ALT, alanine transaminase; PT, prothrombin time; PTT, partial thromboplastin time.
| AE | Primary treatment | |
| TV003 (n = 21) | Placebo (n = 20) | |
| Injection site | ||
| Erythema | 9.5% | 0.0% |
| Pain | 0.0% | 0.0% |
| Tenderness | 0.0% | 0.0% |
| Induration | 0.0% | 0.0% |
| Systemic | ||
| Viremia | 0.0% | 100.0%* |
| Fever | 0.0% | 0.0% |
| Headache | 23.8% | 30.0% |
| Rash | 0.0% | 80.0%* |
| Neutropenia | 0.0% | 20.0%† |
| Elevated ALT | 0.0% | 5.0% |
| Myalgia | 4.8% | 20.0% |
| Arthralgia | 0.0% | 10.0% |
| Retro-orbital pain | 9.5% | 25.0% |
| Fatigue | 14.3% | 15.0% |
| Nausea | 14.3% | 20.0% |
| Photophobia | 4.8% | 0.0% |
| Elevated PT | 0.0% | 0.0% |
| Elevated PTT | 4.8% | 0.0% |
| Thrombocytopenia | 0.0% | 10.0% |
*P < 0.0001, two-sided.
†P = 0.048, two-sided.