Table 1.
Everolimus C min and C 2 h at weeks 2, 4, 12, 24 and 48 of the study irrespective of the actual dose received by the patients or by the actual dose received by the patients (10 mg day‐1 or 5 mg day‐1) for all evaluable everolimus‐treated patients during double‐blind period
| Week 2 | Week 4 | Week 12 | Week 24 | Week 48 | |
|---|---|---|---|---|---|
| All patients, irrespective of the dose received | |||||
| C min (ng ml‐1 ) | |||||
| n | 43 | 44 | 49 | 46 | 15 |
| Mean ± SD | 7.63 ± 4.32 | 7.72 ± 4.35 | 8.79 ± 6.75 | 9.37 ± 8.83 | 11.49 ± 12.01 |
| CV% | 56.7% | 56.4% | 76.8% | 94.2% | 104.5% |
| Median (range) | 6.6(0.6–19.6) | 7.0(1.4–22.2) | 7.5(1.0–32.6) | 6.7(0.0–52.8) | 6.9 (2.5–50.0) |
| C 2 h (ng ml‐1 ) | |||||
| n | 55 | 49 | 56 | 50 | 14 |
| Mean ± SD | 33.38 ± 15.66 | 30.89 ± 14.96 | 34.48 ± 15.10 | 39.27 ± 22.25 | 33.20 ± 18.45 |
| CV% | 46.9% | 48.4% | 43.8% | 56.7% | 55.6% |
| Median (range) | 31.5(4.9–75.8) | 28.2(4.3–75.9) | 34.4(10.5–77.9) | 38.9(5.4–98.6) | 29.0(10.0–71.2) |
| Patients who received 10 mg day ‐1 dose | |||||
|---|---|---|---|---|---|
| C min (ng ml‐1 ) | |||||
| n | 43 | 41 | 42 | 39 | 11 |
| Mean ± SD | 7.63 ± 4.32 | 7.85 ± 4.49 | 9.40 ± 7.03 | 10.13 ± 9.34 | 13.10 ± 13.69 |
| CV% | 56.7% | 57.2% | 74.8% | 92.2% | 105% |
| Median (range) | 6.6(0.6–19.6) | 7.2(1.4–22.2) | 7.6(1.0–32.6) | 6.9(0.0–52.8) | 7.8(2.5–50.0) |
| C 2 h (ng ml‐1 ) | |||||
| n | 55 | 46 | 45 | 39 | 10 |
| Mean ± SD | 33.38 ± 15.66 | 31.44 ± 15.28 | 37.39 ± 14.76 | 44.18 ± 22.55 | 36.54 ± 21.03 |
| CV% | 46.9% | 48.6% | 39.5% | 51.0% | 57.6% |
| Median (range) | 31.5(4.9–75.8) | 29.1(4.3–75.9) | 36.2(10.5–77.9) | 41.5(5.4–98.6) | 35.0(10.0–71.2) |
| Patients who received 5 mg day ‐1 dose | |||||
|---|---|---|---|---|---|
| C min (ng ml‐1 ) | |||||
| n | 0 | 3 | 5 | 5 | 3 |
| Mean ± SD | 6.04 ± 0.22 | 4.89 ± 2.82 | 4.57 ± 1.92 | 5.30 ± 0.93 | |
| CV% | 3.6% | 57.6% | 41.9% | 17.6% | |
| Median (range) | 6.0(5.8–6.3) | 3.9(2.1–8.0) | 5.0(2.5–6.8) | 5.7 (4.2–6.0) | |
| C 2 h (ng ml‐1 ) | |||||
| n | 0 | 3 | 9 | 9 | 4 |
| Mean ± SD | 22.47 ± 3.29 | 19.40 ± 6.26 | 19.93 ± 6.69 | 24.88 ± 4.34 | |
| CV% | 14.6% | 32.3% | 33.6% | 17.5% | |
| Median (range) | 21.6(19.7–26.1) | 19.7(11.4–30.9) | 19.6(12.6–35.7) | 24.0(20.8–30.7) | |
C min, predose trough concentration; C 2 h, 2 h post‐dose concentration; CV, coefficient of variation; SD, standard deviation.