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 |
|---|---|---|---|---|---|---|---|---|
| Intermittent Theta Burst Stimulation (iTBS) to the Left dlPFC | For intermittent theta burst stimulation (iTBS) (Aim 1), participants will receive 20 trains of stimulation over the dlPFC (middle frontal gyrus) (F3) (each train: 3 pulse bursts presented at 5 hertz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% resting motor threshold, MagPro; 600 pulses total) using a figure 8 coil (Coil Cool-B65 A/P). iTBS to the left dlPFC: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the Universal Serial Bus (USB) key). | 0 | None | 0 | 11 | 0 | 11 | View |
| Intermittent Theta Burst Stimulation (iTBS) to the Motor Cortex | For intermittent theta burst stimulation (iTBS) (Aim 1), participants will receive 20 trains of stimulation over the Motor Cortex (each train: 3 pulse bursts presented at 5 hertz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% resting motor threshold, MagPro; 600 pulses total) using a figure 8 coil (Coil Cool-B65 A/P). iTBS to the Motor Cortex: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the Universal Serial Bus (USB) key). | 0 | None | 0 | 11 | 0 | 11 | View |