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 @ 10:57 PM
Ignite Modification Date: 2025-12-25 @ 8:25 PM
NCT ID: NCT00615069
Description: Note: only major/minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events had to result in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Frequency Threshold: 5
Time Frame: Adverse Event results reflect the final (through 5 year) data.
Study: NCT00615069
Study Brief: Study of the Large Diameter GORE EXCLUDER® AAA Endoprosthesis in Abdominal 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
31 mm GORE EXCLUDER® Test Subjects GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). None None 24 35 33 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bleeding None Blood and lymphatic system disorders None View
Cardiac None Cardiac disorders None View
Bowel None Gastrointestinal disorders None View
Endoleak None General disorders None View
Other None General disorders None View
Sepsis None Infections and infestations None View
Wound None Injury, poisoning and procedural complications None View
Neoplasm None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Neurologic None Nervous system disorders None View
Renal Function None Renal and urinary disorders None View
Pulmonary None Respiratory, thoracic and mediastinal disorders None View
Lumen Obstruction None Vascular disorders None View
Vascular None Vascular disorders None View
Other Events(If Any):

Other Events

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