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: 2025-12-26 @ 10:46 PM
Ignite Modification Date: 2025-12-26 @ 10:46 PM
NCT ID: NCT01171612
Description: We registered the adverse events from surgery to 90 days after All the events were included in our outcomes definitions
Frequency Threshold: 0.2
Time Frame: Perioperative events from surgery to 90 days after
Study: NCT01171612
Study Brief: Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cardiac and Cerebrovascular Events Adverse events registered independently related with antiplatelet therapy management None None 61 432 6 432 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Death SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Unstable Angina SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Significant Arrythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Stroke, Transient Ischaemic Attack SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Deep Venous Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Arterial ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders None View