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.