Table 1.
Toxicity by arm (frequency)
| Toxicity type | Treatment arm | |||
|---|---|---|---|---|
| A (n = 40) | B (n = 44) | |||
| Grade | Grade | |||
| 1,2 | ≥3a | 1,2 | ≥3a | |
| Hematologic | ||||
| Anemia | 28 | 4 | 27 | 4 |
| White blood cell count decreased | 11 | 2 | 15 | 6 |
| Lymphocyte count decreased | 13 | 8 | 12 | 8 |
| Neutrophil count decreasedb | 8 | 3 | 10 | 8 |
| Platelet count decreased | 6 | — | 10 | 1 |
| Constitutional | ||||
| Fatigue | 26 | 3 | 27 | 1 |
| Pruritis | 3 | — | 5 | — |
| Weight loss | 8 | — | 8 | 1 |
| Myalgia | 1 | 1 | 5 | — |
| Dizziness | 2 | — | 5 | — |
| Anorexia | 7 | — | 12 | — |
| Gastrointestinal | ||||
| Constipation | 4 | — | 2 | — |
| Diarrhea | 8 | — | 10 | — |
| Mucositis | 2 | — | 3 | 2 |
| Nausea | 8 | 1 | 13 | 1 |
| Vomiting | 6 | — | 8 | 2 |
| Alanine aminotransferase increased | 5 | — | 4 | — |
| Alkaline phosphatase increased | 5 | — | 10 | — |
| Aspartate aminotransferase increased | 5 | — | 8 | — |
| Dysgeusia | 1 | — | 5 | — |
| Electrolyte abnormality | ||||
| Hypocalcemia | — | — | 5 | — |
| Hypokalemia | 3 | 1 | 3 | — |
| Hypomagnesemia | 5 | — | 6 | — |
| Hyponatremia | 3 | — | 8 | 1 |
| Hypophosphatemia | 2 | 2 | 2 | 1 |
| Endocrine | ||||
| Glucose intolerance | 3 | — | 4 | 1 |
| Hyperglycemia | 9 | 2 | 15 | 5 |
| Dermatologic | ||||
| Acneiform rash | 1 | — | 5 | — |
| Maculopapular rash | 2 | 1 | 8 | — |
| Other | ||||
| Peripheral sensory neuropathy | 13 | 1 | 15 | 1 |
| Edema of limbs | 4 | — | — | — |
| Alopecia | 13 | — | 12 | — |
| Visual flashing lights | — | — | 7 | — |
aOne treatment-related Grade 5 event was observed in each arm - death not otherwise specified in arm A, and death due to respiratory failure in arm B.
bNo neutropenic fever was observed.