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 |
|---|---|---|---|---|---|---|---|---|
| Panitumuab and Gemcitabine | Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle. | None | None | 3 | 8 | 8 | 8 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fatigue | None | General disorders | None | View |
| Anemia | None | Investigations | None | View |
| Hypocalcemia | None | Investigations | None | View |
| Abdominal pain | None | General disorders | None | View |
| Epistaxis | None | General disorders | None | View |
| Edema-limbs | None | Skin and subcutaneous tissue disorders | None | View |
| Calciphylaxis | None | Skin and subcutaneous tissue disorders | None | View |
| Rash | None | Skin and subcutaneous tissue disorders | None | View |
| Platelet count decreased | None | Investigations | None | View |