Table 4.

Severity categories of adverse events (AEs)

Severity	Description
Mild	NCI-CTCAE v4.03 grade 1
	The AE does not limit daily activities; the patients may experience slight discomfort
Moderate	NCI-CTCAE v4.03 grade 2
	The AE results in some limitation of daily activities; the patients may experience considerable discomfort
Severe	NCI-CTCAE v4.03 grade 3
	The AE results in an inability to perform daily activities; the patients may experience intolerable discomfort
Life-threatening/disabling	NCI-CTCAE v4.03 grade 4
	The AE results in a disabling situation
	The AE results in a life-threatening situation
Death	NCI-CTCAE v4.03 grade 5

*The term life-threatening in the definition of severe refers to an event, in which the patients are at a risk of death at the time of the event; it does not refer to an event which, hypothetically, might have caused death if it were more severe (ICH-E2A)