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 @ 4:23 PM
Ignite Modification Date: 2025-12-25 @ 2:18 PM
NCT ID: NCT02213666
Description: All patients were screened for any complications at the conclusion of the clinical procedure (average of 6 hour period).
Frequency Threshold: 3
Time Frame: During enrollment, the clinical ablation procedure, while in the hospital.
Study: NCT02213666
Study Brief: Comparison of Intracardiac Echocardiography and Transesophageal Echocardiography
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Enrolled Patients The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter. None None 0 71 2 71 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Oropharyngeal bleeding from TEE SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View