Table III.
Non-dose limiting toxicities related to protocol therapy and observed in more than 10 percent of evaluable patients.
| Toxicity Type | Maximum grade of toxicity across cycle 1 (total, 18 cycles) | Maximum grade of toxicity across cycles 2–13 (total, 45 cycles) | ||||||
|---|---|---|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Hematologic Toxicities | ||||||||
| Anemia | 2 | 5 | 1 | 2 | 2 | 1 | ||
| Neutrophil count decreased | 5 | 1 | 2 | 2 | ||||
| Platelet count decreased | 5 | 1 | 1 | 1 | 4 | 1 | 1 | 2 |
| White blood cell decreased | 3 | 2 | 4 | 1 | 3 | 3 | 1 | |
| Lymphocyte count decreased | 3 | 4 | 3 | 1 | 2 | 2 | 3 | 1 |
| Non-Hematologic Toxicities | ||||||||
| Anorexia | 2 | 2 | 1 | 1 | ||||
| Alanine aminotransferase increased | 2 | 1 | 1 | |||||
| Aspartate aminotransferase increased | 2 | 1 | ||||||
| Constipation | 1 | 2 | ||||||
| Diarrhea | 3 | 1 | 2 | 1 | ||||
| Fatigue | 3 | 1 | 1 | 1 | ||||
| Fever | 2 | 1 | ||||||
| Headache | 1 | 1 | 1 | |||||
| Hyperglycemia | 4 | 1 | ||||||
| Hypermagnesemia | 3 | 1 | ||||||
| Hypernatremia | 2 | 1 | ||||||
| Hypoalbuminemia | 2 | 2 | ||||||
| Hypocalcemia | 3 | 1 | ||||||
| Hypokalemia | 2 | 3 | ||||||
| Hyponatremia | 3 | |||||||
| Nausea | 7 | 2 | 2 | 1 | ||||
| Stomach pain | 2 | |||||||
| Vomiting | 5 | 2 | 2 | |||||
| Weight loss | 2 | 1 | ||||||