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 |
|---|---|---|---|---|---|---|---|---|
| Treatment (Liposomal Cytarabine, High-dose Methotrexate) | Induction phase: All patients receive 3 doses of High-Dose Methotrexate (HD-MTX) every 2 weeks given intravenously and 3 doses of Intrathecal (IT) Liposomal Cytarabine (Depocyt) every 2 weeks over 6 weeks. Consolidation phase: 2 additional doses of HD-MTX every 2 weeks and IT-Depocyt every 2 weeks for 4 more weeks. Maintenance phase: Monthly doses of HD-MTX (up to 6 doses) and IT-Depocyt (up to 5 doses) Patients must stop participation anytime MRI shows progressive disease or positive CSF cytology. | 3 | None | 0 | 3 | 2 | 3 | View |