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 |
|---|---|---|---|---|---|---|---|---|
| Effects of tACS During SWS- Standard/Nested 1 | Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture. This is a triple crossover: standard tACS, then nested, then sham | 0 | None | 0 | 2 | 0 | 2 | View |
| Effects of tACS During SWS- Standard/Nested 2 | This is a triple crossover: standard tACS, then sham, then nested tACS | 0 | None | 0 | 2 | 0 | 2 | View |
| Effects of tACS During SWS- Standard/Nested 3 | This is a triple crossover: sham, then nested tACS, then standard tACS, | 0 | None | 0 | 3 | 0 | 3 | View |
| Effects of tACS During SWS- Standard/Nested 4 | This is a triple crossover: sham, then standard tACS, then nested tACS, | 0 | None | 0 | 1 | 0 | 1 | View |
| Effects of tACS During SWS- Standard/Nested 5 | This is a triple crossover: nested tACS, then sham, then standard tACS, | 0 | None | 0 | 1 | 0 | 1 | View |
| Effects of tACS During SWS- Standard/Nested 6 | This is a triple crossover: nested tACS, then standard tACS then sham. | 0 | None | 0 | 3 | 0 | 3 | View |
| Effects of tACS During SWS- Older Adults Active 1 | Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture. This is a crossover: standard tACS, then sham | 0 | None | 0 | 9 | 0 | 9 | View |
| Effects of tACS During SWS- Older Adults Active 2 | This is a crossover: sham and then standard tACS | 0 | None | 0 | 3 | 0 | 3 | View |
| Effects of tACS During SWS- MCI Active 1 | Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture. This is a crossover: standard tACS, then sham | 0 | None | 0 | 0 | 0 | 0 | View |
| Effects of tACS During SWS- MCI Active 2 | This is a crossover: sham and then standard tACS | 0 | None | 0 | 0 | 0 | 0 | View |