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 |
|---|---|---|---|---|---|---|---|---|
| Sham-CES | Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current. | 0 | None | 0 | 15 | 0 | 15 | View |
| Self-CES | Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX). | 0 | None | 0 | 15 | 0 | 15 | View |