Table 4.

Toxicities.

	Group, N (%)
	Arm A (N = 65)			Arm B (N = 64)
	Any grade	Grade 3/4	Grade 5	Any grade	Grade 3/4	Grade 5
Neutrophil count decreased	7 (10.8)	1 (1.5)	0	60 (93.8)	57 (89.1)	0
Platelet count decreased	7 (10.8)	0	0	26 (40.6)	1 (1.6)	0
Febrile neutropenia	0	0	0	13 (20.3)	13 (20.3)	0
Anemia	17 (26.2)	2 (3.1)	0	46 (71.9)	8 (12.5)	0
Nausea	5 (7.7)	0	0	12 (18.8)	1 (1.6)	0
Diarrhea	12 (18.5)	1 (1.5)	0	10 (15.6)	0	0
Mucositis oral	3 (4.6)	0	0	8 (12.5)	1 (1.6)	0
Constipation	8 (12.3)	0	0	15 (23.4)	0	0
Vomiting	2 (3.1)	0	0	7 (10.9)	0	0
Fatigue	20 (30.8)	0	0	37 (57.8)	0	0
Malaise	8 (12.3)	2 (3.1)	0	13 (20.3)	3 (4.7)	0
Sepsis	1 (1.5)	1 (1.5)	0	0	0	0
Lung infection	3 (4.6)	0	0	6 (9.4)	2 (3.1)	0
Creatine phosphokinase increased	1 (1.5)	1 (1.5)	0	1 (1.6)	1 (1.6)	0
ALT increased	10 (15.4)	1 (1.5)	0	20 (31.3)	2 (3.1)	0
AST increased	16 (24.6)	2 (3.1)	0	23 (35.9)	5 (7.8)	0
Creatinine increased	17 (26.2)	1 (1.5)	0	14 (21.9)	1 (1.6)	0
Hyponatremia	14 (21.5)	1 (1.5)	0	25 (39.1)	5 (7.8)	0
Myocarditis	0	0	0	1 (1.6)	0 (0)	1 (1.6)
Sclerosing cholangitis	1 (1.5)	1 (1.5)	0	0	0	0
Myositis	0	0	0	1 (1.6)	1 (1.6)	0
Myasthenia gravis	0	0	0	1 (1.6)	1 (1.6)	0
Peripheral sensory neuropathy	2 (3.1)	0	0	7 (10.9)	0	0
Pneumonitis	9 (13.8)	1 (1.5)	1 (1.5)	8 (12.5)	2 (3.1)	0
Alopecia	0	0	0	28 (43.8)	0	0
Dermatologic disorders	6 (9.2)	0	0	37 (57.8)	1 (1.6)	0