Table 1.
Adverse Events for All Patients Who Received Any Protocol Treatment
| Toxicity | Grade* |
Patients (%) | |||
|---|---|---|---|---|---|
| 4 | 3 | 2 | 1 | ||
| Some grade 3 to 4 severity | |||||
| Fatigue | 0 | 1 | 16 | 2 | 90 |
| Neutropenia | 2 | 5 | 8 | 2 | 81 |
| Anemia | 0 | 2 | 9 | 6 | 81 |
| Hypophosphatemia | 3 | 9 | 3 | 1 | 76 |
| Anorexia | 0 | 2 | 11 | 2 | 71 |
| Lymphopenia | 1 | 4 | 9 | 1 | 71 |
| Thrombocytopenia | 0 | 2 | 6 | 6 | 67 |
| Hypokalemia | 0 | 6 | 0 | 7 | 62 |
| Hypertriglyceridemia | 2 | 0 | 0 | 10 | 57 |
| Infection | 0 | 4 | 6 | 0 | 48 |
| Hypercholesterolemia | 0 | 2 | 1 | 3 | 29 |
| Diarrhea | 0 | 1 | 4 | 0 | 24 |
| Hyperglycemia | 0 | 1 | 1 | 1 | 14 |
| Febrile neutropenia | 0 | 2 | 0 | 0 | 10 |
| Grade 1 to 2 | |||||
| Rash | 12 | 4 | 76 | ||
| Nausea | 8 | 5 | 62 | ||
| Taste alterations | 7 | 5 | 57 | ||
| Constipation | 7 | 2 | 43 | ||
| ALT/AST | 3 | 6 | 43 | ||
| Depression | 2 | 0 | 10 | ||
| Insomnia | 1 | 1 | 10 | ||
| Dizziness | 0 | 1 | 5 | ||
NOTE. Adverse events with attribution of possible, likely, or definite are listed. Maximum grade for each toxicity per patient (n = 21) was recorded; each toxicity was recorded only once per patient, regardless of No. of recurrences. Infection events were two pneumonias, four upper respiratory infections, one sinusitis, one cellulitus, one urinary tract infection, and one oral herpes outbreak.
*
According to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.