Table 7. Severity grading of adverse events.

Grade	Definition
0	None
1	Mild: Transient or mild discomfort (< 48 hours); no medical intervention/therapy required
2	Moderate: Mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required
3	Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalization possible