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 |
|---|---|---|---|---|---|---|---|---|
| R-CAT | While the original design called for participants to either be randomized to CAT or R-CAT or to indicate a preference and be assigned to these groups, due to risk of COVID-19 infection during the pandemic, only R-CAT could be offered during the early parts of the trial. Therefore, 21 individuals were simply assigned to R-CAT and 14 received R-CAT based upon preference. This treatment group provided Cognitive Adaptation Remotely via secure video conference, sent text message reminders, delivered environmental supports by mail. Environmental supports targeted medication and appointment follow-through, independent living skills and organization, and socialization. Supports were set up on virtual visits conducted weekly. | 0 | None | 0 | 35 | 0 | 35 | View |
| CAT Cognitive Adaptation Training | While the original design called for participants to either be randomized to CAT or R-CAT or to indicate a preference and be assigned to these groups, due to risk of COVID-19 infection during the pandemic, only R-CAT could be offered during the early parts of the trial. 21 participants received CAT based upon preference for CAT versus R-CAT. CAT involved in person assessment and establishing supports in the home for medication follow-through, independent living skills/organization and socialization. | 0 | None | 0 | 21 | 0 | 21 | View |