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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Control | Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment. control group: Medical counseling and ano-sphinctal exercises. | None | None | 0 | 4 | 0 | 4 | View |
| Study Grp/Biofeedback | Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment. Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem. | None | None | 0 | 3 | 0 | 3 | View |