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 |
|---|---|---|---|---|---|---|---|---|
| Liposomal Bupivacaine Group | No peripheral nerve block will be given. Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area. Liposomal bupivacaine: Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area | 0 | None | 0 | 1 | 0 | 1 | View |
| Peripheral Nerve Block Group | Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). No local analgesic agent infiltration Peripheral Nerve Block: Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). | 0 | None | 0 | 0 | 0 | 0 | View |