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 |
|---|---|---|---|---|---|---|---|---|
| Opioid-Free Anesthesia (OFA) | Opioid-free anesthesia using dexmedetomidine, ketamine, and lidocaine infusion, combined with propofol induction, desflurane maintenance, and opioid-free multimodal analgesia, continued into early recovery. | 0 | None | 0 | 30 | 0 | 30 | View |
| Opioid-Based Anesthesia (OBA) | Standard opioid-based anesthesia using remifentanil infusion plus propofol induction, desflurane maintenance, and conventional multimodal analgesia, with opioids permitted for rescue. | 0 | None | 0 | 30 | 0 | 30 | View |