TABLE 1.
Final model parameter estimatesa
| Model parameter terms | Estimate | Confidence interval |
|---|---|---|
| THETA terms on fixed effects | ||
| F1 (fixed) | 1 | |
| F1∼FASTED | 0.513 | 0.485 to 0.541 |
| F1∼DOSE&FASTED | −0.264 | −0.302 to −0.226 |
| F1∼FED&1,000 mg | −0.00302 | −0.148 to 0.142 |
| F1∼MOX*PZA | 0.925 | 0.848 to 1.00 |
| F1∼BDQ*MOX*PZA | 1.25 | 1.04 to 1.46 |
| F1∼EFV | 1.24 | 1.03 to 1.45 |
| F1∼HIV | 0.789 | 0.721 to 0.856 |
| F1∼TBIL (ref=5) | 0.0880 | 0.0495 to 0.126 |
| F1∼NIX | 1.54 | 1.28 to 1.80 |
| KA, h−1 | 1.38 | 1.25 to 1.52 |
| KA∼FASTED | 0.482 | 0.453 to 0.511 |
| KA∼DOSE | −0.128 | −0.158 to −0.0990 |
| KA∼NC5 | 0.186 | 0.150 to 0.221 |
| MTT, h | 1.25 | 1.14 to 1.35 |
| MTT∼FASTED | 0.311 | 0.293 to 0.329 |
| MTT∼DOSE&FASTED | −0.155 | −0.187 to −0.123 |
| MTT∼NC5 | 6.95E−07 | −0.0350 to 0.0350 |
| CL, liters/h | 3.30 | 3.14 to 3.46 |
| CL∼WT (fixed) | 0.75 | |
| SS CL, liters/h | 0.175 | 0.135 to 0.214 |
| CL∼HS | 1.16 | 1.09 to 1.23 |
| CL∼MOX | 0.967 | 0.902 to 1.03 |
| CL∼MOX*PZA | 0.733 | 0.663 to 0.804 |
| CL∼MDR, TI/NR MDR, or XDR | 1.15 | 1.04 to 1.27 |
| CL∼BDQ*MOX*PZA | 1.32 | 1.12 to 1.51 |
| CL∼EFV | 2.17 | 1.89 to 2.45 |
| CL∼LPVR | 1.14 | 1.10 to 1.18 |
| CL∼HIV | 0.842 | 0.779 to 0.905 |
| CL∼INDUC | 1.35 | 1.24 to 1.46 |
| CL∼FEMALE | 0.837 | 0.808 to 0.867 |
| CL∼ALB (ref=35) | 0.200 | 0.0789 to 0.322 |
| CL NIX WK ≥ 6, liters/h | 0.466 | 0.285 to 0.646 |
| V2, liters | 90.4 | 85.8 to 94.9 |
| V2∼WT (fixed) | 1 | |
| V2∼DOSE | 0.111 | 0.0845 to 0.137 |
| V2∼MDR or TI/NR MDR | 1.44 | 1.24 to 1.64 |
| V2∼XDR | 1.75 | 1.39 to 2.11 |
| F1 Var∼NIX | 0.919 | 0.558 to 1.28 |
| MTT Var∼NC3 | −0.645 | −1.06 to −0.226 |
| Box-Cox V2 non-NIX | 9.55 | 2.25 to 16.9 |
| Box-Cox V2 NIX | 26.0 | −8.54 to 60.5 |
| Box-Cox CL non-NIX | 1.36 | 0.733 to 1.99 |
| Box-Cox CL NIX | 2.78 | 1.36 to 4.20 |
| Proportional error (variance) | 0.548 | 0.506 to 0.589 |
| Additive error (variance) | 11.5 | 5.84 to 17.2 |
| Error power | 0.795 | 0.789 to 0.800 |
| OMEGA matrix terms | ||
| F1∼dose/fasted | 0.0274 | 0.018 to 0.0368 |
| CL | 0.0373 | 0.029 to 0.0455 |
| V2 | 0.00892 | 0.0018 to 0.016 |
| KA | 0.309 | 0.252 to 0.366 |
| KA-MTT | 0.0649 | 0.00363 to 0.126 |
| MTT | 0.593 | 0.475 to 0.71 |
| KA-F1 | −0.0339 | −0.0509 to −0.0168 |
| MTT-F1 | 0.00391 | −0.0184 to 0.0262 |
| F1 | 0.0227 | 0.0136 to 0.0319 |
| IOC F1 | 0.0412 | 0.0362 to 0.0462 |
| IOC F1-CL | 0.0101 | 0.00697 to 0.0132 |
| IOC CL | 0.0185 | 0.0155 to 0.0214 |
a
ETA shrinkage (%): 6.6E+01, 2.5E+01, 5.8E+01, 4.2E+01, 4.5E+01, and 4.5E+01 (for dose/fasted-F1, CL, V2, KA, MTT, and F1) and 4.2E+01, 5.3E+01, 4.7E+01, 5.2E+01, 5.9E+01, and 6.2E+01 (for interoccasion F1 and CL [times three occasions]). All values are rounded to three significant digits. Units of measure are provided in column 1 where applicable. EPS shrinkage (%): 1.0E+01 and 1.0E+01 (for proportional and additive error terms).