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 Block | Liposomal Bupivacaine (1.3%) solution (20 mL dose). This solution has demonstrated increased efficacy in prolonged analgesia following injection. This solution will be injected as an ultrasound-guided subpectoral interfacial plane block. Liposomal bupivacaine: Sternal Block during Coronary Artery Bypass Graft Surgery and/or surgical aortic valve replacement through mini- or full sternotomy. We couldn't enroll sufficient mini sternotomies to infer anything statistically so our analysis concentrated on full sterntomies. | 0 | None | 0 | 27 | 0 | 27 | View |
| Saline Block | Normal saline (0.9%) will be used as the control solution for patients not receiving the liposomal bupivacaine solution. Injection procedure of this solution will be identical to that of the liposomal bupivacaine solution. Normal Saline Flush, 0.9% Injectable Solution\_#1: Sternal Block during Coronary Artery Bypass Graft Surgery and/or surgical aortic valve replacement through mini- or full sternotomy. We couldn't enroll sufficient mini sternotomies to infer anything statistically so our analysis concentrated on full sterntomies. | 0 | None | 0 | 25 | 0 | 25 | View |