TABLE 1

Demographic and baseline characteristics (safety population)

Patients89
Age years68.2±6.8
Male71 (80)
Race
 White84 (94)
 Black or African-American3 (3)
 Other#2 (2)
Weight kg84.9±15.5
Body mass index kg·m−228.6±4.6
Previous tobacco use61 (69)
Duration of previous pirfenidone treatment months20.4±12.3
FVC % pred mean±se
 Historical value closest to 6 months prior to screening72.6±1.7
 At baseline71.8±1.7
Patients categorised by baseline FVC % pred
 <65%32 (36)
 65– <80%31 (35)
 ≥80%26 (29)
DLCO % pred mean±se
 Historical value closest to 6 months prior to screening+50.0±1.4
 At baseline48.4±1.3

Data are presented as n, mean±sd or n (%), unless otherwise stated. FVC: forced vital capacity; DLCO: diffusing capacity of the lung for carbon monoxide. #: includes Asian and mixed Asian/White; : mean±sd time from assessment of historical value to screening was 3.0±1.9 months (n=87); +: mean±sd time from assessment of historical value to screening was 3.3±2.6 months (n=87).