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 |
|---|---|---|---|---|---|---|---|---|
| Normal Saline | Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil Normal Saline | None | None | 0 | 28 | 0 | 28 | View |
| Flurbiprofen AxetilⅠ | Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated | None | None | 0 | 28 | 0 | 28 | View |
| Flurbiprofen AxetilⅡ | Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated | None | None | 0 | 28 | 0 | 28 | View |
| Butorphanol | Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentani | None | None | 0 | 28 | 0 | 28 | View |
| Butorphanol-Flurbiprofen Axetil | A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentani | None | None | 0 | 28 | 0 | 28 | View |
| Sufentanil | Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil | None | None | 0 | 28 | 0 | 28 | View |