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 @ 1:19 AM
Ignite Modification Date: 2025-12-25 @ 11:27 PM
NCT ID: NCT03614793
Description: As this was a pragmatic comparative trial of standard-of-care procedures, only specific Adverse Events were to be recorded: spinal infection, epidural hematoma, and neurological damages to the spinal nerve root(s) at the treated level(s).
Frequency Threshold: 1
Time Frame: 24 Months
Study: NCT03614793
Study Brief: A Prospective Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves Versus Facet Joint Injection of Corticosteroid for the Treatment of Lumbar Facet 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
Cooled Radiofrequency Ablation Procedure Cooled Radiofrequency Ablation (C-RFA) Procedure: Radiofrequency ablation (RFA) is a medical procedure in which heat is generated from high-frequency electrical current to lesion (burn) a targeted nerve. The procedure was performed under fluoroscopy guidance for the accuracy of needle placement. A Cooled Radiofrequency electrode was placed at the surface of the facet joint. After appropriate electrode positioning, a local anesthetic (lidocaine) was injected through the needle to help with pain during the ablation. Once the procedure was completed, all needles were removed and additional local anesthetic (bupivacaine) was injected. No corticosteroids were injected. 0 None 0 20 0 20 View
Facet Joint Inject Procedure Facet joint injection (FJI) Procedure: The procedure was performed under fluoroscopy guidance for the accuracy of needle placement. A needle was carefully placed in the facet joint(s) causing pain. Contrast dye was injected to confirm the ideal needle placement. The injection was then completed with triamcinolone (steroid) and lidocaine. This technique was repeated for each facet joint injected. For bilateral low back pain, a maximum of 4 facet joints (two on each side) were treated. For unilateral low back pain, up to 3 facet joints were treated. 0 None 0 19 0 19 View
Serious Events(If Any):
Other Events(If Any):