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 |
|---|---|---|---|---|---|---|---|---|
| 595nm PDL - 595/1064nm Multiplex Laser - Control | A third of each participant's scar was treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). Another third of the scar was treated with 595nm PDL solely for 3 weeks (1 treatment session per week). The remaining third of the scar was left untreated for the duration of the study. A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system. 595/1064nm Multiplex Laser: The multiplex cynergy laser will be used for this study. A third of the scar will solely be treated with the 595nm PDL. | 0 | None | 0 | 18 | 2 | 18 | View |