Table 3.
Selected drug-related toxicities in all patients for all cycles
| Normal (N=15) | Mild (N=17) | Moderate (N=18) | Severe (N=3) | Dialysis (N=9) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1.3 mg/m2 (n=14) |
1.5 mg/m2 (n=1) |
1.0 mg/m2 (n=3) |
1.3 mg/m2 (n=14) |
0.7 mg/m2 (n=4) |
1.0 mg/m2 (n=3) |
1.3 mg/m2 (n=11) |
0.7 mg/m2 (n=3) |
1.0 mg/m2 |
1.3 mg/m2 |
0.7 mg/m2 (n=3) |
1.0 mg/m2 (n=2) |
1.3 mg/m2 (n=4) |
|
| Hematologic AEs, n | |||||||||||||
| Neutropenia | |||||||||||||
| Grade 1 or 2 | 2 | 1 | 1 | 1 | 1 | ||||||||
| Grade 3 | 1 | 1 | |||||||||||
| Lymphopenia | |||||||||||||
| Grade 1 or 2 | 1 | 1 | 1 | ||||||||||
| Grade 3 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | ||||||
| Thrombocytopenia | |||||||||||||
| Grade 1 or 2 | 3 | 1 | 1 | 4 | 2 | 1 | |||||||
| Grade 3 | 2 | 1 | 1 | 2 | 1 | 2 | |||||||
| Hemoglobin | |||||||||||||
| Grade 1 or 2 | 2 | 2 | 1 | 1 | 1 | 2 | 1 | 2 | |||||
| Grade 3 | 1 | 1 | |||||||||||
| Non-hematologic AEs, n | |||||||||||||
| Nausea/Vomiting | |||||||||||||
| Grade 1 or 2 | 9/3 | 1/1 | 1/0 | 5/4 | 2/0 | 3/2 | 3/2 | 2/1 | 1/1 | 1/1 | |||
| Grade 3 | 1/0 | 0/1 | |||||||||||
| Diarrhea | |||||||||||||
| Grade 1 or 2 | 6 | 1 | 4 | 2 | 1 | 1 | 3 | ||||||
| Grade 3 | 1 | 1 | 1 | 1 | 1 | ||||||||
| Peripheral neuropathy | |||||||||||||
| Grade 1 or 2 | 4 | 1 | 2 | 1 | 2 | 1 | 1 | ||||||
| Grade 3 | 1 | 1 | |||||||||||
| Fatigue | |||||||||||||
| Grade 1 or 2 | 9 | 1 | 1 | 6 | 3 | 2 | 4 | 2 | 1 | ||||
| Grade 3 | 1 | 1 | 4 | 1 | |||||||||
Adverse event score based upon National Cancer Institute Common Toxicity Criteria, Version 2.0. There were no grade 4 toxicities observed.