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 @ 9:49 PM
Ignite Modification Date: 2025-12-25 @ 7:27 PM
NCT ID: NCT00935532
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00935532
Study Brief: Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus
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 Subcutaneous injection, 2.0mg, once a week. None None 6 215 145 215 View
Insulin Glargine Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day None None 5 212 65 212 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Fibula fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Lacunar infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Cholecystitis acute NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Jaundice cholestatic NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Status asthmaticus NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Tibia fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Diverticulitis intestinal haemorrhagic NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Injection site induration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Induration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Injection site pruritus NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View