Table 1 Categories for adverse events
Category | Definition |
|---|---|
Mild | The adverse event does not interfere with the participant’s daily routine and does not require intervention; it causes slight discomfort |
Moderate | The adverse event interferes with some aspects of the participant’s routine or requires intervention, but is not damaging to health; it causes moderate discomfort |
Severe | The adverse event results in an alteration, discomfort or disability that is clearly damaging to health |