Table 3.
Non-dose limiting toxicities with possible, probable or definite relationship to protocol therapy
| Toxicity Type | Maximum grade of toxicity observed in a pt | Maximum grade of toxicity observed in a pt across all courses | ||||
|---|---|---|---|---|---|---|
| Course 1 (18 pt-courses) | Courses 2–8 (19 pt-courses) | |||||
| Grade 1 | Grade 2 | Grade 3 | Grade 1 | Grade 2 | Grade 3 | |
| Hematologic Toxicities | ||||||
| Hemoglobin | 1 | 1 | ||||
| Leukopenia (WBC) | 5 | 1 | 2 | |||
| Lymphopenia | 2 | 1 | 2 | |||
| Neutropenia | 1 | 1 | 1 | |||
| Platelets | 1 | |||||
| Non-hematologic Toxicities* | ||||||
| Hypertension | 2 | 5 | 1 | 1 | ||
| Fatigue | 3 | 1 | 1 | 2 | ||
| Proteinuria | 3 | 1 | 1 | |||
| Voice changes | 3 | |||||
| ALT | 2 | 2 | ||||
| AST | 2 | 2 | ||||
| Hypoalbuminemia | 2 | 1 | ||||
| PTT | 1 | 1 | 2 | |||
*
Non-hematologic toxicities that were observed in more than 10 % of patients.