Classification | Magnitude of the adverse event |
---|---|
Grade 1 | Mild adverse event. Asymptomatic or mild clinical symptoms or just an observation; intervention not indicated. |
Grade 2 | Moderate adverse event. Minimal, local or non-invasive intervention indicated. |
Grade 3 | Serious or medically significant adverse event, but not immediately life-threatening. Hospitalization or hospitalization prolongation indicated; important limitation of self-care. |
Grade 4 | Adverse event with risk of mortality or disability. |
Grade 5 | Death associated with an adverse event. |