Table 3 Comparison of characteristics and examination findings with and without hepatotoxicity.

From: Low body surface area predicts hepatotoxicity of nintedanib in patients with idiopathic pulmonary fibrosis

 

hepatotoxicity

no hepatotoxicity

p-value

Number of patients

16

52

 

Age

75.0 (68.8–76.3)

72.0 (68.0–76.0)

0.519

Gender (male/female)

11/5

41/11

0.502

Physique

    Height (cm)

160 (153–166)

164 (158–169)

0.188

    Body weight (kg)

53.2 (49.2–57.9)

62.0 (52.3–70.3)

0.0765

    Body mass index

21.5 (19.4–24.3)

22.4 (20.0–25.0)

0.311

    Body surface area (DuBois, m2)

1.52 (1.45–1.67)

1.67 (1.54–1.80)

0.0484

Laboratory data

    Aspartate aminotransferase (IU/L)

20.5 (16.5–31.5)

21.0 (18.0–24.0)

0.612

    Alanine aminotransferase (IU/L)

14.0 (11.0–29.0)

14.0 (11.0–20.3)

0.524

    Alkaline phosphatase (IU/L)

247 (211–280)

240 (189–283)

0.608

    Total bilirubin (mg/dL)

0.50 (0.40–0.62)

0.50 (0.40–0.62)

1.00

    γ-glutamyl transpeptidase (IU/L)

28.5 (21.5–63.8)

28.0 (20.0–48.0)

0.573

    Creatinine (mg/dL)

0.80 (0.68–0.90)

0.83 (0.70–0.92)

0.385

    Krebs von den Lungen-6 (U/mL)

920 (694–1356)

1080 (766–1592)

0.800

    Surfactant protein D (ng/dL)

262 (167–440)

309 (188–400)

0.691

Pulmonary function test

    forced vital capacity (L)

1.75 (1.37–2.42)

1.96 (1.65–2.34)

0.457

    %forced vital capacity (%)

64.0 (55.0–71.7)

60.9 (48.9–72.7)

0.822

    %DLCO (%)

51.4 (36.1–60.1)

50.4 (42.2–65.6)

0.464

Six-minute walk test

    lowest SpO2 (%)

81.5 (77.5–87.0)

82.0 (76.0–87.0)

0.922

    walking distance (meter)

378 (281–450)

430 (355–480)

0.299

Concomitant therapy

    Prednisolone (%)

3 (18.8%)

8 (15.4%)

0.712

    Cyclosporine (%)

0

2 (3.8%)

1.00

    Cyclophosphamide (%)

0

2 (3.8%)

1.00

    Tacrolimus (%)

1 (6.2%)

4 (7.7%)

1.00

    Pirfenidone (%)

1 (6.2%)

1 (1.9%)

0.418

  1. Categorical data are presented as numbers (percentages) while continuous data are presented as medians (interquartile ranges). Fisher’s exact test was used to compare categorical data and the Mann-Whitney U test was used to compare continuous data. Abbreviations: DLCO = diffusing capacity for lung carbon monoxide.