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 |
|---|---|---|---|---|---|---|---|---|
| Erchonia FX-635 | The Erchonia FX-635 is administered to the foot 12 times over 6 weeks (2 times each week) for 15 minutes per foot. Erchonia FX-635: The Erchonia FX-635 has three independent 17 milliWatts (mW) 635 nanometer (nm) red laser diodes mounted in scanner devices. | 0 | None | 0 | 11 | 0 | 11 | View |
| Placebo Laser | Noise and appearance of output is the same but no active therapy applied. Treatment administration procedure is the same as with the experimental arm. Placebo Laser: Non-therapeutic output. | 0 | None | 0 | 6 | 0 | 6 | View |