Table 4.
Summary of Serious Adverse Events (n = 54 patients)
| Grade 3* Adverse Event (National Cancer Institute Common Toxicity Criteria version 2) | No. for Capecitabine Dose Level (mg/m2/d) |
|
|---|---|---|
| 2,000 (n = 32) | 1,700 (n = 23) | |
| Hematologic | ||
| Neutropenia | 1 | 0 |
| Thrombocytopenia | 0 | 0 |
| Hepatic | ||
| AST | 1 | 4 |
| Bilirubin | 2 | 1 |
| Alkaline phosphatase | 1 | 1 |
| ALT | 3 | 6 |
| Gastrointestinal | ||
| Abdominal pain | 6 | 1 |
| Nausea | 6 | 2 |
| Vomiting | 7 | 3 |
| Diarrhea | 11 | 4 |
| Neurologic | ||
| Paresthesia | 6 | 4 |
| Laryngeal dysesthesia | 1 | 0 |
| Neuro/sensory | 0 | 1 |
| Pulmonary | ||
| Dyspnea | 1 | 2 |
| Constitutional | ||
| Fatigue | 5 | 1 |
| Dermatology/skin | ||
| Hand/foot | 1 | 0 |
*
Events reported at least possibly related to study treatment.