TABLE 1

Baseline characteristics of the study population

CharacteristicPBI-4050 alonePBI-4050+nintedanibPBI-4050+pirfenidone
Subjects n91616
Age years
 Mean71.669.466.1
 Median69.072.065.5
 Range65.0–84.046.0–83.058.0–80.0
Sex n (%)
 Male6 (66.7)12 (75.0)13 (81.3)
 Female3 (33.3)4 (25.0)3 (18.8)
Race n (%)
 White9 (100.0)15 (93.8)16 (100.0)
 Other01 (6.3)0
Height cm
 Mean168.0170.8171.5
 Median172.0171.0170.5
 Range151.0–178.0157.0–186.0153.0–193.0
Weight kg
 Mean76.876.389.0
 Median78.874.586.2
 Range61.5–87.057.5–97.062.1–130.4
BMI kg·m2
 Mean27.326.130.4
 Median26.625.728.4
 Range23.4–35.123.3–31.023.8–55.7
Duration of IPF disease years
 Mean2.801.841.24
 Median2.11.70.9
 Range0.8–5.40.0–5.90.1–5.7
Stage of IPF disease n (%)#
 Mild5 (55.6)9 (56.3)6 (37.5)
 Moderate4 (44.4)6 (37.5)8 (50.0)
 Severe01 (6.3)2 (12.5)
HRCT compatible with UIP pattern n (%)
 Definite9 (100.0)15 (93.8)14 (93.3)
 Possible01 (6.3)1 (6.7)
FVC % pred
 Mean83.171.370.8
 Median79.069.068.0
 Range58.0–109.045.0–107.045.0–100.0
FVC mL
 Mean288427612849
 Median265027352930
 Range1750–43801290–34801580–4280
DLCO % pred
 Mean45.250.849.1
 Median47.053.045.0
 Range27.0–64.024.0–70.023.0–83.0

BMI: body mass index; IPF: idiopathic pulmonary fibrosis; HRCT: high-resolution computed tomography; UIP: usual interstitial pnuemonia; FVC: forced vital capacity; DLCO: diffusing capacity of the lung for carbon monoxide. #: stage as determined by the investigator; : data based on efficacy population.