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 |
|---|---|---|---|---|---|---|---|---|
| Early FDG PET/CT Imaging Group | Patients with advanced melanoma (Stage 3B - Stage 4) scheduled to be treated with pembrolizumab had a baseline 18F-fluorodeoxyglucose (FDG) PET/CT scan (PET0) at a median of 9 days (range, 0 - 24 days) prior to initiation of pembrolizumab, and a follow-up FDG PET/CT scan (PET1) at a median of 7 days (range, 3 - 21 days) after the first dose of pembrolizumab. | 6 | None | 0 | 19 | 0 | 19 | View |