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 |
|---|---|---|---|---|---|---|---|---|
| Hydrocodone 5mg/Acetaminophen 325mg | Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days Hydrocodone 5Mg/Acetaminophen 325Mg Tab: 5 mg/325 mg tablet Acetaminophen 1000mg: 1000 mg tablet Ibuprofen 400 mg: 400 mg tablet | 0 | None | 0 | 10 | 0 | 10 | View |
| Acetaminophen 1000mg + Ibuprofen 400mg | Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days Acetaminophen 1000mg: 1000 mg tablet Ibuprofen 400 mg: 400 mg tablet | 0 | None | 0 | 10 | 0 | 10 | View |