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 |
|---|---|---|---|---|---|---|---|---|
| Individual Analysis | Study subjects randomized to the "Individual Analysis" arm received access to a decision support tool that provided personalized information on the financial implications of enrolling in different plans, including plan premiums and spending on prescription drugs, and the Medicare star ratings (a measure of average customer satisfaction). | 0 | None | 0 | 0 | 0 | 0 | View |
| Control | Usual Care: Study subjects randomized to the control arm received access to information on resources available in the community to help them choose a prescription drug plan and on how to download their prescription drug information from their electronic medical record. | 0 | None | 0 | 0 | 0 | 0 | View |
| Expert Recommendation | Study subjects randomized to the "Expert Recommendation" arm received access to a decision support tool that provided personalized, expert recommendations of particular plans as well as personalized information on the financial implications of enrolling in different plans, including plan premiums and spending on prescription drugs, and the Medicare star ratings (a measure of average customer satisfaction). | 0 | None | 0 | 0 | 0 | 0 | View |