TABLE 3.
AE type | No. (%) of subjects with indicated AEb |
|
---|---|---|
Cohort 1: POS i.v. 200 mg q.d.c (n = 21) | Cohort 2: POS i.v. 300 mg q.d. (n = 24) | |
Any treatment-emergent AE | 20 (95) | 24 (100) |
Treatment-related AE | 3 (14) | 8 (33) |
SAEd | 4 (19) | 9 (38) |
Treatment-related SAE | 0 | 1 (4) |
AE leading to study drug discontinuation | 4 (19) | 7 (29) |
Discontinuation during POS i.v. | 3 | 5 |
Discontinuation during POS oral suspension | 1 | 2 |
SAE leading to study drug discontinuation | 1 (5) | 2 (8) |
Death | 1 (5) | 3 (13) |
AE, adverse event; POS, posaconazole; i.v., intravenous.
All subjects received POS i.v. 200 or 300 mg on days 1 to 14 followed by 14 days of twice-daily POS oral suspension 400 mg.
q.d., once daily
SAE, serious adverse event.