Table 2.
Grade ≥ 3 Clinically Significant Related Adverse Events
| Adverse Event | Cy/GVAX Plus CRS-207 (n = 61) |
Cy/GVAX (n = 29) |
Total (N = 90) |
|||
|---|---|---|---|---|---|---|
| No. | % | No. | % | No. | % | |
| Hematologic | ||||||
| Anemia | 0 | 0.0 | 1 | 3.4 | 1 | 1.1 |
| Lymphopenia | 5 | 8.2* | 1 | 3.4 | 6 | 6.7 |
| Neutropenia | 1 | 1.6 | 0 | 0.0 | 1 | 1.1 |
| Nonhematologic | ||||||
| ALT increased | 1 | 1.6 | 0 | 0.0 | 1 | 1.1 |
| AST increased | 3 | 4.9 | 0 | 0.0 | 3 | 3.3 |
| Hyperglycemia | 1 | 1.6 | 0 | 0.0 | 1 | 1.1 |
| Hyponatremia | 1 | 1.6 | 0 | 0.0 | 1 | 1.1 |
| Hypophosphatemia | 2 | 3.3 | 0 | 0.0 | 2 | 2.2 |
| Myalgia | 1 | 1.6 | 0 | 0.0 | 1 | 1.1 |
| Hypotension | 2 | 3.3 | 0 | 0.0 | 2 | 2.2 |
| Abdominal pain | 1 | 1.6 | 1 | 3.4 | 2 | 2.2 |
| Diarrhea | 1 | 1.6 | 0 | 0.0 | 1 | 1.1 |
| Chills | 2 | 3.3 | 0 | 0.0 | 2 | 2.2 |
| Fatigue | 3 | 4.9 | 0 | 0.0 | 3 | 3.3 |
| Pyrexia | 3 | 4.9 | 0 | 0.0 | 3 | 3.3 |
| Vaccination site exfoliation | 1 | 1.6 | 0 | 0.0 | 1 | 1.1 |
| Vaccination site pain | 1 | 1.6 | 1 | 3.4 | 2 | 2.2 |
*
Two patients with grade 4 lymphopenia; these were the only treatment-related grade > 3 adverse events.