TABLE 1

Patient demographics and baseline characteristics

Patients who provided data#Result
Age years100969.6±8.47
Male1009807 (80.0)
Ethnicity758
 White753 (99.3)
 Other5 (0.7)
BMI kg·m−2100627.8±4.57
Smoking status1004
 Current smoker25 (2.5)
 Ex-smoker602 (60.0)
 Never-smoker377 (37.5)
Patients with IPF10091006 (99.7)
 Time since IPF diagnosis years10061.7±3.0
 Patients with other reason for pirfenidone prescription+10093 (0.3)
Supplementary oxygen use1006277 (27.5)
FVC L970
 Mean±sd2.6±0.78
 Median (range)2.5 (0.7–5.0)
FVC % pred968
 Mean±sd66.0±16.1
 Median (range)64.8 (21–121)
FVC% pred <50%968144 (14.9)
FEV1 L975
 Mean±sd2.1±0.6
 Median (range)2.1 (0.0–4.3)
Liver function test
 ALT961
  <1.5×ULN947 (98.5)
  1.5– <3.0×ULN14 (1.5)
  ≥3.0×ULN0 (0.0)
 AST745
  <1.5×ULN736 (98.8)
  1.5– <3.0×ULN9 (1.2)
  ≥3.0×ULN0 (0.0)
 Total bilirubin847
  <1.5×ULN842 (99.4)
  1.5– <3.0×ULN5 (0.6)
  ≥3.0×ULN0 (0.0)
One or more ongoing medical conditions§ other than IPFƒ1009921 (91.3)
 Hypertension423 (41.9)
 Gastro-oesophageal reflux disease166 (16.5)
 Hypercholesterolaemia121 (12.0)
 Coronary artery disease106 (10.5)
 Diabetes mellitus97 (9.6)
 Type 2 diabetes mellitus87 (8.6)
 Sleep apnoea syndrome81 (8.0)
 Osteoarthritis63 (6.2)
 Cough56 (5.6)
 Benign prostatic hyperplasia55 (5.5)
 Hypothyroidism55 (5.5)
 Atrial fibrillation53 (5.3)
 Hyperlipidaemia52 (5.2)
 Obesity52 (5.2)
 Depression50 (5.0)
Pre-baseline exposure to pirfenidone
 Patients319 (31.6)
 Days15.0±9.3

Data are presented as n, mean±sd or n (%), unless otherwise stated. BMI: body mass index; IPF: idiopathic pulmonary fibrosis; FVC: forced vital capacity; FEV1: forced expiratory volume in 1 s; ALT: alanine aminotransferase; ULN: upper limit of normal; AST: aspartate aminotransferase. #: number of patients who had values for select parameters; : includes Asian, Black or African-American, or any other ethnicities reported; +: includes two patients with extrinsic allergic alveolitis and one patient with nonspecific interstitial pneumonia; §: each medical condition was recorded by investigators using the Medical Dictionary for Regulatory Activities version 19.0 (www.meddra.org) system organ class and preferred term; ƒ: occurring in ≥5% of patients in PASSPORT.