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 |
|---|---|---|---|---|---|---|---|---|
| GogyUp | Participants in the GogyUp arm will have the GogyUp Reader app preloaded on a cellular-enabled tablet with the same patient education documents as the Control arm. Patients will be able to use on-demand / in-the-moment assistive-reading technologies to understand any word or phrase: * Speech-to-Text * Word-by-Word Translation * Alternative Formatting * Simplified and Contextualized Definitions * No-Fail Comprehension Questions * Personalized Training in Phonemic Awareness GogyUp Reader: Participants will have unlimited access to the assistive-reading technologies available in the GogyUp Reader app for help understanding post-visit educational documents on type 2 diabetes mellitus disease management. | 0 | None | 0 | 101 | 0 | 101 | View |
| Control | Participants in the Standard Care arm will receive the standard after-visit patient education documents the clinics current provide for type 2 diabetes education and self-management. | 0 | None | 0 | 92 | 0 | 92 | View |