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 |
|---|---|---|---|---|---|---|---|---|
| CES Device | cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM. | None | None | 0 | 17 | 0 | 17 | View |
| Sham Device | Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device. sham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device. | None | None | 0 | 14 | 0 | 14 | View |
| Usual Care Alone | No intervention; participants will receive usual medical care for fibromyalgia | None | None | 0 | 15 | 0 | 15 | View |