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 |
|---|---|---|---|---|---|---|---|---|
| Imaginal Exposure Writing | People with hoarding disorder will write for 20 minutes on each of 3 consecutive days about their worst-case scenario regarding discarding a possession (i.e., imaginal exposure). Imaginal Exposure Writing: Imaginal exposure is a psychotherapy strategy that has been studied and shown to be helpful in the improvement of symptoms (e.g., anxiety, worry) for other psychiatric conditions, including excessive worry and obsessive-compulsive disorder symptoms. | 0 | None | 0 | 17 | 0 | 17 | View |
| Neutral Writing | People with hoarding disorder will write for 20 minutes on each of 3 consecutive days about what they would do if they had a day off work or school. Neutral Writing: Used in prior research as a control condition for imaginal exposure. Neutral writing will involve writing about what one would do on a day off work or school. | 0 | None | 0 | 15 | 0 | 15 | View |