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Table 4 Baseline characteristics of patients included in the INPULSIS® pooled data set, by stratification subgroup (analysis 3)

From: Health-related quality of life and symptoms in patients with IPF treated with nintedanib: analyses of patient-reported outcomes from the INPULSIS® trials

 Entire cohort (N = 1061)GAPFVCDLCOCPISGRQ
I (n = 500)II/III (n = 560)>  80% (n = 485)≤ 80% (n = 576)>  40% (n = 709)≤ 40% (n = 351)≤ 45 (n = 462)>  45 (n = 598)≤ 40 (n = 555)>  40 (n = 488)
Women, n (%)220 (20.7)160 (32.0)59 (10.5)119 (24.5)101 (17.5)136 (19.2)83 (23.6)102 (22.1)117 (19.6)99 (17.8)112 (23.0)
Age, years66.8 (8.0)63.0 (8.1)70.1 (6.3)67.8 (7.7)65.9 (8.2)66.4 (8.0)67.4 (8.1)66.1 (8.0)67.2 (8.1)66.1 (7.9)67.4 (8.2)
Time since IPF diagnosis, years1.6 (1.3)1.6 (1.3)1.7 (1.3)1.6 (1.3)1.7 (1.3)1.6 (1.3)1.7 (1.4)1.6 (1.3)1.6 (1.3)1.5 (1.3)1.7 (1.3)
Ethnicity, n (%)
 White608 (57.3)283 (56.6)324 (57.9)263 (54.2)345 (59.9)426 (60.1)181 (51.6)273 (59.1)334 (55.9)297 (53.5)301 (61.7)
 Black2 (0.2)0 (0)2 (0.4)0 (0)2 (0.3)2 (0.3)0 (0)0 (0)2 (0.3)1 (0.2)1 (0.2)
 Asian322 (30.3)154 (30.8)168 (30.0)154 (31.8)168 (29.2)198 (27.9)124 (35.3)134 (29.0)188 (31.4)188 (33.9)133 (27.3)
 Missing129 (12.2)63 (12.6)66 (11.8)68 (14.0)61 (10.6)83 (11.7)46 (13.1)55 (11.9)74 (12.4)69 (12.4)53 (10.9)
BMI, kg/m227.9 (4.6)28.2 (4.5)27.6 (4.6)27.6 (4.1)28.1 (5.0)28.2 (4.5)27.3 (4.6)28.1 (4.2)27.8 (4.8)27.3 (3.9)28.6 (5.1)
Smoking history, n (%)
 Non-smoker296 (27.9)161 (32.2)134 (23.9)127 (26.2)169 (29.3)192 (27.1)103 (29.3)130 (28.1)165 (27.6)145 (26.1)146 (29.9)
 Ex-smoker718 (67.7)308 (61.6)410 (73.2)325 (67.0)393 (68.2)480 (67.7)238 (67.8)302 (65.4)416 (69.6)383 (69.0)322 (66.0)
 Current smoker47 (4.4)31 (6.2)16 (2.9)33 (6.8)14 (2.4)37 (5.2)10 (2.8)30 (6.5)17 (2.8)27 (4.9)20 (4.1)
Comorbidities, n (%)
 PH30 (2.8)7 (1.4)23 (4.1)15 (3.1)15 (2.6)17 (2.4)13 (3.7)10 (2.2)20 (3.3)10 (1.8)20 (4.1)
 COPD27 (2.5)9 (1.8)18 (3.2)11 (2.3)16 (2.8)17 (2.4)10 (2.8)10 (2.2)17 (2.8)9 (1.6)18 (3.7)
 Lung cancera4 (0.4)2 (0.4)2 (0.4)3 (0.6)1 (0.2)3 (0.3)1 (0.3)2 (0.4)2 (0.4)1 (0.2)3 (0.6)
 GERD248 (23.4)113 (22.6)135 (24.1)115 (23.7)133 (23.1)178 (25.1)70 (19.9)118 (25.5)130 (21.7)108 (19.5)133 (27.3)
 CAD88 (8.3)26 (5.2)62 (11.1)36 (7.4)52 (9.0)54 (7.6)34 (9.7)29 (6.3)59 (9.9)44 (7.9)44 (9.0)
FVC, % predicted79.6 (17.8)86.4 (17.9)73.5 (15.3)95.2 (12.9)66.4 (8.0)83.3 (18.0)72.1 (14.9)90.4 (17.2)71.2 (13.2)83.1 (18.1)75.4 (16.7)
FEV1/FVC ratio81.7 (5.9)81.3 (5.8)82.0 (6.0)79.8 (5.8)83.2 (5.5)81.0 (5.9)83.1 (5.7)79.5 (5.8)83.3 (5.4)81.0 (5.7)82.4 (6.1)
DLCO, % predicted47.2 (13.5)53.8 (13.9)41.4 (9.9)51.3 (12.9)43.8 (13.0)53.8 (11.4)33.9 (4.6)58.2 (11.7)38.8 (7.2)49.5 (12.4)44.8 (14.2)
  1. Data are shown in mean (standard deviation), unless otherwise indicated
  2. BMI body mass index, CAD coronary artery disease, COPD chronic obstructive pulmonary disease, CPI composite physiologic index, DLCO diffusing capacity of the lung for carbon monoxide, FEV1 forced expiratory volume in 1 s, FVC forced vital capacity, GAP gender, age and physiology, GERD gastroesophageal reflux disease, IPF idiopathic pulmonary fibrosis, PH pulmonary hypertension, SGRQ St George’s respiratory questionnaire
  3. aLung cancer includes malignant lung neoplasm, squamous cell carcinoma of lung, non-small-cell lung cancer and metastatic lung adenocarcinoma; Number of patients is 1060