Table 2.

Drug-related adverse events according to CTCAE v.3.0

CTCAE grade	L19IL2/DTIC Arm 1 (n = 22)				L19IL2/DTIC Arm 2 (n = 22)				DTIC Arm 3 (n = 23)
	G1	G2	G3	G4	G1	G2	G3	G4	G1	G2	G3	G4
ALT increaseda	3	3	2	0	0	1	0	0	0	1	0	0
Anorexiaa	7	0	0	0	3	1	0	0	2	0	0	0
Arthralgia	4	2	1	0	5	5	2	0	0	0	0	0
AST increaseda	1	4	0	0	0	0	0	0	1	0	0	0
Chills	7	1	0	0	3	2	0	0	0	0	0	0
Diarrhea	5	1	0	0	4	0	0	0	0	1	0	0
Fatigue	6	0	0	0	6	1	0	0	0	0	0	0
GGT increaseda	0	1	2	0	0	0	0	0	0	1	0	0
Nausea	11	2	0	0	8	6	0	0	4	1	0	0
Neutropenia	0	0	0	2	0	0	1	2	0	0	0	1
Edema peripheralb	3	0	0	0	3	0	0	0	0	0	0	0
Pyrexia	14	3	0	0	12	2	0	0	0	0	0	0
Rashb	2	0	0	0	4	0	0	0	0	0	0	0
Thrombocytopeniaa	1	1	0	0	1	1	3	1	0	0	1	0
Vomiting	6	0	0	0	5	2	0	0	2	0	0	0

^aIncidence > 15% in at least one arm of the randomized part of the study

^bIncidence was also > 15% in the previously published phase IIa + IIb step 1 parts of the study [26]