PVR, dyn·sec/cm5 (relative benefit* to placebo expressed in %) | CI, L/min/m2 | |||||||
---|---|---|---|---|---|---|---|---|
Macitentan 3mg | p-value | Macitentan 10mg | p-value | Macitentan 3mg | p-value | Macitentan 10mg | p-value | |
All | -28.7 (-32.2,-19.2) | <0.0001 | -37.4 (-46.3,-26.6) | <0.0001 | 0.5 (0.3,0.8) | <0.0001 | 0.6 (0.4,0.9) | <0.0001 |
Treatment Naïve | -19.9 (-34.2,0.8) | 0.06 | -40.3 (-52.0,-22.3) | 0.0002 | 0.4 (0.1,0.8) | 0.01 | 0.6 (0.2,1.0) | 0.004 |
Treated | -34.4 (-45.6,-22.3) | <0.0001 | -33.3 (-45.6,-20.7) | 0.0001 | 0.6 (0.4,1.0) | <0.0001 | 0.6 (0.2,1.0) | 0.005 |
FC I/II | -35.2 (-49.2,-21.6) | <0.0001 | -46.0 (-57.2,-28.8) | <0.0001 | 0.5 (0.2,0.9) | 0.002 | 0.7 (0.2,1.1) | 0.005 |
FC III/IV | -21.8 (-37.8,-9.2) | 0.002 | -29.0 (-43.8,-16.6) | 0.0003 | 0.5 (0.3,0.9) | 0.0001 | 0.6 (0.3,1.0) | 0.001 |
Median (95% CL) placebo-corrected change from baseline and Wilcoxon test p-values;
↵* based on the log of Month 6/baseline values