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 @ 4:59 AM
Ignite Modification Date: 2025-12-26 @ 4:00 AM
NCT ID: NCT04618718
Description: None
Frequency Threshold: 0
Time Frame: 30 days (+/- 7 days)
Study: NCT04618718
Study Brief: The PROTEMBO C Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention ProtEmbo device will be used as distal protection device in subjects undergoing TAVR cerebral embolic protection during TAVR: The ProtEmbo system is an adjunctive device placed in the central arterial system at the beginning of a TAVR procedure to deflect embolic particles during the procedure and removed following the completion of the procedure. 0 None 20 64 21 64 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Left Bundle Branch Block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
TAVR access site complication NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Sedative Circulatory Complication NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Acute Kidney Injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pulmonary Edema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cardiac Tamponade/Sternotomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Radial artery dissection NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Drop in Hemoglobin NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
1st degree AV Block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
3rd degree AV block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cerebral Infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
TAVR access site hematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Left Bundle Branch Block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Postoperative nausea and vomitting/ vertigo NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Short period of delirium post TAVR NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Radial Artery Occlusion NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Vascular access site hematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Abnormal Alkaline Phosphatase and Gamma GT NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cardiac Arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Left Anterior Fascicular Block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Loss of Sphincter Tone NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View