Table 2.
Most Common (≥5%) Adverse Events (n=19)
| Adverse Event | Any AE | Drug Related AE | ||
|---|---|---|---|---|
|
| ||||
| # of Pts | % | # of Pts | % | |
|
| ||||
| Hematologic | ||||
|
| ||||
| Thrombocytopenia | 13 | 68% | 12 | 63% |
| Leukopenia | 11 | 58% | 11 | 58% |
|
| ||||
| Anemia | 8 | 42% | 6 | 32% |
| Neutropenia | 7 | 37% | 7 | 37% |
|
| ||||
| Non-Hematologic | ||||
|
| ||||
| Fatigue | 17 | 89% | 14 | 74% |
| Abdominal pain | 13 | 68% | 2 | 11% |
|
| ||||
| Nausea | 8 | 42% | 7 | 37% |
| Anorexia | 8 | 42% | 4 | 21% |
|
| ||||
| Diarrhea | 7 | 37% | 5 | 26% |
| Mucositis | 7 | 37% | 7 | 37% |
|
| ||||
| HTN | 7 | 37% | 7 | 37% |
| Hypothyroidism | 7 | 37% | 7 | 37% |
|
| ||||
| Constipation | 6 | 32% | 2 | 11% |
| Vomiting | 4 | 21% | 4 | 21% |
|
| ||||
| Asthenia | 4 | 21% | 1 | 5% |
| Dyspepsia/Heartburn | 4 | 21% | 4 | 21% |
|
| ||||
| Rash | 4 | 21% | 2 | 11% |
| Palmar Plantar Erythrodysesthesia | 4 | 21% | 4 | 21% |
|
| ||||
| Abdominal distension | 4 | 21% | 0 | 0% |
| Pyrexia | 3 | 16% | 0 | 0% |
|
| ||||
| Dry Skin | 3 | 16% | 2 | 11% |
| Weight loss | 3 | 16% | 1 | 5% |
|
| ||||
| Peripheral edema | 2 | 11% | 0 | 0% |
| Foot pain | 2 | 11% | 1 | 5% |
|
| ||||
| Insomnia | 2 | 11% | 1 | 5% |
| Peripheral sensory neuropathy | 2 | 11% | 1 | 5% |
|
| ||||
| Peripheral motor neuropathy | 2 | 11% | 0 | 0% |
| Hyperhidrosis | 2 | 11% | 0 | 0% |
|
| ||||
| Flatulence | 2 | 11% | 1 | 5% |
| Cough | 2 | 11% | 0 | 0% |
|
| ||||
| Back Pain | 2 | 11% | 0 | 0% |
| Psychiatric d/o | 2 | 11% | 0 | 0% |
|
| ||||
| Dizziness | 2 | 11% | 1 | 5% |
| Bleeding | 2 | 11% | 1 | 5% |
|
| ||||
| Laboratory Abnormalities | ||||
|
| ||||
| Elevated AST | 16 | 84% | 14 | 74% |
| Elevated Alkaline phosphatase | 14 | 74% | 5 | 26% |
|
| ||||
| Hyperglycemia | 13 | 68% | 1 | 5% |
| Elevated ALT | 12 | 63% | 9 | 47% |
|
| ||||
| Hyponatremia | 12 | 63% | 6 | 32% |
| Hypomagnesemia | 7 | 37% | 4 | 21% |
|
| ||||
| Hyperbilirubinemia | 4 | 21% | 1 | 5% |
| Hypophosphatemia | 4 | 21% | 2 | 11% |
|
| ||||
| Hypoalbuminemia | 4 | 21% | 1 | 5% |
| Hypokalemia | 2 | 11% | 0 | 0% |
|
| ||||
| Hyperkalemia | 2 | 11% | 0 | 0% |
AEs: Adverse Events; AST: Aspartate aminotranferase; ALT: Alanine aminotransferase Drug related AE = attribution of possibly, probably, or definitely