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: 2025-12-25 @ 2:34 AM
Ignite Modification Date: 2025-12-26 @ 1:11 AM
NCT ID: NCT00537134
Description: The definition of adverse event does not differ from the ClinicalTrials.gov definition
Frequency Threshold: 0
Time Frame: The number of patients in each period of time over which Adverse event data was collected is variable, because the study was terminated while patients were at variable points through their expected follow-up period. For example, only 52/80 participants were evaluated at 1 month before the study was terminated; at each subsequent time point, fewer participants were evaluated. - 3 years: 2 patients - 2 years: 11 patients - 1 year: 25 patients - 6 months: 41 patients - 1 month: 52 patients
Study: NCT00537134
Study Brief: Trial on Endovascular Aneurysm Management
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Conservative Conservative management (watchful observation) 0 None 0 38 2 38 View
Endovascular Endovascular treatment Embolization, coiling: Endovascular embolization with platinum coils 0 None 1 42 3 42 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Migraine NON_SYSTEMATIC_ASSESSMENT General disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
arm hematoma NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View