In the Per-protocol analysis population (PP) in which additional patients were censored at end study therapy, tumour progression or tumour-related death was observed in 19 and 38 Sandostatin LAR and placebo recipients, respectively (HR = 0.24; 95% CI, 0.13 to 0.45; p-value =0.0000036). Figure 1 Kaplan-Meier estimates of TTP comparing Sandostatin LAR with placebo (conservative ITT population) Table 1 TTP results by analysis populations TTP Events Median TTP months [95% HR [95% C.I.] C.I.] p-value * Sandostati Placebo Sandostatin Placebo n LAR LAR ITT 26 41 NR NR 0.32 [95% CI, 0.19 to 0.55] P=0.000015 cITT 26 40 14.3 6.0 0.34 [95% CI, [95% CI, [95% CI, 0.20 to 0.59] P=0.000072 11.0 to 28.8] 3.7 to 9.4] PP 19 38 NR NR 0.24 [95% CI, 0.13 to 0.45] P =0.0000036
In the Per-protocol analysis population (PP) in which additional patients were censored at end study therapy, tumour progression or tumour-related death was observed in 19 and 38 Sandostatin LAR and placebo recipients, respectively (HR = 0.24; 95% CI, 0.13 to 0.45; p-value =0.0000036). Figure 1 Kaplan-Meier estimates of TTP comparing Sandostatin LAR with placebo (conservative ITT population) Table 1 TTP results by analysis populations TTP Events Median TTP months [95% C.I.] HR [95% C.I.] p-value * Sandostati n LAR Placebo Sandostatin LAR Placebo ITT 26 41 NR NR 0.32 [95% CI, 0.19 to 0.55] P=0.000015 cITT 26 40 14.3 [95% CI, 11.0 to 28.8] 6.0 [95% CI, 3.7 to 9.4] 0.34 [95% CI, 0.20 to 0.59] P=0.000072 PP 19 38 NR NR 0.24 [95% CI, 0.13 to 0.45] P =0.0000036
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