Table 2.
Toxicities
| Toxicity^# | Grade | |||||
|---|---|---|---|---|---|---|
| 1&2 | 3 | 4 | ||||
| N | % | N | % | N | % | |
| Abdominal pain | 12 | 24.00 | . | . | . | . |
| Alanine aminotransferase increased | 20 | 40.00 | 1 | 2.00 | . | . |
| Alkaline phosphatase increased | 11 | 22.00 | . | . | . | . |
| Alopecia | 7 | 14.00 | . | . | . | . |
| Anemia | 28 | 56.00 | . | . | . | . |
| Anorexia | 6 | 12.00 | . | . | . | . |
| Aspartate aminotransferase increased | 25 | 50.00 | . | . | . | . |
| CPK increased | 34 | 68.00 | 5 | 10.00 | . | . |
| Constipation | 11 | 22.00 | . | . | . | . |
| Cough | 7 | 14.00 | . | . | . | . |
| Creatinine increased | 7 | 14.00 | . | . | . | . |
| Diarrhea | 27 | 54.00 | 2 | 4.00 | . | . |
| Dizziness | 5 | 10.00 | . | . | . | . |
| Dry skin | 28 | 56.00 | . | . | . | . |
| Duodenal ulcer | 29 | 58.00 | . | . | . | . |
| Dyspnea | 30 | 60.00 | . | . | . | . |
| Edema limbs | 13 | 26.00 | . | . | . | . |
| Ejection fraction decreased | 19 | 38.00 | 1 | 2.00 | . | . |
| Erythema multiforme | 5 | 10.00 | . | . | . | . |
| Fatigue | 28 | 56.00 | . | . | . | . |
| Gastric hemorrhage | . | . | 1 | 2.00 | . | . |
| Headache | 14 | 28.00 | 1 | 2.00 | . | . |
| Hyperglycemia | 10 | 20.00 | . | . | . | . |
| Hypertension | 11 | 22.00 | . | . | . | . |
| Hypoalbuminemia | 31 | 62.00 | . | . | . | . |
| Hypocalcemia | 9 | 18.00 | . | . | . | . |
| Hypokalemia | 12 | 24.00 | . | . | . | . |
| Hypomagnesemia | 18 | 36.00 | . | . | . | . |
| Hyponatremia | 5 | 10.00 | . | . | . | . |
| Hypophosphatemia | 7 | 14.00 | . | . | . | . |
| Lymphocyte count decreased | 19 | 38.00 | . | . | 1 | 2.00 |
| Lymphocyte count increased | 21 | 42.00 | . | . | . | . |
| Metabolism and nutrition disorders - Other, specify | 5 | 10.00 | . | . | . | . |
| Mucositis oral | 7 | 14.00 | . | . | . | . |
| Nausea | 21 | 42.00 | . | . | . | . |
| Neutrophil count decreased | 14 | 28.00 | 3 | 6.00 | . | . |
| Paronychia | 19 | 38.00 | 3 | 6.00 | . | . |
| Pericardial effusion | 20 | 40.00 | . | . | . | . |
| Platelet count decreased | 8 | 16.00 | . | . | . | . |
| Pruritus | 10 | 20.00 | . | . | . | . |
| Rash acneiform | 29 | 58.00 | 2 | 4.00 | . | . |
| Rash maculo-papular | 26 | 52.00 | 5 | 10.00 | . | . |
| Skin and subcutaneous tissue disorders - Other, specify | 25 | 50.00 | . | . | . | . |
| Skin infection | 7 | 14.00 | 1 | 2.00 | . | . |
| Tooth infection | . | . | 1 | 2.00 | . | . |
| Vomiting | 22 | 44.00 | . | . | . | . |
| Weight gain | 5 | 10.00 | 1 | 2.00 | . | . |
| White blood cell decreased | 19 | 38.00 | . | . | . | . |
^
All grade 1 and 2 attributable toxicities seen in 10% or more of patients combining both strata 1 and 3 are listed. Grade 1 and 2 non-attributable toxicities were not reported.
All grade 3 and 4 toxicities combining both strata are also included.
The highest grade observed within a subject for each toxicity is reported.
#
There were no grade 5 events reported.