Table 1

Probability of statistical significance of zero, one or two treatment comparisons with placebo

mL0 successful, %1 successful, %2 successful, %Power, %
∆600=80 ∆200=806.823.469.993.2
∆600=80 ∆200=6010.146.943.089.9
∆600=80 ∆200=2011.584.44.188.5
∆600=80 ∆200=
∆600=90 ∆200=605.151.143.894.9
∆600=0 ∆200=
  • Denoting ∆600 and ∆200, the true treatment differences of the two GLPG1690 treatment groups with placebo, and assuming a common standard deviation on the week 52 decline in forced vital capacity of 275 mL, the probability that zero, one or two of the treatment comparisons with placebo will be statistically significant and the power for each scenario are provided in the table.

  • A sample size of 250 patients in each treatment group will have at least 80% power to show a significant effect, assuming the GLPG1690 600 mg group has a treatment effect of at least 80 mL in the overall population of treatment-naïve patients and patients on standard of care.