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 |
|---|---|---|---|---|---|---|---|---|
| Calcium Sulfate Study Group | Group of members that will be submitted to prophylaxis with medicated calcium sulfate beads for hip or knee joint replacement Antibiotic local prophylaxis with medicated calcium sulfate beads: Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection. 3g of vancomycin mixed with Stimulan Kit (Biocomposites Ltd, United Kingdom) which includes 10 cc (20 g) of calcium sulfate hemihydrate powder | 0 | None | 0 | 44 | 0 | 44 | View |
| Control Group | Group of members that will be submitted to classic prophylaxis for hip or knee joint replacement Classical parenteral antibiotic prophylaxis: Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection. 750 mgs of Intra Venous Ceftriaxone 20 minutes before joint replacement surgery and every 8 hours for 24 hours | 0 | None | 0 | 43 | 0 | 43 | View |