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 |
|---|---|---|---|---|---|---|---|---|
| Intervention Cohort | Open cerebral oximetry monitoring; observed desaturations will be treated with an intervention algorithm including increase FiO2, head/neck repositioning,vasoconstrictor agents, IV fluid bolus, increase ETCO2, additional anesthesia, RBC transfusion. Vasoconstrictor Agents: cerebral desaturations may be treated with IV vasoactives to increase blood pressure or cardiac output at attending physician's descretion. Head/neck repositioning: Assure that arterial and venous neck blood flow is not obstructed related to patient positioning Increase ETCO2: Allow normalization or slight increase in end tidal CO2 to cause selective cerebral vasodilation and increased tissue blood flow/O2 delivery IV fluid bolus: Administer IV fluids to increase preload and cardiac output Additional anesthesia: By deepening anesthetic there will be a decrease in cerebral metabolic oxygen consumption. RBC transfusion: By administering RBCs there will be a increase in intravascular volume and cardiac preload and an increase in oxygen carrying capacity Increase FiO2: Increase FiO2 to improve oxygen delivery to tissue | 0 | None | 0 | 0 | 0 | 0 | View |
| Blinded Cerebral Oximetry Monitoring | These subjects will have continous cerebral oximetry monitoring like the experimental cohort but the values will be blinded to all clinicians and research staff. There will be no cerebral desaturation interventions in this group because the clinicians will not be aware of a desaturation as the monitor's output is blinded in this group. | 0 | None | 0 | 0 | 0 | 0 | View |