Table 3.
Parameter estimates for PK/PD model for fibrin D‐dimer
| Parameter | Estimate (% RSE) * | Inter‐individual variability % (% RSE) * |
|---|---|---|
| BASEmale † (µg l−1) | 94 (92) | 65 (6.2) |
| kout, AZD (day−1) | 0.142 (11) | ‐ |
| kout, VKA (day−1) | 0.0622 (14) | ‐ |
| Emax, AZD | 0.60 (5.5) | ‐ |
| EC50 males ‡, AZD | 0.13 (14) | 238 (23) |
| Effect VKA | 0.58 (5.4) | 65 (32.6) |
| SHP | 0.37 (39) | ‐ |
| Covariate effects | ||
| BASE‐GENDER † | 0.42 (32) | ‐ |
| EC50 females (%) ‡ | −0.79 (21) | |
| Residual error | ||
| Error above LOQ | 0.52 (8.2) | 45 (8.2) |
| Error below LOQ | 0.31 (6.6) | ‐ |
AZD, AZD0837 treatment; BASE, D‐dimer baseline; EC 50, the concentration at which half of the maximum effect is achieved; Effect VKA, D‐dimer response for VKA treatment; Emax, maximal effect on D‐dimer; k out, D‐dimer elimination rate constant; SHP, shape parameter of Cox–Box distribution; VKA, VKA treatment.
*
Relative standard error (%);
†
Baseline was 42% higher in females patients: BASE = θBASE × (1 + θGENDER=FEMALE);
‡
Females had on average a lower EC 50 compared with males: EC 50 = θEC50 × (1 + θGENDER=FEMALE).