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Table 2 Adverse events requiring changes in dosage regimen, such as dosage reduction, withdrawal, or discontinuation within one year

From: Clinical significance of high monocyte counts for the continuous treatment with nintedanib

 

Total

With Adverse Event

Without Adverse Event

P-value

 

(n = 111)

(n = 66)

(n = 45)

 

Age (years)

70 (66–75)

70 (66–75.3)

71 (65–75)

0.7499

Male, n (%)

80 (72.1)

50 (75.8)

30 (66.7)

0.3890

IPF/PF-ILD/SSc-ILD

59/35/17

38/17/11

21/18/6

0.3120

Dosage reduction

47

47

0

 

Dosage withdrawal

33

33

0

 

Dosage discontinuation

21

21

0

 

Smoking (pack-years)

40 (20–57.6)

40 (20–60)

40 (19.3–56.8)

0.9446

BMI (kg/m2)

22.9 (20.6–25.2)

23.2 (21.3–25.7)

22.1 (19.7–24.5)

0.0332

BSA (m2)

1.62 (1.51–1.72)

1.63 (1.56–1.73)

1.56 (1.46–1.69)

0.0471

Albumin

3.87 (3.59–4.10)

3.83 (3.52–4.10)

3.90 (3.61–4.11)

0.2898

 C-reactive protein (mg/dL)

0.28 (0.10–0.59)

0.28 (0.10–0.77)

0.28 (0.08–0.50)

0.2382

KL-6 (U/mL)

943 (633–1463)

922 (626–1342)

993 (645–1694)

0.3663

White blood cell count (x109/L)

7.400 (6.000–9.700)

7.550 (6.375–9.725)

6.800 (5.550–9.725)

0.2170

Monocyte count (x109/L)

0.451 (0.352–0.600)

0.492 (0.385–0.630)

0.410 (0.397–0.557)

0.0178

mMRC score*

1.62 ± 1.05

1.58 ± 0.16

1.65 ± 0.13

0.8867

FVC

2.18 (1.61–2.86)

2.18 (1.69–2.89)

2.25 (1.54–2.85)

0.8073

%FVC

70.4 (57.1–87.4)

70.4 (55.4–87.6)

70.4 (59.3–83.5)

0.7645

%DLco

56.3 (44.8–73.7)

55.8 (46.6–71.4)

61.8 (44.4–76.9)

0.3962

Starting dosage 300 mg (%)

83 (74.8)

55 (83.3)

28 (62.2)

0.0150

  1. *The mMRC scores are presented as mean values ± standard deviations
  2. IPF, Idiopathic pulmonary fibrosis; PF-ILD, progressive fibrosing interstitial lung disease; SSc-ILD, systemic sclerosis with interstitial lung disease, %DLco, percent predicted diffusing capacity of the lung for carbon monoxide; %FVC, percent predicted FVC; AE, adverse events; BMI, body mass index; BSA, body surface area; FVC, forced vital capacity; KL-6, Krebs von den Lungen-6; mMRC, modified Medical Research Council Dyspnea Scale