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 @ 7:16 PM
Ignite Modification Date: 2025-12-25 @ 4:53 PM
NCT ID: NCT02148003
Description: None
Frequency Threshold: 0
Time Frame: Adverse events data were collected from the end of procedure to the 1-year follow-up.
Study: NCT02148003
Study Brief: Effect of the Temperature Used in Thermal Radiofrequency Ablation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RFA at 90 Degrees Celsius Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 90 degrees Celsius RFA at 90 degrees Celsius: Ablation at 90 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 90 degrees Celsius C-arm guided 20-gauge radiofrequency needle: Needles will be adjusted to optimize sensory and motor stimulation. 0 None 0 59 0 59 View
RFA at 80 Degrees Celsius Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 80 degrees Celsius RFA at 80 degrees Celsius: Ablation at 80 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 80 degrees Celsius C-arm guided 20-gauge radiofrequency needle: Needles will be adjusted to optimize sensory and motor stimulation. 0 None 0 58 0 58 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Persistent Parethesia NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Nerve injuries NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Bleeding NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Infection NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View