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 |
|---|---|---|---|---|---|---|---|---|
| No TP53/Rb1 Co-Mutation | HG-LCNEC tumor lacking the TP53/Rb1 co-mutation (non-small cell-like). Treatment Specific for Non-Small Cell Carcinoma/Adenocarcinoma: Treatment assigned to targetable mutation. Or, for tumors that are by and large without any targetable mutation follow Large-Cell Neuroendocrine Carcinoma (NCCN) guideline-directed best front-line treatment for specific non-small cell carcinoma/adenocarcinoma. | 0 | None | 0 | 0 | 0 | 0 | View |
| TP53/Rb1 Co-Mutation Present | HG-LCNEC tumor with the TP53/Rb1 co-mutation. Treatment for Small Cell Lung Cancer: Treatment assigned to a targetable mutation or the current standard-of-care regimen for the treatment of small cell lung cancer. | 0 | None | 0 | 0 | 0 | 0 | View |