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 @ 7:47 PM
Ignite Modification Date: 2025-12-25 @ 5:24 PM
NCT ID: NCT00757003
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00757003
Study Brief: To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease
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 Arm - Placement of TAG Device A TAG device will be placed in the Aorta to treat the AAA. A TAG device will be used to repair the aneurysm in the thoracic aorta Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the aneurysm in the thoracic aorta None None 43 100 16 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atelectasis/Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cardiac arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
respiratory failure None Respiratory, thoracic and mediastinal disorders None View
pulmonary embolism None Respiratory, thoracic and mediastinal disorders None View
change in mental status None Nervous system disorders None View
cerebrovascular accident None Nervous system disorders None View
renal failure None Renal and urinary disorders None View
renal insufficiency None Renal and urinary disorders None View
procedural hemorrhage None Surgical and medical procedures None View
paraplegia/paraparesis None Nervous system disorders None View
type I endoleak None Surgical and medical procedures None View
type II endoleak None Surgical and medical procedures None View
access failure None Surgical and medical procedures None View
urinary tract infection None Renal and urinary disorders None View
bowel ischemia None Gastrointestinal disorders None View
thrombosis None Vascular disorders None View
lymphocele None Skin and subcutaneous tissue disorders None View
angina None Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
aortic diameter enlargement None Vascular disorders None View