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 @ 3:23 PM
Ignite Modification Date: 2025-12-25 @ 1:41 PM
NCT ID: NCT00509392
Description: Number of subjects at risk = Number of subjects with adverse event information
Frequency Threshold: 0
Time Frame: 1 Month
Study: NCT00509392
Study Brief: ClosureFAST vs. Laser Ablation for the Treatment of GSV Disease: A Multicenter, Single-Blinded, Randomized 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
Radiofrequency (RF) Ablation Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA) None None 0 46 2 46 View
Endovenous Laser (EVL) Ablation Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA) None None 1 41 9 41 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thrombus extension (TE) into Common Femoral Vein (CFV) NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperpigmentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Phlebitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View