Table 5.
Event type | Description | Prevalence (%) Low/High/Placebo |
Comments |
---|---|---|---|
Infections: Serious Opportunistic |
Infection most common emergent adverse event |
2.6 / 4.0 / 2.3 0.7 / 0.9 / 0.5 |
No cases of TB One fungal bronchitis H. Zoster |
Abnormal liver function tests |
ALT more than 3× ULN |
9.5/ 8.0 / 2.1 | 24 patients were discontinued due to elevations |
Elevated total cholesterol |
From < 240 mg/dl to ≥ 240 mg/dl |
36.8 / 43.0 / 18.3 | No cardiac events |
Decreased neutrophil counts |
0.5 – <1.0 × 109/L < 0.5 × 109/L |
5.1 / 7.8 / 0.0 0.9 / 0.7 / 0.0 |
No relationship of low neutrophil count to infections. |