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 |
|---|---|---|---|---|---|---|---|---|
| Control - no Reminder | For Group 1, there will be no changes to their instructions or smart phone, which is the most common clinical situation. | 0 | None | 0 | 2 | 1 | 2 | View |
| Integrated Daily Reminder Using the D3 App | For Group 2, they will have their D3 app turned on to deliver both a push notification reminder to their smart phone and audio and visual reminders to their D3 device. Devers Drop Device (D3) app: A universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior. | 0 | None | 0 | 3 | 0 | 3 | View |
| Baseline Adherence | All subjects pre-randomization had the device with no reminders. If they took their eye drops at least 90% of the prescribed number of days they left the study | 1 | None | 0 | 50 | 1 | 50 | View |