{"protocolSection":{"identificationModule":{"nctId":"NCT04109547","orgStudyIdInfo":{"id":"NN9924-4338"},"secondaryIdInfos":[{"id":"U1111-1188-1173","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"2018-002590-22","type":"REGISTRY","domain":"European Medicines Agency (EudraCT)"},{"id":"2018","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2018"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Research Study Comparing a New Medicine Oral Semaglutide to Placebo in People With Type 2 Diabetes","officialTitle":"China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only","acronym":"PIONEER 11"},"statusModule":{"statusVerifiedDate":"2024-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-10-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-09-23","type":"ACTUAL"},"completionDateStruct":{"date":"2021-10-27","type":"ACTUAL"},"studyFirstSubmitDate":"2019-09-27","studyFirstSubmitQcDate":"2019-09-27","studyFirstPostDateStruct":{"date":"2019-09-30","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-09-21","resultsFirstSubmitQcDate":"2023-09-04","resultsFirstPostDateStruct":{"date":"2023-09-14","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-09-06","lastUpdatePostDateStruct":{"date":"2024-09-19","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and placebo (a dummy medicine). Researchers will test semaglutide to see how well it works compared to placebo. The study will also test if semaglutide is safe. Participants will either get semaglutide or placebo - which treatment is decided by chance. Participants will get 1 tablet a day to take with up to half a glass of water. Participants must take the tablet first thing in the morning on an empty stomach. After taking the tablet, participants must not eat or drink anything for at least 30 minutes. After the 30 minutes, participants can have their first meal of the day and take any other medicines they may need. The study will last for about 8 months (36 weeks). Participants will have 9 clinic visits and 2 phone calls with the study doctor. At all 9 of the clinic visits, participants will have blood samples taken. At 5 of the clinic visits, participants must arrive fasting. This means they cannot eat for 8 hours before the visit. It is fine to drink water up to 2 hours before the visit. This is for some of the blood samples that will be taken at the visit. Women cannot take part if pregnant, breastfeeding or planning to become pregnant during the study period."},"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":521,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Oral semaglutide 3mg","type":"EXPERIMENTAL","description":"Subjects will remain on 3 mg for the entire treatment period (26 weeks)","interventionNames":["Drug: Oral semaglutide"]},{"label":"Oral semaglutide 7mg","type":"EXPERIMENTAL","description":"Subjects will receive 3 mg for for the first 4 weeks, 7 mg for the remainder of the treatment period","interventionNames":["Drug: Oral semaglutide"]},{"label":"Oral semaglutide 14mg","type":"EXPERIMENTAL","description":"Subjects will receive 3 mg for the first 4 weeks, 7 mg for the next 4 weeks and 14 mg for the remainder of the treatment period","interventionNames":["Drug: Oral semaglutide"]},{"label":"Placebo (oral semaglutide)","type":"PLACEBO_COMPARATOR","description":"Subjects will receive placebo tablets for the entire treatment period","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Oral semaglutide","description":"Tablets to be taken once-daily for 26 weeks","armGroupLabels":["Oral semaglutide 14mg","Oral semaglutide 3mg","Oral semaglutide 7mg"]},{"type":"DRUG","name":"Placebo","description":"Tablets to be taken once-daily for 26 weeks","armGroupLabels":["Placebo (oral semaglutide)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Glycosylated Haemoglobin (HbA1c)","description":"Change from baseline (week 0) in HbA1c at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Baseline (Week 0), Week 26"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Body Weight (Kilograms [kg])","description":"Change from baseline (week 0) in body weight at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Fasting Plasma Glucose (FPG)","description":"Change from baseline (week 0) in FPG at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Fasting 7-point Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile","description":"Change from baseline (week 0) in mean 7-point SMPG profile at week 26 is presented. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Fasting 7-point Self-measured Plasma Glucose Profile: Mean Postprandial Increment (Over All Meals)","description":"Change from baseline (week 0) in fasting 7-point SMPG: Mean postprandial increment (over all meals) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Body Weight (Percentage [%])","description":"Change from baseline (week 0) in body weight (measured in kg) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Body Mass Index (BMI)","description":"Change from baseline (week 0) in BMI at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Waist Circumference","description":"Change from baseline (week 0) in waist circumference at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline)","description":"Change from baseline (week 0) in total cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)","description":"Change from baseline (week 0) in LDL cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)","description":"Change from baseline (week 0) in HDL cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Fasting Lipid Profile: Triglycerides (Ratio to Baseline)","description":"Change from baseline (week 0) in triglycerides (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey","description":"SF-36 v2.0 is a 36-item, patient-reported survey of patient health. SF-36 measures the participant's overall Health Related Quality of Life on 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) and two component summary scores (physical component summary and mental component summary). Range of score for domains and component summary scores : 1-100 (Higher scores indicated a better health state). Change form baseline in each domain, physical component summary score and mental component summary score at week 26 is presented. A positive change score indicates an improvement since baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Number of Participants Who Achieved HbA1c Less Than (<) 7.0 % (53 Millimoles Per Mole [mmol/Mol]) (American Diabetes Association (ADA) Target) (Yes/no)","description":"Number of participants who achieved HbA1c \\< 7.0 % (53 mmol/mol) (ADA target) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Week 26"},{"measure":"Number of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no)","description":"Number of participants who achieved HbA1c \\<= 6.5 percent (48 mmol/mol) (AACE target) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Week 26"},{"measure":"Number of Participants Who Achieved HbA1c Reduction Greater Than or Equal to (>=) 1 Percent (10.9 mmol/Mol) (Yes/no)","description":"Number of participants who achieved HbA1c reduction \\>= 1 percent (10.9 mmol/mol) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Week 26"},{"measure":"Number of Participants Who Achieved Body Weight Loss >= 3 Percent (Yes/no)","description":"Number of participants who achieved body weight loss \\>= 3 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Week 26"},{"measure":"Number of Participants Who Achieved Body Weight Loss >= 5 Percent (Yes/no)","description":"Number of participants who achieved body weight loss \\>= 5 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Week 26"},{"measure":"Number of Participants Who Achieved Body Weight Loss >= 10 Percent (Yes/no)","description":"Number of participants who achieved body weight loss \\>= 10 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Week 26"},{"measure":"Number of Participants Who Achieved HbA1c < 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or Blood Glucose [BG] Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no)","description":"Number of participants who achieved HbA1c \\< 7.0 percent (53 mmol/mol) without hypoglycaemia (treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes) and no body weight gain (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Week 26"},{"measure":"Number of Participants Who Achieved HbA1c Reduction >= 1% (10.9 mmol/Mol) and Body Weight Loss >= 3 Percent (Yes/no)","description":"Number of participants who achieved HbA1c reduction \\>= 1% (10.9 mmol/mol) and body weight loss \\>= 3% (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Week 26"},{"measure":"Time From First Dose to Initiation of Rescue Medication","description":"Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomization and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomization and before last day on trial product. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"From baseline (Week 0) to Week 26"},{"measure":"Semaglutide Plasma Concentrations","description":"Semaglutide plasma concentrations at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","timeFrame":"Week 26: post dose any time"},{"measure":"Change From Baseline in Haematology - Haematocrit (Ratio to Baseline)","description":"Change from baseline (week 0) in haematocrit (measured in %) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Haematology - Haemoglobin (Ratio to Baseline)","description":"Change from baseline (week 0) in haemoglobin (measured in millimoles per liter \\[mmol/L\\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Haematology - Leucocytes (Ratio to Baseline)","description":"Change from baseline (week 0) in leucocytes (measured in 10\\^9 per liter \\[10\\^9/L\\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Haematology - Thrombocytes (Ratio to Baseline)","description":"Change from baseline (week 0) in thrombocytes (measured in 10\\^9/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils","description":"Change from baseline (week 0) in basophils, eosinophils, lymphocytes, monocytes and neutrophils at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Biochemistry - Urea (Ratio to Baseline)","description":"Change from baseline (week 0) in urea (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Biochemistry - Creatinine (Ratio to Baseline)","description":"Change from baseline (week 0) in creatinine (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Biochemistry - Alanine Aminotransferase (Ratio to Baseline)","description":"Change from baseline (week 0) in alanine aminotransferase (measured in units per liter \\[U/L\\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Biochemistry - Aspartate Aminotransferase (Ratio to Baseline)","description":"Change from baseline (week 0) in aspartate aminotransferase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Biochemistry - Alkaline Phosphatase (Ratio to Baseline)","description":"Change from baseline (week 0) in alkaline phosphatase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Biochemistry - Total Bilirubin (Ratio to Baseline)","description":"Change from baseline (week 0) in total bilirubin (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Biochemistry - Amylase (Ratio to Baseline)","description":"Change from baseline (week 0) in amylase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Biochemistry - Lipase (Ratio to Baseline)","description":"Change from baseline (week 0) in lipase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Biochemistry - Creatine Kinase (Ratio to Baseline)","description":"Change from baseline (week 0) in creatine kinase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Calcium (Ratio to Baseline)","description":"Change from baseline (week 0) in calcium (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Potassium (Ratio to Baseline)","description":"Change from baseline (week 0) in potassium (measured in milliequivalents per liter \\[mEq/L\\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Sodium (Ratio to Baseline)","description":"Change from baseline (week 0) in sodium (measured in mEq/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Albumin (Ratio to Baseline)","description":"Change from baseline (week 0) in albumin (measured in g/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Calcitonin (Ratio to Baseline)","description":"Change from baseline (week 0) in calcitonin (measured in picograms per milliliter \\[pg/mL\\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Pulse Rate","description":"Change from baseline (week 0) in pulse rate at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Systolic Blood Pressure","description":"Change from baseline (week 0) in systolic blood pressure at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Diastolic Blood Pressure","description":"Change from baseline (week 0) in diastolic blood pressure at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Electrocardiogram (ECG) Category","description":"Change from baseline (week 0) in ECG category at week 26 is presented. Change from baseline results are presented as shift in findings categorized as: normal, abnormal and not clinically significant (NCS), and abnormal and clinically significant (CS). The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last dose of trial product plus 38 days or the end-date for the in-trial observation period.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Physical Examination Category","description":"Change from baseline (week 0) in physical examination category at week 26 is presented. The physical examination shift in findings were categorized as normal, abnormal NCS and abnormal CS and are presented for the following body systems: cardiovascular system; central and peripheral nervous system; gastrointestinal system, including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin; and thyroid gland. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Change From Baseline in Eye Examination Category","description":"Change from baseline (week 0) in eye examination category at week 26 is presented. Eye examination shift in findings were categorized as normal, abnormal NCS and abnormal CS. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period.","timeFrame":"Baseline (Week 0), Week 26"},{"measure":"Number of Treatment-emergent Adverse Events (TEAEs)","description":"An adverse event (AE) is any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. TEAE was defined as an AE with onset in the on-treatment observation period. On-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period.","timeFrame":"Up to 31 weeks"},{"measure":"Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes","description":"Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose (PG) value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period.","timeFrame":"Up to 31 weeks"},{"measure":"Number of Participants With Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes","description":"Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose (PG) value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period.","timeFrame":"Up to 31 weeks"},{"measure":"Anti-semaglutide Binding Antibody Levels","description":"Anti-semaglutide binding antibody levels measured anytime during post-baseline visits (week 0 to week 31) are presented. The outcome data are presented as percentage of bound radioactivity-labelled semaglutide/total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period - the in-trial observation period started at randomization and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact, and death for participants who died before any of the above.","timeFrame":"Up to 31 weeks"},{"measure":"Number of Participants With Anti-semaglutide Binding Antibodies","description":"Number of participants who had anti-semaglutide binding antibody levels anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period - the in-trial observation period started at randomization and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participants-investigator contact, and death for participants who died before any of the above.","timeFrame":"Up to 31 weeks"},{"measure":"Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1","description":"Number of participants who had anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period - the in-trial observation period started at randomization and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact, and death for participants who died before any of the above.","timeFrame":"Up to 31 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.\n* Male or female, age above or equal to 18 years at the time of signing informed consent.\n\nFor Algeria only: Male or female, age above or equal to 19 years at the time of signing the informed consent.\n\nFor Taiwan only: Male or female, age above or equal to 20 years at the time of signing the informed consent.\n\n* Diagnosed with type 2 diabetes mellitus\n* HbA1c between 7.0 -10.0% (53-86 mmol/mol) (both inclusive).\n\nExclusion Criteria:\n\n* \\- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an highly effective contraceptive method.\n* Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC). 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Council","city":"Ternopil","zip":"46002","country":"Ukraine","geoPoint":{"lat":49.55404,"lon":25.59067}},{"facility":"Zaporizhia Regional Clinical Endocrinology Dispensary","city":"Zaporizhia","zip":"69600","country":"Ukraine"}]},"referencesModule":{"references":[{"pmid":"38985162","type":"DERIVED","citation":"Wang W, Bain SC, Bian F, Chen R, Gabery S, Huang S, Jensen TB, Luo B, Yuan G, Ning G; PIONEER 11 investigators. Efficacy and safety of oral semaglutide monotherapy vs placebo in a predominantly Chinese population with type 2 diabetes (PIONEER 11): a double-blind, Phase IIIa, randomised trial. Diabetologia. 2024 Sep;67(9):1783-1799. doi: 10.1007/s00125-024-06142-3. Epub 2024 Jul 10."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com","url":"http://novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Total of 521 participants with type 2 diabetes mellitus treated with diet and exercise only were randomized 1:1:1:1 to receive once-daily blinded treatment for 26 weeks with oral semaglutide 3, 7 or 14 milligrams (mg), or with placebo. The trial included a 4-week run-in period, a treatment period of 26 weeks and a 5-week follow-up period.","recruitmentDetails":"The trial was conducted at 52 sites in 3 countries and Region China (China mainland and Taiwan) as follows: China mainland (37 sites), Taiwan (3 sites); Hungary (4 sites), Serbia (2 sites) and Ukraine (6 sites).","groups":[{"id":"FG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"FG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"FG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"FG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"130"},{"groupId":"FG001","numSubjects":"130"},{"groupId":"FG002","numSubjects":"130"},{"groupId":"FG003","numSubjects":"131"}]},{"type":"Treated","achievements":[{"groupId":"FG000","numSubjects":"130"},{"groupId":"FG001","numSubjects":"130"},{"groupId":"FG002","numSubjects":"129"},{"groupId":"FG003","numSubjects":"131"}]},{"type":"Full Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"130"},{"groupId":"FG001","numSubjects":"130"},{"groupId":"FG002","numSubjects":"130"},{"groupId":"FG003","numSubjects":"131"}]},{"type":"Safety Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"130"},{"groupId":"FG001","numSubjects":"130"},{"groupId":"FG002","numSubjects":"129"},{"groupId":"FG003","numSubjects":"131"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"126"},{"groupId":"FG001","numSubjects":"126"},{"groupId":"FG002","numSubjects":"124"},{"groupId":"FG003","numSubjects":"124"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"7"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"6"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set included all randomized participants.","groups":[{"id":"BG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"BG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"BG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"BG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"130"},{"groupId":"BG001","value":"130"},{"groupId":"BG002","value":"130"},{"groupId":"BG003","value":"131"},{"groupId":"BG004","value":"521"}]}],"measures":[{"title":"Age, 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The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"106"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.1","spread":"0.7"},{"groupId":"OG001","value":"-1.5","spread":"0.8"},{"groupId":"OG002","value":"-1.6","spread":"1.0"},{"groupId":"OG003","value":"-0.2","spread":"0.9"}]}]}],"analyses":[{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Unadjusted two-sided p-value for test of no difference from 0.","statisticalMethod":"MMRM","paramType":"Treatment difference","paramValue":"-1.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.8","ciUpperLimit":"-1.3"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Unadjusted two-sided p-value for test of no difference from 0.","statisticalMethod":"MMRM","paramType":"Treatment difference","paramValue":"-1.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.6","ciUpperLimit":"-1.2"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Unadjusted two-sided p-value for test of no difference from 0.","statisticalMethod":"MMRM","paramType":"Treatment difference","paramValue":"-1.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.2","ciUpperLimit":"-0.8"}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight (Kilograms [kg])","description":"Change from baseline (week 0) in body weight at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized 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 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"119"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"106"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.1","spread":"3.3"},{"groupId":"OG001","value":"-2.2","spread":"3.4"},{"groupId":"OG002","value":"-3.1","spread":"3.7"},{"groupId":"OG003","value":"-1.1","spread":"2.7"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Plasma Glucose (FPG)","description":"Change from baseline (week 0) in FPG at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"milligrams per deciliter (mg/dL)","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"118"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"104"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-19.07","spread":"32.44"},{"groupId":"OG001","value":"-32.28","spread":"27.95"},{"groupId":"OG002","value":"-32.50","spread":"24.91"},{"groupId":"OG003","value":"0.00","spread":"27.49"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting 7-point Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile","description":"Change from baseline (week 0) in mean 7-point SMPG profile at week 26 is presented. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"110"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"115"},{"groupId":"OG003","value":"104"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-29.4","spread":"29.3"},{"groupId":"OG001","value":"-43.0","spread":"36.1"},{"groupId":"OG002","value":"-44.5","spread":"36.9"},{"groupId":"OG003","value":"-10.3","spread":"37.5"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting 7-point Self-measured Plasma Glucose Profile: Mean Postprandial Increment (Over All Meals)","description":"Change from baseline (week 0) in fasting 7-point SMPG: Mean postprandial increment (over all meals) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"112"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"115"},{"groupId":"OG003","value":"104"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-14.5","spread":"34.2"},{"groupId":"OG001","value":"-20.0","spread":"39.9"},{"groupId":"OG002","value":"-27.9","spread":"40.6"},{"groupId":"OG003","value":"-6.7","spread":"35.6"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight (Percentage [%])","description":"Change from baseline (week 0) in body weight (measured in kg) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage change","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"119"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"106"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1","spread":"4"},{"groupId":"OG001","value":"-3","spread":"4"},{"groupId":"OG002","value":"-4","spread":"5"},{"groupId":"OG003","value":"-1","spread":"3"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Mass Index (BMI)","description":"Change from baseline (week 0) in BMI at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kilograms per square meter (kg/m^2)","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"119"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"106"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"1.2"},{"groupId":"OG001","value":"-0.8","spread":"1.2"},{"groupId":"OG002","value":"-1.1","spread":"1.3"},{"groupId":"OG003","value":"-0.4","spread":"0.9"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Waist Circumference","description":"Change from baseline (week 0) in waist circumference at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"centimetres (cm)","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"119"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"105"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.1","spread":"4.5"},{"groupId":"OG001","value":"-2.2","spread":"4.8"},{"groupId":"OG002","value":"-2.8","spread":"4.4"},{"groupId":"OG003","value":"-1.4","spread":"3.3"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline)","description":"Change from baseline (week 0) in total cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total cholesterol","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"119"},{"groupId":"OG002","value":"114"},{"groupId":"OG003","value":"104"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"14.75"},{"groupId":"OG001","value":"0.98","spread":"16.62"},{"groupId":"OG002","value":"0.94","spread":"19.92"},{"groupId":"OG003","value":"1.00","spread":"14.45"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)","description":"Change from baseline (week 0) in LDL cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of LDL cholesterol","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"119"},{"groupId":"OG002","value":"114"},{"groupId":"OG003","value":"102"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"29.65"},{"groupId":"OG001","value":"1.00","spread":"28.35"},{"groupId":"OG002","value":"0.94","spread":"31.12"},{"groupId":"OG003","value":"1.00","spread":"25.32"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)","description":"Change from baseline (week 0) in HDL cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HDL cholesterol","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"119"},{"groupId":"OG002","value":"114"},{"groupId":"OG003","value":"102"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.03","spread":"15.78"},{"groupId":"OG001","value":"1.02","spread":"15.41"},{"groupId":"OG002","value":"1.02","spread":"17.72"},{"groupId":"OG003","value":"1.04","spread":"14.61"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Lipid Profile: Triglycerides (Ratio to Baseline)","description":"Change from baseline (week 0) in triglycerides (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of triglycerides","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"119"},{"groupId":"OG002","value":"114"},{"groupId":"OG003","value":"102"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"45.32"},{"groupId":"OG001","value":"0.90","spread":"45.56"},{"groupId":"OG002","value":"0.87","spread":"51.82"},{"groupId":"OG003","value":"0.93","spread":"49.08"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey","description":"SF-36 v2.0 is a 36-item, patient-reported survey of patient health. SF-36 measures the participant's overall Health Related Quality of Life on 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) and two component summary scores (physical component summary and mental component summary). Range of score for domains and component summary scores : 1-100 (Higher scores indicated a better health state). Change form baseline in each domain, physical component summary score and mental component summary score at week 26 is presented. A positive change score indicates an improvement since baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a score","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"119"},{"groupId":"OG002","value":"115"},{"groupId":"OG003","value":"106"}]}],"classes":[{"title":"Physical functioning","categories":[{"measurements":[{"groupId":"OG000","value":"0.25","spread":"4.83"},{"groupId":"OG001","value":"0.97","spread":"5.16"},{"groupId":"OG002","value":"0.34","spread":"4.24"},{"groupId":"OG003","value":"0.87","spread":"4.98"}]}]},{"title":"Role physical","categories":[{"measurements":[{"groupId":"OG000","value":"0.34","spread":"5.70"},{"groupId":"OG001","value":"0.43","spread":"5.83"},{"groupId":"OG002","value":"-0.00","spread":"5.02"},{"groupId":"OG003","value":"0.33","spread":"7.50"}]}]},{"title":"Bodily pain","categories":[{"measurements":[{"groupId":"OG000","value":"0.11","spread":"8.72"},{"groupId":"OG001","value":"-0.86","spread":"8.19"},{"groupId":"OG002","value":"-0.34","spread":"6.56"},{"groupId":"OG003","value":"0.49","spread":"8.40"}]}]},{"title":"General health","categories":[{"measurements":[{"groupId":"OG000","value":"2.01","spread":"7.14"},{"groupId":"OG001","value":"2.51","spread":"7.52"},{"groupId":"OG002","value":"1.32","spread":"8.61"},{"groupId":"OG003","value":"1.17","spread":"5.91"}]}]},{"title":"Vitality","categories":[{"measurements":[{"groupId":"OG000","value":"1.23","spread":"7.62"},{"groupId":"OG001","value":"-0.23","spread":"6.96"},{"groupId":"OG002","value":"0.54","spread":"8.02"},{"groupId":"OG003","value":"0.49","spread":"6.35"}]}]},{"title":"Social functioning","categories":[{"measurements":[{"groupId":"OG000","value":"0.22","spread":"6.26"},{"groupId":"OG001","value":"0.25","spread":"7.22"},{"groupId":"OG002","value":"-0.60","spread":"6.18"},{"groupId":"OG003","value":"0.98","spread":"7.04"}]}]},{"title":"Role emotional","categories":[{"measurements":[{"groupId":"OG000","value":"0.46","spread":"6.94"},{"groupId":"OG001","value":"0.58","spread":"8.34"},{"groupId":"OG002","value":"0.33","spread":"7.03"},{"groupId":"OG003","value":"-0.04","spread":"9.03"}]}]},{"title":"Mental health","categories":[{"measurements":[{"groupId":"OG000","value":"0.22","spread":"7.59"},{"groupId":"OG001","value":"-0.38","spread":"7.96"},{"groupId":"OG002","value":"-0.30","spread":"7.78"},{"groupId":"OG003","value":"0.05","spread":"6.99"}]}]},{"title":"Physical component score","categories":[{"measurements":[{"groupId":"OG000","value":"0.66","spread":"5.21"},{"groupId":"OG001","value":"0.88","spread":"4.98"},{"groupId":"OG002","value":"0.39","spread":"4.60"},{"groupId":"OG003","value":"0.94","spread":"4.71"}]}]},{"title":"Mental component score","categories":[{"measurements":[{"groupId":"OG000","value":"0.51","spread":"6.86"},{"groupId":"OG001","value":"-0.15","spread":"7.65"},{"groupId":"OG002","value":"-0.10","spread":"6.44"},{"groupId":"OG003","value":"0.08","spread":"6.88"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Achieved HbA1c Less Than (<) 7.0 % (53 Millimoles Per Mole [mmol/Mol]) (American Diabetes Association (ADA) Target) (Yes/no)","description":"Number of participants who achieved HbA1c \\< 7.0 % (53 mmol/mol) (ADA target) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"106"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"100"},{"groupId":"OG002","value":"92"},{"groupId":"OG003","value":"27"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"17"},{"groupId":"OG002","value":"24"},{"groupId":"OG003","value":"79"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no)","description":"Number of participants who achieved HbA1c \\<= 6.5 percent (48 mmol/mol) (AACE target) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"106"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"76"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"12"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"41"},{"groupId":"OG002","value":"40"},{"groupId":"OG003","value":"94"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Achieved HbA1c Reduction Greater Than or Equal to (>=) 1 Percent (10.9 mmol/Mol) (Yes/no)","description":"Number of participants who achieved HbA1c reduction \\>= 1 percent (10.9 mmol/mol) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"106"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"89"},{"groupId":"OG002","value":"87"},{"groupId":"OG003","value":"19"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"28"},{"groupId":"OG002","value":"29"},{"groupId":"OG003","value":"87"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Achieved Body Weight Loss >= 3 Percent (Yes/no)","description":"Number of participants who achieved body weight loss \\>= 3 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"106"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"49"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"28"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"81"},{"groupId":"OG001","value":"68"},{"groupId":"OG002","value":"54"},{"groupId":"OG003","value":"78"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Achieved Body Weight Loss >= 5 Percent (Yes/no)","description":"Number of participants who achieved body weight loss \\>= 5 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"119"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"106"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"29"},{"groupId":"OG002","value":"43"},{"groupId":"OG003","value":"11"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"98"},{"groupId":"OG001","value":"90"},{"groupId":"OG002","value":"73"},{"groupId":"OG003","value":"95"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Achieved Body Weight Loss >= 10 Percent (Yes/no)","description":"Number of participants who achieved body weight loss \\>= 10 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"119"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"106"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"0"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"110"},{"groupId":"OG001","value":"112"},{"groupId":"OG002","value":"104"},{"groupId":"OG003","value":"106"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Achieved HbA1c < 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or Blood Glucose [BG] Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no)","description":"Number of participants who achieved HbA1c \\< 7.0 percent (53 mmol/mol) without hypoglycaemia (treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes) and no body weight gain (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"106"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"80"},{"groupId":"OG002","value":"84"},{"groupId":"OG003","value":"19"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"32"},{"groupId":"OG003","value":"87"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Achieved HbA1c Reduction >= 1% (10.9 mmol/Mol) and Body Weight Loss >= 3 Percent (Yes/no)","description":"Number of participants who achieved HbA1c reduction \\>= 1% (10.9 mmol/mol) and body weight loss \\>= 3% (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"106"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"53"},{"groupId":"OG003","value":"10"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"63"},{"groupId":"OG003","value":"96"}]}]}]},{"type":"SECONDARY","title":"Time From First Dose to Initiation of Rescue Medication","description":"Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomization and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomization and before last day on trial product. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"Days","timeFrame":"From baseline (Week 0) to Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Median days to event could not be calculated because less than 50% of participants experienced the event. Hence the days are reported as Not available (NA)."},{"groupId":"OG001","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Median days to event could not be calculated because less than 50% of participants experienced the event. Hence the days are reported as NA."},{"groupId":"OG003","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Median days to event could not be calculated because less than 50% of participants experienced the event. Hence the days are reported as NA."}]}]}]},{"type":"SECONDARY","title":"Semaglutide Plasma Concentrations","description":"Semaglutide plasma concentrations at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.","populationDescription":"Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanomoles per liter (nmol/L)","timeFrame":"Week 26: post dose any time","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"88"},{"groupId":"OG002","value":"79"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.36","spread":"103.74"},{"groupId":"OG001","value":"11.22","spread":"106.34"},{"groupId":"OG002","value":"17.71","spread":"232.82"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Haematology - Haematocrit (Ratio to Baseline)","description":"Change from baseline (week 0) in haematocrit (measured in %) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of haematocrit","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"118"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"7.14"},{"groupId":"OG001","value":"1.00","spread":"8.10"},{"groupId":"OG002","value":"1.00","spread":"6.15"},{"groupId":"OG003","value":"1.00","spread":"14.42"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Haematology - Haemoglobin (Ratio to Baseline)","description":"Change from baseline (week 0) in haemoglobin (measured in millimoles per liter \\[mmol/L\\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of haemoglobin","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"118"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.01","spread":"6.00"},{"groupId":"OG001","value":"1.00","spread":"6.82"},{"groupId":"OG002","value":"1.00","spread":"6.17"},{"groupId":"OG003","value":"1.00","spread":"7.50"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Haematology - Leucocytes (Ratio to Baseline)","description":"Change from baseline (week 0) in leucocytes (measured in 10\\^9 per liter \\[10\\^9/L\\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of leucocytes","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"118"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.03","spread":"18.79"},{"groupId":"OG001","value":"1.01","spread":"22.23"},{"groupId":"OG002","value":"1.04","spread":"22.60"},{"groupId":"OG003","value":"1.03","spread":"20.80"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Haematology - Thrombocytes (Ratio to Baseline)","description":"Change from baseline (week 0) in thrombocytes (measured in 10\\^9/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of thrombocytes","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"118"},{"groupId":"OG001","value":"115"},{"groupId":"OG002","value":"114"},{"groupId":"OG003","value":"118"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.03","spread":"23.24"},{"groupId":"OG001","value":"1.01","spread":"17.69"},{"groupId":"OG002","value":"1.04","spread":"17.55"},{"groupId":"OG003","value":"1.02","spread":"19.98"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils","description":"Change from baseline (week 0) in basophils, eosinophils, lymphocytes, monocytes and neutrophils at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"10^9 cells per liters (10^9 cells/L)","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"118"}]}],"classes":[{"title":"Basophils","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.06"},{"groupId":"OG001","value":"-0.01","spread":"0.06"},{"groupId":"OG002","value":"-0.01","spread":"0.06"},{"groupId":"OG003","value":"-0.01","spread":"0.07"}]}]},{"title":"Eosinophils","categories":[{"measurements":[{"groupId":"OG000","value":"0.01","spread":"0.10"},{"groupId":"OG001","value":"0.02","spread":"0.10"},{"groupId":"OG002","value":"0.02","spread":"0.12"},{"groupId":"OG003","value":"0.01","spread":"0.08"}]}]},{"title":"Lymphocytes","categories":[{"measurements":[{"groupId":"OG000","value":"0.05","spread":"0.43"},{"groupId":"OG001","value":"-0.03","spread":"0.49"},{"groupId":"OG002","value":"-0.09","spread":"0.49"},{"groupId":"OG003","value":"0.02","spread":"0.46"}]}]},{"title":"Monocytes","categories":[{"measurements":[{"groupId":"OG000","value":"0.01","spread":"0.12"},{"groupId":"OG001","value":"-0.00","spread":"0.16"},{"groupId":"OG002","value":"0.01","spread":"0.16"},{"groupId":"OG003","value":"0.01","spread":"0.15"}]}]},{"title":"Neutrophils","categories":[{"measurements":[{"groupId":"OG000","value":"0.18","spread":"0.98"},{"groupId":"OG001","value":"0.06","spread":"1.44"},{"groupId":"OG002","value":"0.28","spread":"1.19"},{"groupId":"OG003","value":"0.21","spread":"1.14"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Biochemistry - Urea (Ratio to Baseline)","description":"Change from baseline (week 0) in urea (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of urea","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"122"},{"groupId":"OG002","value":"114"},{"groupId":"OG003","value":"119"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"21.23"},{"groupId":"OG001","value":"1.00","spread":"24.90"},{"groupId":"OG002","value":"1.02","spread":"23.12"},{"groupId":"OG003","value":"1.07","spread":"23.97"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Biochemistry - Creatinine (Ratio to Baseline)","description":"Change from baseline (week 0) in creatinine (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of creatinine","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"122"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"119"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.03","spread":"10.39"},{"groupId":"OG001","value":"1.02","spread":"13.25"},{"groupId":"OG002","value":"1.03","spread":"11.50"},{"groupId":"OG003","value":"0.99","spread":"11.49"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Biochemistry - Alanine Aminotransferase (Ratio to Baseline)","description":"Change from baseline (week 0) in alanine aminotransferase (measured in units per liter \\[U/L\\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of alanine aminotransferase","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"122"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"118"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.88","spread":"44.27"},{"groupId":"OG001","value":"0.89","spread":"45.23"},{"groupId":"OG002","value":"0.85","spread":"47.44"},{"groupId":"OG003","value":"0.88","spread":"42.72"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Biochemistry - Aspartate Aminotransferase (Ratio to Baseline)","description":"Change from baseline (week 0) in aspartate aminotransferase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of aspartate aminotransferase","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"120"},{"groupId":"OG002","value":"111"},{"groupId":"OG003","value":"116"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.91","spread":"30.50"},{"groupId":"OG001","value":"0.91","spread":"34.42"},{"groupId":"OG002","value":"0.90","spread":"35.09"},{"groupId":"OG003","value":"0.89","spread":"38.14"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Biochemistry - Alkaline Phosphatase (Ratio to Baseline)","description":"Change from baseline (week 0) in alkaline phosphatase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of alkaline phosphatase","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"122"},{"groupId":"OG002","value":"114"},{"groupId":"OG003","value":"119"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.94","spread":"15.14"},{"groupId":"OG001","value":"0.92","spread":"20.54"},{"groupId":"OG002","value":"0.95","spread":"17.83"},{"groupId":"OG003","value":"0.95","spread":"13.83"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Biochemistry - Total Bilirubin (Ratio to Baseline)","description":"Change from baseline (week 0) in total bilirubin (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total bilirubin","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"122"},{"groupId":"OG002","value":"114"},{"groupId":"OG003","value":"117"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.89","spread":"34.97"},{"groupId":"OG001","value":"0.84","spread":"32.62"},{"groupId":"OG002","value":"0.85","spread":"41.55"},{"groupId":"OG003","value":"0.95","spread":"39.68"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Biochemistry - Amylase (Ratio to Baseline)","description":"Change from baseline (week 0) in amylase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of amylase","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"122"},{"groupId":"OG002","value":"114"},{"groupId":"OG003","value":"119"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.09","spread":"23.53"},{"groupId":"OG001","value":"1.20","spread":"27.17"},{"groupId":"OG002","value":"1.11","spread":"21.64"},{"groupId":"OG003","value":"1.05","spread":"26.52"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Biochemistry - Lipase (Ratio to Baseline)","description":"Change from baseline (week 0) in lipase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of lipase","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"122"},{"groupId":"OG002","value":"114"},{"groupId":"OG003","value":"119"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.24","spread":"43.99"},{"groupId":"OG001","value":"1.60","spread":"55.40"},{"groupId":"OG002","value":"1.35","spread":"51.48"},{"groupId":"OG003","value":"1.05","spread":"32.22"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Biochemistry - Creatine Kinase (Ratio to Baseline)","description":"Change from baseline (week 0) in creatine kinase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of creatine kinase","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"122"},{"groupId":"OG002","value":"114"},{"groupId":"OG003","value":"118"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.06","spread":"67.51"},{"groupId":"OG001","value":"0.96","spread":"48.18"},{"groupId":"OG002","value":"1.00","spread":"46.25"},{"groupId":"OG003","value":"0.93","spread":"58.87"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Calcium (Ratio to Baseline)","description":"Change from baseline (week 0) in calcium (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of calcium","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"122"},{"groupId":"OG002","value":"114"},{"groupId":"OG003","value":"119"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.98","spread":"6.66"},{"groupId":"OG001","value":"0.97","spread":"4.87"},{"groupId":"OG002","value":"0.98","spread":"4.52"},{"groupId":"OG003","value":"0.97","spread":"3.79"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Potassium (Ratio to Baseline)","description":"Change from baseline (week 0) in potassium (measured in milliequivalents per liter \\[mEq/L\\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of potassium","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"121"},{"groupId":"OG002","value":"114"},{"groupId":"OG003","value":"118"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"9.73"},{"groupId":"OG001","value":"1.01","spread":"8.96"},{"groupId":"OG002","value":"1.00","spread":"9.94"},{"groupId":"OG003","value":"1.01","spread":"9.98"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Sodium (Ratio to Baseline)","description":"Change from baseline (week 0) in sodium (measured in mEq/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of sodium","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"122"},{"groupId":"OG002","value":"114"},{"groupId":"OG003","value":"118"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"1.49"},{"groupId":"OG001","value":"1.00","spread":"1.46"},{"groupId":"OG002","value":"1.00","spread":"1.42"},{"groupId":"OG003","value":"1.00","spread":"1.32"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Albumin (Ratio to Baseline)","description":"Change from baseline (week 0) in albumin (measured in g/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of albumin","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"122"},{"groupId":"OG002","value":"114"},{"groupId":"OG003","value":"119"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"4.07"},{"groupId":"OG001","value":"0.99","spread":"4.73"},{"groupId":"OG002","value":"0.99","spread":"4.41"},{"groupId":"OG003","value":"0.99","spread":"3.95"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Calcitonin (Ratio to Baseline)","description":"Change from baseline (week 0) in calcitonin (measured in picograms per milliliter \\[pg/mL\\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of calcitonin","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"119"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"118"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.01","spread":"23.53"},{"groupId":"OG001","value":"1.09","spread":"39.69"},{"groupId":"OG002","value":"1.15","spread":"42.68"},{"groupId":"OG003","value":"0.98","spread":"46.93"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Pulse Rate","description":"Change from baseline (week 0) in pulse rate at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. 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 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"122"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"121"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2","spread":"9"},{"groupId":"OG001","value":"4","spread":"9"},{"groupId":"OG002","value":"5","spread":"9"},{"groupId":"OG003","value":"1","spread":"9"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Systolic Blood Pressure","description":"Change from baseline (week 0) in systolic blood pressure at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimeters of mercury (mmHg)","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"122"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"121"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1","spread":"13"},{"groupId":"OG001","value":"-2","spread":"12"},{"groupId":"OG002","value":"-4","spread":"13"},{"groupId":"OG003","value":"-2","spread":"13"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Diastolic Blood Pressure","description":"Change from baseline (week 0) in diastolic blood pressure at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. 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 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"122"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"121"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"9"},{"groupId":"OG001","value":"-1","spread":"8"},{"groupId":"OG002","value":"-2","spread":"9"},{"groupId":"OG003","value":"-2","spread":"9"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Electrocardiogram (ECG) Category","description":"Change from baseline (week 0) in ECG category at week 26 is presented. Change from baseline results are presented as shift in findings categorized as: normal, abnormal and not clinically significant (NCS), and abnormal and clinically significant (CS). The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last dose of trial product plus 38 days or the end-date for the in-trial observation period.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. 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Abnormal CS (week 0) to normal (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}],"categories":[{"measurements":[{"groupId":"OG003","value":"0"}]}]},{"title":"Cardiovascular system - Abnormal CS (week 0) to abnormal NCS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}],"categories":[{"measurements":[{"groupId":"OG003","value":"0"}]}]},{"title":"Cardiovascular system - Abnormal CS (week 0) to abnormal CS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}],"categories":[{"measurements":[{"groupId":"OG003","value":"1"}]}]},{"title":"Central and Peripheral Nervous System - Normal (week 0) to normal (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"121"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"120"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"121"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"120"}]}]},{"title":"Central and Peripheral Nervous System - Normal (week 0) to abnormal NCS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"121"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"120"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Central and Peripheral Nervous System - Normal (week 0) to abnormal CS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"121"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"120"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Central and Peripheral Nervous System - Abnormal NCS (week 0) to normal (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Central and Peripheral Nervous System - Abnormal NCS (week 0) to abnormal NCS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG003","value":"1"}]}]},{"title":"Central and Peripheral Nervous System - Abnormal NCS (week 0) to abnormal CS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Central and Peripheral Nervous System - Abnormal CS (week 0) to normal (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"0"}]}]},{"title":"Central and Peripheral Nervous System - 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Mouth - Normal (week 0) to normal (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"118"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"114"},{"groupId":"OG003","value":"115"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"114"},{"groupId":"OG003","value":"115"}]}]},{"title":"Gastrointestinal System incl. Mouth - Normal (week 0) to abnormal NCS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"118"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"114"},{"groupId":"OG003","value":"115"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Gastrointestinal System incl. Mouth - Normal (week 0) to abnormal CS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"118"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"114"},{"groupId":"OG003","value":"115"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to normal (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"5"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Gastrointestinal System incl. 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Abnormal CS (week 0) to abnormal NCS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}],"categories":[{"measurements":[{"groupId":"OG003","value":"0"}]}]},{"title":"Thyroid Gland - Abnormal CS (week 0) to abnormal CS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}],"categories":[{"measurements":[{"groupId":"OG003","value":"1"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Eye Examination Category","description":"Change from baseline (week 0) in eye examination category at week 26 is presented. Eye examination shift in findings were categorized as normal, abnormal NCS and abnormal CS. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure and Number Analyzed = number of participants with available data for each specified category.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline (Week 0), Week 26","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"121"},{"groupId":"OG002","value":"119"},{"groupId":"OG003","value":"121"}]}],"classes":[{"title":"Left Eye Ophthalmoscopy - Normal (week 0) to normal (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"81"},{"groupId":"OG001","value":"86"},{"groupId":"OG002","value":"90"},{"groupId":"OG003","value":"85"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"83"},{"groupId":"OG003","value":"75"}]}]},{"title":"Left Eye Ophthalmoscopy - Normal (week 0) to abnormal NCS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"81"},{"groupId":"OG001","value":"86"},{"groupId":"OG002","value":"90"},{"groupId":"OG003","value":"85"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"5"}]}]},{"title":"Left Eye Ophthalmoscopy - Normal (week 0) to abnormal CS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"81"},{"groupId":"OG001","value":"86"},{"groupId":"OG002","value":"90"},{"groupId":"OG003","value":"85"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"5"}]}]},{"title":"Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to normal (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"23"},{"groupId":"OG002","value":"17"},{"groupId":"OG003","value":"20"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"}]}]},{"title":"Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal NCS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"23"},{"groupId":"OG002","value":"17"},{"groupId":"OG003","value":"20"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"19"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"18"}]}]},{"title":"Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal CS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"23"},{"groupId":"OG002","value":"17"},{"groupId":"OG003","value":"20"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}]},{"title":"Left Eye Ophthalmoscopy - Abnormal CS (week 0) to normal (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"16"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"7"}]}]},{"title":"Left Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal NCS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"16"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Left Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal CS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"16"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"9"}]}]},{"title":"Right Eye Ophthalmoscopy - Normal (week 0) to normal (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"85"},{"groupId":"OG001","value":"86"},{"groupId":"OG002","value":"89"},{"groupId":"OG003","value":"82"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"76"},{"groupId":"OG002","value":"82"},{"groupId":"OG003","value":"74"}]}]},{"title":"Right Eye Ophthalmoscopy - Normal (week 0) to abnormal NCS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"85"},{"groupId":"OG001","value":"86"},{"groupId":"OG002","value":"89"},{"groupId":"OG003","value":"82"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"5"}]}]},{"title":"Right Eye Ophthalmoscopy - Normal (week 0) to abnormal CS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"85"},{"groupId":"OG001","value":"86"},{"groupId":"OG002","value":"89"},{"groupId":"OG003","value":"82"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"}]}]},{"title":"Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to normal (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"19"},{"groupId":"OG003","value":"22"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"}]}]},{"title":"Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal NCS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"19"},{"groupId":"OG003","value":"22"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"19"}]}]},{"title":"Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal CS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"19"},{"groupId":"OG003","value":"22"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}]},{"title":"Right Eye Ophthalmoscopy - Abnormal CS (week 0) to normal (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"17"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"8"}]}]},{"title":"Right Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal NCS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"17"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}]},{"title":"Right Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal CS (week 26)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"17"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"9"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Adverse Events (TEAEs)","description":"An adverse event (AE) is any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. TEAE was defined as an AE with onset in the on-treatment observation period. On-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"Up to 31 weeks","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"130"},{"groupId":"OG001","value":"130"},{"groupId":"OG002","value":"129"},{"groupId":"OG003","value":"131"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"292"},{"groupId":"OG002","value":"231"},{"groupId":"OG003","value":"212"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes","description":"Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose (PG) value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"Up to 31 weeks","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"130"},{"groupId":"OG001","value":"130"},{"groupId":"OG002","value":"129"},{"groupId":"OG003","value":"131"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes","description":"Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose (PG) value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Up to 31 weeks","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."},{"id":"OG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"130"},{"groupId":"OG001","value":"130"},{"groupId":"OG002","value":"129"},{"groupId":"OG003","value":"131"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}]},{"type":"SECONDARY","title":"Anti-semaglutide Binding Antibody Levels","description":"Anti-semaglutide binding antibody levels measured anytime during post-baseline visits (week 0 to week 31) are presented. The outcome data are presented as percentage of bound radioactivity-labelled semaglutide/total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period - the in-trial observation period started at randomization and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact, and death for participants who died before any of the above.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"%B/T","timeFrame":"Up to 31 weeks","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG001","value":"2.1"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Anti-semaglutide Binding Antibodies","description":"Number of participants who had anti-semaglutide binding antibody levels anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period - the in-trial observation period started at randomization and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participants-investigator contact, and death for participants who died before any of the above.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Up to 31 weeks","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"91"},{"groupId":"OG001","value":"93"},{"groupId":"OG002","value":"85"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1","description":"Number of participants who had anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period - the in-trial observation period started at randomization and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact, and death for participants who died before any of the above.","populationDescription":"Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Up to 31 weeks","groups":[{"id":"OG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26."},{"id":"OG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26."},{"id":"OG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"91"},{"groupId":"OG001","value":"93"},{"groupId":"OG002","value":"85"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From week 0 to week 31","description":"All presented adverse events (AEs) are treatment-emergent (i.e., TEAEs). TEAE was defined as an AE with onset in the on-treatment observation period.\n\nResults are based on the safety analysis set (SAS) which included all participants exposed to at least one dose of trial product.","eventGroups":[{"id":"EG000","title":"Oral Semaglutide 3 mg","description":"Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26.","deathsNumAffected":0,"deathsNumAtRisk":130,"seriousNumAffected":6,"seriousNumAtRisk":130,"otherNumAffected":30,"otherNumAtRisk":130},{"id":"EG001","title":"Oral Semaglutide 7 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26.","deathsNumAffected":0,"deathsNumAtRisk":130,"seriousNumAffected":10,"seriousNumAtRisk":130,"otherNumAffected":47,"otherNumAtRisk":130},{"id":"EG002","title":"Oral Semaglutide 14 mg","description":"Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.","deathsNumAffected":0,"deathsNumAtRisk":129,"seriousNumAffected":5,"seriousNumAtRisk":129,"otherNumAffected":40,"otherNumAtRisk":129},{"id":"EG003","title":"Placebo","description":"Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26.","deathsNumAffected":0,"deathsNumAtRisk":131,"seriousNumAffected":2,"seriousNumAtRisk":131,"otherNumAffected":16,"otherNumAtRisk":131}],"seriousEvents":[{"term":"Angina unstable","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":130},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":130},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":129},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":131}]},{"term":"Asthma","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":130},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":130},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":129},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":131}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":130},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":130},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":129},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":131}]},{"term":"COVID-19 pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":130},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":130},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":129},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":131}]},{"term":"Cataract","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":130},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":130},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":129},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":131}]},{"term":"Cholecystitis acute","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 24","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":130},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":130},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":129},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":131}]},{"term":"Cholelithiasis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 24","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":130},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":130},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":129},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":131}]},{"term":"Dermal cyst","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":130},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":130},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":129},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":131}]},{"term":"Epilepsy","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 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