TABLE II.
Valspodar dose levels and non-bilirubin, non-hematologic grade 3 or 4 toxicity
| Dose Level |
Valspodar Dose (mg/kg/day) |
Number of Patients Treated at Dose Level |
Number of Patients with Grade 3 or 4 Toxicity in First Course |
Specific Toxicity | Toxicity Grade |
|---|---|---|---|---|---|
| 1 | 8 | 3 | 1 | Stomatitis$ | Grade 4 |
| 2 | 10 | 5 | 1 | Stomatitis | Grade 3 |
| 3 | 12.5 | 6 | 1 | Cerebellar | Grade 3* |
| 1 | Infection | Grade 5 (death) | |||
| 1 | Stomatitis | Grade 3 | |||
| 1 | Hyperglycemia | Grade 3# | |||
| 2 | Hypokalemia | Grade 3# | |||
| 4 | 15 | 7 | 3 | Stomatitis | Grade 4* |
| 1 | Bone marrow aplasia > 6 weeks |
Grade 4* | |||
| 1 | Hypokalemia | Grade 4* | |||
| 2 | Hypertension | Grade 3# |
$
Occurred in patient with Down syndrome
*
Dose-limiting toxicity
#
noted during retrospective chart review after study completion, not reported during therapy