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 |
|---|---|---|---|---|---|---|---|---|
| Bupivacaine Supraclavicular Block | Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block. Bupivacaine supraclavicular block: 20-30mL 0.5% bupivacaine | None | None | 0 | 21 | 0 | 21 | View |
| Exparel Forearm Block | Under ultrasound guidance, 3-5 mL Exparel will be injected around the 3 nerves of the forearm prior to surgery. 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block. Exparel Forearm block: 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block. | None | None | 0 | 16 | 0 | 16 | View |