Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 6:39 PM
Ignite Modification Date: 2025-12-25 @ 4:09 PM
NCT ID: NCT03552757
Description: All presented AEs are treatment-emergent (i.e., TEAEs).
Frequency Threshold: 5
Time Frame: 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.
Study: NCT03552757
Study Brief: Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Semaglutide 1.0 mg 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. 1 None 31 402 261 402 View
Semaglutide 2.4 mg 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. 1 None 40 403 284 403 View
Placebo 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. 1 None 37 402 190 402 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Adenocarcinoma gastric SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Anaemia postoperative SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Aortic rupture SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Bladder outlet obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Cachexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Cardiac pacemaker replacement SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 22 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 22 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Cerebral artery thrombosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Cervical vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22 View
Cholecystitis chronic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22 View
Colonic abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Diabetes mellitus inadequate control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Diabetic metabolic decompensation SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Diverticular perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Empyema SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Gastric cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Gastric cancer stage IV SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Gastrointestinal lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Gastrointestinal stromal tumour SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 22 View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Hepatocellular carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Hyperaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22 View
Hypertensive urgency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hyponatraemic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Immunisation reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 22 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Invasive ductal breast carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Joint abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Keratinising squamous cell carcinoma of nasopharynx SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Lactic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Ligament rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Lisfranc fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Myeloid leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Neuroendocrine tumour SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Neuropathic arthropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Non-alcoholic steatohepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22 View
Obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Obstructive pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Pneumonia influenzal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Sperm aspiration SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 22 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Spinal epidural haematoma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Spondylolisthesis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Stag horn calculus SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22 View
Stent placement SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 22 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Thoracic vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Thyroidectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 22 View
Traumatic haemothorax SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Trigger finger SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Ureterolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Uterine cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Uterine polyp SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 22 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Wound infection staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 22 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View