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 |
|---|---|---|---|---|---|---|---|---|
| High Modal Controllability TMS Target in ADHD Participants | We will administer TMS to an individualized target of high regional controllability while patient completes a working memory task inside the MRI scanner. Transcranial Magnetic Stimulation (TMS): Transcranial Magnetic Stimulation (TMS) is a non-invasive form of brain stimulation. TMS can influence activity in various brain regions, and it allows researchers to test or modify brain circuit communication. High controllability TMS target: Administer TMS to a brain regions with high modal controllability while the subject engages in a working memory task. | 0 | None | 0 | 19 | 2 | 19 | View |
| High & Low Modal Controllability TMS Target in Non-symptomatic Participants | Non-symptomatic participants will complete 2 TMS/fMRI visits with alternate targets for a high and low modal controllability target. We will administer TMS to an individualized target of high \& low modal controllability while asymptomatic participant completes a working memory task inside the MRI scanner. Transcranial Magnetic Stimulation (TMS): Transcranial Magnetic Stimulation (TMS) is a non-invasive form of brain stimulation. TMS can influence activity in various brain regions, and it allows researchers to test or modify brain circuit communication. High controllability TMS target: Administer TMS to a brain regions with high modal controllability while the subject engages in a working memory task. | 0 | None | 0 | 26 | 0 | 26 | View |