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 @ 3:34 PM
Ignite Modification Date: 2025-12-25 @ 1:47 PM
NCT ID: NCT00345592
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00345592
Study Brief: TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Device Managed Arm Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device. Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed. None None 103 199 39 199 View
Traditional Arm Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias. Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment None None 93 197 22 197 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
worsening of cardiac disorders SYSTEMATIC_ASSESSMENT Cardiac disorders None View
hopspitalizatin/intervention SYSTEMATIC_ASSESSMENT General disorders None View
transplant SYSTEMATIC_ASSESSMENT Cardiac disorders None View
worsening of non-cardiac disorders SYSTEMATIC_ASSESSMENT General disorders None View
worsening of unknown conditions leading to death SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
device reprogramming SYSTEMATIC_ASSESSMENT Cardiac disorders None View
clinical observation SYSTEMATIC_ASSESSMENT General disorders None View