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 |
|---|---|---|---|---|---|---|---|---|
| Pilot Training | In this arm participants will complete a variety of baseline assessments then participate in 15-20 minute conversation based on motivational interviewing principles in which they are trained in shame resilience. Follow-ups will be conducted a month later. Assessments will be repeated and then participants will engage in a qualitative interview regarding the training. Motivational Interviewing Informed Shame Resilience Training: Shame resilience involves four elements. Understating shame, normalizing shame thoughts, reaching out, and speaking shame. Motivational interviewing will be used to elicit and guide participants through these four elements. | 0 | None | 0 | 20 | 0 | 20 | View |