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 MLS & Erchonia THL | The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator. The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject. | None | None | 0 | 12 | 0 | 12 | View |