Table 2 Summary of treatment-emergent adverse events (HRR-deficient safety population)^a

	Talazoparib + enzalutamide (N = 198)		Placebo + enzalutamide (N = 199)
Adverse event	All grades	Grade ≥3	All grades	Grade ≥3
Any adverse event	196 (99)	134 (68)	191 (96)	79 (40)
Treatment-related adverse event	180 (91)	105 (53)	144 (72)	28 (14)
Serious adverse event	60 (30)	54 (27)	40 (20)	32 (16)
Serious and treatment-related adverse event	27 (14)	23 (12)	0	0
Adverse event resulting in dose interruption of:
Talazoparib/placebo^b	114 (58)	·	34 (17)	·
Enzalutamide^c	67 (34)	·	31 (16)	·
Adverse event resulting in dose reduction of:
Talazoparib/placebo^b	103 (52)	·	11 (6)	·
Enzalutamide^c	28 (14)	·	12 (6)	·
Adverse event resulting in permanent drug discontinuation of:
Talazoparib/placebo^b	20 (10)	·	14 (7)	·
Enzalutamide^c	15 (8)	·	14 (7)	·
Grade 5 adverse event	3 (2)^d	·	5 (3)^d	·
Most common adverse events (all grades in ≥10% of patients)^e
Anemia	128 (65)	81 (41)	31 (16)	9 (5)
Fatigue	66 (33)	3 (2)	53 (27)	2 (1)
Neutropenia	64 (32)	37 (19)	13 (7)	2 (1)
Thrombocytopenia	49 (25)	14 (7)	5 (3)	1 (<1)
Nausea	41 (21)	3 (2)	34 (17)	1 (<1)
Decreased appetite	40 (20)	2 (1)	28 (14)	2 (1)
Back pain	39 (20)	3 (2)	44 (22)	2 (1)
Leukopenia	37 (19)	11 (6)	15 (8)	0
Hypertension	36 (18)	16 (8)	38 (19)	16 (8)
Asthenia	31 (16)	4 (2)	29 (15)	0
Constipation	26 (13)	0	33 (17)	0
Fall	26 (13)	4 (2)	24 (12)	3 (2)
Arthralgia	25 (13)	0	44 (22)	0
Diarrhea	24 (12)	0	22 (11)	0
Hot flush	23 (12)	0	28 (14)	0
Dizziness	20 (10)	1 (<1)	15 (8)	2 (1)
Headache	12 (6)	0	22 (11)	1 (<1)

Data are n (%).
^aShown are adverse events that occurred from the time of the first dose of study treatment through 28 d after permanent discontinuation of all study treatments or before initiation of a new antineoplastic or any investigational therapy, whichever occurs first. Adverse events were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. All data are reported per the safety population defined as all patients who were treated with at least one dose of study treatment, including one patient who was randomized to talazoparib plus enzalutamide but received enzalutamide only (patients treated with both study treatments: N = 197 for talazoparib plus enzalutamide; N = 199 for placebo plus enzalutamide).
^bIncludes permanent discontinuation/dose reduction/dose interruption of talazoparib/placebo only plus permanent discontinuation/dose reduction/dose interruption of both talazoparib/placebo and enzalutamide.
^cIncludes permanent discontinuation/dose reduction/dose interruption of enzalutamide only plus permanent discontinuation/dose reduction/dose interruption of both talazoparib/placebo and enzalutamide.
^dNone were considered treatment related.
^eNone of these events were recorded as grade 5.

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