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 @ 11:35 PM
Ignite Modification Date: 2025-12-25 @ 9:24 PM
NCT ID: NCT00641056
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00641056
Study Brief: Efficacy of Exenatide Once Weekly and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea (DURATION - 3)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Exenatide Once Weekly Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week. None None 11 233 100 233 View
Insulin Glargine Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L. None None 10 223 52 223 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute coronary syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Atrioventricular block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cardioversion NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Drug exposure during pregnancy NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Injection site nodule NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Myocardial ischaemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Oedematous pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Viral pericarditis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Vitrectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Bile duct stone NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Carotid artery stenosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Myocarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Peripheral nerve transposition NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Colon polypectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Retinal detachment NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Injection site nodule NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View