Table 4 Classifications of adverse event (AE) intensity
Grade | Description |
|---|---|
Grade 1 (mild) | Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated |
Grade 2 (moderate) | Minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental ADL |
Grade 3 (severe) | Medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL |
Grade 4 (life-threatening) | Life-threatening consequences; urgent intervention indicated |
Grade 5 (death) | Death related to AE |