Table 3.
Non-Dose Limiting toxicities related to protocol therapy observed in evaluable patients (n=33)
| Toxicity Type | Maximum grade of toxicity across cycle 1 (total, 33 cycles) | Maximum grade of toxicity across cycles 2 to 20 (Total, 77+22 follow-up cycles) | ||||||
|---|---|---|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Hematologic | ||||||||
| Anemia | 11 | 2 | 3 | 5 | 7 | |||
| Lymphocyte count decreased | 11 | 4 | 1 | 1 | 8 | 2 | 2 | |
| Neutrophil count decreased | 3 | 7 | 3 | 1 | 3 | 4 | 1 | |
| Platelet count decreased | 17 | 3 | 4 | 9 | 1 | 2 | ||
| White blood cell decreased | 8 | 6 | 2 | 6 | 3 | 2 | ||
| Non-Hematologic* | ||||||||
| Alanine aminotransferase increased | 9 | 2 | 3 | 3 | 1 | |||
| Aspartate aminotransferase increased | 6 | 2 | 4 | 3 | ||||
| Cholesterol high | 13 | 2 | 5 | 1 | ||||
| Constipation | 3 | 1 | ||||||
| Creatinine increased | 4 | 1 | ||||||
| Fatigue | 7 | 1 | 4 | |||||
| Headache | 5 | 1 | 2 | |||||
| Hyperglycemia | 15 | 6 | 6 | 6 | ||||
| Hypermagnesemia | 4 | 2 | ||||||
| Hypertriglyceridemia | 14 | 4 | 7 | 3 | ||||
| Hypocalcemia | 6 | 1 | 4 | |||||
| Hypokalemia | 4 | 3 | ||||||
| Hyponatremia | 5 | 5 | ||||||
| Hypophosphatemia | 7 | 2 | 3 | 1 | 2 | 2 | ||
| Mucositis oral | 5 | 5 | 3 | 1 | 2 | |||
| Nausea | 6 | 3 | 3 | 1 | 1 | |||
| Proteinuria | 1 | 3 | 1 | |||||
| Rash acneiform | 5 | 1 | ||||||
| Weight loss | 5 | 1 | 1 | 2 | ||||
*
Non-hematologic toxicities are those that occurred in >10% of patients as determined in the first cycle of therapy