Table 3. Treatment Related Adverse Events (AEs) by Arm and Dose Level:
Treatment related adverse events are broken down by Arm and Dose Level. A total of 9 patients were treated on Arm A on Dose Levels 1,2, and 3 (3 per dose level) and 2 patients total experienced AEs. A total of 11 patients were treated on Arm B, on Dose Levels 0, 0.5, and 1. AST/ALT elevations were observed in 3 patients on Dose Level 1 of Arm B. Treatment related adverse events in Arm B occurred in 4 of 11 patients.
| ARM A: Fowlpox GM-CSF | ||||||
|---|---|---|---|---|---|---|
| Adverse Event | Dose Level 0 (N=0) |
Dose Level 0.5 (N=0) |
Dose Level 1 (N=3) |
Dose Level 2 (N=3) |
Dose Level 3 (N=3) |
Grade ≥ 3 (N=9) |
| Patients with AE | 1 | - | 1 | - | ||
| Dysuria | N/A | N/A | - | - | 1 | - |
| Urinary Frequency | 1 | - | - | - | ||
| ARM B: Fowlpox-TRICOM | ||||||
| Adverse Event | Dose Level 0 (N=3) |
Dose Level 0.5 (N=3) |
Dose Level 1 (N=5) |
Dose Level 2 (N=0) |
Dose Level 3 (N=0) |
Grade ≥ 3 (N=11) |
| Patients with AE | - | - | 4 | 2 | ||
| ALT Increase1 | - | - | 3 | 1 | ||
| AST Increase2 | - | - | 3 | 2 | ||
| Constipation | - | - | 1 | - | ||
| Decreased Appetite | - | - | 1 | - | ||
| Decreased Hemoglobin | - | - | 1 | N/A | N/A | - |
| Erythema | - | - | 1 | - | ||
| Fever without Neutropenia | - | - | 1 | - | ||
| Malaise | - | - | 1 | - | ||
| Nausea | - | - | 1 | - | ||
1
ALT = Alanine aminotransferase;
2
AST = Aspartate aminotransferase