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 @ 12:13 AM
Ignite Modification Date: 2025-12-25 @ 10:14 PM
NCT ID: NCT01074658
Description: None
Frequency Threshold: 0
Time Frame: 30 days post procedure
Study: NCT01074658
Study Brief: CoreValve Advance International Post Market 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
Medtronic CoreValve System Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System None None 541 996 541 996 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac tamponade None Cardiac disorders None View
Vessel dissection None Injury, poisoning and procedural complications None View
Access site complication None Injury, poisoning and procedural complications None View
Access vessel dissection None Injury, poisoning and procedural complications None View
Access vessel perforation None Injury, poisoning and procedural complications None View
Acute vessel occlusion None Injury, poisoning and procedural complications None View
Hemorrhage requiring transfusion None Injury, poisoning and procedural complications None View
Bradycardia None Cardiac disorders None View
Reposition with snare None Injury, poisoning and procedural complications None View
Valve in valve None Injury, poisoning and procedural complications None View
Valve retrieval None Injury, poisoning and procedural complications None View
Valve dislocation into LVOT None Injury, poisoning and procedural complications None View
Valve dislocation into annular aorta None Injury, poisoning and procedural complications None View
Ventricular rupture None Injury, poisoning and procedural complications None View
Hemodynamic instability requiring Heart/Lung machine None Vascular disorders None View
Resuscitation None Surgical and medical procedures None View
Ventricular fibrillation None Cardiac disorders None View
Failure of closure device requiring surgery None Surgical and medical procedures None View
Arrhythmia None Cardiac disorders None View
Other Procedural Complication None Injury, poisoning and procedural complications None View
Death None General disorders None View
Stroke/TIA None Nervous system disorders None View
Myocardial Infarction None Cardiac disorders None View
Renal Failure None Renal and urinary disorders None View
Structural Valve Deterioration None Cardiac disorders None View
Nonstructural Valve Dysfunction None Cardiac disorders None View
Bleeding Event None Vascular disorders None View
Permanent Pacemaker Implantation None Surgical and medical procedures None View
Other Serious Adverse Event None General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
AE related to Device None General disorders None View
AE related to Index procedure None General disorders None View