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 |
|---|---|---|---|---|---|---|---|---|
| Alliance A031201 | Denosumab plus enzalutamide, abiraterone and prednisone Denosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity. Enzalutamide: 160 mg enzalutamide by mouth daily Abiraterone: 1000 mg abiraterone by mouth daily Prednisone: 5 mg prednisone by mouth twice daily | 0 | None | 0 | 0 | 0 | 0 | View |
| Standard of Care | Denosumab plus enzalutamide alone Denosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity. Enzalutamide: 160 mg enzalutamide by mouth daily | 1 | None | 1 | 1 | 0 | 0 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| intracranial hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |