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 @ 4:15 PM
Ignite Modification Date: 2025-12-25 @ 2:13 PM
NCT ID: NCT06059066
Description: None
Frequency Threshold: 0
Time Frame: 6-8 weeks post-injection
Study: NCT06059066
Study Brief: Optimization of OnabotulinumtoxinA (BTX-A) Injection for the Treatment of Neurogenic Lower Urinary Tract Dysfunction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard Injection Sites (20) Standard number of injections (20 injections): 200 units or 300 units BTX-A reconstituted in 20 mL normal saline, injected into the bladder detrusor in 20 separate injections of 1 mL including the trigone. 0 None 0 28 7 28 View
Reduced Injection Sites (5) Reduced number of injections (5 injections): 200 units or 300 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder detrusor in 5 separate injections of 1 mL including the trigone. 0 None 0 26 8 26 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary Tract Infection (UTI) SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Catheter Clogging SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
New onset gross hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Increased bladder spasms SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Decreased cold tolerance SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperglycemia requiring emergency evaluation SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Plasmapheresis for CIDP SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View