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
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| ACB Within True AC With Bupivacaine | The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine ACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block. | 0 | None | 0 | 20 | 0 | 20 | View |
| ACB Proximal to True AC With Bupivacaine | The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine ACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine | 0 | None | 0 | 23 | 0 | 23 | View |