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 |
|---|---|---|---|---|---|---|---|---|
| Single Arm | In this trial, we will deliver low-dose (8Gy in a single fraction) radiotherapy (SBRT or any other acceptable delivery method as determined by the treating physician) for palliation of symptoms in patients in whom it is clinically indicated. This dose is far lower than what has been used in the definitive settings described above. This is a safe dose, and is entirely consistent with the dose range used for routine palliation. Therefore, this trial does not involve an experimental intervention; the research aspect of this protocol is the evaluation of the immune response to clinically indicated palliative radiotherapy. Radiation therapy | 1 | None | 1 | 4 | 0 | 4 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Death NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |