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 |
|---|---|---|---|---|---|---|---|---|
| Electrical Neuromodulation | Subjects had the Nerivio ® applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes. Nerivio ®: Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm. | 0 | None | 0 | 60 | 0 | 60 | View |
| Sham | Subjects had the sham device applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes. Sham: Electrical stimulation to mimic study treatment intervention | 0 | None | 0 | 60 | 0 | 60 | View |