Age, years
|
75.4 ± 9.4
|
Sex
|
Female, n (%)
|
9 (16)
|
Male, n (%)
|
48 (84)
|
Body height, cm
|
162.2 ± 7.7
|
Body weight, kg
|
63.5 ± 10.8
|
Body mass index, kg/m2
|
24.0 (21.5 to 26.5)
|
Body surface area, m2
|
1.67 ± 0.15
|
Charlson comorbidity index
|
5 (3 to 6)
|
Echocardiographic evidence of pulmonary hypertension, n (%)
|
36 (63)
|
Echocardiographic evidence of LV dysfunction, n (%)
|
2 (4)
|
Dyslipidaemia, n (%)
|
26 (46)
|
Chronic hepatitis B, n (%)
|
6 (11)
|
Chronic hepatitis C, n (%)
|
5 (9)
|
Other non-viral liver condition, n (%)
|
3 (5)
|
Fatty liver on baseline sonography, n (%)
|
15 (26)
|
Cigarette smoking status
|
Never smoker, n (%)
|
26 (46)
|
Current smoker, n (%)
|
4 (7)
|
Former smoker, n (%)
|
27 (47)
|
Baseline plasma KL-6 level, ng/mL
|
1.48 (0.55 to 2.82)
|
Baseline plasma SPA level, pg/mL
|
283.6 (157.3 to 435.4)
|
Baseline oximetry breathing ambient air, %
|
95 (93 to 97)
|
Baseline DLCO, mmol/min/kPa
|
2.78 (2.11 to 3.96)
|
Baseline DLCO, % predicted
|
55 (38 to 70)
|
Baseline FVC, L
|
2.02 ± 0.49
|
Baseline FVC, % predicted
|
67 ± 12
|
Stages based on the GAP index
|
Stage 1, n (%)
|
14 (25)
|
Stage 2, n (%)
|
31 (54)
|
Stage 3, n (%)
|
12 (21)
|
Nintedanib-related hepatic injury, n (%)
|
24 (42)
|
On-treatment AE-IPF, n (%)
|
20 (35)
|
On-treatment mortality, n (%)
|
16 (28)
|
Duration of nintedanib therapy, days
|
345 (91 to 706)
|
Time to first nintedanib-related hepatic injury, days
|
69 (17 to 156)
|
Time to first on-treatment AE-IPF, days
|
238 (111 to 431)
|
Time to on-treatment mortality, days
|
486 (217 to 811)
|
Time between plasma sampling and nintedanib initiation, days
|
6 (0 to 28)
|
Time between baseline pulmonary functions and nintedanib initiation, days
|
28 (16 to 51)
|
Time between plasma sampling and baseline pulmonary functions, days
|
24 (12 to 81)
|
Annual rate of change in FVC, L/52 weeks
|
− 0.13 (− 0.26 to + 0.06)
|
Annual rate of change in DLCO, % predicted/52 weeks
|
− 9 (− 29 to − 2)
|