Table 5 Adverse events severity scale

Grade 1

Mild

Transient or mild discomfort (< 48 h); no medical intervention/therapy required

Grade 2

Moderate

Mild to moderate limitation in activity—some assistance may be needed; no or minimal medical intervention/therapy required

Grade 3

Severe

Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible

Grade 4

Life-threatening

Extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable

Grade 5

Death