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 |
|---|---|---|---|---|---|---|---|---|
| All Participants | Patients will be treated as per department protocols and no additional intervention will be performed. Each patient will have an arterial catheter inserted as per our usual practice. All patients will have the FloTrac® connected to the arterial catheter (standard of care in CGH SICU) and the NICOM Cheetah® electrodes placed on the skin across the anterior thoracic wall. The NICOM CO monitor involves the application of non-invasive sensor strips. In this study, it will be applied to patients receiving the FloTrac (standard of care), on top of the standard care of monitoring with Flotrac. No additional intervention: Patients will be treated as per department protocols and no additional intervention will be performed | 0 | None | 0 | 26 | 0 | 26 | View |