Table 3.

Grade 3 or higher adverse events at first-line chemotherapy affecting ≥ 5% of patients.

		Cohort 1			Cohort 2
		Second-line chemotherapy n = 156	BSC n = 77	P	Combination therapy n = 89	Monotherapy n = 67	P
Hematological, n (%)	Leukopenia	50 (32)	23 (30)	0.74	25 (28)	25 (37)	0.22
	Neutropenia	96 (62)	38 (49)	0.08	54 (61)	42 (63)	0.80
	Anemia	17 (11)	16 (21)	0.04	9 (10)	8 (12)	0.72
	Thrombocytopenia	16 (10)	10 (13)	0.53	6 (7)	10 (15)	0.10
Nonhematological, n (%)	Febrile neutropenia	17 (11)	10 (13)	0.64	9 (10)	8 (12)	0.72
	Anorexia	12 (8)	11 (14)	0.11	7 (8)	5 (8)	0.93
	Nausea	7 (5)	5 (7)	0.52	6 (7)	1 (2)	0.12
	Diarrhea	9 (6)	1 (1)	0.11	6 (7)	3 (5)	0.55
	Sensory neuropathy	15 (10)	7 (9)	0.90	5 (6)	10 (15)	0.051
	ALT increased	9 (6)	6 (8)	0.55	7 (8)	2 (3)	0.20
	Biliary tract infection	7 (5)	5 (7)	0.52	4 (5)	3 (5)	0.996

Correlation of adverse events during first-line treatment with the treatment details of cohort 1 and cohort 2.