Table 2 Hepatotoxicity.

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

 

CTCAE grading of the worst value

All grade

≥2

≥3

Our patients (N = 68)

    AST elevation

44 (64.7%)

14 (20.6%)

6 (8.8%)

    ALT elevation

38 (55.9%)

12 (17.6%)

2 (2.9%)

    AST and/or ALT elevation

46 (67.6%)

16 (23.5%)

6 (8.8%)

    ALP elevation

29 (42.6%)

1 (1.5%)

0

    Total bilirubin elevation

5 (7.4%)

3 (4.4%)

2 (2.9%)

    γ-GTP elevation

40 (58.8%)

17 (25.0%)

2 (2.9%)

Nintedanib group in INPULSIS trials

Japanese patients (N = 76)

    AST elevation

26/72* (36.1%)

4 (5.3%)

2 (2.6%)

    ALT elevation

30/71* (42.3%)

4 (5.3%)

1 (1.3%)

    AST and/or ALT elevation

—

5 (6.6%)

3 (3.9%)

  Overall population (N = 638)

    AST elevation

134/625* (21.4%)

21 (3.3%)

8 (1.3%)

    ALT elevation

169/620* (27.3%)

28 (4.4%)

10 (1.6%)

    AST and/or ALT elevation

—

32 (5.0%)

14 (2.2%)

  1. Categorical data are presented as numbers (percentages). *The number of patients whose test results increased >the upper limit of the normal range/the number of patients whose test results were within the reference values at baseline. Abbreviations; AST = aspartate aminotransferase; ALT = alanine aminotransferase; ALP = alkaline phosphatase; T-Bil = total bilirubin; γ-GTP = γ-glutamyl transpeptidase; CTCAE = Common Terminology Criteria for Adverse Events.
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