Table 3.
Patients with treatment-related, grade 2 or higher, adverse events that occurred in ≥10% of patients
| Adverse event | Grade 1 |
Grade 2 |
Grade 3 |
Grade 4 |
Total |
|||||
|---|---|---|---|---|---|---|---|---|---|---|
| n | Percent | n | Percent | n | Percent | n | Percent | n | Percent | |
| Fatigue | 17 | 44 | 13 | 33 | 2 | 5 | 0 | 0 | 32 | 82 |
| Neuropathy, sensorya | 10 | 26 | 15 | 38 | 7 | 18 | 0 | 0 | 32 | 82 |
| Anemia | 22 | 56 | 7 | 18 | 0 | 0 | 0 | 0 | 29 | 74 |
| Leukopenia | 16 | 41 | 6 | 15 | 3 | 8 | 1 | 3 | 26 | 67 |
| Alopecia | 10 | 26 | 14 | 36 | 0 | 0 | 0 | 0 | 24 | 62 |
| Hyperglycemia | 22 | 56 | 1 | 3 | 0 | 0 | 0 | 0 | 23 | 59 |
| Nausea | 16 | 41 | 4 | 10 | 1 | 3 | 0 | 0 | 21 | 54 |
| Myalgias | 12 | 31 | 7 | 18 | 1 | 3 | 0 | 0 | 20 | 51 |
| AST | 13 | 33 | 2 | 5 | 2 | 5 | 0 | 0 | 17 | 44 |
| Diarrhea | 15 | 38 | 2 | 5 | 0 | 0 | 0 | 0 | 17 | 44 |
| Anorexia | 10 | 26 | 6 | 15 | 0 | 0 | 0 | 0 | 16 | 41 |
| Arthralgia | 6 | 15 | 9 | 23 | 1 | 3 | 0 | 0 | 16 | 41 |
| Neutropenia | 6 | 15 | 2 | 5 | 6 | 15 | 1 | 3 | 15 | 38 |
| Alkaline phosphatase | 8 | 21 | 2 | 5 | 3 | 8 | 0 | 0 | 13 | 33 |
| Extremity Pain | 9 | 23 | 4 | 10 | 0 | 0 | 0 | 0 | 13 | 33 |
| ALT | 9 | 23 | 3 | 8 | 0 | 0 | 0 | 0 | 12 | 31 |
| Back pain | 7 | 18 | 2 | 5 | 0 | 0 | 1 | 3 | 10 | 26 |
| Constipation | 9 | 23 | 1 | 3 | 0 | 0 | 0 | 0 | 10 | 26 |
| Hyponatremia | 8 | 21 | 0 | 0 | 2 | 5 | 0 | 0 | 10 | 26 |
| Fever without Neutropenia | 9 | 23 | 0 | 0 | 0 | 0 | 0 | 0 | 9 | 23 |
| Headache | 7 | 18 | 1 | 3 | 1 | 3 | 1 | 3 | 10 | 26 |
| Stomatitis | 7 | 18 | 1 | 3 | 1 | 3 | 0 | 0 | 9 | 23 |
| Rash | 5 | 13 | 3 | 8 | 1 | 3 | 0 | 0 | 9 | 23 |
| Vomiting | 5 | 13 | 4 | 10 | 0 | 0 | 0 | 0 | 9 | 23 |
| Cough | 6 | 15 | 2 | 5 | 0 | 0 | 0 | 0 | 8 | 21 |
| Dyspnea | 4 | 10 | 3 | 8 | 0 | 0 | 1 | 3 | 8 | 21 |
| Lymphopenia | 8 | 21 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 21 |
| Thrombocytopenia | 8 | 21 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 21 |
| Allergic reaction | 4 | 10 | 3 | 8 | 0 | 0 | 0 | 0 | 7 | 18 |
| Hematologic-other | 5 | 13 | 0 | 0 | 0 | 0 | 1 | 3 | 6 | 15 |
| Insomnia | 5 | 13 | 1 | 3 | 0 | 0 | 0 | 0 | 6 | 15 |
| Abdominal pain | 3 | 8 | 2 | 5 | 2 | 5 | 0 | 0 | 7 | 18 |
| Bone pain | 3 | 8 | 1 | 3 | 1 | 3 | 0 | 0 | 5 | 13 |
| Dizziness | 4 | 10 | 1 | 3 | 0 | 0 | 0 | 0 | 5 | 13 |
| Hypoalbuminemia | 5 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 13 |
| Hypoalbuminemia | 5 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 13 |
| Hypocalcemia | 4 | 10 | 1 | 3 | 0 | 0 | 0 | 0 | 5 | 13 |
| Nail changes | 2 | 5 | 3 | 8 | 0 | 0 | 0 | 0 | 5 | 13 |
| Dyspepsia | 3 | 8 | 1 | 3 | 0 | 0 | 0 | 0 | 4 | 10 |
| Limb edema | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 10 |
| Influenza-like symptoms | 2 | 5 | 2 | 5 | 0 | 0 | 0 | 0 | 4 | 10 |
| Hot flashes | 3 | 8 | 1 | 3 | 0 | 0 | 0 | 0 | 4 | 10 |
| Hypernatremia | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 10 |
| Hypokalemia | 3 | 8 | 0 | 0 | 1 | 3 | 0 | 0 | 4 | 10 |
| Rigors/chills | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 10 |
| Weight loss | 3 | 8 | 1 | 3 | 0 | 0 | 0 | 0 | 4 | 10 |
aSensory neuropathy was assessed and graded according to symptoms as reported by the patient; neurosensory studies were not carried out.