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 @ 7:04 PM
Ignite Modification Date: 2025-12-25 @ 4:38 PM
NCT ID: NCT03362957
Description: None
Frequency Threshold: 0
Time Frame: All adverse events were captured following the Sham procedure for 1 month and for the GAE procedure for the duration of the study, approximately 12 months
Study: NCT03362957
Study Brief: Geniculate Artery Embolization for Knee Pain Secondary to Osteoarthritis (OA)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GAE Procedure Patients will be randomized to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis. 0 None 0 14 8 14 View
Sham Procedure Patients will be randomized to a sham procedure. Sham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram 0 None 0 7 2 7 View
Crossover Arm If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis. 0 None 0 7 5 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin changes NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Ischemia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ecchymosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
bleeding at access site NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Knee pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Purpura NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nausea/Vomiting NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hematoma NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View