| Macitentan 10 mg | Placebo | |
| Subjects n | 119 | 59 |
| FVC L | ||
| Baseline | 2.83 (1.24–5.42) | 2.74 (1.36–4.61) |
| Up to month 12 | 2.57 (0.00–5.16) | 2.40 (0.00–4.67) |
| Change from baseline | -0.20 (-2.86–0.42) | -0.20 (-4.12–0.62) |
| FEV1# L | ||
| Baseline | 2.34 (0.93–4.24) | 2.23 (1.12–3.84) |
| Up to month 12 | 2.14 (0.00–4.34) | 1.96 (0.00–3.85) |
| Change from baseline | -0.18 (-2.47–0.35) | -0.15 (-3.46–0.51) |
| Corrected DLCO# mmol·kPa−1·min−1 | ||
| Baseline | 4.18 (2.38–8.75) | 4.13 (2.25–8.70) |
| Up to month 12 | 3.82 (0.00–8.46) | 3.54 (0.00–7.27) |
| Change from baseline | -0.40 (-6.64–1.07) | -0.42 (-5.17–0.90) |
Data are presented as median (range), unless otherwise stated. For the FVC analysis, eight (6.8%) subjects in the macitentan group had no post-baseline data: for four (3.4%) subjects the worst values were imputed and for four (3.4%) subjects the mean percentage change was imputed. In subjects with post-baseline data, five (4.2%) macitentan-treated subjects and four (6.8%) placebo recipients had data carried forward and three (2.5%) macitentan-treated subjects and two (3.4%) placebo recipients had worst values substituted for missing data. For the FEV1 analysis, six (5.2%) subjects in the macitentan group had no post-baseline data and the worst values were imputed. In subjects with post-baseline data, three (2.6%) macitentan-treated subjects and four (6.8%) placebo recipients had data carried forward and three (2.6%) macitentan-treated subjects and two (3.4%) placebo recipients had worst values substituted for missing data. For the DLCO analysis, four (3.5%) subjects in the macitentan group had no post-baseline data and the worst value was imputed. In subjects with post-baseline data, six (5.2%) macitentan-treated subjects and four (6.8%) placebo recipients had data carried forward and four (3.5%) macitentan-treated subjects and three (5.1%) placebo recipients had worst values substituted for missing data. #: n=115 in macitentan treatment arm.