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 |
|---|---|---|---|---|---|---|---|---|
| Caudal Infusion | Awake continuous caudal infusion. Bupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg | 0 | None | 0 | 11 | 0 | 11 | View |
| General Anesthesia | General anesthesia and single-dose caudal injection Propofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg. single shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg) | 0 | None | 0 | 9 | 0 | 9 | View |