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 |
|---|---|---|---|---|---|---|---|---|
| Oral Naproxen | participants will be randomized to oral naproxen naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks | None | None | 0 | 44 | 0 | 44 | View |
| Oral Placebo | oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks | None | None | 0 | 42 | 0 | 42 | View |
| Transdermal Estradiol | participants will be randomized to transdermal estradiol transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks. | None | None | 0 | 43 | 0 | 43 | View |