{"protocolSection":{"identificationModule":{"nctId":"NCT03819153","orgStudyIdInfo":{"id":"NN9535-4321"},"secondaryIdInfos":[{"id":"U1111-1217-6259","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"2018-002878-50","type":"REGISTRY","domain":"European Medicines Agency (EudraCT)"},{"id":"JapicCTI-194843","type":"REGISTRY","domain":"JAPIC (Japan)"},{"id":"2018","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2018"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease","officialTitle":"Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease","acronym":"FLOW"},"statusModule":{"statusVerifiedDate":"2025-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-06-17","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-01-09","type":"ACTUAL"},"completionDateStruct":{"date":"2024-01-09","type":"ACTUAL"},"studyFirstSubmitDate":"2019-01-18","studyFirstSubmitQcDate":"2019-01-25","studyFirstPostDateStruct":{"date":"2019-01-28","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-01-05","resultsFirstSubmitQcDate":"2025-03-13","resultsFirstPostDateStruct":{"date":"2025-03-20","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-03-13","lastUpdatePostDateStruct":{"date":"2025-03-20","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The researchers are doing this study to see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes. Participants will get semaglutide (active medicine) or placebo ('dummy medicine'). This is known as participants' study medicine - which treatment participants get is decided by chance. Semaglutide is a medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes. Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine in a skin fold once a week. The study will close when there is enough information collected to show clear result of the study. The total time participants will be in this study is about 3 to 5 years, but it could be longer."},"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":3533,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide","type":"EXPERIMENTAL","description":"Participants are to receive semglutide for up to 5 years or more (event driven). The trial is event driven with a pre-defined minimum number of renal endpoint events for the primary endpoint.","interventionNames":["Drug: Semaglutide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants are to receive placebo (semglutide) for up to 5 years or more (event driven). The trial is event driven with a pre-defined minimum number of renal endpoint events for the primary endpoint.","interventionNames":["Drug: Placebo (semaglutide)"]}],"interventions":[{"type":"DRUG","name":"Semaglutide","description":"Participants are to inject semaglutide with a needle in the stomach, thigh or upper arm. Participants will use a pen to inject semaglutide under their skin. Participants will inject semaglutide 1 time a week on the same day of the week. Participants' dose of semaglutide will be changed over time. Participants start by taking a smaller amount (0.25 mg). After 4 weeks the dose will be increased to 0.5 mg. It will be increased more (to 1 mg) at 8 weeks. Participants will then stay on the same dose for the rest of the study.","armGroupLabels":["Semaglutide"]},{"type":"DRUG","name":"Placebo (semaglutide)","description":"Participants are to inject placebo (semaglutide) with a needle in the stomach, thigh or upper arm. Participants will use a pen to inject placebo (semaglutide) under their skin. Participants will inject placebo (semaglutide) 1 time a week on the same day of the week. Participants' dose of placebo (semaglutide) will be changed over time. Participants start by taking a smaller amount (0.25 mg). After 4 weeks the dose will be increased to 0.5 mg. It will be increased more (to 1 mg) at 8 weeks. Participants will then stay on the same dose for the rest of the study.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV Death","description":"Number of participants with first composite renal event i.e., from time of randomization to first occurrence of an onset of persistent greater than or equal to (≥) 50 percent (%) reduction in estimated glomerular filtration rate (eGFR) (chronic kidney disease - epidemiology collaboration \\[CKD-EPI\\]), onset of persistent eGFR (CKD-EPI) \\<15 milliliter per minute per 1.73 meter square (mL/min/1.73m\\^2), initiation of chronic renal replacement therapy (dialysis or kidney transplantation), renal death, and cardiovascular (CV) death combined data were reported in this outcome measure.","timeFrame":"From Week 0 up to Week 234"}],"secondaryOutcomes":[{"measure":"Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope)","description":"Annual rate of change in Total eGFR slope CKD-EPI were reported from baseline at Week 234 in-trial period. eGFR was calculated using the CKD-EPI formula. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From Week 0 up to Week 234"},{"measure":"Number of Participants From Time of Randomization to Occurrence of Onset of Persistent ≥50% Reduction in eGFR (CKD-EPI)","description":"Number of participants from time of randomization to time to occurrence of onset of persistent ≥50% reduction in eGFR (CKD-EPI) were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From Week 0 up to Week 234"},{"measure":"Number of Participants From Time of Randomization to Occurrence of Onset of Persistent eGFR (CKD-EPI) <15mL/Min/1.73m^2","description":"Number of participants from time of randomization to time to occurrence of onset of persistent eGFR (CKD-EPI) \\<15 mL/min/1.73m\\^2 were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From Week 0 up to Week 234"},{"measure":"Number of Participants From Time of Randomization to Occurrence of Initiation of Chronic Renal Replacement Therapy","description":"Number of participants from time of randomization to time to occurrence of initiation of chronic renal replacement therapy (dialysis or kidney transplantation) were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From Week 0 up to Week 234"},{"measure":"Number of Participants From Time of Randomization to Occurrence of Renal Death","description":"Number of participants from time of randomization to time to occurrence of renal death were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From Week 0 up to Week 234"},{"measure":"Number of Participants From Time of Randomization to Occurrence of CV Death","description":"Number of participants from time of randomization to time to occurrence of CV death were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From Week 0 up to Week 234"},{"measure":"Annual Rate of Change in eGFR (Chronic Kidney Disease CKD-EPI) (Chronic eGFR Slope)","description":"Annual rate of change in eGFR in terms of chronic kidney disease CKD-EPI were reported from Week 12 to Week 234 in-trial period. eGFR was calculated using the CKD-EPI formula. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"Week 12, Week 234"},{"measure":"Change From Baseline in eGFR (CKD-EPI) at Week 12","description":"Change from baseline in eGFR at Week 12 during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"Baseline (Week 0), Week 12"},{"measure":"Change From Baseline in eGFR (Cystatin C CKD-EPI) at Week 104","description":"Changes from baseline in eGFR (cystatin C) at Week 104 in-trial period were reported. Cystatin C was calculated using the CKD-EPI formula. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"Baseline (Week 0), Week 104"},{"measure":"Change From Baseline in Urinary Albumin-to-creatinine Ratio (UACR) at Week 104: Ratio to Baseline","description":"Change from baseline in UACR (ratio to baseline) at Week 104 in-trial period were reported. For UACR, the baseline assessment is defined as the mean of the two assessments from the randomization visit. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"Baseline (Week 0), Week 104"},{"measure":"Number of Participants From Time of Randomization to Time to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Acute Myocardial Infarction (Non Fatal); Non-fatal Stroke; and CV Death","description":"Number of participants who reported first occurence of non-fatal acute myocardial infarction, non-fatal stroke, and CV death combined data were presented from Week 0 up to Week 234 during on-treatment period. MACE consisted of non-fatal acute myocardial infarction, cardiovascular death and non-fatal stroke. First on-treatment period is defined as period from date of first dose until first time where no dose had been administered within 5 weeks (35 days) or end of the in-trial period, whichever came first.","timeFrame":"From Week 0 up to Week 234"},{"measure":"Number of Participants From Time of Randomization to Time to Occurrence of All-cause Death","description":"Number of participants who reported occurence of deaths from Week 0 up to Week 234 during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From Week 0 up to Week 234"},{"measure":"Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Myocardial Infarction","description":"Number of participants who reported occurrence of non-fatal acute myocardial infarction from Week 0 up to Week 234 during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From Week 0 up to Week 234"},{"measure":"Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Stroke","description":"Number of participants who reported occurrence of non-fatal stroke from Week 0 up to Week 234 during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From Week 0 up to Week 234"},{"measure":"Number of Participants From Time of Randomization to Time to First Occurrence of Major Adverse Limb Events (MALE): Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization","description":"Number of participants with combined data of first occurence of acute limb ischaemia hospitalization and chronic limb ischaemia hospitalization from Week 0 up to Week 234 during on-treatment period were presented. MALE consisted of acute and chronic limb ischaemia hospitalisation.","timeFrame":"From Week 0 up to Week 234"},{"measure":"Number of Participants With Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization","description":"Number of participants of acute limb ischaemia hospitalization and chronic limb ischaemia hospitalization from Week 0 up to Week 234 during in-trial period were presented. MALE consisted of acute and chronic limb ischaemia hospitalisation. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From Week 0 up to Week 234"},{"measure":"Change From Baseline in Body Weight at Week 104","description":"Change in body weight from Week 0 up to Week 104 during in-trial period, measured in kilograms, were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"Baeline (Week 0), Week 104"},{"measure":"Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 104","description":"Change in HbA1c from Week 0 to Week 104 during in-trial period, measured in percentage point of HbA1c, were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"Baseline (Week 0), Week 104"},{"measure":"Change From Baseline in Systolic Blood Pressure at Week 104","description":"Change in systolic blood pressure from Week 0 to Week 104 during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"Baseline (Week 0), Week 104"},{"measure":"Change From Baseline in Diastolic Blood Pressure at Week 104","description":"Change in diastolic blood pressure from Week 0 to Week 104 during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"Baseline (Week 0), Week 104"},{"measure":"Number of Severe Hypoglycaemic Episodes","description":"The number of severe hypoglycaemic episodes (such as the seriousness of hypoglycaemia, contributing factors, seizures, and unconsciousness; classified by American Diabetes Association) observed during the in-trial period were reported in this endpoint. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","timeFrame":"From Week 0 up to Week 234"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female, age above or equal to 18 years at the time of signing informed consent. Japan: Male or female, age above or equal to 20 years at the time of signing informed consent\n* Diagnosed with type 2 diabetes mellitus\n* HbA1c less than or equal to 10% (less than or equal to 86 mmol/mol)\n* Renal impairment defined either by:\n\n  1. serum creatinine-based eGFR greater than or equal to 50 and less than or equal to 75 mL/min/1.73 m\\^2 (CKD-EPI) and UACR greater than 300 and less than 5000 mg/g or\n  2. serum creatinine-based eGFR greater than or equal to 25 and less than 50 mL/min/1.73 m\\^2 (CKD-EPI) and UACR greater than 100 and less than 5000 mg/g\n* Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of the inclusion criteria for renal impairment and kept stable until screening\n\nExclusion Criteria:\n\n* Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations\n* Use of any glucagon-like peptide-1 (GLP-1) receptor agonist within 30 days prior to screening\n* Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening\n* Presently classified as being in New York Heart Association (NYHA) Class IV heart failure\n* Planned coronary, carotid or peripheral artery revascularisation\n* Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis\n* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Transparency (dept. 1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Dr. Terence Hart","city":"Tuscumbia","state":"Alabama","zip":"35674","country":"United States","geoPoint":{"lat":34.7312,"lon":-87.70253}},{"facility":"California Inst Of Renal Res","city":"Chula Vista","state":"California","zip":"91910","country":"United States","geoPoint":{"lat":32.64005,"lon":-117.0842}},{"facility":"John Muir Physician Network","city":"Concord","state":"California","zip":"94520","country":"United States","geoPoint":{"lat":37.97798,"lon":-122.03107}},{"facility":"John Muir Physicians Network","city":"Concord","state":"California","zip":"94520","country":"United States","geoPoint":{"lat":37.97798,"lon":-122.03107}},{"facility":"Valley Research","city":"Fresno","state":"California","zip":"93720","country":"United States","geoPoint":{"lat":36.74773,"lon":-119.77237}},{"facility":"California Institute of Renal Research","city":"La Mesa","state":"California","zip":"91942","country":"United States","geoPoint":{"lat":32.76783,"lon":-117.02308}},{"facility":"First Valley Med Grp Lancaster","city":"Lancaster","state":"California","zip":"93534","country":"United States","geoPoint":{"lat":34.69804,"lon":-118.13674}},{"facility":"Clinical Trials Research_Sacramento","city":"Lincoln","state":"California","zip":"95648","country":"United States","geoPoint":{"lat":38.89156,"lon":-121.29301}},{"facility":"VA Loma Linda Hlthcr Sys","city":"Loma Linda","state":"California","zip":"92357","country":"United States","geoPoint":{"lat":34.04835,"lon":-117.26115}},{"facility":"Long Beach Center For Clinical Research","city":"Long Beach","state":"California","zip":"90807","country":"United States","geoPoint":{"lat":33.76696,"lon":-118.18923}},{"facility":"VA Long Beach Healthcare System","city":"Long Beach","state":"California","zip":"90822","country":"United States","geoPoint":{"lat":33.76696,"lon":-118.18923}},{"facility":"Academic Medical Research Institute","city":"Los Angeles","state":"California","zip":"90022","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"Valley Renal Medical Group Research","city":"Northridge","state":"California","zip":"91324","country":"United States","geoPoint":{"lat":34.22834,"lon":-118.53675}},{"facility":"Desert Oasis Hlthcr Med Group","city":"Palm Springs","state":"California","zip":"92262","country":"United States","geoPoint":{"lat":33.8303,"lon":-116.54529}},{"facility":"Saviers Medical Group","city":"Port Hueneme","state":"California","zip":"93041","country":"United States","geoPoint":{"lat":34.14778,"lon":-119.19511}},{"facility":"Inland Empire Clin Trials LLC","city":"Rialto","state":"California","zip":"92377","country":"United States","geoPoint":{"lat":34.1064,"lon":-117.37032}},{"facility":"Sierra Clinical Research","city":"Roseville","state":"California","zip":"95661","country":"United States","geoPoint":{"lat":38.75212,"lon":-121.28801}},{"facility":"California Research Foundation","city":"San Diego","state":"California","zip":"92123","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"N America Res Inst - 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The rationale, design and baseline data of FLOW, a kidney outcomes trial with once-weekly semaglutide in people with type 2 diabetes and chronic kidney disease. Nephrol Dial Transplant. 2023 Aug 31;38(9):2041-2051. doi: 10.1093/ndt/gfad009."},{"pmid":"42233552","type":"DERIVED","citation":"Tuttle KR, Bakris GL, Baeres FMM, Bang CN, Bax WA, Belmar N, Musinga D, Cherney DZI, Chernin G, Lim SK, Mann JFE, Perkovic V, Pratley R, Ridker PM, Rossing P, Schmieder R, Shamkhalova MS, Sreenivasamurthy L, Mahaffey KW. Kidney and Survival Benefits of Semaglutide in Diabetes With Chronic Kidney Disease: FLOW Trial Cardiovascular Subgroup Analyses. J Am Coll Cardiol. 2026 Jun 2;87(21):2996-3012. doi: 10.1016/j.jacc.2026.02.5125."},{"pmid":"41728915","type":"DERIVED","citation":"Rayner B, Mahaffey KW, Mann JFE, Pratley RE, Rossing P, Belmar N, Bosch-Traberg H, Jeppesen OK, Tran MC, Chernin G, Tuttle KR. Effect of semaglutide on COVID-19 and other infections: an analysis from the FLOW randomized clinical trial. Nephrol Dial Transplant. 2026 Feb 23:gfag036. doi: 10.1093/ndt/gfag036. Online ahead of print."},{"pmid":"41706532","type":"DERIVED","citation":"Tuttle KR, Mann JFE, Mayrdorfer MM, Rayner B, Pugliese G, Pratley RE, Perkovic V, Mahaffey KW, Kashihara N, Jeppesen OK, Gumprecht J, Correa-Rotter R, Cherney DZI, Bosch-Traberg H, Arici M, Rossing P; FLOW Trial Investigators. Kidney and Survival Outcomes with Semaglutide by CKD Severity in the FLOW Trial. Clin J Am Soc Nephrol. 2026 Feb 18;21(5):841-51. doi: 10.2215/CJN.0000000974. Online ahead of print."},{"pmid":"41422027","type":"DERIVED","citation":"Rossing P, Lindhardt M, Tikkanen CK, Menon J, Cattin J, Hunt B, Malkin SJP, Chubb B, Damgaard T, Borg R. Once-weekly semaglutide versus placebo for the treatment of type 2 diabetes and chronic kidney disease in Denmark: A long-term cost-effectiveness analysis based on FLOW. Cardiovasc Diabetol. 2025 Dec 20;25(1):32. doi: 10.1186/s12933-025-03002-1."},{"pmid":"41207620","type":"DERIVED","citation":"Pruijm M, Belmar N, Bjornstad P, Cherney DZI, Das V, Gunnarsson T, Hodgin JB, Schytz PA, Tuttle KR, Kretzler M. REMODELing mechanistic trials for kidney disease: a multimodal, tissue-centered approach to understand the renal mechanism of action of semaglutide. Kidney Int. 2026 Jan;109(1):6-16. doi: 10.1016/j.kint.2025.10.005. Epub 2025 Nov 7."},{"pmid":"39963952","type":"DERIVED","citation":"Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2."},{"pmid":"39480988","type":"DERIVED","citation":"Mendonca L, Moura H, Chaves PC, Neves JS, Ferreira JP. The Impact of Glucagon-Like Peptide-1 Receptor Agonists on Kidney Outcomes: A Meta-Analysis of Randomized Placebo-Controlled Trials. Clin J Am Soc Nephrol. 2025 Feb 1;20(2):159-168. doi: 10.2215/CJN.0000000584. Epub 2024 Oct 8."},{"pmid":"39222642","type":"DERIVED","citation":"Kosiborod MN, Deanfield J, Pratley R, Borlaug BA, Butler J, Davies MJ, Emerson SS, Kahn SE, Kitzman DW, Lingvay I, Mahaffey KW, Petrie MC, Plutzky J, Rasmussen S, Ronnback C, Shah SJ, Verma S, Weeke PE, Lincoff AM; SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM Trial Committees and Investigators. Semaglutide versus placebo in patients with heart failure and mildly reduced or preserved ejection fraction: a pooled analysis of the SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM randomised trials. Lancet. 2024 Sep 7;404(10456):949-961. doi: 10.1016/S0140-6736(24)01643-X. Epub 2024 Aug 30."},{"pmid":"39217553","type":"DERIVED","citation":"Pratley RE, Tuttle KR, Rossing P, Rasmussen S, Perkovic V, Nielsen OW, Mann JFE, MacIsaac RJ, Kosiborod MN, Kamenov Z, Idorn T, Hansen MB, Hadjadj S, Bakris G, Baeres FMM, Mahaffey KW; FLOW Trial Committees and Investigators. Effects of Semaglutide on Heart Failure Outcomes in Diabetes and Chronic Kidney Disease in the FLOW Trial. J Am Coll Cardiol. 2024 Oct 22;84(17):1615-1628. doi: 10.1016/j.jacc.2024.08.004. Epub 2024 Aug 30."},{"pmid":"38914124","type":"DERIVED","citation":"Mann JFE, Rossing P, Bakris G, Belmar N, Bosch-Traberg H, Busch R, Charytan DM, Hadjadj S, Gillard P, Gorriz JL, Idorn T, Ji L, Mahaffey KW, Perkovic V, Rasmussen S, Schmieder RE, Pratley RE, Tuttle KR. Effects of semaglutide with and without concomitant SGLT2 inhibitor use in participants with type 2 diabetes and chronic kidney disease in the FLOW trial. Nat Med. 2024 Oct;30(10):2849-2856. doi: 10.1038/s41591-024-03133-0. Epub 2024 Jun 24."},{"pmid":"38862303","type":"DERIVED","citation":"De La Flor JC, Moral E, Deira J, Monzon T, Valga F, Albarracin C, Rodeles M. Response to \"Experience with dulaglutide in an obese diabetic patient on incremental peritoneal dialysis\". Response to related letter. Nefrologia (Engl Ed). 2024 May-Jun;44(3):444-446. doi: 10.1016/j.nefroe.2023.10.010. Epub 2024 Jun 10. No abstract available."},{"pmid":"38785209","type":"DERIVED","citation":"Perkovic V, Tuttle KR, Rossing P, Mahaffey KW, Mann JFE, Bakris G, Baeres FMM, Idorn T, Bosch-Traberg H, Lausvig NL, Pratley R; FLOW Trial Committees and Investigators. Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes. N Engl J Med. 2024 Jul 11;391(2):109-121. doi: 10.1056/NEJMoa2403347. Epub 2024 May 24."},{"pmid":"35441935","type":"DERIVED","citation":"Cohen S, Sternlicht H, Bakris GL. Mineralocorticoid Receptor Antagonists in the Treatment of Diabetic Kidney Disease: Their Application in the Era of SGLT2 Inhibitors and GLP-1 Receptor Agonists. Curr Diab Rep. 2022 May;22(5):213-218. doi: 10.1007/s11892-022-01461-4. Epub 2022 Apr 20."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com","url":"https://www.novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"A total of 3533 eligible participants were randomized (1:1) to treatment with semaglutide 1 milligram (mg) (1767) or placebo (1766). The study included a treatment period (up to 60 months or more) and a follow-up period (5 weeks).","recruitmentDetails":"Trial participants were randomized to treatment at 383 sites in 28 countries as follows: Argentina (7); Australia (7); Belgium (8); Brazil (7); Bulgaria (7); Canada (25); China (4); France (11); Germany (9); Greece (13); Hungary (10); India (16); Israel (4); Italy (8); Japan (26); Malaysia (6); Mexico (6); Netherlands (9); Poland (7); Russia (21); Slovakia (10); South Africa (8); Spain (7); Thailand (6); Turkey (12); Ukraine (7); United Kingdom (11); and United States (111).","groups":[{"id":"FG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"FG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"1767"},{"groupId":"FG001","numSubjects":"1766"}]},{"type":"Full Analysis Set (FAS)","achievements":[{"groupId":"FG000","numSubjects":"1767"},{"groupId":"FG001","numSubjects":"1766"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1724"},{"groupId":"FG001","numSubjects":"1708"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"43"},{"groupId":"FG001","numSubjects":"58"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"28"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"30"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Analysis of participants were performed on full analysis set (FAS) that was defined as all unique randomised participants and were grouped according to the treatment assigned at randomization.","groups":[{"id":"BG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"BG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"1767"},{"groupId":"BG001","value":"1766"},{"groupId":"BG002","value":"3533"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"66.6","spread":"9.0"},{"groupId":"BG001","value":"66.7","spread":"9.0"},{"groupId":"BG002","value":"66.6","spread":"9.0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"519"},{"groupId":"BG001","value":"550"},{"groupId":"BG002","value":"1069"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"1248"},{"groupId":"BG001","value":"1216"},{"groupId":"BG002","value":"2464"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"273"},{"groupId":"BG001","value":"283"},{"groupId":"BG002","value":"556"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"1421"},{"groupId":"BG001","value":"1411"},{"groupId":"BG002","value":"2832"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"72"},{"groupId":"BG002","value":"145"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Race","categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"25"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"439"},{"groupId":"BG001","value":"407"},{"groupId":"BG002","value":"846"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"78"},{"groupId":"BG001","value":"82"},{"groupId":"BG002","value":"160"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"5"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"1155"},{"groupId":"BG001","value":"1168"},{"groupId":"BG002","value":"2323"}]},{"title":"Other","measurements":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"95"}]},{"title":"Not reported","measurements":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"79"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV Death","description":"Number of participants with first composite renal event i.e., from time of randomization to first occurrence of an onset of persistent greater than or equal to (≥) 50 percent (%) reduction in estimated glomerular filtration rate (eGFR) (chronic kidney disease - epidemiology collaboration \\[CKD-EPI\\]), onset of persistent eGFR (CKD-EPI) \\<15 milliliter per minute per 1.73 meter square (mL/min/1.73m\\^2), initiation of chronic renal replacement therapy (dialysis or kidney transplantation), renal death, and cardiovascular (CV) death combined data were reported in this outcome measure.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From Week 0 up to Week 234","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1767"},{"groupId":"OG001","value":"1766"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"331"},{"groupId":"OG001","value":"410"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Time from randomization to first composite renal event was analyzed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by use of sodium glucose cotransporter-2 (SGLT-2) inhibitor (yes/no) at baseline. Based on the available number of events for analysis, the nominal significance level was updated to 0.01612 using the Lan-DeMets alpha spending function. eGFR was calculated using the CKD-EPI formula.","nonInferiorityType":"SUPERIORITY","pValue":"0.0001","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.76","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.66","ciUpperLimit":"0.88"}]},{"type":"SECONDARY","title":"Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope)","description":"Annual rate of change in Total eGFR slope CKD-EPI were reported from baseline at Week 234 in-trial period. eGFR was calculated using the CKD-EPI formula. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"(mL/min/1.73 m^2)/year","timeFrame":"From Week 0 up to Week 234","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1767"},{"groupId":"OG001","value":"1766"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.19","spread":"0.1"},{"groupId":"OG001","value":"-3.36","spread":"0.1"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Time of Randomization to Occurrence of Onset of Persistent ≥50% Reduction in eGFR (CKD-EPI)","description":"Number of participants from time of randomization to time to occurrence of onset of persistent ≥50% reduction in eGFR (CKD-EPI) were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From Week 0 up to Week 234","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1767"},{"groupId":"OG001","value":"1766"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"165"},{"groupId":"OG001","value":"213"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Time of Randomization to Occurrence of Onset of Persistent eGFR (CKD-EPI) <15mL/Min/1.73m^2","description":"Number of participants from time of randomization to time to occurrence of onset of persistent eGFR (CKD-EPI) \\<15 mL/min/1.73m\\^2 were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From Week 0 up to Week 234","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1767"},{"groupId":"OG001","value":"1766"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"110"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Time of Randomization to Occurrence of Initiation of Chronic Renal Replacement Therapy","description":"Number of participants from time of randomization to time to occurrence of initiation of chronic renal replacement therapy (dialysis or kidney transplantation) were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From Week 0 up to Week 234","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1767"},{"groupId":"OG001","value":"1766"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"87"},{"groupId":"OG001","value":"100"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Time of Randomization to Occurrence of Renal Death","description":"Number of participants from time of randomization to time to occurrence of renal death were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From Week 0 up to Week 234","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1767"},{"groupId":"OG001","value":"1766"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Time of Randomization to Occurrence of CV Death","description":"Number of participants from time of randomization to time to occurrence of CV death were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From Week 0 up to Week 234","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1767"},{"groupId":"OG001","value":"1766"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"169"}]}]}]},{"type":"SECONDARY","title":"Annual Rate of Change in eGFR (Chronic Kidney Disease CKD-EPI) (Chronic eGFR Slope)","description":"Annual rate of change in eGFR in terms of chronic kidney disease CKD-EPI were reported from Week 12 to Week 234 in-trial period. eGFR was calculated using the CKD-EPI formula. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mL/min/1.73 m^2","timeFrame":"Week 12, Week 234","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1735"},{"groupId":"OG001","value":"1736"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.36","spread":"0.1"},{"groupId":"OG001","value":"-3.30","spread":"0.1"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in eGFR (CKD-EPI) at Week 12","description":"Change from baseline in eGFR at Week 12 during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mL/min/1.73m^2","timeFrame":"Baseline (Week 0), Week 12","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1665"},{"groupId":"OG001","value":"1663"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.07","spread":"8.16"},{"groupId":"OG001","value":"-1.07","spread":"7.73"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in eGFR (Cystatin C CKD-EPI) at Week 104","description":"Changes from baseline in eGFR (cystatin C) at Week 104 in-trial period were reported. Cystatin C was calculated using the CKD-EPI formula. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mL/min/1.73m^2","timeFrame":"Baseline (Week 0), Week 104","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1425"},{"groupId":"OG001","value":"1391"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.1","spread":"11.4"},{"groupId":"OG001","value":"-5.4","spread":"9.7"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Urinary Albumin-to-creatinine Ratio (UACR) at Week 104: Ratio to Baseline","description":"Change from baseline in UACR (ratio to baseline) at Week 104 in-trial period were reported. For UACR, the baseline assessment is defined as the mean of the two assessments from the randomization visit. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio","timeFrame":"Baseline (Week 0), Week 104","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1454"},{"groupId":"OG001","value":"1423"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.60","spread":"224.09"},{"groupId":"OG001","value":"0.89","spread":"211.70"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Time of Randomization to Time to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Acute Myocardial Infarction (Non Fatal); Non-fatal Stroke; and CV Death","description":"Number of participants who reported first occurence of non-fatal acute myocardial infarction, non-fatal stroke, and CV death combined data were presented from Week 0 up to Week 234 during on-treatment period. MACE consisted of non-fatal acute myocardial infarction, cardiovascular death and non-fatal stroke. First on-treatment period is defined as period from date of first dose until first time where no dose had been administered within 5 weeks (35 days) or end of the in-trial period, whichever came first.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From Week 0 up to Week 234","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1767"},{"groupId":"OG001","value":"1766"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"254"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Time of Randomization to Time to Occurrence of All-cause Death","description":"Number of participants who reported occurence of deaths from Week 0 up to Week 234 during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From Week 0 up to Week 234","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1767"},{"groupId":"OG001","value":"1766"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"227"},{"groupId":"OG001","value":"279"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Myocardial Infarction","description":"Number of participants who reported occurrence of non-fatal acute myocardial infarction from Week 0 up to Week 234 during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From Week 0 up to Week 234","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1767"},{"groupId":"OG001","value":"1766"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"64"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Stroke","description":"Number of participants who reported occurrence of non-fatal stroke from Week 0 up to Week 234 during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From Week 0 up to Week 234","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1767"},{"groupId":"OG001","value":"1766"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"51"}]}]}]},{"type":"SECONDARY","title":"Number of Participants From Time of Randomization to Time to First Occurrence of Major Adverse Limb Events (MALE): Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization","description":"Number of participants with combined data of first occurence of acute limb ischaemia hospitalization and chronic limb ischaemia hospitalization from Week 0 up to Week 234 during on-treatment period were presented. MALE consisted of acute and chronic limb ischaemia hospitalisation.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From Week 0 up to Week 234","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1767"},{"groupId":"OG001","value":"1766"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"28"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization","description":"Number of participants of acute limb ischaemia hospitalization and chronic limb ischaemia hospitalization from Week 0 up to Week 234 during in-trial period were presented. MALE consisted of acute and chronic limb ischaemia hospitalisation. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From Week 0 up to Week 234","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1767"},{"groupId":"OG001","value":"1766"}]}],"classes":[{"title":"Acute limb ischaemia hospitalization","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"}]}]},{"title":"Chronic limb ischaemia hospitalization","categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"25"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight at Week 104","description":"Change in body weight from Week 0 up to Week 104 during in-trial period, measured in kilograms, were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilograms","timeFrame":"Baeline (Week 0), Week 104","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1502"},{"groupId":"OG001","value":"1468"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.54","spread":"6.57"},{"groupId":"OG001","value":"-1.43","spread":"6.33"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 104","description":"Change in HbA1c from Week 0 to Week 104 during in-trial period, measured in percentage point of HbA1c, were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Baseline (Week 0), Week 104","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1448"},{"groupId":"OG001","value":"1427"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.86","spread":"1.35"},{"groupId":"OG001","value":"-0.04","spread":"1.29"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Systolic Blood Pressure at Week 104","description":"Change in systolic blood pressure from Week 0 to Week 104 during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeters of mercury","timeFrame":"Baseline (Week 0), Week 104","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1511"},{"groupId":"OG001","value":"1472"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.9","spread":"17.6"},{"groupId":"OG001","value":"-1.4","spread":"18.3"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Diastolic Blood Pressure at Week 104","description":"Change in diastolic blood pressure from Week 0 to Week 104 during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimeters of mercury","timeFrame":"Baseline (Week 0), Week 104","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1511"},{"groupId":"OG001","value":"1472"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"9.6"},{"groupId":"OG001","value":"-0.8","spread":"10.4"}]}]}]},{"type":"SECONDARY","title":"Number of Severe Hypoglycaemic Episodes","description":"The number of severe hypoglycaemic episodes (such as the seriousness of hypoglycaemia, contributing factors, seizures, and unconsciousness; classified by American Diabetes Association) observed during the in-trial period were reported in this endpoint. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.","populationDescription":"FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"From Week 0 up to Week 234","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1767"},{"groupId":"OG001","value":"1766"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"37"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From Week 0 up to Week 238","description":"The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.","eventGroups":[{"id":"EG000","title":"Semaglutide","description":"Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.","deathsNumAffected":227,"deathsNumAtRisk":1767,"seriousNumAffected":877,"seriousNumAtRisk":1767,"otherNumAffected":507,"otherNumAtRisk":1767},{"id":"EG001","title":"Placebo","description":"Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.","deathsNumAffected":279,"deathsNumAtRisk":1766,"seriousNumAffected":950,"seriousNumAtRisk":1766,"otherNumAffected":522,"otherNumAtRisk":1766}],"seriousEvents":[{"term":"Abdominal distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1767},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":1766}]},{"term":"Abdominal hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1767},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":1766}]},{"term":"Abdominal hernia obstructive","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1767},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":1766}]},{"term":"Abdominal hernia repair","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1767},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":1766}]},{"term":"Abdominal incarcerated hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1767},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":1766}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":4,"numAtRisk":1767},{"groupId":"EG001","numEvents":6,"numAffected":6,"numAtRisk":1766}]},{"term":"Abdominal pain lower","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1767},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":1766}]},{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":1767},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":1766}]},{"term":"Abdominal wall abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1767},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":1766}]},{"term":"Abnormal behaviour","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1767},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":1766}]},{"term":"Abnormal loss of weight","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1767},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":1766}]},{"term":"Abnormal uterine bleeding","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1767},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":1766}]},{"term":"Abscess limb","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":1767},{"groupId":"EG001","numEvents":3,"numAffected":2,"numAtRisk":1766}]},{"term":"Accelerated hypertension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1767},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":1766}]},{"term":"Acute coronary syndrome","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":1767},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":1766}]},{"term":"Acute kidney injury","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":165,"numAffected":124,"numAtRisk":1767},{"groupId":"EG001","numEvents":143,"numAffected":123,"numAtRisk":1766}]},{"term":"Acute left ventricular failure","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":1767},{"groupId":"EG001","numEvents":6,"numAffected":6,"numAtRisk":1766}]},{"term":"Acute myeloid leukaemia","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1767},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":1766}]},{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":52,"numAffected":49,"numAtRisk":1767},{"groupId":"EG001","numEvents":81,"numAffected":67,"numAtRisk":1766}]},{"term":"Acute pulmonary oedema","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":1767},{"groupId":"EG001","numEvents":13,"numAffected":12,"numAtRisk":1766}]},{"term":"Acute respiratory failure","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":31,"numAffected":30,"numAtRisk":1767},{"groupId":"EG001","numEvents":37,"numAffected":32,"numAtRisk":1766}]},{"term":"Acute sinusitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1767},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":1766}]},{"term":"Adenocarcinoma gastric","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":1767},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":1766}]},{"term":"Adenocarcinoma of colon","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":1767},{"groupId":"EG001","numEvents":7,"numAffected":7,"numAtRisk":1766}]},{"term":"Adenocarcinoma pancreas","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1767},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":1766}]},{"term":"Adenoma benign","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1767},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":1766}]},{"term":"Adjustment disorder","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1767},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":1766}]},{"term":"Adnexa uteri mass","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1767},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":1766}]},{"term":"Adrenal insufficiency","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":1767},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":1766}]},{"term":"Adrenal neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1767},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":1766}]},{"term":"Alanine aminotransferase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1767},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":1766}]},{"term":"Albuminuria","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1767},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":1766}]},{"term":"Alcohol poisoning","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 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