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 @ 2:45 PM
Ignite Modification Date: 2025-12-25 @ 1:14 PM
NCT ID: NCT00590759
Description: Note - the severity of adverse events (serious vs non-serious) was not collected, so all events, regardless of whether they would be classified as serious or not, are reported under "Other adverse events"
Frequency Threshold: 5
Time Frame: Total Study Follow-up.
Study: NCT00590759
Study Brief: Evaluation of the GORE TAG Thoracic Endoprosthesis in the Treatment of Aneurysms
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
0502 TAG Device Subjects None None None 0 150 147 150 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bleeding Complication None Blood and lymphatic system disorders None View
Cardiac Complication None Cardiac disorders None View
Bowel Complication None Gastrointestinal disorders None View
Additional Implantation None General disorders None View
Other Complication None General disorders None View
Endoleak None Injury, poisoning and procedural complications None View
Wound Complication None Injury, poisoning and procedural complications None View
Neoplasm None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Neurologic Complication None Nervous system disorders None View
Genitourinary None Renal and urinary disorders None View
Renal Function Complication None Renal and urinary disorders None View
Pulmonary Complication None Respiratory, thoracic and mediastinal disorders None View
Vascular Complication None Vascular disorders None View