Table 1.
Classification of adverse toxicity reactions | All levels (number of patients) | Level 1 or 2 (number of patients) | Level 3 or 4 (number of patients) | |
---|---|---|---|---|
Hematologic toxicity | Anemia | 2 | 1 | 1 |
Leukopenia | 2 | 1 | 1 | |
Neutropenia | 2 | 1 | 1 | |
Lymphocytopenia | 3 | 2 | 1 | |
Thrombocytopenia | 1 | 1 | 0 | |
Infection | Transient Epstein-Barr viremia | 1 | 1 | 0 |
Other opportunistic infections | 0 | 0 | 0 | |
Electrolyte | Hypercalcemia | 0 | 0 | 0 |
Hypocalcemia | 0 | 0 | 0 | |
Hypokalemia | 0 | 0 | 0 | |
Hyponatremia | 0 | 0 | 0 | |
Central Nervous System | 0 | 0 | 0 | |
Urinary System | 0 | 0 | 0 | |
Respiratory System | 1 | 1 | 0 | |
Digestive System | 1 | 1 | 0 | |
Other Systems | 0 | 0 | 0 | |
Brief Summary | 13 | 9 | 4 |
Toxicity profile demonstrates that toxicity experienced is predominantly level 1 or 2 and predominantly limited to the hematological system.