TABLE 5.
Summary of all-causality AEs and incidence of frequently reported treatment-related AEs in studies A and B
| Parameter | Value
|
|||||
|---|---|---|---|---|---|---|
| Study Aa (high-dose ritonavir)
|
Study B (low-dose ritonavir)
|
|||||
| Vorib | Ritoc | Vori + Ritod | Vorib | Ritoc | Vori + Ritod | |
| No. of subjects exposed | 17 | 16 | 15 | 17 | 17 | 17 |
| No. of subjects with AEs | 9 | 15 | 14 | 10 | 6 | 17 |
| No. of all-causality AEs | 16 | 63 | 78 | 14 | 11 | 47 |
| No. of treatment-related AEs | 12 | 55 | 57 | 14 | 7 | 37 |
| No. of subjects with treatment-related AEs | ||||||
| Abdominal pain | 1 | 5 | 5 | 0 | 0 | 0 |
| Headache | 0 | 1 | 5 | 3 | 1 | 5 |
| Hot flashes | 0 | 2 | 4 | 0 | 0 | 0 |
| Diarrhea | 0 | 7 | 7 | 0 | 0 | 0 |
| Nausea | 1 | 8 | 4 | 0 | 0 | 1 |
| ALT ↑e | 0 | 4 | 5 | 0 | 0 | 1 |
| AST ↑e | 0 | 3 | 1 | 0 | 0 | 0 |
| Hypesthesia | 0 | 7 | 1 | 0 | 0 | 0 |
| Dizziness | 0 | 1 | 2 | 1 | 0 | 2 |
| Insomnia | 0 | 2 | 1 | 0 | 0 | 10 |
| Dry eyes | 1 | 1 | 3 | 0 | 0 | 0 |
| Photophobia | 0 | 0 | 2 | 10 | 0 | 3 |
| Abnormal vision | 3 | 0 | 0 | 0 | 0 | 5 |
| Dry skin | 0 | 0 | 0 | 0 | 1 | 7 |
| Hematuria | 1 | 2 | 2 | 0 | 0 | 0 |
a
The AEs in the placebo group are not presented.
b
Three-day voriconazole alone plus seven-day washout.
c
Ten-day ritonavir alone.
d
Ten-day ritonavir and voriconazole plus seven-days after last dose.
e
↑, increased.