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 @ 11:50 PM
Ignite Modification Date: 2025-12-25 @ 9:45 PM
NCT ID: NCT04702451
Description: None
Frequency Threshold: 5
Time Frame: 1 year after the study index ablation procedure
Study: NCT04702451
Study Brief: Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tailored Tailored ablation strategy Dispersion ablation + PVI: Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation VX1: VX1-based dispersion mapping 2 None 21 187 12 187 View
Anatomical Anatomical ablation strategy PVI: Pulmonary vein antrum isolation 0 None 11 183 10 183 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac tamponade or perforation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Severe cardiac decompensation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Puncture-site hemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Transient phrenic nerve palsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pneumonia aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fluid overload NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericarditis or pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vascular access complications NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Post-ablation fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abnormal ECG requiring hospitalization NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Transient ischemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Covid-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View