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 |
|---|---|---|---|---|---|---|---|---|
| Active tDCS+PA | active tDCS: tDCS is a therapeutic treatment that utilizes low amplitude direct currents (\<4 mA) to induce changes in cortical excitability. Physical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer | 0 | None | 0 | 13 | 12 | 13 | View |
| Sham tDCS+PA | sham tDCS: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session. Physical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer | 0 | None | 0 | 9 | 9 | 9 | View |