Table 4.

Safety.

	All grades			Grades ≥3
	Zercepac (n = 65)	Reference trastuzumab (n = 40)	p	Zercepac (n = 65)	Reference trastuzumab (n = 40)	p
Any AE	65 (100.0)	40 (100.0)	—	53 (81.5)	28 (70.0)	0.172
Nausea	28 (43.1)	16 (40.0)	0.756	6 (9.2)	3 (7.5)	0.758
Vomit	33 (50.8)	17 (42.5)	0.410	9 (13.8)	4 (10.0)	0.561
Fatigue	44 (67.7)	23 (57.5)	0.291	2 (3.1)	6 (15.0)	0.025
Infusion-related reaction	2 (3.1)	15 (37.5)	<0.001	0	1 (2.5)	0.200
Diarrhea	36 (55.4)	17 (42.5)	0.200	5 (7.7)	5 (12.5)	0.415
Decreased appetite	31 (47.7)	28 (70.0)	0.025	3 (4.6)	4 (10.0)	0.283
Elevated AST	45 (69.2)	26 (65.0)	0.653	19 (29.2)	6 (15.0)	0.096
Elevated ALT	36 (55.4)	28 (70.0)	0.136	15 (23.1)	5 (12.5)	0.180
Elevated GGT	12 (18.5)	11 (27.5)	0.277	1 (1.5)	0 (0.0)	0.431
Anemia	33 (50.8)	22 (55.0)	0.673	16 (24.6)	5 (12.5)	0.132
Thrombocytopenia	32 (49.2)	13 (32.5)	0.093	5 (7.7)	2 (5.0)	0.591
Hypertriglyceridemia	14 (21.5)	17 (42.5)	0.022	3 (4.6)	5 (12.5)	0.139
Hypokalemia	3 (4.6)	0	0.168	1 (1.5)	0 (0.0)	0.431
Neutropenia	20 (30.8)	3 (7.5)	0.005	1 (1.5)	0 (0.0)	0.431
Leukopenia	30 (46.2)	11 (27.5)	0.057	2 (3.1)	3 (7.5)	0.301
Infection	7 (10.8)	2 (5.0)	0.305	0	0	—
Dizziness	26 (40.0)	15 (37.5)	0.799	7 (10.8)	1 (2.5)	0.121
Hectic fever	22 (33.8)	15 (37.5)	0.703	10 (15.4)	4 (10.0)	0.431
Difficulty breathing	5 (7.7)	2 (5.0)	0.591	0	0	—
Rash	13 (20.0)	17 (42.5)	0.013	1 (1.5)	1 (2.5)	0.726
Myalgia	23 (35.4)	25 (62.5)	0.007	2 (3.1)	0 (0.0)	0.263
Cough	7 (10.8)	9 (22.5)	0.104	0	2 (5.0)	0.069
Hair loss	58 (89.2)	35 (87.5)	0.787	0	0	—
Insomnia	17 (26.2)	23 (57.5)	0.001	0	9 (22.5)	<0.001

AST—aspartate aminotransferase; ALT—alanine aminotransferase; GGT—gamma-glutamyl transferase.