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 @ 9:50 PM
Ignite Modification Date: 2025-12-25 @ 7:27 PM
NCT ID: NCT00004732
Description: None
Frequency Threshold: 0
Time Frame: Periprocedural period
Study: NCT00004732
Study Brief: Carotid Revascularization Endarterectomy Versus Stenting Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Carotid-Artery Stenting Patients Randomized to CAS None None 322 1262 213 1262 View
Carotid Endarterectomy Patients Randomized to CEA None None 292 1240 212 1240 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neurologic SAE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hemorrhagic/Vascular SAE SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hemodynamic SAE SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infectious Disorder SAE SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cardiovascular SAE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angiographic/Procedural SAE SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Miscellaneous SAE SYSTEMATIC_ASSESSMENT General disorders None View
Metabolic/Electrolyte SAE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other SAE SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiovascular AE (non-endpoint, non-serious) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angiographic/Procedural AE (not serious) SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other AE (not serious) SYSTEMATIC_ASSESSMENT General disorders None View
Metabolic/Electrolyte AE (not serious) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Neurologic AE (non-endpoint, non-serious) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hemorrhagic/vascular AE (not serious) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hemodynamic AE (not serious) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infectious Disorder AE (not serious) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Miscellaneous Types of AEs (not serious) SYSTEMATIC_ASSESSMENT General disorders None View
Neurologic AE (endpoint, non-serious) SYSTEMATIC_ASSESSMENT Nervous system disorders None View