Table 2.

Number of patients with metastasis post-baseline, PSA progression by PCWG2 criteria, and any rise in PSA by treatment group.

	Darolutamide (n = 955)		Placebo (n = 554)
Metastasis after baseline	130 (14% of patients)		158 (28.5% of patients)
	No. of patients	% of ITT/metastatic events	No. of patients	% of ITT/metastatic events
PSA progression by PCWG2 criteria before metastasis	59	6.2%/45%	101	18.2%/64%
No PSA progression by PCWG2 criteria before metastasis	71	7.4%/55%	57	10.3%/36%
Any PSA progression before metastasisa	85	8.9%/65%	122	22%/77%
No PSA progression before metastasis	45	4.7%/35%	36	6.5%/23%

ITT intent-to-treat, PCWG2 Prostate Cancer Working Group 2, PSA prostate-specific antigen.

^aIncludes PSA progression by PCWG2 criteria and an increase of >0.2 ng/ml for patients with a PSA nadir before metastasis of ≤2 ng/ml and as an increase of >0.5 ng/ml for patients with a PSA nadir of >2 ng/ml.