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: 2025-12-25 @ 3:24 AM
Ignite Modification Date: 2025-12-26 @ 2:03 AM
NCT ID: NCT01661205
Description: None
Frequency Threshold: 5
Time Frame: 24-months
Study: NCT01661205
Study Brief: Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AtriCure Bipolar System Combined With a Catheter Ablation Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart None None 12 26 16 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Device lead damage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Procedural hypotension SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Intervertebral disc degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Unresponsive to stimuli SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Vocal cord paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Diaphragmatic paralysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Ankle operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.1 View
Heart valve operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.1 View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Cardiac tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Multi-organ failure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Diaphragmatic paralysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View