Table 2.
Adverse events during therapy in all 54 treated patients.
| Adverse Event | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Any Grade | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| N | % | N | % | N | % | N | % | N | % | ||
| Hematologic | |||||||||||
| Neutropenia | 6 | 11 | 14 | 26 | 11 | 20 | 4 | 7 | 35 | 65 | |
| Febrile neutropenia | 0 | 0 | 0 | 0 | 2 | 4 | 0 | 0 | 2 | 4 | |
| Anemia | 21 | 39 | 11 | 20 | 2 | 4 | 1 | 2 | 35 | 65 | |
| Thrombocytopenia | 15 | 28 | 3 | 6 | 1 | 2 | 0 | 0 | 19 | 35 | |
| Infection | 0 | 0 | 15 | 28 | 4 | 7 | 0 | 0 | 19 | 35 | |
| Gastrointestinal | |||||||||||
| Diarrhea | 30 | 56 | 10 | 19 | 3 | 6 | 0 | 0 | 43 | 80 | |
| Nausea | 23 | 43 | 16 | 30 | 1 | 2 | 0 | 0 | 40 | 74 | |
| Vomiting | 16 | 30 | 5 | 9 | 4 | 7 | 0 | 0 | 25 | 46 | |
| Mucositis | 20 | 37 | 3 | 6 | 1 | 2 | 0 | 0 | 24 | 44 | |
| Constitutional | |||||||||||
| Fatigue | 16 | 30 | 19 | 35 | 9 | 17 | 1 | 2 | 45 | 83 | |
| Anorexia | 17 | 31 | 10 | 19 | 1 | 2 | 0 | 0 | 28 | 52 | |
| Taste disturbance | 14 | 26 | 10 | 19 | 0 | 0 | 0 | 0 | 24 | 44 | |
| Pain | 21 | 39 | 11 | 20 | 4 | 7 | 3 | 6 | 39 | 72 | |
| Arthralgia | 18 | 33 | 6 | 11 | 0 | 0 | 0 | 0 | 24 | 44 | |
| Neurologic | |||||||||||
| Headache | 15 | 28 | 4 | 7 | 3 | 6 | 0 | 0 | 22 | 41 | |
| Neuropathy | 14 | 26 | 11 | 20 | 12 | 22 | 0 | 0 | 37 | 69 | |
| Muscle weakness (Generalized) | 9 | 17 | 3 | 6 | 2 | 4 | 0 | 0 | 14 | 26 | |
| Dizziness | 13 | 24 | 3 | 6 | 2 | 4 | 0 | 0 | 18 | 33 | |
| Renal/Metabolic | |||||||||||
| Creatinine | 4 | 7 | 3 | 6 | 0 | 0 | 0 | 0 | 7 | 13 | |
| AST | 15 | 28 | 3 | 6 | 0 | 0 | 0 | 0 | 18 | 33 | |
| ALT | 11 | 20 | 4 | 7 | 0 | 0 | 0 | 0 | 15 | 28 | |
| Hypocalcemia | 13 | 24 | 2 | 4 | 0 | 0 | 1 | 2 | 16 | 30 | |
| Hypokaelemia | 5 | 9 | 0 | 0 | 1 | 2 | 0 | 0 | 6 | 11 | |
| Hyponatremia | 13 | 24 | 0 | 0 | 1 | 2 | 0 | 0 | 14 | 26 | |
| Proteinuria | 1 | 2 | 0 | 0 | 0 | 0 | 1 | 2 | 2 | 4 | |
| Vascular | |||||||||||
| Hypertension | 6 | 11 | 4 | 7 | 4 | 7 | 0 | 0 | 14 | 26 | |
| Thrombosis | 0 | 0 | 1 | 2 | 4 | 7 | 2 | 4 | 7 | 13 | |
| Epistaxis | 29 | 54 | 2 | 4 | 1 | 2 | 0 | 0 | 32 | 59 | |
| Skin | |||||||||||
| Rash | 12 | 22 | 8 | 15 | 0 | 0 | 0 | 0 | 20 | 37 | |
| Pulmonary | |||||||||||
| Dyspnea | 13 | 24 | 3 | 6 | 6 | 11 | 0 | 0 | 22 | 41 | |