lat":58.36319,"lon":25.59159}},{"facility":"Institut für Klinische Forschung und Entwicklung","city":"Berlin","zip":"10437","country":"Germany","geoPoint":{"lat":52.52437,"lon":13.41053}},{"facility":"Plassmann","city":"Essen","zip":"45359","country":"Germany","geoPoint":{"lat":51.45657,"lon":7.01228}},{"facility":"Zentrum für klinische Forschung, Dr. med. Lüdemann","city":"Falkensee","zip":"14612","country":"Germany","geoPoint":{"lat":52.56014,"lon":13.0927}},{"facility":"Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR","city":"Hamburg","zip":"22041","country":"Germany","geoPoint":{"lat":53.55073,"lon":9.99302}},{"facility":"Wendisch/Dahl Hamburg (DZHW)","city":"Hamburg","zip":"22607","country":"Germany","geoPoint":{"lat":53.55073,"lon":9.99302}},{"facility":"Institut für Diabetesforschung GmbH Münster - Dr. med. Rose","city":"Münster","zip":"48145","country":"Germany","geoPoint":{"lat":51.96236,"lon":7.62571}},{"facility":"RED-Institut für medizinische Forschung und Fortbildung GmbH","city":"Oldenburg in Holstein","zip":"23758","country":"Germany","geoPoint":{"lat":54.29498,"lon":10.89043}},{"facility":"Praxis Dr. med. Wenzl-Bauer","city":"Rehlingen-Siersburg","zip":"66780","country":"Germany","geoPoint":{"lat":49.37565,"lon":6.68439}},{"facility":"PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum","city":"Pécs","state":"Baranya Vármegye","zip":"7623","country":"Hungary","geoPoint":{"lat":46.07617,"lon":18.22814}},{"facility":"Komáromi Selye János Kórház","city":"Komárom","state":"Komárom-Esztergom","zip":"2900","country":"Hungary","geoPoint":{"lat":47.74318,"lon":18.11913}},{"facility":"Óbudai Egészségügyi Centrum","city":"Budapest","state":"Pest County","zip":"1036","country":"Hungary"},{"facility":"Szőcs Depot Egészségügyi Szolgáltató Kft.","city":"Budapest","zip":"1042","country":"Hungary","geoPoint":{"lat":47.49835,"lon":19.04045}},{"facility":"Bajcsy-Zsilinszky Kórház","city":"Budapest","zip":"1106","country":"Hungary","geoPoint":{"lat":47.49835,"lon":19.04045}},{"facility":"Dr. Vass László Egészségügyi Intézmény Diab. Szakrendelés","city":"Budapest","zip":"1152","country":"Hungary","geoPoint":{"lat":47.49835,"lon":19.04045}},{"facility":"Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület","city":"Debrecen","zip":"4043","country":"Hungary","geoPoint":{"lat":47.53167,"lon":21.62444}},{"facility":"Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika","city":"Debrecen","zip":"H-4032","country":"Hungary","geoPoint":{"lat":47.53167,"lon":21.62444}},{"facility":"Tolna megyei Balassa János Kórház","city":"Szekszárd","zip":"7100","country":"Hungary","geoPoint":{"lat":46.34723,"lon":18.71189}},{"facility":"Fejér Megyei Szent György Oktatókórház","city":"Székesfehérvár","zip":"8000","country":"Hungary","geoPoint":{"lat":47.18995,"lon":18.41034}},{"facility":"Vas Vármegyei Markusovszky Egyetemi Oktatókórház","city":"Szombathely","zip":"9700","country":"Hungary","geoPoint":{"lat":47.23088,"lon":16.62155}},{"facility":"Endolife Specialty Hospitals","city":"Guntur","state":"Andhra Pradesh","zip":"522001","country":"India","geoPoint":{"lat":16.29974,"lon":80.45729}},{"facility":"Care Outpatient Centre","city":"Hyderabad","state":"Andhra Pradesh","zip":"500034","country":"India"},{"facility":"Kurnool Medical Collage","city":"Kurnool","state":"Andhra Pradesh","zip":"518002","country":"India","geoPoint":{"lat":15.82887,"lon":78.03602}},{"facility":"Nirmal Hospital Pvt. Ltd.","city":"Surat","state":"Gujarat","zip":"395002","country":"India","geoPoint":{"lat":21.19594,"lon":72.83023}},{"facility":"PGIMS Rohtak","city":"Rohtak","state":"Haryana","zip":"124001","country":"India","geoPoint":{"lat":28.89447,"lon":76.58917}},{"facility":"Ramaiah Memorial Hospital","city":"Bangalore","state":"Karnataka","zip":"560054","country":"India","geoPoint":{"lat":12.97194,"lon":77.59369}},{"facility":"Belgaum Diabetes Centre","city":"Belagavi","state":"Karnataka","zip":"590001","country":"India","geoPoint":{"lat":15.85212,"lon":74.50447}},{"facility":"KLES & Prabhakar Kore Hospital and Research Centre","city":"Belagavi","state":"Karnatka","zip":"590010","country":"India","geoPoint":{"lat":15.85212,"lon":74.50447}},{"facility":"Amrita Institute Of Medical Sciences & Research Centre","city":"Kochi","state":"Kerala","zip":"682041","country":"India","geoPoint":{"lat":9.93988,"lon":76.26022}},{"facility":"Seth GS medical college and KEM Hospital","city":"Mumbai","state":"Maharashtra","zip":"400012","country":"India","geoPoint":{"lat":19.07283,"lon":72.88261}},{"facility":"Apollo Hospital, Navi Mumbai","city":"Mumbai","state":"Maharashtra","zip":"400614","country":"India","geoPoint":{"lat":19.07283,"lon":72.88261}},{"facility":"Deenanath Mangeshkar Hospital & Research Centre","city":"Pune","state":"Maharashtra","zip":"411004","country":"India","geoPoint":{"lat":18.51957,"lon":73.85535}},{"facility":"Deenanath Mangeshkar Hospital and Research Centre","city":"Pune","state":"Maharashtra","zip":"411004","country":"India","geoPoint":{"lat":18.51957,"lon":73.85535}},{"facility":"Inamdar Multispeciality Hospital","city":"Pune","state":"Maharashtra","zip":"411040","country":"India","geoPoint":{"lat":18.51957,"lon":73.85535}},{"facility":"Fortis Hospital, Shalimar Bagh, New Delhi","city":"New Delhi","state":"National Capital Territory of Delhi","zip":"110088","country":"India","geoPoint":{"lat":28.62137,"lon":77.2148}},{"facility":"Apollo Hospital","city":"Delhi","state":"New Delhi","zip":"110076","country":"India","geoPoint":{"lat":28.65195,"lon":77.23149}},{"facility":"All India Institute of Medical Sciences","city":"New Dehli","state":"New Delhi","zip":"110029","country":"India"},{"facility":"Dayanand Medical College & Hospital","city":"Ludhiana","state":"Punjab","zip":"141001","country":"India","geoPoint":{"lat":30.91204,"lon":75.85379}},{"facility":"Christian Medical College Hospital, Vellore","city":"Vellore","state":"Tamil Nadu","zip":"632004","country":"India","geoPoint":{"lat":12.9184,"lon":79.13255}},{"facility":"Gandhi Hospital & Medical college","city":"Hyderabad","state":"Telangana","zip":"500003","country":"India","geoPoint":{"lat":17.38405,"lon":78.45636}},{"facility":"Gleneagles Hospitals","city":"Hyderabad","state":"Telangana","zip":"500004","country":"India","geoPoint":{"lat":17.38405,"lon":78.45636}},{"facility":"Osmania General Hospital","city":"Hyderabad","state":"Telangana","zip":"500012","country":"India","geoPoint":{"lat":17.38405,"lon":78.45636}},{"facility":"MV Hospital and Research Centre","city":"Lucknow","state":"Uttar Pradesh","zip":"226003","country":"India","geoPoint":{"lat":26.83928,"lon":80.92313}},{"facility":"I.P.G.M.E & R Hospital","city":"Kolkata","state":"West Bengal","zip":"700020","country":"India","geoPoint":{"lat":22.56263,"lon":88.36304}},{"facility":"Apollo Multispeciality Hospital, Kolkata","city":"Kolkata","state":"West Bengal","zip":"700054","country":"India","geoPoint":{"lat":22.56263,"lon":88.36304}},{"facility":"NZOZ Przychodnia Specjalistyczna Medica","city":"Lublin","state":"Lubelski","zip":"20-538","country":"Poland","geoPoint":{"lat":51.25058,"lon":22.57009}},{"facility":"Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski","city":"Gorzów Wielkopolski","state":"Lubusz Voivodeship","zip":"66-400","country":"Poland","geoPoint":{"lat":52.73371,"lon":15.22505}},{"facility":"Uniwersytecki Szpital Kliniczny w Bialymstoku","city":"Bialystok","state":"Podlaskie Voivodeship","zip":"15-276","country":"Poland","geoPoint":{"lat":53.13333,"lon":23.16433}},{"facility":"NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska","city":"Bialystok","state":"Podlaskie Voivodeship","zip":"15-435","country":"Poland","geoPoint":{"lat":53.13333,"lon":23.16433}},{"facility":"Kresmed Sp. z o. o.","city":"Bialystok","state":"Podlaskie Voivodeship","zip":"15-481","country":"Poland","geoPoint":{"lat":53.13333,"lon":23.16433}},{"facility":"Centrum Zdrowia Metabolicznego","city":"Poznan","state":"Wielkopolskie Voivodeship","zip":"60-589","country":"Poland","geoPoint":{"lat":52.40692,"lon":16.92993}},{"facility":"Uniwersytecki Szpital Kliniczny w Bialymstoku","city":"Bialystok","zip":"15-276","country":"Poland","geoPoint":{"lat":53.13333,"lon":23.16433}},{"facility":"Osteo Medic s.c. Artur Racewicz Jerzy Supronik","city":"Bialystok","zip":"15-351","country":"Poland","geoPoint":{"lat":53.13333,"lon":23.16433}},{"facility":"SNZOZ Lege Artis","city":"Bialystok","zip":"15-404","country":"Poland","geoPoint":{"lat":53.13333,"lon":23.16433}},{"facility":"Centrum Kliniczno Badawcze","city":"Elblag","zip":"82-300","country":"Poland","geoPoint":{"lat":54.1522,"lon":19.40884}},{"facility":"Centrum Badan Klinicznych PI-House","city":"Gdansk","zip":"80-546","country":"Poland","geoPoint":{"lat":54.35227,"lon":18.64912}},{"facility":"Uniwersyteckie Centrum Kliniczne im. prof. Gibinskiego, SUM","city":"Katowice","zip":"40-752","country":"Poland","geoPoint":{"lat":50.2597,"lon":19.02173}},{"facility":"Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie","city":"Krakow","zip":"30-688","country":"Poland","geoPoint":{"lat":50.06143,"lon":19.93658}},{"facility":"Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.","city":"Lodz","zip":"90-338","country":"Poland","geoPoint":{"lat":51.77058,"lon":19.47395}},{"facility":"Gaja Poradnie Lekarskie","city":"Poznan","zip":"61-251","country":"Poland","geoPoint":{"lat":52.40692,"lon":16.92993}},{"facility":"Centrum Medyczne \"Diabetika\"","city":"Radom","zip":"26-600","country":"Poland","geoPoint":{"lat":51.40253,"lon":21.14714}},{"facility":"NBR Polska Tomasz Klodawski","city":"Warsaw","zip":"00-710","country":"Poland","geoPoint":{"lat":52.22977,"lon":21.01178}},{"facility":"SP CSK Klinika Diabetologii i Chorob Wewnetrznych","city":"Warsaw","zip":"02-097","country":"Poland","geoPoint":{"lat":52.22977,"lon":21.01178}},{"facility":"Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji","city":"Warsaw","zip":"02-507","country":"Poland","geoPoint":{"lat":52.22977,"lon":21.01178}},{"facility":"Centrum Medyczne Oporow","city":"Wroclaw","zip":"52-416","country":"Poland","geoPoint":{"lat":51.10286,"lon":17.03006}},{"facility":"Prywatny Gabinet Janusz Gumprecht","city":"Zabrze","zip":"41-800","country":"Poland","geoPoint":{"lat":50.32492,"lon":18.78576}},{"facility":"Manati Ctr For Clin Research","city":"Manati","zip":"00674","country":"Puerto Rico","geoPoint":{"lat":18.42745,"lon":-66.49212}},{"facility":"DIADA, s.r.o.","city":"Bardejov","zip":"08501","country":"Slovakia","geoPoint":{"lat":49.29175,"lon":21.27271}},{"facility":"Diabetologicka ambulancia Diabetes care, s.r.o.","city":"Hnúšťa","zip":"98101","country":"Slovakia","geoPoint":{"lat":48.57257,"lon":19.95395}},{"facility":"Diabetologicka ambulancia DIAMO s.r.o.","city":"Kežmarok","zip":"06001","country":"Slovakia","geoPoint":{"lat":49.13571,"lon":20.43352}},{"facility":"MOMED, s.r.o","city":"Kráľovský Chlmec","zip":"077 01","country":"Slovakia","geoPoint":{"lat":48.42336,"lon":21.97944}},{"facility":"IN-DIA s.r.o.","city":"Lučenec","zip":"984 01","country":"Slovakia","geoPoint":{"lat":48.33249,"lon":19.66708}},{"facility":"Diabetologicka ambulancia MUDr. Alena Lomencikova, s.r.o","city":"Martin","zip":"036 01","country":"Slovakia","geoPoint":{"lat":49.06651,"lon":18.92399}},{"facility":"DIABETOL, s.r.o.","city":"Prešov","zip":"080 01","country":"Slovakia","geoPoint":{"lat":48.99923,"lon":21.2355}},{"facility":"OLIVER - MED s.r.o.","city":"Rimavská Sobota","zip":"979 01","country":"Slovakia","geoPoint":{"lat":48.38284,"lon":20.02239}},{"facility":"MEDI-DIA s.r.o.","city":"Sabinov","zip":"08301","country":"Slovakia","geoPoint":{"lat":49.10309,"lon":21.0988}},{"facility":"Diabetologicka ambulancia MUDr. Gabriela Zimova","city":"Spišská Nová Ves","zip":"052 01","country":"Slovakia","geoPoint":{"lat":48.94464,"lon":20.56153}},{"facility":"General Hospital Celje","city":"Celje","zip":"SI-3000","country":"Slovenia","geoPoint":{"lat":46.23092,"lon":15.26044}},{"facility":"Healthcare Centre Koper","city":"Koper","zip":"SI-6000","country":"Slovenia","geoPoint":{"lat":45.5482,"lon":13.72963}},{"facility":"UKC Ljubljana, Endocrinology and Diabetes","city":"Ljubljana","zip":"SI-1000","country":"Slovenia","geoPoint":{"lat":46.05108,"lon":14.50513}},{"facility":"UKC Maribor - diabetes","city":"Maribor","zip":"SI-2000","country":"Slovenia","geoPoint":{"lat":46.55583,"lon":15.64593}},{"facility":"Healthcare Centre Nova Gorica","city":"Nova Gorica","zip":"SI-5000","country":"Slovenia","geoPoint":{"lat":45.95604,"lon":13.64837}},{"facility":"Taichung Veterans General Hospital","city":"Taichung","zip":"407","country":"Taiwan","geoPoint":{"lat":24.1469,"lon":120.6839}},{"facility":"National Cheng Kung University Hospital","city":"Tainan","zip":"704","country":"Taiwan","geoPoint":{"lat":22.99083,"lon":120.21333}}]},"referencesModule":{"references":[{"pmid":"37385279","type":"RESULT","citation":"Aroda VR, Aberle J, Bardtrum L, Christiansen E, Knop FK, Gabery S, Pedersen SD, Buse JB. Efficacy and safety of once-daily oral semaglutide 25 mg and 50 mg compared with 14 mg in adults with type 2 diabetes (PIONEER PLUS): a multicentre, randomised, phase 3b trial. Lancet. 2023 Aug 26;402(10403):693-704. doi: 10.1016/S0140-6736(23)01127-3. Epub 2023 Jun 26."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com","url":"http://novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants were randomized in 1:1:1 ratio to receive either 14 milligram (mg), 25 mg or 50 mg oral semaglutide once daily. The trial had a 68-week treatment period (8-16 weeks of dose escalation period and 52-60 weeks of maintenance period), followed by a 5-week follow-up period.","recruitmentDetails":"The trial was conducted in 14 countries (184 sites screened/177 randomised participants) as follows: Australia: 7/6; Bulgaria: 15/15; Canada: 13/13; Croatia: 5/5; Czech Republic: 5/5; Estonia: 6/5; Germany: 8/8; Hungary: 9/9; India: 20/20; Poland: 18/18; Slovakia: 9/9; Slovenia: 5/5; Taiwan: 2/2; United States: 62/57. In addition, Bulgaria (1 site), Canada (1 site), Croatia (1 site) and Poland (1 site) were approved by the institutional review board, but did not randomise any participant.","groups":[{"id":"FG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"FG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"FG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"536"},{"groupId":"FG001","numSubjects":"535"},{"groupId":"FG002","numSubjects":"535"}]},{"type":"Treated","achievements":[{"groupId":"FG000","numSubjects":"534"},{"groupId":"FG001","numSubjects":"534"},{"groupId":"FG002","numSubjects":"534"}]},{"type":"Full Analysis Set (FAS)","achievements":[{"groupId":"FG000","numSubjects":"536"},{"groupId":"FG001","numSubjects":"535"},{"groupId":"FG002","numSubjects":"535"}]},{"type":"Safety Analysis Set (SAS)","achievements":[{"groupId":"FG000","numSubjects":"534"},{"groupId":"FG001","numSubjects":"534"},{"groupId":"FG002","numSubjects":"534"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"507"},{"groupId":"FG001","numSubjects":"490"},{"groupId":"FG002","numSubjects":"505"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"45"},{"groupId":"FG002","numSubjects":"30"}]}],"dropWithdraws":[{"type":"Site closure","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"19"},{"groupId":"FG002","numSubjects":"14"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"16"},{"groupId":"FG002","numSubjects":"12"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set (FAS) included all randomised participants.","groups":[{"id":"BG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"BG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"BG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"536"},{"groupId":"BG001","value":"535"},{"groupId":"BG002","value":"535"},{"groupId":"BG003","value":"1606"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"58.4","spread":"10.4"},{"groupId":"BG001","value":"58.8","spread":"10.7"},{"groupId":"BG002","value":"57.6","spread":"11.2"},{"groupId":"BG003","value":"58.2","spread":"10.8"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"211"},{"groupId":"BG001","value":"231"},{"groupId":"BG002","value":"228"},{"groupId":"BG003","value":"670"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"325"},{"groupId":"BG001","value":"304"},{"groupId":"BG002","value":"307"},{"groupId":"BG003","value":"936"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"37"},{"groupId":"BG002","value":"36"},{"groupId":"BG003","value":"111"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"498"},{"groupId":"BG001","value":"498"},{"groupId":"BG002","value":"499"},{"groupId":"BG003","value":"1495"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"85"},{"groupId":"BG001","value":"73"},{"groupId":"BG002","value":"111"},{"groupId":"BG003","value":"269"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"18"},{"groupId":"BG003","value":"59"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"424"},{"groupId":"BG001","value":"432"},{"groupId":"BG002","value":"398"},{"groupId":"BG003","value":"1254"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"21"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Glycated Haemoglobin (HbA1c) (Week 52)","description":"Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.","populationDescription":"Full Analysis Set (FAS) which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage point of HbA1c","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"497"},{"groupId":"OG001","value":"475"},{"groupId":"OG002","value":"492"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.5","spread":"1.3"},{"groupId":"OG001","value":"-1.9","spread":"1.3"},{"groupId":"OG002","value":"-2.1","spread":"1.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Treatment policy estimand","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Change from baseline was analyzed using an ANCOVA model with treatment, strata and region as categorical fixed effects and baseline value as covariate for each of the 1000 imputed complete datasets,and pooled by Rubin's rule to draw inference.","pValue":"0.0006","pValueComment":"Unadjusted two-sided p-value for test of no difference.","statisticalMethod":"ANCOVA","paramType":"Treatment difference","paramValue":"-0.27","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.42","ciUpperLimit":"-0.12"},{"groupIds":["OG000","OG002"],"groupDescription":"Treatment policy estimand","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Change from baseline was analyzed using an ANCOVA model with treatment, strata and region as categorical fixed effects and baseline value as covariate for each of the 1000 imputed complete datasets,and pooled by Rubin's rule to draw inference.","pValue":"<.0001","pValueComment":"Unadjusted two-sided p-value for test of no difference.","statisticalMethod":"ANCOVA","paramType":"Treatment difference","paramValue":"-0.53","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.68","ciUpperLimit":"-0.38"}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight (Week 52)","description":"Change from baseline (week 0) in body weight was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilogram (Kg)","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"503"},{"groupId":"OG001","value":"480"},{"groupId":"OG002","value":"495"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.4","spread":"5.2"},{"groupId":"OG001","value":"-7.1","spread":"6.8"},{"groupId":"OG002","value":"-8.3","spread":"7.5"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in HbA1c (Week 68)","description":"Change from baseline (week 0) in HbA1c was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage point of HbA1c","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"487"},{"groupId":"OG001","value":"469"},{"groupId":"OG002","value":"491"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.5","spread":"1.3"},{"groupId":"OG001","value":"-1.8","spread":"1.3"},{"groupId":"OG002","value":"-2.0","spread":"1.4"}]}]}]},{"type":"SECONDARY","title":"Change From Week 12 in HbA1c (Week 52)","description":"Change in HbA1c was evaluated from week 12 to week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage point of HbA1c","timeFrame":"Week 12, Week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"333"},{"groupId":"OG001","value":"345"},{"groupId":"OG002","value":"339"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"1.2"},{"groupId":"OG001","value":"-0.8","spread":"1.1"},{"groupId":"OG002","value":"-1.0","spread":"1.2"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Plasma Glucose (FPG) (Week 52)","description":"Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimole per litre (mmol/L)","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"494"},{"groupId":"OG001","value":"460"},{"groupId":"OG002","value":"482"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.4","spread":"3.4"},{"groupId":"OG001","value":"-3.0","spread":"3.5"},{"groupId":"OG002","value":"-3.2","spread":"3.4"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in FPG (Week 68)","description":"Change from baseline (week 0) in FPG was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"485"},{"groupId":"OG001","value":"466"},{"groupId":"OG002","value":"485"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.4","spread":"3.4"},{"groupId":"OG001","value":"-3.0","spread":"3.7"},{"groupId":"OG002","value":"-3.2","spread":"3.4"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Week 52)","description":"Percentage of participants who achieved HbA1c \\<7.0 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"At week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"536"},{"groupId":"OG001","value":"535"},{"groupId":"OG002","value":"535"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"50.5"},{"groupId":"OG002","value":"63"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved HbA1c < 7.0 % (Week 68)","description":"Percentage of participants who achieved HbA1c \\<7.0 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"At week 68","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"536"},{"groupId":"OG001","value":"535"},{"groupId":"OG002","value":"535"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"39.2"},{"groupId":"OG001","value":"49.9"},{"groupId":"OG002","value":"58.9"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 % (Week 52)","description":"Percentage of participants who achieved HbA1c \\<=6.5 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"At week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"536"},{"groupId":"OG001","value":"535"},{"groupId":"OG002","value":"535"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"25.8"},{"groupId":"OG001","value":"39.6"},{"groupId":"OG002","value":"51.2"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved HbA1c <= 6.5 % (Week 68)","description":"Percentage of participants who achieved HbA1c \\<=6.5 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"At week 68","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"536"},{"groupId":"OG001","value":"535"},{"groupId":"OG002","value":"535"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23.6"},{"groupId":"OG001","value":"35.8"},{"groupId":"OG002","value":"46.2"}]}]}]},{"type":"SECONDARY","title":"Time to Event Analyses of Rescue Medication","description":"Time to event analyses of rescue medication was evaluated from baseline (week 0) to week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"Weeks","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"54"},{"groupId":"OG002","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Due to insufficient number of participants with events to calculate via Kaplan Meir, data was not estimable."},{"groupId":"OG001","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Due to insufficient number of participants with events to calculate via Kaplan Meir, data was not estimable."},{"groupId":"OG002","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Due to insufficient number of participants with events to calculate via Kaplan Meir, data was not estimable."}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight (Week 68)","description":"Change from baseline (week 0) in body weight was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kg","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"495"},{"groupId":"OG001","value":"477"},{"groupId":"OG002","value":"495"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.5","spread":"5.5"},{"groupId":"OG001","value":"-7.1","spread":"7.4"},{"groupId":"OG002","value":"-8.2","spread":"8.1"}]}]}]},{"type":"SECONDARY","title":"Percentage Change From Baseline in Body Weight (Week 52)","description":"Percentage change from baseline (week 0) in body weight was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage change in body weight","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"503"},{"groupId":"OG001","value":"480"},{"groupId":"OG002","value":"495"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.7","spread":"5.4"},{"groupId":"OG001","value":"-7.3","spread":"6.6"},{"groupId":"OG002","value":"-8.5","spread":"7.3"}]}]}]},{"type":"SECONDARY","title":"Percentage Change From Baseline in Body Weight (Week 68)","description":"Percentage change from baseline (week 0) in body weight was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage change in body weight","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"495"},{"groupId":"OG001","value":"477"},{"groupId":"OG002","value":"495"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.7","spread":"5.6"},{"groupId":"OG001","value":"-7.2","spread":"7.1"},{"groupId":"OG002","value":"-8.4","spread":"7.7"}]}]}]},{"type":"SECONDARY","title":"Percentage Change From Week 12 in Body Weight (Week 52)","description":"Percentage change in body weight was evaluated from week 12 to week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage change in body weight","timeFrame":"Week 12, Week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"370"},{"groupId":"OG001","value":"366"},{"groupId":"OG002","value":"355"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.5","spread":"3.6"},{"groupId":"OG001","value":"-3.8","spread":"5.4"},{"groupId":"OG002","value":"-5.4","spread":"6.1"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Mass Index (BMI) (Week 52)","description":"Change from baseline (week 0) in body mass index (BMI) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kilogram per square metre (kg/m^2)","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"503"},{"groupId":"OG001","value":"480"},{"groupId":"OG002","value":"495"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.6","spread":"1.8"},{"groupId":"OG001","value":"-2.5","spread":"2.5"},{"groupId":"OG002","value":"-2.9","spread":"2.6"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in BMI (Week 68)","description":"Change from baseline (week 0) in BMI was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg/m^2","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"495"},{"groupId":"OG001","value":"477"},{"groupId":"OG002","value":"495"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.6","spread":"1.9"},{"groupId":"OG001","value":"-2.5","spread":"2.7"},{"groupId":"OG002","value":"-2.9","spread":"2.8"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Waist Circumference (Week 52)","description":"Change from baseline (week 0) in waist circumference was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"centimetre (cm)","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"502"},{"groupId":"OG001","value":"479"},{"groupId":"OG002","value":"494"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4","spread":"7"},{"groupId":"OG001","value":"-5","spread":"7"},{"groupId":"OG002","value":"-6","spread":"7"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Waist Circumference (Week 68)","description":"Change from baseline (week 0) in waist circumference was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cm","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"494"},{"groupId":"OG001","value":"476"},{"groupId":"OG002","value":"495"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4","spread":"6"},{"groupId":"OG001","value":"-6","spread":"7"},{"groupId":"OG002","value":"-7","spread":"8"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved Weight Loss Greater Than or Equal to (>=) 5 % (Week 52)","description":"Percentage of participants who achieved weight loss \\>= 5 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"At week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"536"},{"groupId":"OG001","value":"535"},{"groupId":"OG002","value":"535"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"60"},{"groupId":"OG002","value":"67.5"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved Weight Loss >= 5 % (Week 68)","description":"Percentage of participants who achieved weight loss \\>= 5 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"At week 68","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"536"},{"groupId":"OG001","value":"535"},{"groupId":"OG002","value":"535"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"42.2"},{"groupId":"OG001","value":"58.5"},{"groupId":"OG002","value":"65.7"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 52)","description":"Percentage of participants who achieved weight loss \\>= 10 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"At week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"536"},{"groupId":"OG001","value":"535"},{"groupId":"OG002","value":"535"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13.9"},{"groupId":"OG001","value":"29"},{"groupId":"OG002","value":"37.2"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 68)","description":"Percentage of participants who achieved weight loss \\>= 10 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"At week 68","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"536"},{"groupId":"OG001","value":"535"},{"groupId":"OG002","value":"535"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14.3"},{"groupId":"OG001","value":"29.4"},{"groupId":"OG002","value":"34.7"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Total Cholesterol (Week 52)","description":"Change from baseline (week 0) in total cholesterol was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"490"},{"groupId":"OG001","value":"467"},{"groupId":"OG002","value":"486"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.04","spread":"0.96"},{"groupId":"OG001","value":"-0.15","spread":"1.10"},{"groupId":"OG002","value":"-0.06","spread":"0.94"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Total Cholesterol (Week 68)","description":"Change from baseline (week 0) in total cholesterol was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Baseline, Week 68","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"484"},{"groupId":"OG001","value":"470"},{"groupId":"OG002","value":"487"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.03","spread":"0.99"},{"groupId":"OG001","value":"-0.08","spread":"1.05"},{"groupId":"OG002","value":"-0.06","spread":"1.00"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Low Density Lipoproteins (LDL) (Week 52)","description":"Change from baseline (week 0) in LDL was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"477"},{"groupId":"OG001","value":"454"},{"groupId":"OG002","value":"473"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.04","spread":"0.75"},{"groupId":"OG001","value":"-0.01","spread":"0.85"},{"groupId":"OG002","value":"0.11","spread":"0.76"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in LDL (Week 68)","description":"Change from baseline (week 0) in LDL was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Baseline, Week 68","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"472"},{"groupId":"OG001","value":"459"},{"groupId":"OG002","value":"476"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.07","spread":"0.80"},{"groupId":"OG001","value":"0.06","spread":"0.85"},{"groupId":"OG002","value":"0.08","spread":"0.79"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in High Density Lipoproteins (HDL) (Week 52)","description":"Change from baseline (week 0) in HDL was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"477"},{"groupId":"OG001","value":"453"},{"groupId":"OG002","value":"474"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.06","spread":"0.18"},{"groupId":"OG001","value":"0.07","spread":"0.19"},{"groupId":"OG002","value":"0.08","spread":"0.18"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in HDL (Week 68)","description":"Change from baseline (week 0) in HDL was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Baseline, Week 68","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"473"},{"groupId":"OG001","value":"458"},{"groupId":"OG002","value":"476"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.06","spread":"0.19"},{"groupId":"OG001","value":"0.08","spread":"0.21"},{"groupId":"OG002","value":"0.09","spread":"0.20"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Triglycerides (Week 52)","description":"Change from baseline (week 0) in triglycerides was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"489"},{"groupId":"OG001","value":"465"},{"groupId":"OG002","value":"483"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.46","spread":"1.77"},{"groupId":"OG001","value":"-0.65","spread":"2.08"},{"groupId":"OG002","value":"-0.71","spread":"1.40"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Triglycerides (Week 68)","description":"Change from baseline (week 0) in triglycerides was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Baseline, Week 68","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"483"},{"groupId":"OG001","value":"469"},{"groupId":"OG002","value":"486"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.51","spread":"1.77"},{"groupId":"OG001","value":"-0.65","spread":"2.06"},{"groupId":"OG002","value":"-0.70","spread":"1.43"}]}]}]},{"type":"SECONDARY","title":"Number of Adverse Events","description":"An adverse event (AE) defined as any unfavourable and unintended sign, including an abnormal laboratory finding, symptom or disease (new or exacerbated) temporally associated with the use of an investigational medicinal products (IMP). Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.","populationDescription":"Safety Analysis Set (SAS) which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"From baseline (week 0) up to week 73","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"534"},{"groupId":"OG001","value":"534"},{"groupId":"OG002","value":"534"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1641"},{"groupId":"OG001","value":"2055"},{"groupId":"OG002","value":"2115"}]}]}]},{"type":"SECONDARY","title":"Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) or Severe Hypoglycaemic Episodes (Level 3)","description":"Hypoglycaemic episodes were classified according to the American Diabetes Association 2018/ International Hypoglycaemia Study Group 2017, where glycemic criteria for level 2 was \\< 3.0 mmol/L (54 mg/dL) and level 3 had no specific glucose threshold. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.","populationDescription":"SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Count of episodes","timeFrame":"From baseline (week 0) up to week 68","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"534"},{"groupId":"OG001","value":"534"},{"groupId":"OG002","value":"534"}]}],"classes":[{"title":"Level 2","categories":[{"measurements":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"44"},{"groupId":"OG002","value":"35"}]}]},{"title":"Level 3","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Systolic Blood Pressure (Week 52)","description":"Change from baseline (week 0) in systolic blood pressure at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.","populationDescription":"SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimetres of mercury (mmHg)","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"456"},{"groupId":"OG001","value":"426"},{"groupId":"OG002","value":"434"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4","spread":"14"},{"groupId":"OG001","value":"-6","spread":"13"},{"groupId":"OG002","value":"-6","spread":"14"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Systolic Blood Pressure (Week 68)","description":"Change from baseline (week 0) in systolic blood pressure at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.","populationDescription":"SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"442"},{"groupId":"OG001","value":"414"},{"groupId":"OG002","value":"429"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4","spread":"13"},{"groupId":"OG001","value":"-6","spread":"13"},{"groupId":"OG002","value":"-5","spread":"13"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Diastolic Blood Pressure (Week 52)","description":"Change from baseline (week 0) in diastolic blood pressure at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.","populationDescription":"SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"456"},{"groupId":"OG001","value":"426"},{"groupId":"OG002","value":"434"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2","spread":"8"},{"groupId":"OG001","value":"-2","spread":"8"},{"groupId":"OG002","value":"-2","spread":"8"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Diastolic Blood Pressure (Week 68)","description":"Change from baseline (week 0) in diastolic blood pressure at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.","populationDescription":"SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"442"},{"groupId":"OG001","value":"414"},{"groupId":"OG002","value":"429"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3","spread":"8"},{"groupId":"OG001","value":"-3","spread":"8"},{"groupId":"OG002","value":"-2","spread":"8"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Pulse (Week 52)","description":"Change from baseline (week 0) in pulse at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.","populationDescription":"SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"beats per minute (beats/min)","timeFrame":"Baseline (week 0), week 52","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"456"},{"groupId":"OG001","value":"426"},{"groupId":"OG002","value":"434"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2","spread":"10"},{"groupId":"OG001","value":"2","spread":"10"},{"groupId":"OG002","value":"3","spread":"11"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Pulse (Week 68)","description":"Change from baseline (week 0) in pulse at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.","populationDescription":"SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"beats/min","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68."},{"id":"OG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68."},{"id":"OG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"442"},{"groupId":"OG001","value":"413"},{"groupId":"OG002","value":"429"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1","spread":"10"},{"groupId":"OG001","value":"2","spread":"10"},{"groupId":"OG002","value":"2","spread":"10"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Week 0 to week 73","description":"Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.","eventGroups":[{"id":"EG000","title":"Oral Semaglutide 14 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.","deathsNumAffected":2,"deathsNumAtRisk":534,"seriousNumAffected":53,"seriousNumAtRisk":534,"otherNumAffected":277,"otherNumAtRisk":534},{"id":"EG001","title":"Oral Semaglutide 25 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.","deathsNumAffected":6,"deathsNumAtRisk":534,"seriousNumAffected":57,"seriousNumAtRisk":534,"otherNumAffected":294,"otherNumAtRisk":534},{"id":"EG002","title":"Oral Semaglutide 50 mg","description":"Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.","deathsNumAffected":2,"deathsNumAtRisk":534,"seriousNumAffected":44,"seriousNumAtRisk":534,"otherNumAffected":314,"otherNumAtRisk":534}],"seriousEvents":[{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Abdominal pain lower","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Abscess intestinal","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Abscess limb","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Abscess oral","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Acidosis","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Acute kidney injury","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Acute left ventricular failure","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":534},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Anaemia postoperative","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Ankle fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Aortic valve disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Aortic valve stenosis","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Appendicitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Appendicitis perforated","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Arthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Asthenia","organSystem":"General disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Asthma","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Atrial flutter","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Atrioventricular block second degree","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Back pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Basal cell carcinoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Benign prostatic hyperplasia","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Bile duct stenosis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Brachial plexus injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"COVID-19","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":534}]},{"term":"COVID-19 pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":534},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":534},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":534}]},{"term":"Calculus bladder","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Cardiac arrest","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Cardiac failure chronic","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Cardiac failure congestive","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Carotid artery occlusion","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Cataract subcapsular","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Cellulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Cellulitis pharyngeal","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Central nervous system lesion","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Cerebrovascular accident","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Cervical spinal stenosis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Cholangitis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Cholecystitis acute","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Cholelithiasis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Chronic coronary syndrome","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Chronic kidney disease","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Chronic lymphocytic leukaemia","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Chronic myelomonocytic leukaemia","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Circulatory collapse","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Clavicle fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Colon neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Concussion","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Conduction disorder","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Coronary artery disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Coronary artery stenosis","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Cystocele","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Death","organSystem":"General disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Dehydration","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Diabetes mellitus inadequate control","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Diabetic gangrene","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Diabetic ketoacidosis","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Diabetic metabolic decompensation","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":3,"numAffected":2,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Dyspnoea","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Endometrial hyperplasia","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Enterocele","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Epididymitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Epiretinal membrane","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Epistaxis","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Erysipelas","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Escherichia bacteraemia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Food poisoning","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Gallbladder disorder","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Gastritis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Gastroenteritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Glomerular filtration rate decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Greater trochanteric pain syndrome","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Gynaecomastia","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Haematemesis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Haemorrhagic stroke","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Head injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Hemiparesis","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Hepatic cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Hip arthroplasty","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Hyperglycaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Iliac artery stenosis","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Inguinal hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Intervertebral disc disorder","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Intervertebral disc injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Intervertebral disc protrusion","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Intestinal pseudo-obstruction","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Ischaemic skin ulcer","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Ischaemic stroke","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Keratoplasty","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Ligament sprain","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Lumbar spinal stenosis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Lung cancer metastatic","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Lymphoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Macular oedema","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Malignant melanoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Metastases to central nervous system","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Myelopathy","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Myocardial ischaemia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Nasal turbinate hypertrophy","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Non-alcoholic steatohepatitis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Orthostatic hypotension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Ovarian cyst","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Pain in extremity","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Pancreatic carcinoma metastatic","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Pancreatitis acute","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Papilloedema","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Peripheral arterial occlusive disease","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":534}]},{"term":"Pneumothorax","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Prostate cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Prostatic adenoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Pulmonary embolism","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Pulmonary mass","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Pyelonephritis acute","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Pyrexia","organSystem":"General disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Renal colic","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Renal hypertension","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Renal impairment","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Renal neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Respiratory failure","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Rib fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Road traffic accident","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Sepsis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Skin ulcer","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Somatic symptom disorder","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Speech disorder","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Spinal fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Spinal osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Splenic injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Subarachnoid haemorrhage","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Swelling face","organSystem":"General disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Syncope","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Tendon disorder","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Thrombocytopenia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Transient ischaemic attack","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Umbilical hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Upper limb fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Ureterolithiasis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Urinary retention","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Urinary tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Urosepsis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Uterine leiomyoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Vascular graft occlusion","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]},{"term":"Vertigo","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":534},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":534}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":534},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":534},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":534}]}],"otherEvents":[{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":25,"numAffected":14,"numAtRisk":534},{"groupId":"EG001","numEvents":34,"numAffected":27,"numAtRisk":534},{"groupId":"EG002","numEvents":27,"numAffected":21,"numAtRisk":534}]},{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":17,"numAffected":14,"numAtRisk":534},{"groupId":"EG001","numEvents":52,"numAffected":32,"numAtRisk":534},{"groupId":"EG002","numEvents":55,"numAffected":22,"numAtRisk":534}]},{"term":"COVID-19","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":65,"numAffected":63,"numAtRisk":534},{"groupId":"EG001","numEvents":68,"numAffected":64,"numAtRisk":534},{"groupId":"EG002","numEvents":68,"numAffected":66,"numAtRisk":534}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":46,"numAffected":40,"numAtRisk":534},{"groupId":"EG001","numEvents":41,"numAffected":35,"numAtRisk":534},{"groupId":"EG002","numEvents":39,"numAffected":33,"numAtRisk":534}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":43,"numAffected":38,"numAtRisk":534},{"groupId":"EG001","numEvents":42,"numAffected":39,"numAtRisk":534},{"groupId":"EG002","numEvents":61,"numAffected":58,"numAtRisk":534}]},{"term":"Diabetic retinopathy","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":44,"numAffected":41,"numAtRisk":534},{"groupId":"EG001","numEvents":30,"numAffected":26,"numAtRisk":534},{"groupId":"EG002","numEvents":40,"numAffected":35,"numAtRisk":534}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":84,"numAffected":66,"numAtRisk":534},{"groupId":"EG001","numEvents":108,"numAffected":69,"numAtRisk":534},{"groupId":"EG002","numEvents":150,"numAffected":76,"numAtRisk":534}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":32,"numAffected":28,"numAtRisk":534},{"groupId":"EG001","numEvents":47,"numAffected":29,"numAtRisk":534},{"groupId":"EG002","numEvents":50,"numAffected":30,"numAtRisk":534}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":63,"numAffected":34,"numAtRisk":534},{"groupId":"EG001","numEvents":81,"numAffected":28,"numAtRisk":534},{"groupId":"EG002","numEvents":81,"numAffected":38,"numAtRisk":534}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":28,"numAffected":24,"numAtRisk":534},{"groupId":"EG001","numEvents":27,"numAffected":22,"numAtRisk":534},{"groupId":"EG002","numEvents":30,"numAffected":27,"numAtRisk":534}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":119,"numAffected":96,"numAtRisk":534},{"groupId":"EG001","numEvents":222,"numAffected":145,"numAtRisk":534},{"groupId":"EG002","numEvents":218,"numAffected":146,"numAtRisk":534}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":69,"numAffected":52,"numAtRisk":534},{"groupId":"EG001","numEvents":155,"numAffected":91,"numAtRisk":534},{"groupId":"EG002","numEvents":184,"numAffected":97,"numAtRisk":534}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property."},"pointOfContact":{"title":"Clinical Reporting Office (2834)","organization":"Novo Nordisk A/S","email":"clinicaltrials@novonordisk.com","phone":"(+1) 866-867-7178"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2022-09-16","uploadDate":"2024-03-05T08:13","filename":"Prot_000.pdf","size":963998},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2022-12-23","uploadDate":"2024-03-05T08:13","filename":"SAP_001.pdf","size":1661933}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"}],"ancestors":[{"id":"D003920","term":"Diabetes Mellitus"},{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"C000591245","term":"semaglutide"}]}},"hasResults":true}