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 |
|---|---|---|---|---|---|---|---|---|
| Control Group | 20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of ropivacaine) and 1mL of normal saline bilaterally (control) with standard intrathecal bupivacaine and morphine. Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine Morphine Bupivacaine Hydrochloride Normal saline 1ml: 1.0 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine | 0 | None | 0 | 7 | 0 | 7 | View |
| 2mg Dexamethasone | 20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline split between 2 sides with standard intrathecal bupivacaine and morphine. 2mg Dexamethasone: 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine Morphine Bupivacaine Hydrochloride Normal saline 0.5ml: 0.5 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine | 0 | None | 0 | 9 | 0 | 9 | View |
| 4mg Dexamethasone | 20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 20mL of 0.5% ropivacaine) and 1 mL (4mg) of dexamethasone between 2 sides with standard intrathecal bupivacaine and morphine. 4mg Dexamethasone: 1 mL (4mg) of dexamethasone Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine Morphine Bupivacaine Hydrochloride | 0 | None | 0 | 13 | 0 | 13 | View |