Table 2.
Adverse events
| Adverse Event | Enzalutamide+Prostvac (n=20) | Enzalutamide alone (n=18) | Total for all patients (n=38) | ||||||
| Grade 1 | Grade 2 | Grade 3 | Grade 1 | Grade 2 | Grade 3 | Grade1 | Grade 2 | Grade 3 | |
| Injection Site Reaction | 14 (70%) | 4 (20%) | 0 | 0 | 0 | 0 | 14 (37%) | 4 (11%) | 0 |
| Flu-like Symptoms | 6 (30%) | 0 | 0 | 0 | 0 | 0 | 6 (16%) | 0 | 0 |
| Fatigue/Lethargy | 14 (70%) | 4 (20%) | 0 | 13 (72%) | 3 (17%) | 0 | 27 (71%) | 7 (18%) | 0 |
| Breast Pain/Nipple Tenderness | 17 (85%) | 0 | 0 | 14 (78%) | 0 | 0 | 31 (81%) | 0 | 0 |
| Gynecomastia | 6 (30%) | 1 (5%) | 0 | 8 | 1 (6%) | 0 | 14 (37%) | 2 (5%) | 0 |
| Myalgia | 4 (20%) | 0 | 0 | 1 (6%) | 0 | 0 | 5 (13%) | 0 | 0 |
| AST/ALT Elevation | 0 | 0 | 1 (5%) | 3 (17%) | 0 | 1 (6%) | 3 (8%) | 0 | 2 (5%) |
| Anorexia | 5 (20%) | 0 | 0 | 2 (11%) | 0 | 7 (39%) | 0 | 0 | |
| Dizziness | 3 (15%) | 1 (5%) | 0 | 2 (11%) | 2 (11%) | 0 | 5 (28%) | 3 (8%) | 0 |
| Headache | 5 (25%) | 1 (5%) | 0 | 1 (6%) | 0 | 0 | 6 (33%) | 1 (3%) | 0 |
| Hypertension | 0 | 1 (5%) | 0 | 1 (6%) | 1 (6%) | 0 | 1 (6%) | 2 (5%) | 0 |
| Hot Flashes | 4 (20%) | 1 (5%) | 0 | 2 (11%) | 0 | 0 | 6 (16%) | 1 (3%) | 0 |
| Memory Impairment | 3 (15%) | 0 | 0 | 1 (6%) | 0 | 0 | 4 (11%) | 0 | 0 |
| Anemia | 6 (30%) | 0 | 0 | 4 (22%) | 0 | 0 | 10 (26%) | 0 | 0 |
| Decreased White Blood Cells | 5 (25%) | 2 (10%) | 0 | 3 (17%) | 0 | 0 | 8 (31%) | 2 (5%) | 0 |
| Decreased Libido | 3 (15%) | 0 | 0 | 1 (6%) | 0 | 0 | 4 (22%) | 0 | 0 |