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 |
|---|---|---|---|---|---|---|---|---|
| Melanoma 2 Group | Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of first line treatment other than dacarbazine or temozolomide only | 0 | None | 0 | 0 | 0 | 0 | View |
| Melanoma 3 Group | Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of any second-or higherline chemotherapy treatment | 0 | None | 0 | 0 | 0 | 0 | View |
| Melanoma 4 Group | Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of local irradiation of cutaneous/subcutaneous tumor lesions | 0 | None | 0 | 0 | 0 | 0 | View |
| Melanoma 6 Group | Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of ipilimumab | 0 | None | 0 | 0 | 0 | 0 | View |
| Non-Small Cell Group | Non-small cell lung cancer patients nothing other than any standard of care treatment. | 0 | None | 0 | 0 | 0 | 0 | View |
| Melanoma 1 Group | Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of dacarbazine or temozolomide as first line treatment | 0 | None | 0 | 0 | 0 | 0 | View |
| Melanoma 5 Group | Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of local imiquimod | 0 | None | 0 | 0 | 0 | 0 | View |