Table 2.

Treatment-emergent adverse events (TEAEs) in safety population

			AAP + LHRHa (n = 44)		LHRHa (n = 21)
No. of patients with TEAEs (%)^a			44 (100)		21 (100)
No. of patients with grade 3 TEAEs (%)^a			17 (39)		5 (24)
No. of patients with TESAEs(%)^a			2 (4.5)		2 (9.5)
No. of patients with TEAEs leading to treatment discontinuation (%)^a,b			5 (11.4)		0
	AAP+LHRHa			LHRHa
	Grade 1/2	Grade 3^d	Total	Grade 1/2	Grade 3§	Total
Most frequent TEAEs, n(%)^c
Hot flush	37 (84)	0	37 (84)	18 (86)	0	18 (86)
Anaemia	23 (52)	0	23 (52)	8 (38)	0	8 (38)
Fatigue	18 (41)	1 (2)	19 (43)	8 (38)	2 (10)	10 (48)
ALT increase	15 (34)	7 (16)	22 (50)	7 (33)	0	7 (33)
AST increase	16 (36)	1 (2)	17 (39)	7 (33)	0	7 (33)
Hypertension	2 (5)	8 (18)	10 (23)	1 (5)	2 (10)	3 (14)
Hypercholesterolaemia	9 (21)	0	9 (21)	5 (24)	0	5 (24)
Hyperglycaemia	9 (21)	0	9 (21)	3 (14)	0	3 (14)
Hyperbilirubinemia	8 (18)	0	8 (18)	1 (5)	0	1 (5)
Insomnia	3 (7)	0	3 (7)	5 (24)	1(5)	6 (29)

(AA = abiraterone acetate; AAP = abiraterone acetate + prednisone; ALT = alanine aminotransferase; AST = aspartate aminotransferase; LHRHa = luteinising hormone-releasing hormone agonist; P = prednisone; TESAE = treatment-emergent serious adverse event.

Adverse events with toxicity grade 5 are not included.

Discontinuation of study medication includes discontinuation of any of the study drugs (AA, P, or LHRHa).

TEAE in ≥15% of patients in either treatment group.

No grade 4 TEAEs were observed.

PSA recurrence was observed in 44% (19/43) and 59% (10/17) of patients in AAp+LHRHa and LHRHa groups, respectively (p = 0.28; Table 3). A lower tumor epithelium volume correlated with improved biochemical recurrence-free survivak, with a median follow-up of ≥4 yr (p = 0.0014; Table 3).