Table 3.
Selected grade 3/4 treatment-related adverse events commonly reported with vascular endothelial growth factor inhibitors and laboratory test change by dose (all treated patients)
180 mg | 320 mg | 600 mg | 800 mg C | 800 mg I | 1000 mg | 400 mg b.i.d. | |
n = 3 | n = 14 | n = 3 | n = 20 | n = 11 | n = 4 | n = 13 | |
AEa related to study drug | |||||||
Fatigue | 0 (0) | 3 (21) | 0 (0) | 3 (15) | 0 (0) | 1 (25) | 2 (15) |
Hypertension | 0 (0) | 0 (0) | 0 (0) | 3 (15) | 0 (0) | 1 (25) | 1 (8) |
Diarrhea | 0 (0) | 0 (0) | 0 (0) | 2 (10) | 1 (9) | 0 (0) | 0 (0) |
Dizziness | 0 (0) | 0 (0) | 0 (0) | 1 (5) | 0 (0) | 0 (0) | 1 (8) |
Nausea | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (8) |
Vomiting | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (8) |
Laboratory testsb | |||||||
ALT increased | 0 (0) | 0 (0) | 1 (33) | 3 (15) | 0 (0) | 2 (50) | 1 (8) |
AST increased | 0 (0) | 1 (7) | 1 (33) | 1 (5) | 1 (9) | 0 (0) | 0 (0) |
Bilirubin increased | 0 (0) | 1 (7) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Hyponatremia | 1 (33) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (8) |
National Cancer Institute–Common Terminology Criteria for AEs, v 3.
Grade increase from baseline.
AE, adverse event; C, continuous; I, intermittent; ALT, alanine aminotransferase; AST, aspartate aminotransferase.