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 |
|---|---|---|---|---|---|---|---|---|
| Control | Subjects will undergo standard staged-procedures without cell infusion staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied | None | None | 0 | 7 | 0 | 7 | View |
| Cell Infusion | Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data. staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied | None | None | 0 | 7 | 0 | 7 | View |