Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 1:17 AM
Ignite Modification Date: 2025-12-25 @ 11:26 PM
NCT ID: NCT00506493
Description: This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
Frequency Threshold: 5
Time Frame: Adverse events reported from treatment through 9 month follow-up.
Study: NCT00506493
Study Brief: Medtronic Concomitant Utilization of Radio Frequency for Atrial Fibrillation CURE-AF/Persistent
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Study Completion Cohort 75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study. None None 45 75 59 75 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations None View
GI Bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemodynamic Instability SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hemorrhage SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Infection/Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atrioventricular Third Degree AV Heart Block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary Edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Insufficiency/Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Renal Insufficiency/Failure: Dialysis Required SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal Insufficiency/Failure: No Dialysis Required SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Distress Syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhythms with Potentially Deleterious Hemodynamic Consequences Requiring Intervention SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Shock SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sick Sinus Syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angina Presenting as SOB SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ascites with Paracentesis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atrial Fibrillation/Atrial Flutter/Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial tachycardia with dyspnea on exertion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest tube site wound SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
COPD SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Flu SYSTEMATIC_ASSESSMENT General disorders None View
Herniated lumbar disc SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Liver Failure SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Liver Shock SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pain/discomfort on pacer site, right subclavian area SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rectal Bleeding SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Sternal Dehiscence SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Upper Extremity Cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hemodynamic Instability SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Renal Insufficiency/Failure: No Dialysis Required SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View