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 |
|---|---|---|---|---|---|---|---|---|
| Senofilcon A/Alphafilcon A/Etafilcon A | First Intervention: senofilcon A toric contact lenses Second Intervention: alphafilcon A toric contact lenses Third Intervention: etafilcon A sphere contact lenses | None | None | 0 | 17 | 0 | 17 | View |
| Alphafilcon A/Etafilcon A/Senofilcon A | First Intervention: alphafilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: senofilcon A toric contact lenses | None | None | 0 | 17 | 0 | 17 | View |
| Etafilcon A/Senofilcon A/Alphafilcon A | First Intervention: etafilcon A sphere contact lenses Second Intervention: senofilcon A toric contact lenses Third Intervention: alphafilcon A toric contact lenses | None | None | 0 | 16 | 0 | 16 | View |
| Senofilcon A/Etafilcon A/Alphafilcon A | First Intervention: senofilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: alphafilcon A toric contact lenses | None | None | 0 | 14 | 0 | 14 | View |
| Alphafilcon A/Senofilcon A/Etafilcon A | First intervention: alphafilcon A toric Second intervention: senofilcon A toric Third intervention: etafilcon A sphere | None | None | 0 | 16 | 0 | 16 | View |
| Etafilcon A/Alphafilcon A/Senofilcon A | First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses | None | None | 0 | 16 | 0 | 16 | View |