Table 2.
Treatment-related adverse events
| Adverse event | Grades 1 or 2 | Grade 3 | Grade 4 | Any grade | ||||
|---|---|---|---|---|---|---|---|---|
| (N = 17) | No. of patients | % | No. of patients | % | No. of patients | % | No. of patients | % |
| Hematologic | ||||||||
| Anemia | 6 | 35 | 1 | 6 | 7 | 41 | ||
| Neutropenia | 3 | 18 | 3 | 18 | ||||
| Lymphopenia | 1 | 6 | 1 | 6 | ||||
| Thrombocytopenia | 1 | 6 | 1 | 6 | ||||
| Gastrointestinal | ||||||||
| Nausea | 9 | 53 | 9 | 53 | ||||
| Vomiting | 5 | 29 | 5 | 29 | ||||
| Diarrhea | 2 | 12 | 1 | 6 | 3 | 18 | ||
| Dehydration | 1 | 6 | 1 | 6 | ||||
| Constipation | 1 | 6 | 1 | 6 | ||||
| Abdominal pain* | 1 | 6 | 1 | 6 | ||||
| Constitutional | ||||||||
| Fatigue | 5 | 29 | 1 | 6 | 6 | 35 | ||
| Anorexia | 2 | 12 | 2 | 12 | ||||
| Fever | 1 | 6 | 1 | 6 | ||||
| Metabolic | ||||||||
| Hyperglycemia | 9 | 53 | 2 | 12 | 11 | 65 | ||
| Hypomagnesemia | 2 | 12 | 2 | 12 | ||||
| Hypermagnesemia | 1 | 6 | 1 | 6 | ||||
| Hyponatremia | 3 | 18 | 3 | 18 | ||||
| Hypocalcemia | 3 | 18 | 3 | 18 | ||||
| Hypokalemia | 2 | 12 | 2 | 12 | ||||
| Hypophosphatemia | 1 | 6 | 1 | 6 | ||||
| Hypoalbuminemia | 3 | 18 | 3 | 18 | ||||
| ALT, SGPT | 2 | 12 | 2 | 12 | ||||
| AST, SGOT | 2 | 12 | 2 | 12 | ||||
| Hyperbilirubinemia | 1 | 6 | 1 | 6 | ||||
| Hypercholesteremia | 2 | 12 | 2 | 12 | ||||
| Hypertriglyceridemia | 2 | 12 | 2 | 12 | ||||
| Hyperuricemia | 1 | 6 | 1 | 6 | ||||
| Neurologic | ||||||||
| Pain | 4 | 24 | 4 | 24 | ||||
| Neuropathy, sensory | 2 | 12 | 2 | 12 | ||||
| Dizziness | 1 | 6 | 1 | 6 | ||||
| Somnolence | 1 | 6 | 1 | 6 | ||||
| Renal | ||||||||
| Creatinine | 1 | 6 | 1 | 6 | 2 | 12 | ||
| Musculoskeletal | ||||||||
| Musculoskeletal disorder | 1 | 6 | 1 | 6 | ||||
| Cardiovascular | ||||||||
| Supraventricular and nodal arrhythmia | 1 | 6 | 1 | 6 | ||||
| Skin | ||||||||
| Rash/desquamation | 2 | 12 | 2 | 12 | ||||
Patient #11 had severe abdominal pain shortly after starting the treatment, and was off the study as “unlikely” related to treatment.