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 |
|---|---|---|---|---|---|---|---|---|
| Patient Preferences | Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays. | None | None | 0 | 105 | 0 | 105 | View |
| Primary Care Providers | All healthcare providers (physicians, nurses, and other clinic staff) were eligible to participate in this study. For those enrolled, display of patient data in the EMR was dictated by the patient subject's preferences for who should see what data. Patient preferences: Software for recording patients' preferences for which providers see which parts of their EMRs, and EMR software for restricting access to data based on patients' preferences. | None | None | 0 | 31 | 0 | 31 | View |