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 @ 9:57 PM
Ignite Modification Date: 2025-12-25 @ 7:35 PM
NCT ID: NCT04017832
Description: AEs with onset during the on-treatment period correspond to TEAEs. On-treatment observation period represented the time period where participants were considered treated with the trial product following randomization. Results are based on the SAS which included all participants exposed to at least one dose of trial product.
Frequency Threshold: 5
Time Frame: From baseline to week 31
Study: NCT04017832
Study Brief: A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin 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
Oral Semaglutide 3 mg Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks. 2 None 16 361 109 361 View
Oral Semaglutide 7 mg Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks. 2 None 11 358 117 358 View
Oral Semaglutide 14 mg Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks. 1 None 11 361 144 361 View
Sitagliptin 100 mg Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks. 0 None 15 358 65 358 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Calculus urinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Cerebrovascular insufficiency SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Cervical dysplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24 View
Chronic gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Colon adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Dacryocystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Dacryostenosis acquired SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24 View
Dementia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Diabetic retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24 View
Facial bones fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24 View
Fracture treatment SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24 View
Hepatic steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24 View
Infected skin ulcer SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Keratitis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Lacrimal gland abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Lung adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24 View
Macular fibrosis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24 View
Stab wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24 View
Sudden hearing loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24 View
Ulna fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24 View
Umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Ureterolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Vertebrobasilar insufficiency SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View