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 |
|---|---|---|---|---|---|---|---|---|
| Group 1 Tranexamic Acid | A dosis of 2 gr of tranexamic acid (1000mg/10mL X-GEN pharmaceuticals inc.) diluted in 80mL of physiologic solution and will be divided in two applications. First application: 40mL of the solution previously prepared is applied over the surgical site and it will be left for five minutes then drained out completely by suction. Second application: The rest of 40mL of solution previously prepared is applied after placing the final TKR components (femoral, tibial and patellar), over the surgical site and leaving it without draining it by suction. Group 1 Tranexamic Acid: 2 gr of tranexamic acid will be applied on the surgical site. | 0 | None | 0 | 19 | 0 | 19 | View |
| Group 2 Platelet Rich Plasma | A final volumen of 16 ml of platelet rich plasma is obtained from the forearm vein of the patient and will be divided in two applications. First application: 8 mL of PRP are applied over the surgical site and are left for five minutes then drained out completely by suction. Second application: The rest of the 8 mL are applied after placing the final TKR cemented components (femoral, tibial and patellar), over the surgical site and leaving it without draining. Group 2 Platelet rich plasma: 16ml of platelet rich plasma will be applied of the surgical site | 0 | None | 0 | 21 | 0 | 21 | View |