Table 2.
Hepatotoxicity.
| 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%) |
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.