Table 3 –
Treatment Emergent Adverse events (n=45)
| Adverse Event: | Grade 1–2 | Grade 3 | Grade 4 | Grade 5 |
|---|---|---|---|---|
| Anemia | 38 ( 84% ) | 6 ( 13% ) | 0 ( 0% ) | 0 ( 0% ) |
| Nausea | 37 ( 82% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Elevated AST | 34 ( 76% ) | 2 ( 4% ) | 0 ( 0% ) | 0 ( 0% ) |
| Elevated ALT | 32 ( 71% ) | 5 ( 11% ) | 0 ( 0% ) | 0 ( 0% ) |
| Constipation | 24 ( 53% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Alopecia | 23 ( 51% ) | 1 ( 2% ) | 0 ( 0% ) | 0 ( 0% ) |
| Vomiting | 22 ( 49% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Fatigue | 21 ( 47% ) | 1 ( 2% ) | 0 ( 0% ) | 0 ( 0% ) |
| Headache | 21 ( 47% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Peripheral sensory neuropathy | 15 ( 33% ) | 1 ( 2% ) | 0 ( 0% ) | 0 ( 0% ) |
| Sinus Tachycardia | 15 ( 33% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Non-cardiac chest pain | 14 ( 31% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Abdominal Pain | 13 ( 29% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Diarrhea | 13 ( 29% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Rash | 12 ( 27% ) | 1 ( 2% ) | 0 ( 0% ) | 0 ( 0% ) |
| Anorexia | 12 ( 27% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Hypokalemia | 11 ( 24% ) | 3 ( 7% ) | 1 ( 2% ) | 0 ( 0% ) |
| Dyspepsia | 11 ( 24% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Myalgia | 10 ( 22% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Rhinorrhea | 10 ( 22% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Fever | 9 ( 20% ) | 1 ( 2% ) | 0 ( 0% ) | 0 ( 0% ) |
| Cough | 9 ( 20% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Pruritus | 9 ( 20% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Bone pain | 8 ( 18% ) | 1 ( 2% ) | 0 ( 0% ) | 0 ( 0% ) |
| Hypomagnesemia | 8 ( 18% ) | 1 ( 2% ) | 0 ( 0% ) | 0 ( 0% ) |
| Back pain | 8 ( 18% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Hypotension | 7 ( 16% ) | 0 ( 0% ) | 1 ( 2% ) | 0 ( 0% ) |
| Pain in extremity | 7 ( 16% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Thrombocytopenia | 6 ( 13% ) | 18 ( 40% ) | 18 ( 40% ) | 0 ( 0% ) |
| Chills | 6 ( 13% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Dizziness | 6 ( 13% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Upper respiratory infection | 6 ( 13% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Anxiety | 5 ( 11% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Arthralgia | 5 ( 11% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Infusion related reaction | 5 ( 11% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Mucositis oral | 5 ( 11% ) | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) |
| Neutropenia | 4 ( 9% ) | 7 ( 16% ) | 26 ( 58% ) | 0 ( 0% ) |
| Insomnia | 4 ( 9% ) | 1 ( 2% ) | 0 ( 0% ) | 0 ( 0% ) |
| Pain | 4 ( 9% ) | 1 ( 2% ) | 0 ( 0% ) | 0 ( 0% ) |
| Dyspnea | 3 ( 7% ) | 1 ( 2% ) | 0 ( 0% ) | 0 ( 0% ) |
| Hypocalcemia | 2 ( 4% ) | 0 ( 0% ) | 1 ( 2% ) | 0 ( 0% ) |
| Hyperglycemia | 2 ( 4% ) | 3 ( 7% ) | 0 ( 0% ) | 0 ( 0% ) |
| Enterocolitis infectious | 2 ( 4% ) | 1 ( 2% ) | 0 ( 0% ) | 0 ( 0% ) |
| Hypophosphatemia | 1 ( 2% ) | 4 ( 9% ) | 1 ( 2% ) | 0 ( 0% ) |
| Febrile neutropenia | 1 ( 2% ) | 3 ( 7% ) | 0 ( 0% ) | 0 ( 0% ) |
| Cellulitis | 1 ( 2% ) | 1 ( 2% ) | 0 ( 0% ) | 0 ( 0% ) |
| Dehydration | 1 ( 2% ) | 1 ( 2% ) | 0 ( 0% ) | 0 ( 0% ) |
| Multi-system organ failure | 0 ( 0% ) | 0 ( 0% ) | 0 ( 0% ) | 1 ( 2% ) |
| Sepsis | 0 ( 0% ) | 0 ( 0% ) | 6 ( 13% ) | 0 ( 0% ) |
| Acute kidney injury | 0 ( 0% ) | 0 ( 0% ) | 1 ( 2% ) | 0 ( 0% ) |
| Respiratory failure | 0 ( 0% ) | 0 ( 0% ) | 1 ( 2% ) | 0 ( 0% ) |
| Elevated lactate | 0 ( 0% ) | 2 ( 4% ) | 0 ( 0% ) | 0 ( 0% ) |
| Pulmonary Embolism | 0 ( 0% ) | 2 ( 4% ) | 0 ( 0% ) | 0 ( 0% ) |
| Hemorrhoids | 0 ( 0% ) | 1 ( 2% ) | 0 ( 0% ) | 0 ( 0% ) |
| Pneumonia | 0 ( 0% ) | 1 ( 2% ) | 0 ( 0% ) | 0 ( 0% ) |