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 |
|---|---|---|---|---|---|---|---|---|
| Photo in Verification Alert | Patient photo displayed in a patient ID verification alert when placing electronic orders in the electronic health record. Photo in Verification Alert: Patient photograph displayed in a patient ID verification alert when placing electronic orders in the electronic health record. | 0 | None | 0 | 2171 | 0 | 2171 | View |
| Photo in Banner | Patient photo displayed in the banner (at the top of the screen). Photo in Banner: Patient photograph will be displayed in the banner at the top of the screen in the electronic health record. | 0 | None | 0 | 2202 | 0 | 2202 | View |
| Photo in Banner and Verification Alert | Patient photograph displayed in the banner (at the top of the screen) AND patient photo displayed in a verification alert when placing electronic orders. Photo in Banner and Verification Alert: Patient photograph will be displayed in the banner at the top of the screen in the electronic health record AND patient photograph displayed in a patient ID verification alert when placing electronic orders in the electronic health record. | 0 | None | 0 | 2196 | 0 | 2196 | View |
| No Photo | No patient photographs displayed in the electronic health record. | 0 | None | 0 | 2199 | 0 | 2199 | View |