Table 5:
Clinical response to Dose 1 of TV003 or TV005 (CIR268 & 279 and combined)
| Adverse event | Treatment group | |||||
|---|---|---|---|---|---|---|
| TV003 (n=60) | Placebo (n=48) | p value (1-sided)2 | TV005 (n=60) | Placebo (n=48) | p value (1-sided)3 | |
| Injection site: | ||||||
| Erythema | 4.8% | 4.2% | 0.6784 | 5.0% | 4.2% | 0.6784 |
| Pain | 0.0% | 8.3% | 1.0000 | 3.3% | 0.0% | 0.5077 |
| Tenderness | 5.0% | 4.2% | 0.6784 | 1.7% | 4.2% | 0.9208 |
| Induration | 3.3% | 0.0% | 0.5077 | 1.2% | 0.0% | 0.7143 |
| Systemic: | ||||||
| Fever | 0.0% | 0.0% | n/a | 3.3% | 0.0% | 0.5077 |
| Headache | 36.7% | 29.2% | 0.3488 | 51.7% | 41.7% | 0.2792 |
| Rash | 61.7% | 0.0% | <0.0001 | 61.7% | 0.0% | <0.0001 |
| Neutropenia1 | 8.3% | 8.3% | 0.6833 | 6.7% | 0.0% | 0.2527 |
| Elevated ALT | 5.0% | 0.0% | 0.3591 | 3.3% | 4.2% | 0.8050 |
| Myalgia | 8.3% | 8.3% | 0.6833 | 11.7% | 4.2% | 0.2713 |
| Arthralgia | 3.3% | 4.2% | 0.8050 | 0.0% | 0.0% | n/a |
| Retro-orbital Pain | 6.7% | 8.3% | 0.7767 | 6.7% | 8.3% | 0.7767 |
| Fatigue | 16.7% | 4.2% | 0.1159 | 28.3% | 20.8% | 0.3393 |
| Photophobia | 0.0% | 4.2% | 1.0000 | 5.0% | 4.2% | 0.6784 |
| Elevated PT | 6.7% | 12.5% | 0.9012 | 5.0% | 4.2% | 0.6784 |
| Elevated PTT | 6.7% | 8.3% | 0.7767 | 0.0% | 4.2% | 1.0000 |
| Thrombocytopenia | 0.0% | 0.0% | n/a | 0.0% | 0.0% | n/a |
1.
Neutropenia was defined as an ANC ≤ 1,000/mm3 in CIR279. Neutropenia was defined as an ANC≤1,500/mm3 for CIR268.
2.
Probability is greater for TV003 vs placebo
3.
Probability is greater for TV005 vs placebo