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 |
|---|---|---|---|---|---|---|---|---|
| Control: Standard Monitoring and Blinded to Capnography | Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output. | None | None | 0 | 98 | 0 | 98 | View |
| Intervention: Standard Monitoring and Capnography Viewable | Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data. | None | None | 0 | 103 | 0 | 103 | View |