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 |
|---|---|---|---|---|---|---|---|---|
| ICE T | 1. ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge. 2. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge. 3. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge 4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain. 5. Patients will be discharged home with PO Tylenol and PO toradol PRN. Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough | 0 | None | 0 | 30 | 0 | 30 | View |
| Standard | 1. Motrin 600mg PO Q4h PRN pain 1-3 2. Percocet 1 tab PO Q4-6 hours PRN 4-6 pain 3. Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain 4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain. 5. Patients will be discharged home with Motrin and Percocet for pain PRN. Motrin/Percocet/Dilaudid for breakthrough: Standard regimen | 0 | None | 0 | 33 | 0 | 33 | View |