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 @ 2:39 AM
Ignite Modification Date: 2025-12-26 @ 1:17 AM
NCT ID: NCT02558634
Description: This cohort continues to be followed and any future adverse events will be reported.
Frequency Threshold: 0
Time Frame: The study took place from January 1, 2017 - May 30, 2018. The study duration was approximately 1.5 years.
Study: NCT02558634
Study Brief: Thalamic Deep Brain Stimulation for Spasmodic Dysphonia- DEBUSSY Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Blinded DBS-ON When DBS was turned on, none of the patients had any adverse clinical events during the trial. There were no asymptomatic hemorrhages detected on the post-operative CT scans. At the conclusion of the trial (1-year post-operative), there had been no infections, erosions, or technical malfunctions. The cohort continues to be followed and future adverse event will be reported. 0 None 0 6 0 6 View
Blinded DBS-OFF When DBS was turned off, none of the patients had any adverse clinical events during the trial. There were no asymptomatic hemorrhages detected on the post-operative CT scans. At the conclusion of the trial (1-year post-operative), there had been no infections, erosions, or technical malfunctions. The cohort continues to be followed and future adverse event will be reported. 0 None 0 6 0 6 View
Open DBS-ON When DBS was turned on, none of the patients had any adverse clinical events during the trial. There were no asymptomatic hemorrhages detected on the post-operative CT scans. At the conclusion of the trial (1-year post-operative), there had been no infections, erosions, or technical malfunctions. The cohort continues to be followed and future adverse event will be reported. 0 None 0 6 0 6 View
Serious Events(If Any):
Other Events(If Any):