Table 1.

Multivariate analysis of progression-free survival and overall survival in the intent-to-treat population and the PCWG2 bone-metastatic subgroup

Factorb	Intent-to-treat population (n = 201)				Bone-metastatic disease populationa (n = 136)
	Univariate		Multivariate		Univariate		Multivariate
	P	HR (95% CI)	P	HR (95% CI)	P	HR (95% CI)	P	HR (95% CI)
OS
Tasquinimod arm	0.491	0.87 (0.59–1.29)	0.034	0.64 (0.42–0.97)	0.194	0.73 (0.46–1.17)	0.053	0.61 (0.38–1.01)
Hemoglobinc	<0.001	0.13 (0.05–0.35)	0.004	0.20 (0.07–0.59)	0.013	0.22 (0.07–0.73)	0.031	0.24 (0.07–0.88)
LDHc	<0.001	2.68 (1.72–4.18)	0.023	1.75 (1.08–2.82)	0.006	2.06 (1.23–3.44)	0.065	1.65 (0.97–2.81)
PSAc	<0.001	1.25 (1.15–1.35)	<0.001	1.18 (1.08–1.30)	0.001	1.18 (1.07–1.31)	0.051	1.13 (1.00–1.27)
Tumor pain (VAS)	0.013	1.27 (1.05–1.53)	0.026	1.24 (1.03–1.50)	0.010	1.32 (1.07–1.64)	0.010	1.33 (1.07–1.64)
PFS
Tasquinimod arm	0.005	0.57 (0.39–0.85)	0.001	0.52 (0.35–0.78)	0.022	0.56 (0.34–0.92)	0.009	0.51 (0.31–0.85)
LDHc	0.288	0.75 (0.43–1.28)	0.011	0.48 (0.27–0.85)	0.275	0.70 (0.36–1.33)	0.018	0.44 (0.22–0.87)
PSAc	0.028	1.09 (1.01–1.18)	0.010	1.12 (1.03–1.22)	0.112	1.09 (0.98–1.21)	0.059	1.12 (1.00–1.26)
Tumor pain (VAS)	0.039	1.25 (1.01–1.56)	0.003	1.39 (1.12–1.73)	0.003	1.44 (1.14–1.83)	<0.001	1.56 (1.23–1.99)

NOTE: For OS and PFS, the following parameters were evaluated: treatment group, PCWG2 visceral metastases, Gleason sum at diagnosis, Karnofsky Performance Status, VAS pain score, PSA slope (velocity), alkaline phosphatase, hemoglobin, lactate dehydrogenase (LDH), and prostate-specific antigen level at baseline (PSA). Only parameters found statistically significant in the multivariate model are shown.

^aProstate Cancer Working Group 2 classification.

^bRemaining variables after backward selection in the intent-to-treat population.

^clog₂ transformed.