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 |
|---|---|---|---|---|---|---|---|---|
| Second Regimen Group | The second regimen will consist of an initial bolus dose of 30 mg/kg up to maximum of 2000 mg. Following the initial bolus dose a continuous Cefazolin drip will start until the end of surgery. Cefazolin drip dose will be 10 mg/(kg\*h) up to maximum of 667 mg/h.Two microdialysis catheters will be inserted into a paraspinal muscle and two microdialysis catheters will be inserted subcutaneously. Continuous Cefazolin drip: Mode of Cefazolin administration will be a continuous drip Paraspinal muscle microdialysis catheters: Two dialysis probes will be inserted into a paraspinal muscle Subcutaneous microdialysis catheters: Two dialysis probes will be inserted into a paraspinal subcutaneous region | 0 | None | 0 | 6 | 0 | 6 | View |
| First Regimen Group | The first regimen will consist of a bolus dose of Cefazolin 30mg/kg up to a maximum of 2000mg IV administered prior to surgical incision. The same pre-operative dose of Cefazolin will be repeated every 3 hours until the completion of surgery. Two will paraspinal muscle microdialysis catheters and two subcutaneous microdialysis catheters will be inserted. Bolus dose of Cefazolin: Mode of Cefazolin administration will be a intermittent bolus Paraspinal muscle microdialysis catheters: Two dialysis probes will be inserted into a paraspinal muscle Subcutaneous microdialysis catheters: Two dialysis probes will be inserted into a paraspinal subcutaneous region | 0 | None | 0 | 6 | 0 | 6 | View |