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 |
|---|---|---|---|---|---|---|---|---|
| Hippocampus-stimulation | Different stimulation conditions (hippocampal or sham) will be delivered in each round of stimulation (5 days). Repetitive TMS will be applied at 100% resting motor threshold intensity to a region of interest located in the parietal cortex, which will be determined based on its connectivity with the hippocampus. This stimulation consists of a series of 1,600 pulses administered as 2-second periods of 20 Hz pulse trains separated by 28-s inter-train intervals (\~20 minutes for the entire daily stimulation session). | 0 | None | 0 | 10 | 0 | 10 | View |
| Sham-stimulation | Parameters will be identical to the hippocampus-stimulation, except that the coil will be flipped over to the sham side, and a stimulating electrode will be attached to the skin near the parietal rTMS target location. This electrode will be used to deliver a small current mimicking real stimulation sensation; therefore, participants cannot reliably discriminate physical sensations for real versus sham rTMS. | 0 | None | 0 | 10 | 0 | 10 | View |