Table III.
Detailed Toxicities*
| Toxicity Type | Maximum Grade of Toxicity | |||||
|---|---|---|---|---|---|---|
| Dose Level 1(n=4) | Dose Level 2 (n=3) | Dose Level 3 (n=13) | ||||
| Grade 1- 2 |
Grade 3-4 |
Grade 1- 2 |
Grade 3-4 |
Grade 1- 2 |
Grade 3- 4 |
|
| Non-heme | ||||||
| Hypocalcemia | 3 | 2 | 1 | 1 | 7 | 1 |
| Pain^ | 1 | 3 | 1 | |||
| Hypophosphatemia | 2 | 2 | 3 | |||
| Nausea/Vomiting | 1 | 5 | ||||
| Fever | 1 | 2 | 4 | |||
| SGOT (AST) | 2 | 3 | ||||
| Hypercalcemia | 4 | |||||
| Fatigue | 4 | |||||
| Hypermagnesemia | 1 | 2 | ||||
| Infection | 1 | 1 | 1 | |||
| Anorexia | 1 | 2 | ||||
| Heme$ | ||||||
| Evaluable for Heme Toxicity |
n=3 | n=1 | n=5 | |||
| Leukopenia | 3 | 1 | 4 | |||
| Anemia | 2 | 1 | 1 | |||
| Lymphopenia | 1 | 3 | ||||
| Neutropenia | 1 | 2 | 1 | |||
| Thrombocytopenia | 1 | 1 | ||||
*
Toxicities possibly, probably, or definitely related to treatment occurring in more than 10% of patients as determined in the first course of protocol therapy (n=20)
^
Pain described at various sites
$
In patients evaluable for hematologic toxicity