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 |
|---|---|---|---|---|---|---|---|---|
| Sorafenib 200/200 | Dose level 1. Sorafenib 200 mg PO BID | None | None | 0 | 3 | 2 | 3 | View |
| Sorafenib 200/400 | Dose level 2. Sorafenib 200 mg PO Q AM and 400 mg PO Q PM | None | None | 2 | 5 | 3 | 5 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| perirectal abscess | None | Skin and subcutaneous tissue disorders | None | View |
| anemia | None | Blood and lymphatic system disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Hand-Foot syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |