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 |
|---|---|---|---|---|---|---|---|---|
| Reference Arm | 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours. Reference: 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours. | 0 | None | 0 | 41 | 0 | 41 | View |
| Ropivacaine Arm | ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours. Treatment administration = every 6 hours for 48 hours. Ropivacaine: ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours. Treatment administration = every 6 hours for 48 hours. | 0 | None | 0 | 44 | 0 | 44 | View |