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 |
|---|---|---|---|---|---|---|---|---|
| Wearable Health Tracker (WHT) | The WHT group includes only patients newly enrolled in the Geisinger Multidisciplinary Pain Program (MPP) who consent to participate in the study. WHT subjects will be recruited over 1 year, with 1 year of follow-up. | 0 | None | 0 | 113 | 0 | 113 | View |
| Historic Control (MPP) | Patients who were enrolled in the Multidisciplinary Pain Program (MPP) in the preceding year. These patients received the MPP educational program but received no WHT as part of their treatment. | 0 | None | 0 | 146 | 0 | 146 | View |
| Concurrent Control (MPM) | Patients being treated for chronic pain in the Geisinger Medical Pain Management (MPM) program over the same time period as the WHT group. These subjects do not receive the MPP educational program nor use WHT as part of their treatment. | 0 | None | 0 | 161 | 0 | 161 | View |