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 |
|---|---|---|---|---|---|---|---|---|
| Index PDE5i Prescription | Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population). | None | None | 0 | 0 | 0 | 0 | View |
| Control (Without PDE5i Prescription) | Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population). | None | None | 0 | 0 | 0 | 0 | View |