Table 4.

Treatment-emergent adverse events of any grade (≥10% in the total population) and of grade ≥3 by PSOC and PROC cohorts and by preprotocol amendment and postprotocol amendment subgroups.

	PSOC		PROC		Total		Preprotocol amendment		Postprotocol amendment
	(n = 90)		(n = 23)		(N = 113)		(n = 74)		(n = 39)
Adverse event	All grades	Grade ≥3	All grades	Grade ≥3	All grades	Grade ≥3	All grades	Grade ≥3	All grades	Grade ≥3
Anemia	80 (88.9)	34 (37.8)	21 (91.3)	13 (56.5)	101 (89.4)	47 (41.6)	65 (87.8)	37 (50.0)	36 (92.3)	10 (25.6)
Nausea	61 (67.8)	1 (1.1)	16 (69.6)	0	77 (68.1)	1 (0.9)	48 (64.9)	1 (1.4)	29 (74.4)	0
Decreased neutrophil count	56 (62.2)	28 (31.1)	13 (56.5)	10 (43.5)	69 (61.1)	38 (33.6)	46 (62.2)	29 (39.2)	23 (59.0)	9 (23.1)
Decreased white blood cell count	54 (60.0)	17 (18.9)	14 (60.9)	5 (21.7)	68 (60.2)	22 (19.5)	44 (59.5)	16 (21.6)	24 (61.5)	6 (15.4)
Vomiting	46 (51.1)	4 (4.4)	11 (47.8)	1 (4.3)	57 (50.4)	5 (4.4)	42 (56.8)	5 (6.8)	15 (38.5)	0
Decreased platelet count	25 (27.8)	4 (4.4)	10 (43.5)	1 (4.3)	35 (31.0)	5 (4.4)	22 (29.7)	2 (2.7)	13 (33.3)	3 (7.7)
Decreased appetite	29 (32.2)	0	5 (21.7)	0	34 (30.1)	0	21 (28.4)	0	13 (33.3)	0
Asthenia	26 (28.9)	1 (1.1)	6 (26.1)	0	32 (28.3)	1 (0.9)	20 (27.0)	1 (1.4)	12 (30.8)	0
Diarrhea	19 (21.1)	3 (3.3)	6 (26.1)	0	25 (22.1)	3 (2.7)	19 (25.7)	1 (1.4)	6 (15.4)	2 (5.1)
Increased AST	20 (22.2)	0	4 (17.4)	1 (4.3)	24 (21.2)	1 (0.9)	15 (20.3)	1 (1.4)	9 (23.1)	0
Decreased lymphocyte count	19 (21.1)	6 (6.7)	5 (21.7)	2 (8.7)	24 (21.2)	8 (7.1)	19 (25.7)	7 (9.5)	5 (12.8)	1 (2.6)
Increased ALT	18 (20.0)	1 (1.1)	5 (21.7)	0	23 (20.4)	1 (0.9)	15 (20.3)	1 (1.4)	8 (20.5)	0
Leukopenia	20 (22.2)	9 (10.0)	3 (13.0)	3 (13.0)	23 (20.4)	12 (10.6)	17 (23.0)	11 (14.9)	6 (15.4)	1 (2.6)

Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase.