Table 3.

(A) Univariate Cox regression analysis of overall survival (OS) and (B) radiographic progression-free survival (rPFS) and multivariate analysis of (C) OS and (D) rPFS.

(A) Univariate Cox regression OS analysis (ordered by descending P-value)a
Variable	P value	HR (95% CI)
Age group (<65 vs. ≥65)	0.73	0.97 (0.80–1.17)
Region (North America vs. rest of world)	0.0180	1.24 (1.04–1.48)
Prior number of chemotherapy (1 vs. ≥2)	0.0157	0.80 (0.66–0.96)
Baseline PSA (μg/L)d	0.0007	1.00 (1.00–1.00)
Type of progression (PSA only vs. radiographic)	0.0001	0.70 (0.58–0.84)
Treatment (enzalutamide vs. placebo)	<0.0001	0.63 (0.53–0.75)
Baseline ECOG performance status (0–1 vs. 2)	<0.0001	0.49 (0.38–0.64)
Visceral disease at screening (no vs. yes)	<0.0001	0.58 (0.48–0.70)
Baseline mean pain score strata (≤4 vs. >4)	<0.0001	0.48 (0.41–0.58)
Baseline alkaline phosphatase (normal vs. >ULN)	<0.0001	0.39 (0.33–0.47)
Baseline opioids (no vs. yes)	<0.0001	0.38 (0.32–0.45)
Baseline serum albumin (g/L)d	<0.0001	0.87 (0.85–0.89)
Baseline hemoglobin (g/L)d	<0.0001	0.96 (0.96–0.97)
Baseline LDH (normal vs. >ULN)	<0.0001	0.24 (0.20–0.29)
Baseline corticosteroid use (yes vs. no)	<0.0001	2.21 (1.85–2.62)
(B) Univariate Cox regression rPFS analysis (ordered by descending P-value)
Variable	P value	HR (95% CI)
Region North America vs. rest of world	0.18	1.10 (0.96–1.27)
Baseline PSA (μg/L)d	0.16	1.00 (1.00–1.00)
Prior number of chemotherapy (1 vs. ≥2)	0.06	0.87 (0.75–1.01)
Age group (<65 vs. ≥65)	0.03	1.17 (1.01–1.36)
Baseline ECOG performance status (0–1 vs. 2)	0.02	0.76 (0.60–0.95)
Baseline mean pain score strata (≤4 vs. >4)	0.0002	0.76 (0.66–0.88)
Type of progression (PSA only vs. radiographic)	<0.0001	0.75 (0.66–0.87)
Baseline alkaline phosphatase normal vs. >ULN	<0.0001	0.73 (0.64–0.83)
Visceral disease at screening (no vs. yes)	<0.0001	0.63 (0.54–0.74)
Baseline opioids (no vs. yes)	<0.0001	0.65 (0.57–0.74)
Baseline serum albumin (g/L)d	<0.0001	0.95 (0.93–0.96)
Baseline hemoglobin (g/L)d	<0.0001	0.99 (0.98–0.99)
Baseline LDH (normal vs. >ULN)	<0.0001	0.46 (0.40–0.53)
Treatment (enzalutamide vs. placebo)	<0.0001	0.40 (0.35–0.47)
Baseline corticosteroid use (yes vs. no)	<0.0001	1.50 (1.30–1.73)

(C) Results of stepwise multivariate analysis of OSb parameter estimates
Variable	Coefficient ± SE	P value	HR for death (95% CI)
Treatment (enzalutamide vs. placebo)	−0.49 ± 0.090	<0.0001	0.61 (0.51–0.73)
Type of progression (PSA only vs. radiographic)	−0.33 ± 0.094	0.0005	0.72 (0.60–0.87)
Visceral disease at screening (no vs. yes)	−0.43 ± 0.097	<0.0001	0.65 (0.54–0.79)
Baseline serum albumin (g/L)d	−0.06 ± 0.013	<0.0001	0.94 (0.92–0.96)
Baseline hemoglobin (g/L)d	−0.01 ± 0.003	<0.0001	0.99 (0.98–0.99)
Baseline LDH (normal vs. >ULN)	−1.03 ± 0.098	<0.0001	0.36 (0.30–0.44)
Baseline opioids (no vs. yes)	−0.49 ± 0.096	<0.0001	0.61 (0.51–0.74)
Baseline corticosteroid use (yes vs. no)	0.53± 0.091	<0.0001	1.71 (1.43–2.04)
(D) Results of stepwise multivariate analysis of rPFSc
	Parameter estimates		HR for event (95% CI)
	Coefficient ± SE	P value
Treatment (enzalutamide vs. placebo)	−0.85 ± 0.072	<0.0001	0.43 (0.37–0.49)
Type of progression (PSA only vs. radiographic)	−0.28 ± 0.071	0.0001	0.76 (0.66–0.87)
Visceral disease at screening (no vs. yes)	−0.45 ± 0.078	<0.0001	0.64 (0.55–0.75)
Baseline LDH (normal vs. >ULN)	−0.65 ± 0.071	<0.0001	0.52 (0.46–0.60)
Baseline corticosteroid use (yes vs. no)	0.25 ± 0.073	0.0007	1.28 (1.11–1.48)

CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; HR, hazard ratio; LDH, lactate dehydrogenase; PSA, prostate-specific antigen; SE, standard error; ULN, upper limit of normal.

^aSince baseline PSA was skewed, log-transformation was used in the multivariate model.

^bSurvival for patients who had not died by the time of analysis was censored at the date the patient was last known to be alive.

^cProgression for patients who had not yet progressed by the time of analysis was censored at the date of the last radiographic assessment.

^dSerum albumin, PSA, and hemoglobin use was continuous.