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 |
|---|---|---|---|---|---|---|---|---|
| Standard Disposal Instructions | These patients will receive standard instructions on proper disposal of excess pain medication following orthopedic foot and ankle surgery. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal. | 0 | None | 0 | 0 | 0 | 37 | View |
| At Home Disposal | With patients' prescription for post operative pain medication, a Deterra portable drug deactivation system will be provided, along with instructions on proper use. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal. Deterra Drug Deactivation System: A portable bag that will neutralize and dissolve excess medication, rendering it completely unusable and safe for landfill disposal. The system meets FDA and DEA standards for at home disposal systems. | 0 | None | 0 | 0 | 0 | 38 | View |