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 |
|---|---|---|---|---|---|---|---|---|
| Investigational Product | Single Swabstick impregnated with 1.75mL of 2%(w/v) chlorhexidine gluconate in 70%(v/v) isopropyl alcohol | 0 | None | 0 | 609 | 0 | 609 | View |
| Reference Standard | 1.75 mL of 60% (v/v) 1-propanol applied with a single Swabstick | 0 | None | 0 | 419 | 0 | 419 | View |
| Active Control | ChloraPrep® SEPP® clear applicator- 2% (w/v) chlorhexidine gluconate in 70% (v/v) isopropyl alcohol | 0 | None | 0 | 609 | 0 | 609 | View |
| Negative Control | 1.75mL 0.9% Normal saline applied with a single Swabstick | 0 | None | 0 | 605 | 0 | 605 | View |