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 |
|---|---|---|---|---|---|---|---|---|
| Topical Dilator | 40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time. | None | None | 0 | 43 | 0 | 43 | View |
| Placebo | Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time. | None | None | 0 | 43 | 0 | 40 | View |