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 @ 2:39 PM
Ignite Modification Date: 2025-12-25 @ 1:11 PM
NCT ID: NCT05481359
Description: None
Frequency Threshold: 0
Time Frame: From Index Procedure to 12 Month Follow Up
Study: NCT05481359
Study Brief: AF-FLOW Registry to Evaluate Electrographic Flow Mapping in Patients Undergoing Ablation for 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
Subjects That Did Not Receive EGF-guided Ablation Subjects who did not receive Electrographic Flow™ (EGF) guided ablation, which included: * Subjects not inducible in AF after pulmonary vein isolation, preventing EGF mapping * Subjects with no EGF-identified sources above threshold on EGF mapping * Subjects where the physician elected not to ablate an EGF-identified source above threshold 0 None 1 12 1 12 View
Subjects That Received EGF-guided Ablation Subjects who received Electrographic Flow™ (EGF) guided ablation of one or more EGF-identified sources with an activity above threshold 0 None 0 13 0 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemorrhage of iliac vein with retroperitoneal hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View