Table 2.
Model predictive performance for the various scenarios in the fit-for-use validation
| Scenario | n | MPPE (%) [95% CI] |
MAPE (%) [95% CI] |
NRMSE (%) [95% CI] |
P10 (%) | P20 (%) | P30 (%) |
|---|---|---|---|---|---|---|---|
| C0 | |||||||
| Initial | |||||||
| Model 1 | 84 | 7.07 [– 2.92, 17.1] | 32.6 [25.5, 39.8] | 78.1 [76.8, 79.4] | 23.8 | 42.9 | 61.9 |
| Model 2 | 84 | 7.36 [– 2.89, 17.6] | 33.2 [25.7, 40.6] | 82.5 [81.1, 83.9] | 20.2 | 42.9 | 61.9 |
| Model 3 | 84 | 5.38 [– 4.67, 15.4] | 32.3 [25.1, 39.6] | 82.7 [81.3, 84.1] | 25.0 | 45.2 | 61.9 |
| ≤ 6 months | |||||||
| Model 1 | 1212 | 8.12 [5.57, 10.7] | 26.8 [24.7, 28.9] | 39.4 [39.4, 39.5] | 30.9 | 53.7 | 71.1 |
| Model 2 | 1212 | 9.69 [7.06, 12.3] | 27.8 [25.6, 30.0] | 40.3 [40.3, 40.4] | 29.3 | 53.2 | 70.5 |
| Model 3 | 1212 | 13.5 [10.9, 16.1] | 30.1 [27.9, 32.2] | 38.8 [38.7, 38.9] | 25.6 | 47.0 | 65.4 |
| > 6 months | |||||||
| Model 1 | 1272 | 4.74 [2.77, 6.72] | 25.4 [24.0, 26.8] | 36.1 [36.1, 36.1] | 28.2 | 52.7 | 70.7 |
| Model 2 | 1272 | 5.08 [3.11, 7.04] | 25.4 [24.1, 26.8] | 36.2 [36.2, 36.3] | 27.9 | 52.9 | 70.6 |
| Model 3 | 1272 | 6.32 [4.36, 8.27] | 26.2 [24.8, 27.5] | 35.7 [35.7, 35.7] | 25.9 | 50.2 | 68.5 |
| AUC0–12 | |||||||
| Initial | |||||||
| Model 1 | 45 | 46.6 [29.1, 64.1] | 53.6 [38.1, 69.1] | 66.8 [64.7, 69.0] | 24.4 | 31.1 | 46.7 |
| Model 2 | 45 | 49.3 [29.0, 69.6] | 58.0 [39.9, 76.0] | 75.2 [72.8, 77.6] | 24.4 | 37.8 | 48.9 |
| Model 3 | 45 | 42.7 [23.6, 61.9] | 52.7 [36.0, 69.4] | 68.7 [66.5, 70.9] | 26.7 | 44.4 | 48.9 |
| ≤ 6 months | |||||||
| Model 1 | 32 | – 9.70 [– 14.8, – 4.60] | 13.3 [9.40, 17.1] | 17.4 [16.6, 18.2] | 50.0 | 78.1 | 90.6 |
| Model 2 | 32 | – 8.31 [– 13.2, – 3.41] | 12.1 [8.42, 15.8] | 15.9 [15.1, 16.6] | 50.0 | 78.1 | 93.8 |
| Model 3 | 32 | – 6.75 [– 11.5, – 2.00] | 11.1 [7.59, 14.6] | 14.6 [13.9, 15.3] | 56.3 | 81.3 | 93.8 |
| > 6 months | |||||||
| Model 1 | 48 | – 0.13 [– 4.92, 4.66] | 13.3 [10.5, 16.1] | 16.3 [15.8, 16.8] | 37.5 | 79.2 | 95.8 |
| Model 2 | 48 | 0.05 [– 4.81, 4.92] | 13.3 [10.3, 16.2] | 16.7 [16.2, 17.2] | 43.8 | 79.2 | 95.8 |
| Model 3 | 48 | 0.08 [– 4.46, 4.62] | 12.3 [9.56, 15.0] | 15.6 [15.1, 16.1] | 47.9 | 85.4 | 95.8 |
AUC0–12 area under the everolimus concentration–time curve from time zero to 12 h after administration, C0 everolimus trough concentration, CI confidence interval, MAPE mean absolute percentage prediction error, MPPE mean percentage prediction error, n number of observations, NRMSE normalised root median squared error, P10–P30 percentage of predictions within ± 10–30% of observations