A randomized, open-label, multi-center, active-controlled phase II study comparing abiraterone acetate tablets (II), an improved formulation, versus originator abiraterone acetate in patients with metastatic castration-resistant prostate cancer

Table 3 Treatment-emergent adverse events (TEAEs)

	AAT(II) (N = 34)	OAA (N = 35)
TEAEs	26 (76.5)	30 (85.7)
Grade ≥ 3 TEAEs	3 (8.8)	8 (22.9)
SAEs	1 (2.9)	4 (11.4)
TEAEs leading to treatment interruption or discontinuation	2 (5.9)	3 (8.6)
TEAEs leading to withdrawal	0	1 (2.9)
TEAEs leading to death	0	1 (2.9)
TRAEs	18 (52.9)	19 (54.3)
Grade ≥ 3 TRAEs	2 (5.9)	5 (14.3)
Treatment-related SAEs	1 (2.9)	1 (2.9)
TRAEs leading to treatment interruption or discontinuation	1 (2.9)	1 (2.9)
TRAEs leading to withdrawal	0	0
TRAEs leading to death	0	0
Most common TEAEs^a
Alanine aminotransferase increased	6 (17.6)	7 (20.0)
Blood alkaline phosphatase increased	6 (17.6)	4 (11.4)
Aspartate aminotransferase increased	5 (14.7)	8 (22.9)
Urinary tract infection	5 (14.7)	7 (20.0)
Anemia	4 (11.8)	9 (25.7)
Hypertriglyceridemia	3 (8.8)	5 (14.3)
Hypercholesterolemia	2 (5.9)	4 (11.4)
Blood glucose increased	1 (2.9)	4 (11.4)

Data are n (%)
AAT(II), Abiraterone acetate tablets (II), OAA Originator abiraterone acetate, TEAE Treatment-emergent adverse event, SAE Serious adverse event, TRAE Treatment-related adverse event
^aMost common TEAEs are TEAEs that occurred in ≥ 10% of patients in either group

ISSN: 1741-7015