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 |
|---|---|---|---|---|---|---|---|---|
| Combidex and Neurosurgery (Group 2) | Adults with brain tumors to receive Combidex infusion and neurosurgery | None | None | 10 | 41 | 0 | 41 | View |
| Neurosurgery Only (Group 3) | Adults with brain tumors to receive neurosurgery only (NO Combidex) | None | None | 2 | 5 | 0 | 5 | View |
| Combidex Only (Group 4) | Children with brain tumors to receive Combidex only | None | None | 1 | 2 | 0 | 2 | View |
| Combidex and Neurosurgery (Group 5) | Children with brain tumors to receive Combidex and neurosurgery | None | None | 0 | 1 | 0 | 1 | View |
| Neurosurgery Only (Group 6) | Children with brain tumors to receive neurosurgery only, NO Combidex | None | None | 0 | 0 | 0 | 0 | View |
| Inflammatory Lesions (Group 7) | Adults with Inflammatory lesions (stroke or MS) to receive Combidex only | None | None | 0 | 21 | 0 | 21 | View |
| Combidex Only (Group 1) | Adults with brain tumor to receive Combidex infusion only | None | None | 10 | 46 | 0 | 46 | View |