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 @ 11:29 PM
Ignite Modification Date: 2025-12-25 @ 9:16 PM
NCT ID: NCT03801356
Description: None
Frequency Threshold: 0
Time Frame: For subjects who completed study, adverse events were collected during time on study, an average of 12 months. Adverse events were not collected after study termination.
Study: NCT03801356
Study Brief: Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Selective Nerve Root Block Patient will receive a Selective Nerve Root Block injection at the target level prior to surgical intervention. Selective Nerve Root Block: Prior to single level foraminotomy for lumbar foraminal stenosis, patients will undergo SNRB of the suspected nerve root. Patients will undergo surgery despite the response to injection. Patients will complete an ambulation assessment immediately before and after the injection. Distance and time will be noted. Patients will be called within 48 hours of injection to determine response to injection, and recorded as Pre-and Post-injection VAS leg as well as duration of the response. Patients will be seen at 6 weeks, 3,6, and 12 months post-surgery and outcome measured by VAS-leg, ODI, PDQ and EQ-5D scores. Data will be used to determine the ideal improvement in leg pain and duration of improvement, predicting a statistical and meaningful improvement in leg pain following foramintomy. 0 None 0 11 0 11 View
Serious Events(If Any):
Other Events(If Any):