Table 2.
Selected grade 1/2 treatment-related adverse events commonly reported with vascular endothelial growth factor inhibitors and laboratory test change by dose (all treated subjects)
180 mg | 320 mg | 600 mg | 800 mg C | 800 mg I | 1000 mg | 400 mg b.i.d. | |
AEa related to study drug | n = 3 | n = 14 | n = 3 | n = 20 | n = 11 | n = 4 | n = 13 |
Nausea | 1 (33) | 6 (43) | 2 (67) | 7 (35) | 3 (27) | 3 (75) | 5 (38.5) |
Diarrhea | 2 (67) | 2 (14) | 0 (0) | 8 (40) | 3 (27) | 0 (0) | 2 (15) |
Fatigue | 1 (33) | 4 (29) | 1 (33) | 4 (20) | 9 (82) | 1 (25) | 6 (46) |
Dizziness | 0 (0) | 5 (36) | 2 (67) | 4 (20) | 5 (46) | 1 (25) | 3 (23) |
Hypertension | 0 (0) | 2 (14) | 2 (67) | 4 (20) | 5 (46) | 2 (50) | 2 (15) |
Vomiting | 0 (0) | 6 (43) | 0 (0) | 6 (30) | 1 (9) | 0 (0) | 6 (46) |
Constipation | 1 (33) | 2 (14) | 0 (0) | 2 (10) | 0 (0) | 0 (0) | 0 (0) |
Abdominal pain | 0 (0) | 1 (7) | 0 (0) | 1 (5) | 1 (9) | 0 (0) | 0 (0) |
Dyspepsia | 0 (0) | 1 (7) | 1 (33) | 0 (0) | 1 (9) | 0 (0) | 0 (0) |
Stomatitis | 0 (0) | 0 (0) | 0 (0) | 1 (5) | 1 (9) | 1 (25) | 0 (0) |
Anorexia | 2 (67) | 4 (29) | 3 (100) | 6 (30) | 3 (27) | 3 (75) | 7 (54) |
Proteinuria | 0 (0) | 2 (14) | 0 (0) | 2 (10) | 1 (9) | 0 (0) | 1 (8) |
Laboratory testsb | n = 3 | n = 14 | n = 3 | n = 20 | n = 11 | n = 4 | n = 10–12 |
AST increased | 0 (0) | 0 (0) | 1 (33) | 2 (10) | 0 (0) | 2 (50) | 1 (8) |
ALT increased | 0 (0) | 1 (7) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Bilirubin increased | 0 (0) | 0 (0) | 0 (0) | 1 (5) | 0 (0) | 0 (0) | 0 (0) |
Hyponatremia | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
National Cancer Institute–Common Terminology Criteria for AEs, v 3.
Grade increase from baseline.
AE, adverse event; C, continuous; I, intermittent; AST, aspartate aminotransferase; ALT, alanine aminotransferase.