Age 18 to 64 Macitentan Macitentan Placebo 3mg 10mg Macitentan N=198 N=210 N=209 N=419 Number of subjects 200 (95.2%) 196 (93.8%) 396 (94.5%) 189 (95.5%) with at least 1 AE (%) Most commonly reported AE (by PT) in combined macitentan pulmonary 57 (27.1%) 43 (20.6%) 100 (23.9%) 68 (34.3%) arterial hypertension, n (%) URTI, n (%) 44 (21.0%) 33 (15.8%) 77 (18.4%) 29 (14.6%) Age 65 years Macitentan Macitentan Total Placebo ≥ 3mg 10mg Macitentan N=44 N=33 N=27 N=60 Number of subjects 33 (100.0%) 27 (100.0%) 60 (100.0%) 44 (100.0%) with at least 1 AE (%) Most commonly reported AE (by PT) in combined macitentan group pulmonary 14 (42.4%) 9 (33.3%) 23 (38.3%) 15 (34.1%) arterial hypertension, n (%) oedema 10 (30.3%) 7 (25.9%) 17 (28.3%) 8 (18.2%) peripheral, n (%) Subgroup by gender Males Macitentan Macitentan Total Placebo 3mg 10mg Macitentan N=65 N=61 N=48 N=109 Number of subjects 57 (93.4%) 48 (100.0%) 105 (96.3%) 61 (93.8%) with at least 1 AE (%) Most commonly reported AE (by PT) in combined macitentan group pulmonary 19 (31.1%) 11 (22.9%) 30 (27.5%) 26 (40.0%) arterial hypertension, n (%)
Age 18 to 64 Macitentan 3mg N=210 Macitentan 10mg N=209 Macitentan N=419 Placebo N=198 Number of subjects with at least 1 AE (%) 200 (95.2%) 196 (93.8%) 396 (94.5%) 189 (95.5%) Most commonly reported AE (by PT) in combined macitentan pulmonary arterial hypertension, n (%) 57 (27.1%) 43 (20.6%) 100 (23.9%) 68 (34.3%) URTI, n (%) 44 (21.0%) 33 (15.8%) 77 (18.4%) 29 (14.6%) Age ≥ 65 years Macitentan 3mg N=33 Macitentan 10mg N=27 Total Macitentan N=60 Placebo N=44 Number of subjects with at least 1 AE (%) 33 (100.0%) 27 (100.0%) 60 (100.0%) 44 (100.0%) Most commonly reported AE (by PT) in combined macitentan group pulmonary arterial hypertension, n (%) 14 (42.4%) 9 (33.3%) 23 (38.3%) 15 (34.1%) oedema peripheral, n (%) 10 (30.3%) 7 (25.9%) 17 (28.3%) 8 (18.2%) Subgroup by gender Males Macitentan 3mg N=61 Macitentan 10mg N=48 Total Macitentan N=109 Placebo N=65 Number of subjects with at least 1 AE (%) 57 (93.4%) 48 (100.0%) 105 (96.3%) 61 (93.8%) Most commonly reported AE (by PT) in combined macitentan group pulmonary arterial hypertension, n (%) 19 (31.1%) 11 (22.9%) 30 (27.5%) 26 (40.0%)
auspar-macitentan-140428-cer.docx