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 |
|---|---|---|---|---|---|---|---|---|
| All Patients: Multi-Tracer PET Scans | Patients undergo PET scans with \[F-18\]fluorodeoxyglucose and \[F-18\]fluorothymidine at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses. | 1 | None | 1 | 26 | 0 | 26 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other: Death due to disease pr | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |