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 @ 6:30 PM
Ignite Modification Date: 2025-12-25 @ 4:01 PM
NCT ID: NCT02948257
Description: None
Frequency Threshold: 0
Time Frame: 30 days
Study: NCT02948257
Study Brief: VASCADE ANTEGRADE-PVD Post-Market Registry
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
VASCADE VCS The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach. 0 None 2 52 11 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chronic osteomyelitis of ankle/foot NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute Kidney Injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Access site arterial re-bleeding after initial hemostasis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Residual hematoma < 6 cm NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Tissue tract oozing - prolonged NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pseudoaneurysm not requiring repair NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bruising NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Groin pain NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Angina NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Worsening PVD NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Mechanical Fall NON_SYSTEMATIC_ASSESSMENT General disorders None View