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 @ 7:11 PM
Ignite Modification Date: 2025-12-25 @ 4:45 PM
NCT ID: NCT01278303
Description: None
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT01278303
Study Brief: Covered CP Stents for the Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment of Aortic Wall Injury Repair of aortic wall injury with covered CP Stents Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients. None None 1 82 38 82 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Aortic Wall Injury SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Device Specific SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Non-Classified SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bruising or Hemorrhage SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pain or Discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Arterial Wall Injury SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Aortic Wall Injury SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Neurologic Injury SYSTEMATIC_ASSESSMENT Nervous system disorders None View