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 |
|---|---|---|---|---|---|---|---|---|
| nTMS | Patients will receive a single-pulse TMS mapping of the motor area for the following reasons to determine the motor threshold, measure concurrent EMG, and mapping of the upper extremity. The Magstim Rapid2,: Transcranial Magnetic Stimulation, which is a microprocessor-controlled machine which delivers both single and repetitive transcranial magnetic stimulation (TMS). single and repetitive transcranial magnetic stimulation (TMS). TMS will be applied as single pulses to determine motor evoked potentials (MEPs), there will be no modulation of cortical excitability. | 0 | None | 0 | 2 | 0 | 2 | View |