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 @ 10:12 PM
Ignite Modification Date: 2025-12-25 @ 7:47 PM
NCT ID: NCT00514735
Description: All adverse events (serious and nonserious) were recorded. Specific data about the event were entered into the electronic database. A planned hospital admission or unscheduled medical visit for atrial fibrillation that occurred within the follow-up period did not constitute an adverse event.
Frequency Threshold: 4
Time Frame: Adverse events (AEs) were collected from the day of randomization to trial conclusion at the final 6 month follow-up. All adverse events were included even if the subject had a repeat procedure and the 6 month follow-up period was restarted.
Study: NCT00514735
Study Brief: Tailored Treatment of Permanent 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
Ablation Management Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months. None None 41 138 25 138 View
Medical Management Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization. None None 3 72 3 72 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
cardiac tamponade NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
pseudoaneurysm NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
pulmonary infiltrates NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
drop in hematocrit secondary to ablation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
anesthesia reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Urinary tract infection with prolonged hospitalization NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
hypotension secondary to cardiac tamponade NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
hypotension/cardiogenic shock NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
pneumonia NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
acute respiratory failure NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
stroke NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
post-procedure pericarditis NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
pulmonary vein stenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
pulmonary vein narrowing, symptomatic SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
chest pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
pericardial effusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
persistent atrial septal defect secondary to septal puncture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
gastrointestinal bleeds NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
AF with rapid ventricular response NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
fever unknown origin with prolonged hospitalization NON_SYSTEMATIC_ASSESSMENT General disorders None View
nausea and vomiting NON_SYSTEMATIC_ASSESSMENT General disorders None View
pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
congestive heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
sick sinus syndrome with pacemaker insertion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
microcytic, hypochromic anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Seriously elevated INR NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
mitral regurgitation with mitral valve replacement NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
chest discomfort secondary to mitral valve regurgitation NON_SYSTEMATIC_ASSESSMENT General disorders None View
long QT with PVC's NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
rhythmol induced brugada effect NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
mitral regurgitation with surgical repair NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
retroperitoneal bleed with right ureter obstruction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
hematoma NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View