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 @ 2:25 AM
Ignite Modification Date: 2025-12-26 @ 12:58 AM
NCT ID: NCT04516434
Description: None
Frequency Threshold: 0
Time Frame: One month post study completion
Study: NCT04516434
Study Brief: Amplifying Sensation in Underactive Bladder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intravesical Electrical Stimulation To evaluate improvement of sensations during bladder filling and emptying with electrical stimulation to the bladder or urethra. The researchers will use the values obtained from investigational sensory testing to deliver continuous electrical stimulation to the bladder . The location depends on which value is higher compared to normal. A nurse or doctor will place a catheter with electrodes to perform this investigational study procedure to the bladder (up to 60 minutes). The researchers will also place a surface patch on the participant's abdomen to disperse the electrical current and reduce discomfort. 0 None 0 12 3 12 View
Intraurethral Electrical Stimulation To evaluate improvement of sensations during bladder filling and emptying with electrical stimulation to the bladder or urethra. The researchers will use the values obtained from investigational sensory testing to deliver continuous electrical stimulation to the urethra. The location depends on which value is higher compared to normal. A nurse or doctor will place a catheter with electrodes to perform this investigational study procedure to the urethra (up to 15 minutes). Two surface patches (electrodes) will be placed at the 3 o'clock and 9 o'clock positions, 1 to 3 centimeters from the around the vaginal opening. These electronic sensors will record muscle activity while the bladder is contracting. The intraurethral stimulation will occur during routine urodynamic evaluation when the participant urinates on a special toilet. 0 None 0 8 0 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View