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 |
|---|---|---|---|---|---|---|---|---|
| Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone ( | Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). | None | None | 0 | 19 | 0 | 19 | View |
| Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine | Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline. E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline. | None | None | 0 | 16 | 0 | 16 | View |
| Nerve Block With Dexamethasone (4 mg). IV Saline. | B. Nerve Block with Dexamethasone (4 mg). IV saline. B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline. | None | None | 0 | 21 | 0 | 21 | View |
| Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp | Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) | None | None | 0 | 19 | 0 | 19 | View |
| Control Nerve Block. IV Dexamethasone (4 mg). | Control Nerve Block. IV Dexamethasone (4 mg). A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg). | None | None | 0 | 17 | 0 | 17 | View |