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 |
|---|---|---|---|---|---|---|---|---|
| Celebrex, High Sodium | Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized). | None | None | 0 | 3 | 0 | 3 | View |
| Celebrex, Low Sodium | 100 mg Celebrex, twice per day for 7 days on low sodium diet | None | None | 0 | 3 | 0 | 3 | View |
| Placebo, Low Sodium | Placebo pill taken twice per day over the course of the diet | None | None | 0 | 3 | 0 | 3 | View |
| Placebo, High Sodium | Placebo pill taken twice per day over the course of the diet | None | None | 0 | 3 | 0 | 3 | View |