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 |
|---|---|---|---|---|---|---|---|---|
| Group I (Topical Keratin) | Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks). Quality-of-Life Assessment: Ancillary studies Topical Keratin: Given topically | 0 | None | 0 | 13 | 0 | 13 | View |
| Group II (Standard of Care) | Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks). Best Practice: Receive standard of care Quality-of-Life Assessment: Ancillary studies | 0 | None | 0 | 11 | 0 | 11 | View |