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: 2025-12-25 @ 4:32 AM
Ignite Modification Date: 2025-12-26 @ 3:34 AM
NCT ID: NCT05414318
Description: None
Frequency Threshold: 5
Time Frame: 5 years (Post-operative day 0-2006)
Study: NCT05414318
Study Brief: CTAG Dissection/Trauma Post Marketing Surveillance Japan
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dissection Acute complicated Stanford type B dissection 10 None 17 43 0 43 View
Trauma Traumatic thoracic aortic injury 1 None 1 12 0 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Aortic Rupture SYSTEMATIC_ASSESSMENT Vascular disorders None View
New Aortic Dissection SYSTEMATIC_ASSESSMENT Vascular disorders None View
False Lumen Enlargement (>=5mm) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Atelactasis/Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bowel Ischemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Bowel Complication SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Vascular Complication SYSTEMATIC_ASSESSMENT Vascular disorders None View
Paraplegia/Paraparesis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Endoleak Type III SYSTEMATIC_ASSESSMENT Vascular disorders None View
Prosthesis Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Complications (not device complication) SYSTEMATIC_ASSESSMENT General disorders None View
Endoleak Type Ia SYSTEMATIC_ASSESSMENT Vascular disorders None View
Endoleak, Other SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):