Table 1.
Grade 3-4 Adverse Events experienced by dose level. AEs numbers represent the highest AE grade per person for all injections received, regardless of attribution.
| Adverse Event (CTCAE v3.0) | 50 μg/m2 (n=3) | 100 μg/m2 (n=3) | 150 μg/m2 (n=3) | 200 μg/m2 (n=3) | 250 μg/m2 (n=3) | 300 μg/m2 (n=4) | 400 μg/m2 (n=3) | 500 μg/m2 (n=3) | 600 μg/m2 (n=4) | Total (n=29) |
|---|---|---|---|---|---|---|---|---|---|---|
| Blood/Bone Marrow | ||||||||||
| Lymphopenia | 2 | 3 | 1 | 3 | 3 | 4 | 3 | 3 | 4 | 26 |
| Leukocytes (total WBC) | 1 | 1 | 2 | |||||||
| Hemoglobin | 1 | 1 | 2 | |||||||
| Neutrophils/granulocytes | 1 | 1 | ||||||||
| Metabolic/Laboratory | ||||||||||
| Hypoalbuminemia | 1 | 1 | 1 | 2 | 5 | |||||
| Hypokalemia | 1 | 1 | 1 | 2 | 5 | |||||
| Hypercalcemia | 1 | 1 | 2 | |||||||
| AST/SGOT | 1 | 1 | 1 | 2 | 5 | |||||
| ALT/ SGPT | 1 | 1 | ||||||||
| Alkaline phosphatase | 1 | 1 | ||||||||
| Hypophosphatemia | 2 | 2 | 1 | 5 | ||||||
| Hyperbilirubinemia | 1 | 4 | 5 | |||||||
| Adverse Events | ||||||||||
| Fatigue | 1 | 1 | 1 | 3 | ||||||
| Pain, chest wall | 1 | 1 | ||||||||
| Pain, liver | 1 | 1 | ||||||||
| Pain, abdomen | 2 | 1 | 1 | 4 | ||||||
| Pain, bone | 1 | 1 | ||||||||
| Pain, head | 1 | 1 | ||||||||
| Pain, NOS | 1 | 1 | ||||||||
| Nausea | 1 | 1 | 2 | |||||||
| Vomiting | 1 | 1 | 2 | |||||||
| Diarrhea | 1 | 1 | ||||||||
| Infection, pneumonia | 1 | 1 | ||||||||
| Infection, urinary | 1 | 1 | 2 | |||||||
| Anorexia | 1 | 1 | ||||||||
| Thrombosis/embolism | 1 | 1 |