Any AEs | 31 | 83.8 | 13 | 68.4 | 3 | 15.8 | 11 | 61.1 | 4 | 22.2 |
Fatigue | 9 | 24.3 | 3 | 15.8 | 0 | 0 | 6 | 33.3 | 0 | 0 |
Diarrhea | 6 | 16.2 | 4 | 21.1 | 0 | 0 | 2 | 11.1 | 0 | 0 |
Hypertension | 5 | 13.5 | 3 | 15.8 | 0 | 0 | 1 | 5.6 | 1 | 5.6 |
Joint Pain | 5 | 13.5 | 2 | 10.5 | 0 | 0 | 3 | 16.7 | 0 | 0 |
Nausea | 5 | 13.5 | 4 | 21.1 | 0 | 0 | 1 | 5.6 | 0 | 0 |
Platelet count decreased | 5 | 13.5 | 2 | 10.5 | 0 | 0 | 3 | 16.7 | 0 | 0 |
Pain | 5 | 13.5 | 0 | 0 | 0 | 0 | 4 | 22.2 | 1 | 5.6 |
Anemia | 4 | 10.8 | 1 | 5.3 | 0 | 0 | 2 | 11.1 | 1 | 5.6 |
Chills | 4 | 10.8 | 2 | 10.5 | 0 | 0 | 2 | 11.1 | 0 | 0 |
Constipation | 4 | 10.8 | 1 | 5.3 | 0 | 0 | 3 | 16.7 | 0 | 0 |
Fever | 3 | 8.1 | 1 | 5.3 | 0 | 0 | 2 | 11.1 | 0 | 0 |
Hypoglycemia | 3 | 8.1 | 1 | 5.3 | 0 | 0 | 2 | 11.1 | 0 | 0 |
Increased Alkaline Phosphatase | 3 | 8.1 | 2 | 10.5 | 0 | 0 | 1 | 5.6 | 0 | 0 |
Shortness of breath | 3 | 8.1 | 1 | 5.3 | 0 | 0 | 2 | 11.1 | 0 | 0 |
Chest pain | 2 | 5.4 | 0 | 0 | 0 | 0 | 2 | 11.1 | 0 | 0 |
Dizziness | 2 | 5.4 | 1 | 5.3 | 0 | 0 | 1 | 5.6 | 0 | 0 |
Flu like symptoms | 2 | 5.4 | 0 | 0 | 0 | 0 | 2 | 11.1 | 0 | 0 |
Headache | 2 | 5.4 | 0 | 0 | 0 | 0 | 2 | 11.1 | 0 | 0 |
Hyperglycemia | 2 | 5.4 | 1 | 5.3 | 0 | 0 | 1 | 5.6 | 0 | 0 |
Hypermagnesemia | 2 | 5.4 | 1 | 5.3 | 0 | 0 | 1 | 5.6 | 0 | 0 |
Hypernatremia | 2 | 5.4 | 1 | 5.3 | 0 | 0 | 1 | 5.6 | 0 | 0 |
Hypotension | 2 | 5.4 | 0 | 0 | 1 | 5.3 | 0 | 0 | 1 | 5.6 |
Infusion related reaction | 2 | 5.4 | 1 | 5.3 | 0 | 0 | 1 | 5.6 | 0 | 0 |
(B) | | | | | | | | | | |
| All | % | Arm 1 Grade1-2 | % | Arm 1 Grade3-4 | % | Arm 2 Grade1-2 | % | Arm 2 Grade3-4 | % |
Any | 5 | 13.5 | 2 | 10.5 | 0 | 0 | 3 | 16.7 | 0 | 0 |
Dermatologic | 3 | 8.1 | 2 | 10.5 | 0 | 0 | 1 | 5.6 | 0 | 0 |
Endocrine | 1 | 2.7 | 0 | 0 | 0 | 0 | 1 | 5.6 | 0 | 0 |
Hepatitis | 1 | 2.7 | 0 | 0 | 0 | 0 | 1 | 5.6 | 0 | 0 |
Infusion related reaction | 2 | 5.4 | 1 | 5.3 | 0 | 0 | 1 | 5.6 | 0 | 0 |