Table 4.
Number of subjects reporting treatment-related adverse events and withdrawals.
| Study A | Study B | |||
|---|---|---|---|---|
| Adverse event | Voriconazole + phenytoin (n = 12) | Voriconazole + placebo (n = 12) | Phenytoin → phenytoin + voriconazole (n = 11) | Phenytoin → phenytoin + placebo (n = 11) |
| Total | 9 | 5 | 10 | 8 |
| Headache* | 6 (1)‡ | 3 | 3 | 6 (1)‡ |
| Nausea* | 5 | 0 | 1 | 3 |
| Abnormal vision* | 2 | 1 | 3 | 2 |
| Dizziness* | 0 | 1 | 1 | 4 |
| Withdrawals | ||||
| Elevated phenytoin level† | 4 | 0 | 3 | 0 |
| Adverse events | 0 | 0 | 2 | 2 |
*
Adverse events reported by more than two subjects in any treatment group.
†
Trough plasma concentration >20 µg ml−1.
‡
Values in parentheses indicate number of severe adverse events.