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 @ 3:01 PM
Ignite Modification Date: 2025-12-25 @ 1:24 PM
NCT ID: NCT02406859
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data was collected for the entirety of the study which lasted approximately 12 weeks for each subject.
Study: NCT02406859
Study Brief: Utility of an Animated Bowel Biofeedback Training Routine to Improve Bowel Function in Individuals With SCI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Complete Spinal Cord Injury (ASIA A) Anorectal Manometry: SCI subjects medical designated with an injury severity score of ASIA A underwent anorectal manometry as a baseline assessment. Anorectal manometry is the only procedure that put this group an greater than no risk. 0 None 0 14 0 14 View
Incomplete Spinal Cord Injury (ASIA B,C,D) Anorectal Manometry: SCI subjects medical designated with an injury severity score of ASIA B,C and D underwent anorectal manometry as a baseline assessment. Participants were then asked to participate in 12 weeks of twice weekly, biofeedback training. The biofeedback training will consist of in-lab exercises that are paired with a visual feedback. Anorectal manometry was repeated after the training session to assess the effects of bowel biofeedback on anorectal function. 0 None 0 21 0 21 View
Able Body Participants Anorectal Manometry: Able bodied subjects underwent anorectal manometry as a baseline assessment. Anorectal manometry is the only procedure that put this group an greater than no risk. 0 None 0 15 0 15 View
Serious Events(If Any):
Other Events(If Any):