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 @ 12:19 PM
Ignite Modification Date: 2025-12-25 @ 12:02 PM
NCT ID: NCT00583661
Description: Subjects were hospitalized while on device and serious adverse events were assessed on an on-going basis. All reported events were adjudicated by an independent Clinical Events Committee.
Frequency Threshold: 5
Time Frame: Adverse events were recorded during the time the subject was being supported on the device, an average of 58 days.
Study: NCT00583661
Study Brief: Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
EXCOR Pediatric Implantation of the EXCOR Pediatric Ventricular Assist Device None None 41 48 3 48 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bleeding SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Pericardial Fluid Collection SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neurological Dysfunction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Renal Dysfunction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Arterial Non-CNS Thromboembolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Venous Thromboembolism Event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Cardiac Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hepatic Dysfunction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Psychiatric Episode SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Right Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View