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 @ 7:15 PM
Ignite Modification Date: 2025-12-25 @ 4:53 PM
NCT ID: NCT00589303
Description: None
Frequency Threshold: 5
Time Frame: All subjects had a follow up at 2 and 6 months.
Study: NCT00589303
Study Brief: AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Drug Therapy FDA approved rate and rhythm control drugs None None 0 14 1 14 View
Atrioventricular Node (AVN) Ablation / Pacing Atrioventricular Node ablation and device implant None None 0 13 5 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fluid accumulation SYSTEMATIC_ASSESSMENT General disorders None View
Viral Pericarditis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumothroax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Lead Reposition SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Volume Depletion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Left upper extremity swelling SYSTEMATIC_ASSESSMENT General disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Muscle Stimulation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Worsening Chronic Obstructive Pulmonary Disease (COPD) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Worsening Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View