Xgeva zoledronic Xgeva zoledronic Xgeva zoledronic zoledronic acid acid acid acid N 1026 1020 886 890 950 951 2862 2861 First SRE Median NR 26.4 20.6 16.3 20.7 17.1 27.6 19.4 time (months) Diff in NA 4.2 3.5 8.2 median time (months) Hazard trial 0.82 (0.71, 0.95) 0.84 (0.71, 0.98) 0.82 (0.71, 0.95) 0.83 (0.76, 0.90) (95% CI) Risk 18 16 18 17 reduction (%) < 0.0001† 0.0007† 0.0002† < 0.0001 p-value Superiority 0.0101† 0.0619† 0.0085† < 0.0001 p-value Proportion 30.7 36.5 31.4 36.3 35.9 40.6 32.6 37.8 of subjects (%) and subsequent SRE* Mean 0.46 0.60 0.44 0.49 0.52 0.61 0.48 0.57 number/ patient Rate trial 0.77 (0.66, 0.89) 0.90 (0.77, 1.04) 0.82 (0.71, 0.94) 0.82 (0.75, 0.89) (95% CI) Risk 23 10 18 18 reduction (%) Superiority 0.0012† 0.1447† 0.0085† < 0.0001 p-value SMR per 0.45 0.58 0.86 1.04 0.79 0.83 0.69 0.81 year First Radiation to Bone Median NR NR NR NR NR 28.6 NR 33.2 time (months)
Xgeva zoledronic acid Xgeva zoledronic acid Xgeva zoledronic acid zoledronic acid N 1026 1020 886 890 950 951 2862 2861 First SRE Median time (months) NR 26.4 20.6 16.3 20.7 17.1 27.6 19.4 Diff in median time (months) NA 4.2 3.5 8.2 Hazard (95% CI) 0.82 (0.71, 0.95) 0.84 (0.71, 0.98) 0.82 (0.71, 0.95) 0.83 (0.76, 0.90) Risk reduction (%) 18 16 18 17 p-value < 0.0001† 0.0007† 0.0002† < 0.0001 Superiority p-value 0.0101† 0.0619† 0.0085† < 0.0001 Proportion of subjects (%) 30.7 36.5 31.4 36.3 35.9 40.6 32.6 37.8 and subsequent SRE* Mean number/ patient 0.46 0.60 0.44 0.49 0.52 0.61 0.48 0.57 Rate (95% CI) 0.77 (0.66, 0.89) 0.90 (0.77, 1.04) 0.82 (0.71, 0.94) 0.82 (0.75, 0.89) Risk reduction (%) 23 10 18 18 Superiority p-value 0.0012† 0.1447† 0.0085† < 0.0001 SMR per year 0.45 0.58 0.86 1.04 0.79 0.83 0.69 0.81 First Radiation to Bone Median time (months) NR NR NR NR NR 28.6 NR 33.2 trial trial