Definition of severity of adverse event | Grade | Description |
---|---|---|
1. Mild | Grade 1 | Does not interfere with patient’s usual function (awareness of symptoms or signs, but easily tolerated (acceptable) |
2. Moderate | Grade 2 | Interferes to some extent with patient’s usual function (enough discomfort to interfere with usual activity (disturbing) |
3. Severe | Grade 3 | Interferes significantly with patient’s usual function (incapacity to work or to do usual activities (unacceptable) |
4. Life-threatening | Grade 4 | Results in risk of death, organ damage, or permanent disability (unacceptable) |
5. Death | Grade 5 | Results in death (unacceptable) |