Table 5.
Treatment related laboratory abnormalities of interest and that occurred in more than 10% of patients.
| Laboratory abnormality | Sunitinib EAP in mRCC [Gore et al. 2015] (n = 4543 patients) |
Sunitinib phase III first-line mRCC [Motzer et al. 2009a] (n = 375 patients) |
||
|---|---|---|---|---|
| All grades, % | Grade 3/4, % | All grades, % | Grade 3/4, % | |
| Thrombopaenia | 26 | 10 | 68 | 9 |
| Neutropaenia | 18 | 7 | 77 | 18 |
| Anaemia | 18 | 4 | 79 | 8 |
| Leukopaenia | 11 | 2 | 77 | 18 |
| Lymphopaenia | NA | NA | 68 | 18 |
| ALT increased | 3 | 1 | 51 | 2* |
| AST increased | NA | NA | 56 | 2* |
| Creatinine increased | NA | NA | 70 | <1 (each grade 3 and 4) |
| Lipase increased | NA | NA | 56 | 18 |
| Creatinine kinase increased | NA | NA | 49 | 3 |
| Alkaline phosphatase increased | NA | NA | 46 | 2* |
| Uric acid increased | NA | NA | 46 | 14 |
| Hypophosphataemia | NA | NA | 31 | 6* |
| Amylase increased | NA | NA | 35 | 6 |
| Total bilirubin increased | NA | NA | 20 | 1* |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; EAP, early access program; mRCC, metastatic renal cell carcinoma.
*
Only grade 3.