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 |
|---|---|---|---|---|---|---|---|---|
| Retrograde Fill Voiding Trial Method | Bladder drained with indwelling foley catheter, then retrograde filled with 300cc sterile water. Catheter is removed Patient voids w/in 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). patient subjectively quantify their force of stream via visual analog scale (VAS) scale (however information will only be used for research purposes). If she voids \>/= 2/3 (200cc) catheter will remain out as she will have passed her voiding trial. If she voids \<200cc she will be discharged home with a catheter and instructed to follow-up in 2-5 days for an in-office retrograde voiding trial. TOV: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling catheter: If subject is unable to void adequately, a Foley catheter will be placed as per protocol and the subject discharged home with catheter. The sub | 0 | None | 0 | 87 | 0 | 87 | View |
| Force of Stream (FAST) Voiding Trial Method | Bladder drained with indwelling foley catheter, then retrograde filled with 300cc sterile water. Catheter is removed Patient voids within 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). The patient will subjectively quantify their force of stream via VAS scale. If VAS scale \>/=50 (\>/=50%) catheter will remain out, patient discharged home without measuring a PVR. If VAS scale is from 0-49 (=0-49%) a PVR will be checked via bladder scan. If PVR is \<500cc, the patient will be discharged without a catheter; if PVR is \>/=500cc, patient discharged with a catheter. If she is discharged with an indwelling foley catheter, she will have an in-office retrograde voiding trial in 2-5 days. voiding trial: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling Foley catheter: If subject is unable to void adequately | 0 | None | 0 | 86 | 0 | 86 | View |