Adverse event
From IDWiki
Background
- Any untoward medical occurrence in a patient or research participant who is receiving a treatment
- Does not necessarily have a causal relationship with the treatment
- Adverse events that have at least a possible relationship with the treatment are called adverse reactions
- A serious adverse event is also known as a serious adverse drug reaction
Grading
Common Terminology Criteria for Adverse Events (CTCAE)
| Grade | Description |
|---|---|
| Grade 1 | Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated |
| Grade 2 | Moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living. |
| Grade 3 | Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL |
| Grade 4 | Life-threatening consequences; urgent intervention indicated |
| Grade 5 | Death related to AE |
