Table 3.
Cumulative adverse events for groups 1 and 2 (all cycles)
| Adverse event | Group 1 (N = 41) MDX-447 alone | Group 2 (N = 23) MDX-447 + G-CSF | ||||
|---|---|---|---|---|---|---|
| Gr 1 | Gr 2 | Gr 3/4 | Gr 1 | Gr 2 | Gr 3/4 | |
| Chills | 35 | 10 | 0 | 19 | 8 | 0 |
| Fever | 34 | 17 | 2 | 23 | 15 | 0 |
| Nausea | 16 | 4 | 0 | 13 | 3 | 0 |
| Vomiting | 11 | 2 | 0 | 9 | 6 | 0 |
| Hypotension | 14 | 11 | 5 | 5 | 3 | 2 |
| Tachycardia | 10 | 3 | 1 | 10 | 1 | 0 |
| Dyspnea | 9 | 4 | 2 | 9 | 5 | 3 |
| Pain, general | 15 | 5 | 2 | 13 | 6 | 1 |
| Headache | 20 | 12 | 2 | 6 | 1 | 0 |
| Sepsis | 0 | 0 | 1 | 0 | 0 | 0 |
| Hypertension | 9 | 4 | 2 | 6 | 1 | 1 |
| Pulmonary embolism | 0 | 0 | 1 | 0 | 0 | 0 |
| Dysphagia | 2 | 1 | 1 | 2 | 2 | 0 |
| Constipation | 3 | 2 | 0 | 3 | 1 | 1 |
| Diarrhea | 2 | 0 | 0 | 3 | 2 | 2 |
| Hemorrhage, gastrointestinal | 0 | 0 | 0 | 0 | 0 | 1 |
| Dehydration | 2 | 1 | 1 | 0 | 0 | 0 |
| Allergic reaction | 0 | 0 | 0 | 0 | 0 | 1 |
| Dysuria | 1 | 1 | 1 | 0 | 0 | 0 |
| Hematuria | 2 | 1 | 1 | 0 | 0 | 0 |
| Leukopenia | 3 | 2 | 1 | 0 | 0 | 0 |
| Thrombocytopenia | 3 | 2 | 2 | 0 | 0 | 0 |
| Elevated alkaline phosphatase | 3 | 2 | 1 | 0 | 0 | 0 |
| Elevated GGTP | 2 | 0 | 0 | 2 | 2 | 1 |
| Hyperglycemia | 1 | 1 | 1 | 1 | 1 | 1 |
GGTP gamma-glutamyl transpeptidase, Gr grade, N number of subjects