Table 7.
Summary of treatment-related TEAEs by quartile of pCavg values, all Cmin PK-evaluable patients: posaconazole 200 mg and 300 mg dose groups combined
| Quartile | Posaconazole pCavg mean (ng/mL) | pCavg range (ng/mL) | Number of subjects | Subjects reporting any treatment-related TEAEs, n (%) |
|---|---|---|---|---|
| 1 | 860 | 442–1223 | 51 | 29 (57) |
| 2 | 1481 | 1240–1710 | 51 | 19 (37) |
| 3 | 1979 | 1719–2291 | 51 | 16 (31) |
| 4 | 3194 | 2304–9523 | 52 | 20 (38) |
pCavg, predicted average concentration from Cmin.
AEs occurring in >5% of subjects in each quartile were as follows: quartile 1—diarrhoea 12%, nausea 10%, rash 10%, abdominal pain 8%, hypokalaemia 6%, hypophosphatemia 6%, vomiting 6%; quartile 2—diarrhoea 6%, nausea 10%, abdominal pain 6%, vomiting 6%; quartile 3—diarrhoea 12%, nausea 6%, hypokalaemia 6%, increased ALT 8%, dyspepsia 6%, increased AST 6%; quartile 4—nausea 13%, vomiting 8%.