Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT03548935
Status:
COMPLETED
Last Update Posted:
2021-11-19
First Post:
2018-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591245', 'term': 'semaglutide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'phone': '(+1) 866-867-7178', 'title': 'Clinical Reporting Anchor and Disclosure (1452)', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of Semaglutide or placebo.', 'description': 'All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomized treatment and no later than the date of last dose + 7 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Sema 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.', 'otherNumAtRisk': 1306, 'deathsNumAtRisk': 1306, 'otherNumAffected': 1052, 'seriousNumAtRisk': 1306, 'deathsNumAffected': 1, 'seriousNumAffected': 128}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.', 'otherNumAtRisk': 655, 'deathsNumAtRisk': 655, 'otherNumAffected': 447, 'seriousNumAtRisk': 655, 'deathsNumAffected': 1, 'seriousNumAffected': 42}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 135, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 42, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 172, 'numAffected': 127}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 41, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 176, 'numAffected': 125}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 37, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 92, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 47, 'numAffected': 43}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 120, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 55, 'numAffected': 53}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 389, 'numAffected': 305}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 73, 'numAffected': 62}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 45, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 35, 'numAffected': 33}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 139, 'numAffected': 124}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 26, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 765, 'numAffected': 411}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 138, 'numAffected': 104}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 129, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 35, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 179, 'numAffected': 135}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 30, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 139, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 120, 'numAffected': 104}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 29, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 99, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 38, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 92, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 386, 'numAffected': 198}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 104, 'numAffected': 80}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 112, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 79, 'numAffected': 63}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 480, 'numAffected': 281}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 216, 'numAffected': 133}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1067, 'numAffected': 576}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 146, 'numAffected': 114}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 83, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 40, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 158, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 116, 'numAffected': 80}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 83, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 33, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 632, 'numAffected': 321}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 52, 'numAffected': 43}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}], 'seriousEvents': [{'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Abdominoplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Actinic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Acute stress disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Arthritis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Bacterial colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Bone prosthesis insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cervix carcinoma stage 0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 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'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Ovarian adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Peroneal nerve palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Psychogenic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Splenic haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Thoracic vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Toxoplasmosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Uterine haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vascular stent occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vertigo CNS origin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Volvulus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Body Weight (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1306', 'groupId': 'OG000'}, {'value': '655', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'title': 'In-trial observation period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1212', 'groupId': 'OG000'}, {'value': '577', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.6', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'On-treatment observation period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'OG000'}, {'value': '499', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.9', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '6.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.44', 'ciLowerLimit': '-13.37', 'ciUpperLimit': '-11.51', 'groupDescription': 'Treatment policy estimand', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.42', 'ciLowerLimit': '-15.29', 'ciUpperLimit': '-13.55', 'groupDescription': 'Hypothetical estimand', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).', 'unitOfMeasure': 'Percentage point', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = full analysis set (FAS) which comprised all randomized participants. Number Analyzed = number of participants with available data.'}, {'type': 'PRIMARY', 'title': 'Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1306', 'groupId': 'OG000'}, {'value': '655', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'title': 'In-trial observation period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1212', 'groupId': 'OG000'}, {'value': '577', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '1047', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '165', 'groupId': 'OG000'}, {'value': '395', 'groupId': 'OG001'}]}]}, {'title': 'On-treatment observation period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'OG000'}, {'value': '499', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '978', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '334', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.22', 'ciLowerLimit': '8.88', 'ciUpperLimit': '14.19', 'groupDescription': 'Treatment policy estimand', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.03', 'ciLowerLimit': '28.02', 'ciUpperLimit': '48.95', 'groupDescription': 'Hypothetical estimand', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After week 68', 'description': 'Number of participants who achieved weight loss more than or equal to 5% (yes/no) at week 68 are presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = full analysis set (FAS) which comprised all randomized participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1212', 'groupId': 'OG000'}, {'value': '577', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '838', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '374', 'groupId': 'OG000'}, {'value': '508', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 68', 'description': 'Number of participants who achieved weight loss more than or equal to (≥) 10% at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1212', 'groupId': 'OG000'}, {'value': '577', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '612', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '600', 'groupId': 'OG000'}, {'value': '549', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 68', 'description': 'Number of participants who achieved more than or equal to (≥) 15% weight loss at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1212', 'groupId': 'OG000'}, {'value': '577', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '388', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '824', 'groupId': 'OG000'}, {'value': '567', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 68', 'description': 'Number of participants who achieved more than or equal to (≥) 20% weight loss at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Waist Circumference (cm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1210', 'groupId': 'OG000'}, {'value': '575', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.1', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '-4.4', 'spread': '6.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in waist circumference from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to date of last contact with trial site (week 75).', 'unitOfMeasure': 'Centimeter (cm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1210', 'groupId': 'OG000'}, {'value': '574', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7', 'spread': '14', 'groupId': 'OG000'}, {'value': '-1', 'spread': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in systolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to date of last contact with trial site (week 75).', 'unitOfMeasure': 'Millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Short Form 36 (SF-36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1195', 'groupId': 'OG000'}, {'value': '566', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'title': 'Change in physical functioning score (SF-36)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '7.4', 'groupId': 'OG001'}]}]}, {'title': 'Change in SF-36 (role-physical score)', 'categories': [{'measurements': [{'value': '1.1', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '7.2', 'groupId': 'OG001'}]}]}, {'title': 'Change in SF-36 (bodily pain score)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '8.9', 'groupId': 'OG001'}]}]}, {'title': 'Change in SF-36 (general health score)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '7.1', 'groupId': 'OG001'}]}]}, {'title': 'Change in SF-36 (vitality score)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '7.9', 'groupId': 'OG001'}]}]}, {'title': 'Change in SF-36 (social functioning score)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '7.4', 'groupId': 'OG001'}]}]}, {'title': 'Change in SF-36 (role-emotional score)', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '7.6', 'groupId': 'OG001'}]}]}, {'title': 'Change in SF-36 (mental health score)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '7.4', 'groupId': 'OG001'}]}]}, {'title': 'Change in SF-36 (physical component summary)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '7.1', 'groupId': 'OG001'}]}]}, {'title': 'Change in SF-36 (mental component summary)', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '7.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': "SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation, respectively, for the 2009 US general population. Change from week 0 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1193', 'groupId': 'OG000'}, {'value': '566', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'title': 'Change in physical function domain score', 'categories': [{'measurements': [{'value': '15.0', 'spread': '21.6', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '21.1', 'groupId': 'OG001'}]}]}, {'title': 'Change in physical domain score', 'categories': [{'measurements': [{'value': '14.0', 'spread': '20.0', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '19.5', 'groupId': 'OG001'}]}]}, {'title': 'Change in psychosocial domain score', 'categories': [{'measurements': [{'value': '17.4', 'spread': '19.2', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '17.8', 'groupId': 'OG001'}]}]}, {'title': 'Change in total score', 'categories': [{'measurements': [{'value': '16.2', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '16.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': "IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. It is used to assess the impact of body weight changes on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Body Weight (kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1212', 'groupId': 'OG000'}, {'value': '577', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.1', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '7.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Kilogram (kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Body Mass Index (BMI) (kg/m2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1212', 'groupId': 'OG000'}, {'value': '577', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.8', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body mass index from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Kilogram per square meter (kg/sqm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = full analysis set (FAS) which comprised all randomized participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in HbA1C (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1197', 'groupId': 'OG000'}, {'value': '563', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Percentage point of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in HbA1C (mmol/Mol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1197', 'groupId': 'OG000'}, {'value': '563', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.1', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in HbA1c from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'millimoles per mole (mmol/mol)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose (FPG) (mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1175', 'groupId': 'OG000'}, {'value': '557', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.2', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '12.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in fasting plasma glucose from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Fasting Serum Insulin (mIU/L) - Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1147', 'groupId': 'OG000'}, {'value': '550', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.73', 'spread': '62.3', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '56.5', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in fasting serum insulin from week 0 to week 68 is presented as ratio to baseline. Fasting serum insulin was measured in milli-international units per milliliter (mIU/mL). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Ratio of fasting serum insulin', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Diastolic Blood Pressure (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1210', 'groupId': 'OG000'}, {'value': '574', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3', 'spread': '9', 'groupId': 'OG000'}, {'value': '-1', 'spread': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Total Cholesterol (mg/dL) - Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1196', 'groupId': 'OG000'}, {'value': '561', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.96', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '15.5', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in fasting total cholesterol from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Ratio of total cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in High-density Lipoproteins (HDL) (mg/dL) - Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1192', 'groupId': 'OG000'}, {'value': '558', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.05', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '14.9', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in fasting HDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Ratio of HDL cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Low-density Lipoproteins (LDL) (mg/dL) - Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1194', 'groupId': 'OG000'}, {'value': '561', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.97', 'spread': '23.7', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '25.5', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in fasting LDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Ratio of LDL cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Very Low-density Lipoproteins (VLDL) (mg/dL) - Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1193', 'groupId': 'OG000'}, {'value': '561', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'spread': '37.7', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '35.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in fasting VLDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Ratio of VLDL cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Free Fatty Acids (mg/dL) - Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1154', 'groupId': 'OG000'}, {'value': '552', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.83', 'spread': '78.3', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '70.8', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in fasting free fatty acids from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Ratio of free fatty acids', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Triglycerides (mg/dL) - Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1194', 'groupId': 'OG000'}, {'value': '561', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'spread': '38.3', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '36.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in fasting triglycerides from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Ratio of triglycerides', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in High Sensitivity C-Reactive Protein (hsCRP) - (mg/L) - Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1200', 'groupId': 'OG000'}, {'value': '562', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.45', 'spread': '128.2', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '102.5', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in high sensitivity C-reactive protein from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Ratio of hsCRP', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity (AU/ml) - Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1131', 'groupId': 'OG000'}, {'value': '546', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.15', 'spread': '86.5', 'groupId': 'OG000'}, {'value': '1.53', 'spread': '77.3', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in plasminogen activator inhibitor-1 activity from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Ratio of PAI-1', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Soluble Leptin Receptor (ng/mL) - Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1194', 'groupId': 'OG000'}, {'value': '562', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.07', 'spread': '24.9', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '22.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in soluble leptin receptor from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Ratio of soluble leptin receptor', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Leptin (ng/mL) - Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1197', 'groupId': 'OG000'}, {'value': '563', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.52', 'spread': '75.9', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '52.7', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in leptin from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Ratio of leptin', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Body Composition (Total Fat Mass) (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.9', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body composition (total fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using Dual Energy X-ray Absorpmetry (DEXA). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Percentage point', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Body Composition (Total Fat Mass) (kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.3', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '5.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body composition (total fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using Dual Energy X-ray Absorpmetry (DEXA). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Body Composition (Lean Body Mass) (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body composition (lean body mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Percentage point', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Body Composition (Lean Body Mass) (kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.8', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body composition (lean body mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Body Composition (Visceral Fat Mass) (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.2', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '4.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body composition (visceral fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Percentage point', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Body Composition (Visceral Fat Mass) (kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body composition (visceral fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Body Weight (%) - DEXA Subpopulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.8', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '6.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body weight from baseline (week 0) to week 68 is presented in DEXA subpopulation. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Percentage point', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Body Weight (kg) - DEXA Subpopulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.5', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '6.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body weight from baseline (week 0) to week 68 is presented in DEXA subpopulation. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve "Responder Definition Value" (Yes/no) for SF-36 Physical Functioning Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1195', 'groupId': 'OG000'}, {'value': '566', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'title': 'Yes (with threshold 4.3)', 'categories': [{'measurements': [{'value': '318', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'No (with threshold 4.3)', 'categories': [{'measurements': [{'value': '877', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}]}]}, {'title': 'Yes (with threshold 3.7)', 'categories': [{'measurements': [{'value': '478', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}]}, {'title': 'No (with threshold 3.7)', 'categories': [{'measurements': [{'value': '717', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After week 68', 'description': 'The observed number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on two different thresholds. The threshold of 4.3 is the default generic responder threshold defined in SF-36 manual for a general population. The threshold of 3.7 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants\' own perspective based on FDA recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on the in-trial observation period which is the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve "Responder Definition Value" (Yes/no) for IWQoL-Lite for CT Physical Function Domain (5-items) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1193', 'groupId': 'OG000'}, {'value': '566', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'title': 'Yes (with threshold 20)', 'categories': [{'measurements': [{'value': '473', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}]}, {'title': 'No (with threshold 20)', 'categories': [{'measurements': [{'value': '720', 'groupId': 'OG000'}, {'value': '421', 'groupId': 'OG001'}]}]}, {'title': 'Yes (with threshold 14.6)', 'categories': [{'measurements': [{'value': '611', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}]}, {'title': 'No (with threshold 14.6)', 'categories': [{'measurements': [{'value': '582', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After week 68', 'description': 'The observed number of participants experiencing a meaningful within participant improvement in IWQOL-Lite-CT physical function after 68 weeks was determined based on two different thresholds. The threshold of 20 was a preliminary responder threshold based on earlier studies. The threshold of 14.6 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants\' own perspective based on FDA recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers the number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on the in-trial observation period. In trial observation period: the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1306', 'groupId': 'OG000'}, {'value': '655', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '9658', 'groupId': 'OG000'}, {'value': '3302', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (week 0) to week 75', 'description': 'An adverse event (AE) was defined as any unfavorable 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. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event for which the onset of the event occurs in the on-treatment period. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of trial product.'}, {'type': 'SECONDARY', 'title': 'Number of Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1306', 'groupId': 'OG000'}, {'value': '655', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (week 0) to week 75', 'description': 'A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 0 to week 75 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of trial product.'}, {'type': 'SECONDARY', 'title': 'Change in Pulse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'OG000'}, {'value': '499', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '10', 'groupId': 'OG000'}, {'value': '-1', 'spread': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in pulse from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).', 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of trial product. Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Amylase - Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1053', 'groupId': 'OG000'}, {'value': '497', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.14', 'spread': '21.6', 'groupId': 'OG000'}, {'value': '1.03', 'spread': '21.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in amylase (measured as units per litre \\[U/L\\]) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).', 'unitOfMeasure': 'Ratio of amylase', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of trial product. Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Lipase - Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1053', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.41', 'spread': '49.3', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '37.3', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in lipase (measured as units per litre \\[U/L\\]) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).', 'unitOfMeasure': 'Ratio of lipase', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of trial product. Overall number of participants analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Calcitonin - Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1050', 'groupId': 'OG000'}, {'value': '497', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'spread': '37.6', 'groupId': 'OG000'}, {'value': '0.95', 'spread': '40.9', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in calcitonin (measured as ng/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).', 'unitOfMeasure': 'Ratio of calcitonin', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of trial product. Overall number of participants analyzed = number of participants with available data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1306'}, {'groupId': 'FG001', 'numSubjects': '655'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1306'}, {'groupId': 'FG001', 'numSubjects': '655'}]}, {'type': 'Safety Analysis Set (SAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1306'}, {'groupId': 'FG001', 'numSubjects': '655'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1240'}, {'groupId': 'FG001', 'numSubjects': '609'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '46'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The trial was conducted at 129 sites in 16 countries as follows (all sites screened and randomized): Argentina (5 sites), Belgium (5 sites), Bulgaria (5 sites), Canada (7 sites), Denmark (1 site), Finland (2 sites), France (7 sites), Germany (13 sites), India (13 sites), Japan (5 sites), Mexico (3 sites), Poland (4 sites), Russian Federation (8 sites), Taiwan(1 site), UK (10 sites), US (40 sites).', 'preAssignmentDetails': 'The trial included an initial 16-week dose-escalation period and a 52-week dose maintenance period. Participants were randomized in 2:1 ratio either to receive semaglutide 2.4 mg or placebo. The treatment is an adjunct to reduced-calorie diet and increased physical activity.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1306', 'groupId': 'BG000'}, {'value': '655', 'groupId': 'BG001'}, {'value': '1961', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46', 'spread': '13', 'groupId': 'BG000'}, {'value': '47', 'spread': '12', 'groupId': 'BG001'}, {'value': '46', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '955', 'groupId': 'BG000'}, {'value': '498', 'groupId': 'BG001'}, {'value': '1453', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '351', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '508', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1118', 'groupId': 'BG000'}, {'value': '551', 'groupId': 'BG001'}, {'value': '1669', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '261', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '973', 'groupId': 'BG000'}, {'value': '499', 'groupId': 'BG001'}, {'value': '1472', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-29', 'size': 2115980, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-07-20T04:16', 'hasProtocol': True}, {'date': '2020-07-03', 'size': 1019727, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-07-20T04:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sponsor staff involved in the clinical trial is masked according to company standard procedures.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1961}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'dispFirstSubmitDate': '2021-03-03', 'completionDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-18', 'studyFirstSubmitDate': '2018-05-25', 'dispFirstSubmitQcDate': '2021-07-20', 'resultsFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2018-05-25', 'dispFirstPostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-20', 'studyFirstPostDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Body Weight (%)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).'}, {'measure': 'Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no)', 'timeFrame': 'After week 68', 'description': 'Number of participants who achieved weight loss more than or equal to 5% (yes/no) at week 68 are presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption.'}], 'secondaryOutcomes': [{'measure': 'Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no)', 'timeFrame': 'Week 68', 'description': 'Number of participants who achieved weight loss more than or equal to (≥) 10% at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75).'}, {'measure': 'Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no)', 'timeFrame': 'Week 68', 'description': 'Number of participants who achieved more than or equal to (≥) 15% weight loss at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no)', 'timeFrame': 'Week 68', 'description': 'Number of participants who achieved more than or equal to (≥) 20% weight loss at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in Waist Circumference (cm)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in waist circumference from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to date of last contact with trial site (week 75).'}, {'measure': 'Change in Systolic Blood Pressure (mmHg)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in systolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to date of last contact with trial site (week 75).'}, {'measure': 'Change in Short Form 36 (SF-36)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': "SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation, respectively, for the 2009 US general population. Change from week 0 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75)."}, {'measure': 'Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score', 'timeFrame': 'Baseline (week 0) to week 68', 'description': "IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. It is used to assess the impact of body weight changes on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75)."}, {'measure': 'Change in Body Weight (kg)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in Body Mass Index (BMI) (kg/m2)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body mass index from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in HbA1C (%)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in HbA1C (mmol/Mol)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in HbA1c from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in Fasting Plasma Glucose (FPG) (mg/dL)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in fasting plasma glucose from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in Fasting Serum Insulin (mIU/L) - Ratio to Baseline', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in fasting serum insulin from week 0 to week 68 is presented as ratio to baseline. Fasting serum insulin was measured in milli-international units per milliliter (mIU/mL). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in Diastolic Blood Pressure (mmHg)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in Total Cholesterol (mg/dL) - Ratio to Baseline', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in fasting total cholesterol from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in High-density Lipoproteins (HDL) (mg/dL) - Ratio to Baseline', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in fasting HDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in Low-density Lipoproteins (LDL) (mg/dL) - Ratio to Baseline', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in fasting LDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in Very Low-density Lipoproteins (VLDL) (mg/dL) - Ratio to Baseline', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in fasting VLDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in Free Fatty Acids (mg/dL) - Ratio to Baseline', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in fasting free fatty acids from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in Triglycerides (mg/dL) - Ratio to Baseline', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in fasting triglycerides from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in High Sensitivity C-Reactive Protein (hsCRP) - (mg/L) - Ratio to Baseline', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in high sensitivity C-reactive protein from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity (AU/ml) - Ratio to Baseline', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in plasminogen activator inhibitor-1 activity from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in Soluble Leptin Receptor (ng/mL) - Ratio to Baseline', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in soluble leptin receptor from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in Leptin (ng/mL) - Ratio to Baseline', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in leptin from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in Body Composition (Total Fat Mass) (%)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body composition (total fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using Dual Energy X-ray Absorpmetry (DEXA). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in Body Composition (Total Fat Mass) (kg)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body composition (total fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using Dual Energy X-ray Absorpmetry (DEXA). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in Body Composition (Lean Body Mass) (%)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body composition (lean body mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in Body Composition (Lean Body Mass) (kg)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body composition (lean body mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in Body Composition (Visceral Fat Mass) (%)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body composition (visceral fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in Body Composition (Visceral Fat Mass) (kg)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body composition (visceral fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in Body Weight (%) - DEXA Subpopulation', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body weight from baseline (week 0) to week 68 is presented in DEXA subpopulation. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Change in Body Weight (kg) - DEXA Subpopulation', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body weight from baseline (week 0) to week 68 is presented in DEXA subpopulation. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).'}, {'measure': 'Participants Who Achieve "Responder Definition Value" (Yes/no) for SF-36 Physical Functioning Score', 'timeFrame': 'After week 68', 'description': 'The observed number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on two different thresholds. The threshold of 4.3 is the default generic responder threshold defined in SF-36 manual for a general population. The threshold of 3.7 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants\' own perspective based on FDA recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on the in-trial observation period which is the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).'}, {'measure': 'Participants Who Achieve "Responder Definition Value" (Yes/no) for IWQoL-Lite for CT Physical Function Domain (5-items) Score', 'timeFrame': 'After week 68', 'description': 'The observed number of participants experiencing a meaningful within participant improvement in IWQOL-Lite-CT physical function after 68 weeks was determined based on two different thresholds. The threshold of 20 was a preliminary responder threshold based on earlier studies. The threshold of 14.6 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants\' own perspective based on FDA recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers the number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on the in-trial observation period. In trial observation period: the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).'}, {'measure': 'Number of Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Baseline (week 0) to week 75', 'description': 'An adverse event (AE) was defined as any unfavorable 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. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event for which the onset of the event occurs in the on-treatment period. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).'}, {'measure': 'Number of Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline (week 0) to week 75', 'description': 'A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 0 to week 75 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).'}, {'measure': 'Change in Pulse', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in pulse from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).'}, {'measure': 'Change in Amylase - Ratio to Baseline', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in amylase (measured as units per litre \\[U/L\\]) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).'}, {'measure': 'Change in Lipase - Ratio to Baseline', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in lipase (measured as units per litre \\[U/L\\]) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).'}, {'measure': 'Change in Calcitonin - Ratio to Baseline', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in calcitonin (measured as ng/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolism and Nutrition Disorder', 'Overweight or Obesity']}, 'referencesModule': {'references': [{'pmid': '32441473', 'type': 'BACKGROUND', 'citation': 'Kushner RF, Calanna S, Davies M, Dicker D, Garvey WT, Goldman B, Lingvay I, Thomsen M, Wadden TA, Wharton S, Wilding JPH, Rubino D. Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5. Obesity (Silver Spring). 2020 Jun;28(6):1050-1061. doi: 10.1002/oby.22794.'}, {'pmid': '33567185', 'type': 'RESULT', 'citation': 'Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.'}, {'pmid': '40980163', 'type': 'DERIVED', 'citation': 'Schattenberg JM, Gronbaek H, Kliers I, Ladelund S, Long MT, Nygard SB, Sanyal AJ, Davies MJ. Proteomic signatures reflect effects of semaglutide treatment for MASH. JHEP Rep. 2025 Jul 22;7(10):101521. doi: 10.1016/j.jhepr.2025.101521. eCollection 2025 Oct.'}, {'pmid': '39316288', 'type': 'DERIVED', 'citation': 'Kral P, Holst-Hansen T, Olivieri AV, Ivanescu C, Lamotte M, Larsen S. The Correlation Between Body Mass Index and Health-Related Quality of Life: Data from Two Weight Loss Intervention Studies. Adv Ther. 2024 Nov;41(11):4228-4247. doi: 10.1007/s12325-024-02932-8. Epub 2024 Sep 24.'}, {'pmid': '39226070', 'type': 'DERIVED', 'citation': 'Wadden TA, Brown GK, Egebjerg C, Frenkel O, Goldman B, Kushner RF, McGowan B, Overvad M, Fink-Jensen A. Psychiatric Safety of Semaglutide for Weight Management in People Without Known Major Psychopathology: Post Hoc Analysis of the STEP 1, 2, 3, and 5 Trials. JAMA Intern Med. 2024 Nov 1;184(11):1290-1300. doi: 10.1001/jamainternmed.2024.4346.'}, {'pmid': '36876594', 'type': 'DERIVED', 'citation': 'McGowan BM, Houshmand-Oeregaard A, Laursen PN, Zeuthen N, Baker-Knight J. Impact of BMI and comorbidities on efficacy of once-weekly semaglutide: Post hoc analyses of the STEP 1 randomized trial. Obesity (Silver Spring). 2023 Apr;31(4):990-999. doi: 10.1002/oby.23732. Epub 2023 Mar 6.'}, {'pmid': '36801984', 'type': 'DERIVED', 'citation': 'Heerspink HJL, Apperloo E, Davies M, Dicker D, Kandler K, Rosenstock J, Sorrig R, Lawson J, Zeuthen N, Cherney D. Effects of Semaglutide on Albuminuria and Kidney Function in People With Overweight or Obesity With or Without Type 2 Diabetes: Exploratory Analysis From the STEP 1, 2, and 3 Trials. Diabetes Care. 2023 Apr 1;46(4):801-810. doi: 10.2337/dc22-1889.'}, {'pmid': '36200477', 'type': 'DERIVED', 'citation': 'Kosiborod MN, Bhatta M, Davies M, Deanfield JE, Garvey WT, Khalid U, Kushner R, Rubino DM, Zeuthen N, Verma S. Semaglutide improves cardiometabolic risk factors in adults with overweight or obesity: STEP 1 and 4 exploratory analyses. Diabetes Obes Metab. 2023 Feb;25(2):468-478. doi: 10.1111/dom.14890. Epub 2022 Oct 28.'}, {'pmid': '35724304', 'type': 'DERIVED', 'citation': 'Perreault L, Davies M, Frias JP, Laursen PN, Lingvay I, Machineni S, Varbo A, Wilding JPH, Wallenstein SOR, le Roux CW. Changes in Glucose Metabolism and Glycemic Status With Once-Weekly Subcutaneous Semaglutide 2.4 mg Among Participants With Prediabetes in the STEP Program. Diabetes Care. 2022 Oct 1;45(10):2396-2405. doi: 10.2337/dc21-1785.'}, {'pmid': '35441470', 'type': 'DERIVED', 'citation': 'Wilding JPH, Batterham RL, Davies M, Van Gaal LF, Kandler K, Konakli K, Lingvay I, McGowan BM, Oral TK, Rosenstock J, Wadden TA, Wharton S, Yokote K, Kushner RF; STEP 1 Study Group. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes Obes Metab. 2022 Aug;24(8):1553-1564. doi: 10.1111/dom.14725. Epub 2022 May 19.'}, {'pmid': '30122305', 'type': 'DERIVED', 'citation': "O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, Carson CG, Jepsen CH, Kabisch M, Wilding JPH. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial. Lancet. 2018 Aug 25;392(10148):637-649. doi: 10.1016/S0140-6736(18)31773-2. Epub 2018 Aug 16."}]}, 'descriptionModule': {'briefSummary': 'This study will look at the change in participants\' body weight from the start to the end of the study. The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what you can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get, is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study has two phases: A main phase and an extension phase.The main phase will last for about 1.5 years. Participants will have 15 clinic visits and 10 phone calls with the study doctor. Extension phase: Approximately 300 participants will continue in the extension phase in the following countries only: Canada, Germany, the UK and selected sites in the US and Japan. These participants will be in the study for about 2.5 years.They will not receive treatment, but will attend another 5 follow-up visits with the study doctor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nMain phase:\n\n* Male or female, age greater than or equal to 18 years at the time of signing informed consent\n* Body mass index (BMI) greater than or equal to 30.0 kg/sqm or greater than or equal to 27.0 kg/sqm with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease\n* History of at least one self-reported unsuccessful dietary effort to lose body weight\n\nExtension phase:\n\n* Informed consent for the extension phase obtained before any trial related activities for the extension phase\n* On randomised treatment on the target dose at week 68, i.e. treated with 2.4 mg semaglutide once-weekly or semaglutide placebo\n\nExclusion Criteria:\n\nMain phase:\n\n* Glycated haemoglobin (HbA1C) greater than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening\n* A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records\n\nExtension phase:\n\n* Female who is pregnant or intends to become pregnant during the extension phase\n* Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardise the subject's compliance with the extension of the trial"}, 'identificationModule': {'nctId': 'NCT03548935', 'acronym': 'STEP 1', 'briefTitle': 'STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity', 'orgStudyIdInfo': {'id': 'NN9536-4373'}, 'secondaryIdInfos': [{'id': 'U1111-1200-8053', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}, {'id': '2017-003436-36', 'type': 'REGISTRY', 'domain': 'European Medicines Agency (EudraCT)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Semaglutide s.c. 2.4 mg once weekly', 'description': 'Participants will receive semaglutide for 68 weeks.', 'interventionNames': ['Drug: Semaglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Semaglutide placebo', 'description': 'Participants will receive semaglutide matching placebo for 68 weeks.', 'interventionNames': ['Drug: Placebo (semaglutide)']}], 'interventions': [{'name': 'Semaglutide', 'type': 'DRUG', 'description': 'Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks. Dose escalation of semaglutide will take place as follows: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 68.', 'armGroupLabels': ['Semaglutide s.c. 2.4 mg once weekly']}, {'name': 'Placebo (semaglutide)', 'type': 'DRUG', 'description': 'Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks.', 'armGroupLabels': ['Semaglutide placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90717', 'city': 'Lomita', 'state': 'California', 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