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 @ 4:48 PM
Ignite Modification Date: 2025-12-25 @ 2:33 PM
NCT ID: NCT01990950
Description: None
Frequency Threshold: 5
Time Frame: 5 years
Study: NCT01990950
Study Brief: Fenestrated AAA Endovascular Graft Post-Approval Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Zenith® Fenestrated AAA Endovascular Graft The Zenith® Fenestrated AAA Endovascular Graft is a modular system consisting of three components, a proximal body graft, a distal bifurcated body graft and one iliac leg. 3 None 11 21 13 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrioventricular block second degree SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Retroperitoneal haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stent-graft endoleak SYSTEMATIC_ASSESSMENT General disorders None View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Gallbladder mass SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Biliary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acetabulum fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular access site pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Invasive ductal breast carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Intracranial aneurysm SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal tubular necrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dialysis SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Transfusion SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Aortic aneurysm rupture SYSTEMATIC_ASSESSMENT Vascular disorders None View
Aortic dissection SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral artery aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stent-graft endoleak SYSTEMATIC_ASSESSMENT General disorders None View
Transfusion SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Renal infarct SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View