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 |
|---|---|---|---|---|---|---|---|---|
| No Maintenance (Standard of Care) | Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy | None | None | 0 | 0 | 0 | 0 | View |
| Maintenance Therapy | Chemotherapeutic: EN3329-301 (VALSTAR) VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase | None | None | 0 | 1 | 0 | 1 | View |