Table 4:
Laboratory Abnormalities (≥10%) Worsening from Baseline in TAS-120–101.
| Futibatinib N = 103 |
||
|---|---|---|
| Laboratory Abnormalitya | All Gradesb (%) | Grades 3 or 4 (%) |
| Hematology | ||
| Decreased hemoglobin | 52 | 6 |
| Decreased lymphocytes | 46 | 10 |
| Decreased platelets | 42 | 1 |
| Decreased leukocytes | 33 | 1.1 |
| Decreased neutrophils | 31 | 1.6 |
| Chemistry | ||
| Increased phosphatec | 97 | 39 |
| Increased creatinined | 58 | 0 |
| Increased glucose | 52 | 4.9 |
| Increased calcium | 51 | 1.2 |
| Decreased sodium | 51 | 15 |
| Decreased phosphate | 50 | 20 |
| Increased alanine aminotransferase | 50 | 7 |
| Increased alkaline phosphatase | 47 | 4.9 |
| Increased aspartate aminotransferase | 46 | 13 |
| Decreased albumin | 31 | 2.4 |
| Increased creatine kinase | 31 | 5 |
| Increased bilirubin | 28 | 0 |
| Decreased glucose | 25 | 0 |
| Decreased potassium | 22 | 2.1 |
| Increased potassium | 16 | 2 |
| Coagulation | ||
| Increased activated partial thromboplastin time | 36 | 8 |
| Increased prothrombin international normalized ratio | 25 | 0 |
Source: LYTGOBI USPI (13).
a
Graded per NCI CTCAE 4.03.
b
Percentages are based on patients with data at both baseline and at least one post-baseline data value.
c
NCI CTCAE 4.03 does not define grades for increased phosphate. Laboratory value shift table categories were used to assess increased phosphorus levels (Grades ≥3 defined as >7 mg/dL).
d
Graded based on comparison to upper limit of normal.