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 |
|---|---|---|---|---|---|---|---|---|
| Working Memory App (Active Intervention) | A visual-spatial app-based working memory intervention. Working Memory Task: A smartphone-based visual-spatial working memory task that will be optimized in the Stage 1A phase of this study. | 0 | None | 0 | 0 | 0 | 0 | View |
| Visual Search App (Control Condition) | An app-based visual search task to be used as a control condition. Visual Search Task: A smartphone-based visual search task that will be optimized in the Stage 1A phase of this study. | 0 | None | 0 | 0 | 0 | 0 | View |
| Stage 1A Intervention Development | Using the NIH Stage Model of Intervention Development, this study will consist of a non-randomized Stage 1A project designed to gather feedback from adults receiving treatments for OUD. This feedback will help our research team finalize a working memory intervention in preparation for a future Stage 1B trial using a randomized design. | 0 | None | 0 | 10 | 0 | 10 | View |