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 @ 9:40 PM
Ignite Modification Date: 2025-12-25 @ 7:22 PM
NCT ID: NCT03989232
Description: All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
Frequency Threshold: 5
Time Frame: Weeks 0-47
Study: NCT03989232
Study Brief: A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes
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 subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks. 1 None 25 480 126 480 View
Semaglutide 2.0 mg Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks. 2 None 21 479 132 479 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23 View
Adenocarcinoma pancreas SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23 View
Adenomyosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23 View
Aortic dilatation SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23 View
Aortic dissection SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23 View
Aortic valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Asymptomatic bacteriuria SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23 View
B-cell lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 23 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23 View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23 View
Death; reason unknown SYSTEMATIC_ASSESSMENT General disorders MedDRA 23 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Endometrial cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23 View
Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Glomerulonephritis membranous SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Invasive ductal breast carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23 View
Ligament rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Neuromyelitis optica spectrum disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Optic ischaemic neuropathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23 View
Papillary thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23 View
Pneumonia staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23 View
Smear cervix abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 23 View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23 View
Squamous cell carcinoma of the cervix SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23 View
Vestibular disorder SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View