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 |
|---|---|---|---|---|---|---|---|---|
| Sham Enhanced Cleaning | Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution). | None | None | 0 | 97 | 0 | 97 | View |
| Enhanced Cleaning | Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution). | None | None | 0 | 93 | 0 | 93 | View |