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 2 | Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4. Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once | None | None | 0 | 14 | 0 | 14 | View |
| Group 1 | Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3. Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once | None | None | 0 | 16 | 0 | 16 | View |