Table 4.
Toxicity
| Arm A (n = 103) | Arm B (n = 120) | |||||
| Grade | 1,2 (%) | 3 (%) | 4 (%) | 1,2 (%) | 3 (%) | 4 (%) |
| Anemia | 48 | 1 | 1 | 46 | 4 | 0 |
| Neutropenia | 15 | 13 | 17 | 8 | 7 | 20 |
| Febrile neutropenia | — | 4 | — | — | 5 | — |
| Thrombocytopenia | 25 | 2 | — | 26 | 2 | 1 |
| Nausea | 81 | 5 | — | 88 | — | — |
| Mucositis (oral) | 60 | 3 | — | 51 | 3 | — |
| Fatigue | 77 | 11 | — | 81 | 7 | — |
| Increased AST/ALT | 21/25 | -/2 | 1/- | 31/25 | 1/2 | 1/- |
| Sensory neuropathy | 65 | 7 | 1 | 70 | 8 | — |
| Arthralgia/joint pain | 63 | 5 | — | 70 | 10 | — |
| Myalgia/muscle pain | 55 | 7 | — | 69 | 5 | — |
| Dyspnea | 30 | 2 | 1 | 33 | 3 | — |
| Hypertension | 35 | 13 | — | 33 | 11 | — |
| Headache | 50 | 2 | — | 43 | 9 | — |
| Left ventricular diastolic dysfunction | — | 1 | — | — | 2 | — |
| Left ventricular systolic dysfunctiona | 18 | 4 | — | 17 | 3 | — |
| Proteinuria | 9 | 2 | — | 20 | 2 | — |
| Thrombosis/embolism | 2 | 1 | — | 1 | 2 | — |
| Hemorrhage (nose) | 39 | — | — | 35 | — | — |
| Hemorrhage (rectal) | 7 | 1 | — | 4 | — | — |
| Allergic reaction | 4 | 4 | — | 3 | — | — |
| CNS ischemia | — | — | 1 | — | 1 | — |
| Leukoencephalopathy | 1 | — | — | — | — | — |
Worst toxicity reported per patient based on CTCAE version 3.0. ALT, alanine aminotransferase; AST, aspartate aminotransferase; CHF, cardiac dysfunction; CNS, central nervous system; LVEF, left ventricular ejection fraction.
a
Grade 3 left ventricular systolic dysfunction includes decreases in LVEF to 20%–40% and/or symptoms of CHF.