TABLE 3.
Individual plasma concentrations, clinical response, and treatment-related adverse events
Patient no. | Age (yr) | Weight (kg) | Posaconazole Cav (ng/ml) | Clinical responseb | Treatment-related adverse event(s) |
---|---|---|---|---|---|
1a | 8 | 39.4 | 227 | PR | Vomiting; nausea |
2 | 10 | 51.7 | 140 | FL | |
3 | 12 | 24 | 85 | PR | Renal insufficiency |
4 | 12 | 36.7 | 1112 | SD | |
5 | 14 | 34.5 | 2891 | NAc | Renal failure |
6 | 15 | 54.5 | 396 | NAc | |
7 | 15 | 76 | 546 | CR | Vomiting |
8 | 15 | 53.3 | 613 | NAc | |
9 | 16 | 40.6 | 982 | NAc | |
10 | 16 | 36 | 1161 | UTD | Cardiorespiratory arrest; convulsions |
11 | 16 | 59.9 | 927 | CR | |
12 | 17 | 45.4 | 238 | PR |
Received 400 mg/day posaconazole in divided doses on the day of sample collection and 800 mg/day in divided doses before the day of sample collection.
CR indicates complete response; FL, failure; NA, not applicable; PR, partial response; SD, stable disease; UTD, unable to determine.
Only the MITT population was included in determining the clinical response; patients stopped treatment due to an adverse event.