Table 3.
Intergroup comparison of key safety endpoints at 1 yr
| ATG (n = 113) | Daclizumab (n = 114) | P value | |
|---|---|---|---|
| Bacterial infection, n (%) | 53 (46.9%) | 53 (46.5%) | NS |
| No. of bacterial infections/patient (mean ± SD) | 2.5 ± 1,8 | 1.8 ± 1,2 | 0.014 |
| Treated cytomegalovirus infection, n (%) | 21 (18.6%) | 12 (10.5%) | 0.093 |
| Sepsis (n, %) | 8 (7.1%) | 8 (7.0%) | NS |
| Posttransplant lymphoproliferative disorder | 0 | 0 | NS |
| Pneumocystis jiroveci | 0 | 0 | NS |
| Fungal infections | 7 (6.2%) | 6 (5.3%) | NS |
| Cancer | 1 (0.9%) | 0 | NS |
| White blood cell count (×103/mm3) (mean ± SD) | |||
| Day 0 | 7.2 ± 2.5 | 7.1 ± 2.9 | 0,7 |
| 1 wk | 5.3 ± 4.2 | 7.8 ± 3.2 | <0.001 |
| 1 month | 5.8 ± 2.3 | 6.7 ± 2.8 | 0.007 |
| 1 yr | 5.8 ± 2.6 | 6.6 ± 2.5 | 0.056 |
| Lymphocyte count (×103/mm3) (mean ± SD) | |||
| Day 0 | 1.41 ± 0.65 | 1.54 ± 0.72 | 0.2 |
| 1 wk | 0.26 ± 0.23 | 1.29 ± 0.82 | <0.001 |
| 1 month | 0.54 ± 0.40 | 1.39 ± 0.97 | <0.001 |
| 1 yr | 0.97 ± 0.40 | 1.65 ± 0.87 | <0.001 |
| Neutrophil count (×103/mm3) (mean ± SD) | |||
| Day 0 | 4.76 ± 2.29 | 4.48 ± 2.10 | 0.40 |
| 1 wk | 4.61 ± 4.23 | 5.46 ± 2.42 | 0.09 |
| 1 month | 9.54 ± 4.86 | 4.79 ± 2.02 | 0.36 |
| 1 yr | 4.11 ± 2.52 | 4.25 ± 1.93 | 0.66 |
| Platelet count (×106/mm3) (mean ± SD) | |||
| Day 0 | 0.23 ± 0.09 | 0.24 ± 0.07 | 0.4 |
| 1 wk | 0.18 ± 0.07 | 0.23 ± 0.08 | <0.001 |
| 1 month | 0.26 ± 0.10 | 0.27 ± 0.10 | 0.70 |
| 1 yr | 0.23 ± 0.07 | 0.23 ± 0.07 | 0.75 |