right ventricular 11 (18.0%) 8 (16.7%) 19 (17.4%) 16 (24.6%) failure, n (%) Females Macitentan Macitentan Total Placebo 3mg 10mg Macitentan N=184 N=189 N=194 N=383 Number of subjects 183 (96.8%) 181 (93.3%) 364 (95.0%) 179 (97.3%) with at least 1 AE (%) Most commonly reported AE (by PT) in combined macitentan group pulmonary 56 (29.6%) 42 (21.6%) 98 (25.6%) 61 (33.2%) arterial hypertension, n (%) urti, n (%) 40 (21.2%) 33 (17.0%) 73 (19.1%) 28 (15.2%) Subgroup by WHO FC at baseline Baseline WHO FC I or Macitentan Macitentan Total Placebo II 3mg 10mg Macitentan N=130 N=138 N=121 N=259 Number of subjects 131 (94.9%) 117 (96.7%) 248 (95.8%) 123 (94.6%) with at 1 AE (%) Most commonly reported AE (by PT) in combined macitentan group pulmonary 35 (25.4%) 20 (16.5%) 55 (21.2%) 31 (23.8%) arterial hypertension, n (%) urti, n (%) 33 (23.9%) 22 (18.2%) 55 (21.2%) 19 (14.6%) Baseline WHO FC III Macitentan Macitentan Placebo or IV 3mg 10mg Macitentan N=119 N=112 N=121 N=233 Number of subjects 109 (97.3%) 112 (92.6%) 221 (94.8%) 117 (98.3%) with at least 1 AE (%) Most commonly reported AE (by PT) in combined macitentan group pulmonary 40 (35.7%) 33 (27.3%) 73 (31.3%) 56 (47.1%) arterial
right ventricular failure, n (%) 11 (18.0%) 8 (16.7%) 19 (17.4%) 16 (24.6%) Females Macitentan 3mg N=189 Macitentan 10mg N=194 Total Macitentan N=383 Placebo N=184 Number of subjects with at least 1 AE (%) 183 (96.8%) 181 (93.3%) 364 (95.0%) 179 (97.3%) Most commonly reported AE (by PT) in combined macitentan group pulmonary arterial hypertension, n (%) 56 (29.6%) 42 (21.6%) 98 (25.6%) 61 (33.2%) urti, n (%) 40 (21.2%) 33 (17.0%) 73 (19.1%) 28 (15.2%) Subgroup by WHO FC at baseline Baseline WHO FC I or II Macitentan 3mg N=138 Macitentan 10mg N=121 Total Macitentan N=259 Placebo N=130 Number of subjects with at 1 AE (%) 131 (94.9%) 117 (96.7%) 248 (95.8%) 123 (94.6%) Most commonly reported AE (by PT) in combined macitentan group pulmonary arterial hypertension, n (%) 35 (25.4%) 20 (16.5%) 55 (21.2%) 31 (23.8%) urti, n (%) 33 (23.9%) 22 (18.2%) 55 (21.2%) 19 (14.6%) Baseline WHO FC III or IV Macitentan 3mg N=112 Macitentan 10mg N=121 Macitentan N=233 Placebo N=119 Number of subjects with at least 1 AE (%) 109 (97.3%) 112 (92.6%) 221 (94.8%) 117 (98.3%) Most commonly reported AE (by PT) in combined macitentan group pulmonary arterial 40 (35.7%) 33 (27.3%) 73 (31.3%) 56 (47.1%)
auspar-macitentan-140428-cer.docx