TABLE 2

Summary of treatment-emergent safety outcomes at 12 months#

Safety eventBaseline FVC ≥80%Baseline FVC <80%Baseline GAP stage IBaseline GAP stage II–III
PirfenidonePlaceboPirfenidonePlaceboPirfenidonePlaceboPirfenidonePlacebo
Patients146170477454247235376387
Any treatment-emergent adverse event140 (95.9)163 (95.9)475 (99.6)439 (96.7)240 (97.2)225 (95.7)375 (99.7)375 (96.9)
 Grade 332 (21.9)29 (17.1)121 (25.4)121 (26.7)58 (23.5)48 (20.4)95 (25.3)102 (26.4)
 Grade 44 (2.7)8 (4.7)18 (3.8)26 (5.7)8 (3.2)6 (2.6)14 (3.7)28 (7.2)
Any treatment-emergent adverse event leading to discontinuation10 (6.8)10 (5.9)64 (13.4)44 (9.7)24 (9.7)10 (4.3)50 (13.3)44 (11.4)
Any treatment-emergent serious adverse event27 (18.5)27 (15.9)101 (21.2)112 (24.7)50 (20.2)34 (14.5)78 (20.7)105 (27.1)
Treatment-emergent death2 (1.4)3 (1.8)12 (2.5)29 (6.4)3 (1.2)2 (0.9)11 (2.9)30 (7.8)
  • Data are presented as n or n (%). FVC: forced vital capacity; GAP: gender, age and physiology index. #: occurring through 12 months during treatment period (from the first dose up to 28 days after the last dose of study drug).