Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2026-01-04 @ 5:23 AM
Study NCT ID:
NCT03552757
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2018-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Algeria'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'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 Transparency 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 randomised participants exposed to at least one dose of randomised treatment.', 'description': 'All presented AEs are treatment-emergent (i.e., TEAEs).', 'eventGroups': [{'id': 'EG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.', 'otherNumAtRisk': 402, 'deathsNumAtRisk': 402, 'otherNumAffected': 261, 'seriousNumAtRisk': 402, 'deathsNumAffected': 1, 'seriousNumAffected': 31}, {'id': 'EG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.', 'otherNumAtRisk': 403, 'deathsNumAtRisk': 403, 'otherNumAffected': 284, 'seriousNumAtRisk': 403, 'deathsNumAffected': 1, 'seriousNumAffected': 40}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.', 'otherNumAtRisk': 402, 'deathsNumAtRisk': 402, 'otherNumAffected': 190, 'seriousNumAtRisk': 402, 'deathsNumAffected': 1, 'seriousNumAffected': 37}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 30, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 27, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 29, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 30, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 30, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 70, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 82, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 26, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 33, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 41, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 157, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 141, 'numAffected': 86}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 66, 'numAffected': 48}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 30, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 26, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 29, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 48, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 40, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 27, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 69, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 115, 'numAffected': 68}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 92, 'numAffected': 59}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 196, 'numAffected': 128}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 248, 'numAffected': 135}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 45, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 54, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 48, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 50, 'numAffected': 38}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 93, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 186, 'numAffected': 86}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Adenocarcinoma gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Anaemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Aortic rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Bladder outlet obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cachexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cardiac pacemaker replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cerebral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Colonic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Diabetic metabolic decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gastric cancer stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gastrointestinal lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gastrointestinal stromal tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hyperaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypertensive urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hyponatraemic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Immunisation reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Joint abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Keratinising squamous cell carcinoma of nasopharynx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Lactic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Lisfranc fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Neuroendocrine tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Neuropathic arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Non-alcoholic steatohepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Obstructive pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumonia influenzal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Sperm aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Spinal epidural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Stag horn calculus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Stent placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Thoracic vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Thyroidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Traumatic haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Trigger finger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Wound infection staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '404', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'title': 'In-trial observation period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.9', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'On-treatment observation period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.7', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '5.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.21', 'ciLowerLimit': '-7.28', 'ciUpperLimit': '-5.15', 'groupDescription': 'Results are based on the data from in-trial observation period. Week 68 responses were analysed using an analysis of covariance model (ANCOVA) with randomised treatment, stratification groups (oral anti-diabetic (OAD) treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.57', 'ciLowerLimit': '-8.56', 'ciUpperLimit': '-6.58', 'groupDescription': 'Results are based on the data from on-treatment observation period. All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a mixed model for repeated measurements (MMRM) with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate, all nested within visit.', 'statisticalMethod': 'MMRM', '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. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2-week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.', 'unitOfMeasure': 'Percentage point of body weight', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analysed = FAS which comprised all randomised participants. Number analysed = number of participants with available data.'}, {'type': 'PRIMARY', 'title': 'Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '404', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'title': 'In-trial observation period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '267', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}]}, {'title': 'On-treatment observation period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '257', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.88', 'ciLowerLimit': '3.58', 'ciUpperLimit': '6.64', 'groupDescription': 'Results are based on the data from in-trial observation period. Week 68 responses were analysed using a binary logistic regression model with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.69', 'ciLowerLimit': '6.31', 'ciUpperLimit': '11.97', 'groupDescription': 'Results are based on the data from on-treatment observation period. All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a MMRM with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate, all nested within visit.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 68', 'description': 'Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analysed = FAS which comprised all randomised participants. Number analysed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.9', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '6.6', '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. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Percentage point of body weight', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '267', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 68', 'description': 'Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}, {'value': '375', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.9', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '-9.7', 'spread': '8.1', 'groupId': 'OG001'}, {'value': '-4.3', 'spread': '6.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in waist circumference from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Centimetre (cm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Body Weight (Kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}, {'value': '376', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.1', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '-9.9', 'spread': '8.5', 'groupId': 'OG001'}, {'value': '-3.4', 'spread': '6.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body weight (kg) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Kilogram (kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}, {'value': '376', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.6', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '2.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body mass index (BMI) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'kilogram per square meter (kg/m^2)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve (Yes/no): Body Weight Reduction ≥10%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}, {'value': '376', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '271', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '345', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 68', 'description': 'Number of participants who achieved weight reduction ≥10% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve (Yes/no): Body Weight Reduction ≥15%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}, {'value': '376', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '328', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '364', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 68', 'description': 'Number of participants who achieved weight reduction ≥15% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve (Yes/no): Body Weight Reduction ≥20%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}, {'value': '376', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '362', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}, {'value': '370', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 68', 'description': 'Number of participants who achieved weight reduction ≥20% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in HbA1c (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}, {'value': '374', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '1.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in glycated haemoglobin (HbA1c (%)) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Percentage point of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in HbA1c (mmol/Mol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}, {'value': '374', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.9', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '-18.7', 'spread': '13.0', 'groupId': 'OG001'}, {'value': '-3.4', 'spread': '14.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in HbA1c (mmol/mol) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'millimoles per mole (mmol/mol)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in FPG (mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}, {'value': '370', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.5', 'spread': '45.1', 'groupId': 'OG000'}, {'value': '-37.9', 'spread': '45.9', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '53.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in fasting plasma glucose (FPG) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Fasting Serum Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}, {'value': '351', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.94', 'spread': '59.8', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '65.4', 'groupId': 'OG001'}, {'value': '0.93', 'spread': '53.6', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in fasting serum insulin from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Picomoles per litre (pmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve (Yes/no): HbA1c <7.0% (53 mmol/Mol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}, {'value': '374', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '272', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 68', 'description': 'Number of participants who achieved HbA1c \\<7% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve (Yes/no): HbA1c ≤6.5% (48 mmol/Mol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}, {'value': '374', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '226', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '316', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 68', 'description': 'Number of participants who achieved HbA1c ≤6.5% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% and HbA1c <7.0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}, {'value': '374', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '271', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '349', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 68', 'description': 'Number of participants who achieved weight reduction ≥10% of their baseline body weight and HbA1c \\<7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% and HbA1c <7.0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}, {'value': '374', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '327', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}, {'value': '363', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 68', 'description': 'Number of participants who achieved weight reduction ≥15% of their baseline body weight and HbA1c \\<7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}, {'value': '376', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3', 'spread': '15', 'groupId': 'OG000'}, {'value': '-4', 'spread': '14', 'groupId': 'OG001'}, {'value': '0', 'spread': '15', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in systolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Millimetre of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}, {'value': '376', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1', 'spread': '9', 'groupId': 'OG000'}, {'value': '-2', 'spread': '9', 'groupId': 'OG001'}, {'value': '-1', 'spread': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Millimetre of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}, {'value': '373', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.97', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '17.9', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '18.9', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in total cholesterol (measured in milligram per decilitre (mg/dL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Ratio of total cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in HDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}, {'value': '369', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.06', 'spread': '16.0', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '15.7', 'groupId': 'OG001'}, {'value': '1.04', 'spread': '15.3', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in high density lipoprotein (HDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Ratio of HDL cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in LDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}, {'value': '373', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'spread': '37.5', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '30.9', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '28.9', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in low density lipoprotein (LDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Ratio of LDL cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in VLDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}, {'value': '373', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.82', 'spread': '42.1', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '42.0', 'groupId': 'OG001'}, {'value': '0.92', 'spread': '40.5', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in very low density lipoprotein (VLDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Ratio of VLDL cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Free Fatty Acids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}, {'value': '354', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.85', 'spread': '61.4', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '68.7', 'groupId': 'OG001'}, {'value': '1.01', 'spread': '62.3', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in free fatty acids (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Ratio of free fatty acids', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}, {'value': '373', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.81', 'spread': '44.5', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '43.8', 'groupId': 'OG001'}, {'value': '0.92', 'spread': '44.5', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in triglycerides (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Ratio of triglycerides', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in hsCRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}, {'value': '373', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.59', 'spread': '115.7', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '125.7', 'groupId': 'OG001'}, {'value': '0.84', 'spread': '90.9', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in high sensitivity C-reactive protein (hsCRP; measured in milligram per ilitre (mg/L)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Ratio of hsCRP', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in PAI-1 Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}, {'value': '336', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.21', 'spread': '73.7', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '80.8', 'groupId': 'OG001'}, {'value': '1.42', 'spread': '68.9', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in Plasminogen Activator Inhibitor-1 (PAI-1; measured in arbritary units per millilitre (AU/mL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.', 'unitOfMeasure': 'Ratio of PAI-1 activity', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Short Form 36 v2.0 Acute (SF-36) (Physical Functioning Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}, {'value': '365', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '7.7', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '7.0', 'groupId': 'OG002'}]}]}], '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 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for 'physical functioning domain'. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in SF-36 (All Scores Except Physical Functioning)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}, {'value': '365', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'title': 'Role-Physical', 'categories': [{'measurements': [{'value': '0.6', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '7.4', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '7.1', 'groupId': 'OG002'}]}]}, {'title': 'Bodily Pain', 'categories': [{'measurements': [{'value': '0.4', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '9.0', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '8.6', 'groupId': 'OG002'}]}]}, {'title': 'General Health', 'categories': [{'measurements': [{'value': '1.7', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '7.3', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '7.5', 'groupId': 'OG002'}]}]}, {'title': 'Vitality', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '7.9', 'groupId': 'OG002'}]}]}, {'title': 'Social Functioning', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '6.6', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '7.4', 'groupId': 'OG002'}]}]}, {'title': 'Role-Emotional', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '7.7', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '7.8', 'groupId': 'OG002'}]}]}, {'title': 'Mental Health', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '6.9', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '7.5', 'groupId': 'OG002'}]}]}, {'title': 'Physical component summary', 'categories': [{'measurements': [{'value': '1.9', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '7.2', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '6.6', 'groupId': 'OG002'}]}]}, {'title': 'Mental component summary', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '6.9', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '7.6', 'groupId': 'OG002'}]}]}], '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 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for all the domains, except physical functioning. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. 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. Results are based on the data from in-trial observation period.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in IWQOL-Lite for CT (Physical Function Domain (5-items) Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}, {'value': '365', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '20.8', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '20.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': "The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical function domain'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in IWQOL-Lite for CT (All Scores Except Physical Function)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}, {'value': '365', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'title': 'Physical', 'categories': [{'measurements': [{'value': '7.6', 'spread': '18.0', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '19.6', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '19.1', 'groupId': 'OG002'}]}]}, {'title': 'Psychosocial', 'categories': [{'measurements': [{'value': '8.6', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '16.7', 'groupId': 'OG001'}, {'value': '5.6', 'spread': '16.5', 'groupId': 'OG002'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '8.2', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '15.9', 'groupId': 'OG001'}, {'value': '5.2', 'spread': '15.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': "The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical and psychosocial domains, and for total'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}, {'value': '365', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'title': 'Yes (with threshold 4.3)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}]}, {'title': 'No (with threshold 4.3)', 'categories': [{'measurements': [{'value': '282', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '297', 'groupId': 'OG002'}]}]}, {'title': 'Yes (with threshold 3.7)', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}]}, {'title': 'No (with threshold 3.7)', 'categories': [{'measurements': [{'value': '240', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '263', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 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 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 overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants\' own perspective based on Food and Drug Administration (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. Endpoint was evaluated based on 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 randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve (Yes/no): Responder Definition Value for IWQOL-Lite for CT Physical Function Domain (5-items) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}, {'value': '365', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'title': 'Yes (with threshold 20)', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}]}, {'title': 'No (with threshold 20)', 'categories': [{'measurements': [{'value': '262', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}, {'value': '282', 'groupId': 'OG002'}]}]}, {'title': 'Yes (with threshold 14.6)', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}]}, {'title': 'No (with threshold 14.6)', 'categories': [{'measurements': [{'value': '225', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '252', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 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 which was defined as 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 randomised participants. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Number of TEAEs - Semaglutide 2.4 mg Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '2197', 'groupId': 'OG000'}, {'value': '1388', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to week 75', 'description': 'Adverse events (AEs) with onset during the on-treatment observation period were defined as treatment-emergent AEs (TEAEs). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set (SAS) included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Number of SAEs - Semaglutide 2.4 mg Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to week 75', 'description': 'Serious adverse event (SAE) results are based on the on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemia Episodes - Semaglutide 2.4 mg Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to week 75', 'description': 'Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least 7 consecutive missed doses. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration. Blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that is BG confirmed by PG value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Pulse - Semaglutide 2.4 mg Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'spread': '9', 'groupId': 'OG000'}, {'value': '0', 'spread': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in pulse from baseline (week 0) to week 68 is presented. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.', 'unitOfMeasure': 'Beats/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Amylase - Semaglutide 2.4 mg Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '350', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.24', 'spread': '28.3', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '25.0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in amylase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.', 'unitOfMeasure': 'Ratio of amylase', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Lipase - Semaglutide 2.4 mg Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '350', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.41', 'spread': '57.2', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '51.8', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in lipase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.', 'unitOfMeasure': 'Ratio of lipase', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Calcitonin - Semaglutide 2.4 mg Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.94', 'spread': '60.3', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '38.6', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in calcitonin (nanogram/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.', 'unitOfMeasure': 'Ratio of calcitonin', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly subcutaneous (s.c; under the skin) semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'FG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '403'}, {'groupId': 'FG001', 'numSubjects': '404'}, {'groupId': 'FG002', 'numSubjects': '403'}]}, {'type': 'Exposed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '402'}, {'groupId': 'FG001', 'numSubjects': '403'}, {'groupId': 'FG002', 'numSubjects': '402'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '403'}, {'groupId': 'FG001', 'numSubjects': '404'}, {'groupId': 'FG002', 'numSubjects': '403'}]}, {'type': 'Safety Analysis Set (SAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '402'}, {'groupId': 'FG001', 'numSubjects': '403'}, {'groupId': 'FG002', 'numSubjects': '402'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '390'}, {'groupId': 'FG001', 'numSubjects': '391'}, {'groupId': 'FG002', 'numSubjects': '383'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The trial was conducted at 149 sites in 12 countries as follows: Argentina (5 sites), Canada (10 sites), Germany (9 sites), Greece (6 sites), India (18 sites), Japan (12 sites), Russian Federation (9 sites), South Africa (6 sites), Spain (8 sites), United Arab Emirates (5 sites), United Kingdom (10 sites) and United States (51 sites).', 'preAssignmentDetails': "Participants were randomised in 1:1:1 ratio to receive either 'semaglutide 2.4 milligram (mg) and placebo II (placebo matched to semaglutide 1.0 mg) once weekly', 'semaglutide 1.0 mg and placebo I (placebo matched to semaglutide 2.4 mg) once weekly' or 'placebo I and placebo II once weekly'."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'BG000'}, {'value': '404', 'groupId': 'BG001'}, {'value': '403', 'groupId': 'BG002'}, {'value': '1210', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Semaglutide 1.0 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'BG001', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56', 'spread': '10', 'groupId': 'BG000'}, {'value': '55', 'spread': '11', 'groupId': 'BG001'}, {'value': '55', 'spread': '11', 'groupId': 'BG002'}, {'value': '55', 'spread': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}, {'value': '616', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}, {'value': '594', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '272', 'groupId': 'BG000'}, {'value': '237', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}, {'value': '751', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '317', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Applicable', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Not Hispanic or Latino', 'measurements': [{'value': '344', 'groupId': 'BG000'}, {'value': '357', 'groupId': 'BG001'}, {'value': '354', 'groupId': 'BG002'}, {'value': '1055', 'groupId': 'BG003'}]}, {'title': 'Hispanic or Latino', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}]}, {'title': 'Not Applicable', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) which comprised all randomised participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-08', 'size': 2838077, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-07-20T04:09', 'hasProtocol': True}, {'date': '2020-05-19', 'size': 1089031, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-07-20T04:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'dispFirstSubmitDate': '2021-03-11', 'completionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-08', 'studyFirstSubmitDate': '2018-05-30', 'dispFirstSubmitQcDate': '2021-07-20', 'resultsFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2018-05-30', 'dispFirstPostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-20', 'studyFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2-week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.'}, {'measure': 'Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo', 'timeFrame': 'At week 68', 'description': 'Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.'}], 'secondaryOutcomes': [{'measure': 'Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg', 'timeFrame': 'At week 68', 'description': 'Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Change in Waist Circumference', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in waist circumference from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Change in Body Weight (Kg)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body weight (kg) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Change in BMI', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in body mass index (BMI) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Participants Who Achieve (Yes/no): Body Weight Reduction ≥10%', 'timeFrame': 'At week 68', 'description': 'Number of participants who achieved weight reduction ≥10% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Participants Who Achieve (Yes/no): Body Weight Reduction ≥15%', 'timeFrame': 'At week 68', 'description': 'Number of participants who achieved weight reduction ≥15% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Participants Who Achieve (Yes/no): Body Weight Reduction ≥20%', 'timeFrame': 'At week 68', 'description': 'Number of participants who achieved weight reduction ≥20% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Change in HbA1c (%)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in glycated haemoglobin (HbA1c (%)) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Change in HbA1c (mmol/Mol)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in HbA1c (mmol/mol) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Change in FPG (mg/dL)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in fasting plasma glucose (FPG) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Change in Fasting Serum Insulin', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in fasting serum insulin from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Participants Who Achieve (Yes/no): HbA1c <7.0% (53 mmol/Mol)', 'timeFrame': 'At week 68', 'description': 'Number of participants who achieved HbA1c \\<7% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Participants Who Achieve (Yes/no): HbA1c ≤6.5% (48 mmol/Mol)', 'timeFrame': 'At week 68', 'description': 'Number of participants who achieved HbA1c ≤6.5% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% and HbA1c <7.0%', 'timeFrame': 'At week 68', 'description': 'Number of participants who achieved weight reduction ≥10% of their baseline body weight and HbA1c \\<7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% and HbA1c <7.0%', 'timeFrame': 'At week 68', 'description': 'Number of participants who achieved weight reduction ≥15% of their baseline body weight and HbA1c \\<7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Change in Systolic Blood Pressure', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in systolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Change in Diastolic Blood Pressure', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Change in Total Cholesterol', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in total cholesterol (measured in milligram per decilitre (mg/dL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Change in HDL Cholesterol', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in high density lipoprotein (HDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Change in LDL Cholesterol', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in low density lipoprotein (LDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Change in VLDL Cholesterol', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in very low density lipoprotein (VLDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Change in Free Fatty Acids', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in free fatty acids (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Change in Triglycerides', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in triglycerides (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Change in hsCRP', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in high sensitivity C-reactive protein (hsCRP; measured in milligram per ilitre (mg/L)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Change in PAI-1 Activity', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in Plasminogen Activator Inhibitor-1 (PAI-1; measured in arbritary units per millilitre (AU/mL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.'}, {'measure': 'Change in Short Form 36 v2.0 Acute (SF-36) (Physical Functioning Score)', '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 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for 'physical functioning domain'. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period."}, {'measure': 'Change in SF-36 (All Scores Except Physical Functioning)', '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 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for all the domains, except physical functioning. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. 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. Results are based on the data from in-trial observation period."}, {'measure': 'Change in IWQOL-Lite for CT (Physical Function Domain (5-items) Score)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': "The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical function domain'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact."}, {'measure': 'Change in IWQOL-Lite for CT (All Scores Except Physical Function)', 'timeFrame': 'Baseline (week 0) to week 68', 'description': "The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical and psychosocial domains, and for total'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact."}, {'measure': 'Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score', 'timeFrame': 'At 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 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 overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants\' own perspective based on Food and Drug Administration (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. Endpoint was evaluated based on 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 (Yes/no): Responder Definition Value for IWQOL-Lite for CT Physical Function Domain (5-items) Score', 'timeFrame': 'At 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 which was defined as the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).'}, {'measure': 'Number of TEAEs - Semaglutide 2.4 mg Versus Placebo', 'timeFrame': 'Week 0 to week 75', 'description': 'Adverse events (AEs) with onset during the on-treatment observation period were defined as treatment-emergent AEs (TEAEs). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses.'}, {'measure': 'Number of SAEs - Semaglutide 2.4 mg Versus Placebo', 'timeFrame': 'Week 0 to week 75', 'description': 'Serious adverse event (SAE) results are based on the on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses.'}, {'measure': 'Number of Treatment Emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemia Episodes - Semaglutide 2.4 mg Versus Placebo', 'timeFrame': 'Week 0 to week 75', 'description': 'Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least 7 consecutive missed doses. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration. Blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that is BG confirmed by PG value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.'}, {'measure': 'Change in Pulse - Semaglutide 2.4 mg Versus Placebo', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in pulse from baseline (week 0) to week 68 is presented. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.'}, {'measure': 'Change in Amylase - Semaglutide 2.4 mg Versus Placebo', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in amylase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.'}, {'measure': 'Change in Lipase - Semaglutide 2.4 mg Versus Placebo', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in lipase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.'}, {'measure': 'Change in Calcitonin - Semaglutide 2.4 mg Versus Placebo', 'timeFrame': 'Baseline (week 0) to week 68', 'description': 'Change in calcitonin (nanogram/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Overweight']}, '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': '33667417', 'type': 'RESULT', 'citation': 'Davies M, Faerch L, Jeppesen OK, Pakseresht A, Pedersen SD, Perreault L, Rosenstock J, Shimomura I, Viljoen A, Wadden TA, Lingvay I; STEP 2 Study Group. Semaglutide 2.4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. Lancet. 2021 Mar 13;397(10278):971-984. doi: 10.1016/S0140-6736(21)00213-0. Epub 2021 Mar 2.'}, {'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': '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': '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': '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 the participant\'s body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the study medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what else the participant can do to lose weight. Overweight and obesity is associated with an increased risk of type 2 diabetes. Therefore, weight loss has shown to have a beneficial impact on the blood sugar levels. The participant will either get semaglutide or "dummy" medicine - which treatment the participant get is decided by chance. The participant will need to take 2 injections at the same time 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 will last for about 1.5 years'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\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 27 kg/m\\^2 '\n* History of at least one self-reported unsuccessful dietary effort to lose body weight\n* Diagnosed with type 2 diabetes (haemoglobin A1c 7-10% (53-86 mmol/mol) (both inclusive)) 180 days or longer prior to the day of screening\n\nExclusion Criteria:\n\n* A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records\n* Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 mL/min/1.73 m\\^2 (less than 60 ml/min/1.73 m\\^2 in subjects treated with Sodium-glucose Cotransporter 2 Inhibitors) according to chronic kidney disease (CKD)-Epidemiology Collaboration (EPI) creatinine equation as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening\n* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (e.g. optometrist) within the past 90 days prior to screening or in the period between screening and randomisation"}, 'identificationModule': {'nctId': 'NCT03552757', 'acronym': 'STEP 2', 'briefTitle': 'Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes 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 and Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'NN9536-4374'}, 'secondaryIdInfos': [{'id': 'U1111-1200-8148', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}, {'id': '2017-003414-10', 'type': 'OTHER', 'domain': 'European Medicines Agency (EudraCT)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Semaglutide 1.0 mg', 'description': 'Participants will receive semaglutide 1.0 mg and semaglutide placebo I during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.', 'interventionNames': ['Drug: Semaglutide 1.0 mg', 'Drug: Placebo I (Semaglutide)']}, {'type': 'EXPERIMENTAL', 'label': 'Semaglutide 2.4 mg', 'description': 'Participants will receive semaglutide 2.4 mg and semaglutide placebo II during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.', 'interventionNames': ['Drug: Semaglutide 2.4 mg', 'Drug: Placebo II (Semaglutide)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Semaglutide placebo I/II', 'description': 'Participants will receive semaglutide placebo I and II during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.', 'interventionNames': ['Drug: Placebo I (Semaglutide)', 'Drug: Placebo II (Semaglutide)']}], 'interventions': [{'name': 'Semaglutide 1.0 mg', 'type': 'DRUG', 'description': 'Subcutaneous (s.c.) injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.', 'armGroupLabels': ['Semaglutide 1.0 mg']}, {'name': 'Semaglutide 2.4 mg', 'type': 'DRUG', 'description': 'Subcutaneous injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.', 'armGroupLabels': ['Semaglutide 2.4 mg']}, {'name': 'Placebo I (Semaglutide)', 'type': 'DRUG', 'description': 'S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 2.4 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.', 'armGroupLabels': ['Semaglutide 1.0 mg', 'Semaglutide placebo I/II']}, {'name': 'Placebo II (Semaglutide)', 'type': 'DRUG', 'description': 'S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 1.0 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.', 'armGroupLabels': ['Semaglutide 2.4 mg', 'Semaglutide placebo I/II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90620', 'city': 'Buena Park', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.86751, 'lon': -117.99812}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90717', 'city': 'Lomita', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.79224, 'lon': -118.31507}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91345', 'city': 'Mission Hills', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.68609, 'lon': -120.43683}}, {'zip': '91978', 'city': 'Spring Valley', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.74477, 'lon': -116.99892}}, {'zip': '91356-3551', 'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}, {'zip': '80401', 'city': 'Golden', 'state': 'Colorado', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.75554, 'lon': -105.2211}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32205', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34744', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '33709', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30022', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '30318', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30076', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62711', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '50265', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40213', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '55416', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '38654-3573', 'city': 'Olive Branch', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.96176, 'lon': -89.82953}}, {'zip': '59701', 'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'zip': '08648', 'city': 'Lawrenceville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.29733, 'lon': -74.7296}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27408', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '28601', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '44281', 'city': 'Wadsworth', 'state': 'Ohio', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.02561, 'lon': -81.72985}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '37620', 'city': 'Bristol', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.59511, 'lon': -82.18874}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78749', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75251', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390-9302', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77079', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78231', 'city': 'Shavano Park', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 29.58495, 'lon': -98.55252}}, {'zip': '84790', 'city': 'St. George', 'state': 'Utah', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.10415, 'lon': -113.58412}}, {'zip': '22601', 'city': 'Winchester', 'state': 'Virginia', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.18566, 'lon': -78.16333}}, {'zip': '98502', 'city': 'Olympia', 'state': 'Washington', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.04491, 'lon': -122.90169}}, {'zip': 'C1060ABA', 'city': 'CABA', 'country': 'Argentina', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': 'B6740ELF', 'city': 'Chacabuco', 'country': 'Argentina', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -34.64203, 'lon': -60.47124}}, {'zip': 'X5016KEH', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '5500', 'city': 'Mendoza', 'country': 'Argentina', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'zip': 'G4200', 'city': 'Santiago del Estero', 'country': 'Argentina', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -27.80047, 'lon': -64.26285}}, {'zip': 'T2V 4J2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'A1N 1W7', 'city': 'Mount Pearl', 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.51659, 'lon': -52.78135}}, {'zip': 'L4K 4M2', 'city': 'Concord', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.80011, 'lon': -79.48291}}, {'zip': 'N5W 6A2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L8J 0B6', 'city': 'Stoney Creek', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.21681, 'lon': -79.76633}}, {'zip': 'M4G 3E8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M9V 4B4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1M 1B1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4T 1Z9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G0A 4B0', 'city': 'Saint-Marc-des-Carrieres', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 46.68335, 'lon': -72.0491}}, {'zip': '45136', 'city': 'Essen', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '14612', 'city': 'Falkensee', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.56014, 'lon': 13.0927}}, {'zip': '22041', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '22607', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '49808', 'city': 'Lingen', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.52143, 'lon': 7.31845}}, {'zip': '48145', 'city': 'Münster', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '66780', 'city': 'Rehlingen-Siersburg', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.37565, 'lon': 6.68439}}, {'zip': '97421', 'city': 'Schweinfurt', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.04937, 'lon': 10.22175}}, {'zip': '70378', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': 'GR-11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': 'GR-12462', 'city': 'Haidari-Athens', 'country': 'Greece', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': 'GR-54636', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': 'GR-54643', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': 'GR-57001', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': 'GR-57010', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '380007', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '380054', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '560054', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '682041', 'city': 'Kochi', 'state': 'Kerala', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 9.93988, 'lon': 76.26022}}, {'zip': '400008', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '400012', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '411013', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '110029', 'city': 'New Dehli', 'state': 'New Delhi', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '302017', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '600 013', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '600086', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '641009', 'city': 'Coimbatore', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}, {'zip': '700054', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '700064', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '110088', 'city': 'New Delhi', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '500 003', 'city': 'Secunderabad', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 17.50427, 'lon': 78.54263}}, {'zip': '260-0804', 'city': 'Chiba-shi, Chiba', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '103-0002', 'city': 'Chuo-ku, Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '812-8582', 'city': 'Fukuoka-shi, Fukuoka', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '060-0062', 'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '062-0007', 'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '311-0113', 'city': 'Ibaraki', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'zip': '582-0005', 'city': 'Kashiwara-shi, Osaka', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '181-0013', 'city': 'Mitaka-shi, Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '565-0871', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '569-1045', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '060-0001', 'city': 'Sapporo-shi, Hokkaido', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '323-0022', 'city': 'Tochigi', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.38333, 'lon': 139.73333}}, {'zip': '00921', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '656043', 'city': 'Barnaul', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'zip': '117036', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '123448', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '127486', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '129110', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '194291', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194354', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '199226', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '634050', 'city': 'Tomsk', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'zip': '2001', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '2013', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '0181', 'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '0184', 'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '4001', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '0250', 'city': 'Brits', 'state': 'North West', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -25.63473, 'lon': 27.78022}}, {'zip': '04009', 'city': 'Almería', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '38320', 'city': 'San Cristóbal de La Laguna', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 28.4853, 'lon': -16.32014}}, {'zip': '41003', 'city': 'Seville', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41010', 'city': 'Seville', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '47010', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'zip': '22241', 'city': 'Dubai', 'country': 'United Arab Emirates', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}, {'zip': '4545', 'city': 'Dubai', 'country': 'United Arab Emirates', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}, {'zip': '9115', 'city': 'Dubai', 'country': 'United Arab Emirates', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}, {'zip': '7272', 'city': 'Hatta', 'country': 'United Arab Emirates', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 24.80073, 'lon': 56.12726}}, {'zip': '24', 'city': 'Umm Al Quwain City', 'country': 'United Arab Emirates', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 25.56473, 'lon': 55.55517}}, {'zip': 'CH2 1UL', 'city': 'Chester', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.1905, 'lon': -2.89189}}, {'zip': 'CW5 5NX', 'city': 'Crewe', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.09787, 'lon': -2.44161}}, {'zip': 'G31 2ER', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'HG2 7SX', 'city': 'Harrogate, North Yorkshire', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': 'LE5 4PW', 'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'TS4 3BW', 'city': 'Middlesbrough', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'zip': 'CB7 5JD', 'city': 'Soham', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.33543, 'lon': 0.33654}}, {'zip': 'SG1 4AB', 'city': 'Stevenage', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.90224, 'lon': -0.20256}}, {'zip': 'WD25 7NL', 'city': 'Watford', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.65531, 'lon': -0.39602}}, {'zip': 'NN8 4RW', 'city': 'Wellingborough', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.30273, 'lon': -0.69446}}], 'overallOfficials': [{'name': 'Clinical Reporting Anchor and Disclosure (1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'http://www.novonordisk-trials.com', 'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk-trials.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}