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 @ 6:38 PM
Ignite Modification Date: 2025-12-25 @ 4:08 PM
NCT ID: NCT02274857
Description: None
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT02274857
Study Brief: Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard PVI Ablation Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF. Standard PVI Ablation: Standard PVI procedure without FIRMap. 1 None 19 179 0 179 View
FIRM-guided Procedure and PVI FIRM-guided procedure followed by standard catheter ablation including PVI. FIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI. 2 None 28 171 0 171 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Arteriovenous fistula operation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
C-reactive protein increased SYSTEMATIC_ASSESSMENT General disorders None View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Vascular disorders None View
Gastroparesis postoperative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericarditis infective SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial hemmorrhage SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Sinus Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fluid overload SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Peritoneal hemorrhage SYSTEMATIC_ASSESSMENT General disorders None View
Vessel puncture site hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):