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 @ 3:26 PM
Ignite Modification Date: 2025-12-25 @ 1:43 PM
NCT ID: NCT02796092
Description: None
Frequency Threshold: 0
Time Frame: Intraoperative, 3, 6, and 12 months
Study: NCT02796092
Study Brief: Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fibered Platinum Coils Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Fibered platinum coils None None 0 50 11 50 View
Vascular Plugs Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) Vascular plugs None None 0 50 5 50 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Migration of implant or internal device NON_SYSTEMATIC_ASSESSMENT Vascular disorders SNOMED CT View
Hematoma of neck NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders SNOMED CT View
Extravasation of blood NON_SYSTEMATIC_ASSESSMENT Vascular disorders SNOMED CT View