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 |
|---|---|---|---|---|---|---|---|---|
| TruEye | All subjects exposed to TruEye contact lenses worn for 8 hours during Period 1, 2, 3, or 4 as randomized | 0 | None | 0 | 28 | 0 | 28 | View |
| Pretreatment | All subjects who consented to participate in the study prior to exposure to the investigational product (including the 'No Lens wear' treatment) | 0 | None | 0 | 37 | 0 | 37 | View |
| DAILIES TOTAL1 | All subjects exposed to DT1 contact lenses worn for 8 hours during Period 1, 2, 3, or 4 as randomized | 0 | None | 0 | 29 | 0 | 29 | View |
| Clariti | All subjects exposed to clariti contact lenses worn for 8 hours during Period 1, 2, 3, or 4 as randomized | 0 | None | 0 | 29 | 0 | 29 | View |
| No Lens | All subjects exposed to "No lens wear" for 8 hours during Period 1, 2, 3, or 4 as randomized | 0 | None | 0 | 29 | 0 | 29 | View |