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 |
|---|---|---|---|---|---|---|---|---|
| Part 2 - Etanercept and nbUVB | Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week. | None | None | 0 | 37 | 3 | 37 | View |
| Part 2 - Etanercept | Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week. | None | None | 2 | 38 | 11 | 38 | View |
| Part 1 - Etanercept | All participants received etanercept 50 mg twice a week for 12 weeks. | None | None | 1 | 99 | 17 | 99 | View |