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 of Care | Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care Standard of care: Patients will be instructed to follow institutional standard of care for radiation dermatitis | 0 | None | 0 | 11 | 0 | 11 | View |
| KeraStat Cream | Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application. KeraStat(R) Cream: KeraStat Cream is a cream wound dressing that contains 5% keratin. | 0 | None | 0 | 13 | 0 | 13 | View |