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 @ 1:34 AM
Ignite Modification Date: 2025-12-25 @ 11:48 PM
NCT ID: NCT00519194
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00519194
Study Brief: CONcomitant eValuation of Epicor Left atRial Therapy for AF
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Epicor Cardiac Ablation Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery None None 11 112 1 112 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Newly developed third degree AV block requiring permanent pacemaker implantation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Peripheral arterial embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Death SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac injury related to Epicor device rsulting in unplanned surgical or catheter intervention SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Acute heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View