Table 6.
Zolinza™ (vorinostat) clinical or laboratory adverse events occurring in CTCL patients (incidence ≥ 10% of patients)
| Zolinza 400-mg once daily (n = 86)
|
||||
|---|---|---|---|---|
| Adverse events | All grades | Grades 3–5* | ||
| n | % | n | % | |
| Fatigue | 45 | 52.3 | 3 | 3.5 |
| Diarrhea | 45 | 52.3 | 0 | 0.0 |
| Nausea | 35 | 40.7 | 3 | 3.5 |
| Dysgeusia | 24 | 27.9 | 0 | 0.0 |
| Thrombocytopenia | 22 | 25.6 | 5 | 5.8 |
| Anorexia | 21 | 24.4 | 2 | 2.3 |
| Weight decreased | 18 | 20.9 | 1 | 1.2 |
| Muscle spasms | 17 | 19.8 | 2 | 2.3 |
| Alopecia | 16 | 18.6 | 0 | 0.0 |
| Dry mouth | 14 | 16.3 | 0 | 0.0 |
| Blood creatinine increased | 14 | 16.3 | 0 | 0.0 |
| Chills | 14 | 16.3 | 1 | 1.2 |
| Vomiting | 13 | 15.1 | 1 | 1.2 |
| Constipation | 13 | 15.1 | 0 | 0.0 |
| Dizziness | 13 | 15.1 | 1 | 1.2 |
| Anemia | 12 | 14.0 | 2 | 2.3 |
| Decreasd appetite | 12 | 14.0 | 1 | 1.2 |
| Peripheral edema | 11 | 12.8 | 0 | 0.0 |
| Headache | 10 | 11.6 | 0 | 0.0 |
| Pruritus | 10 | 11.6 | 1 | 1.2 |
| Cough | 9 | 10.5 | 0 | 0.0 |
| Upper respiratory infection | 9 | 10.5 | 0 | 0.0 |
| Pyrexia | 9 | 10.5 | 1 | 1.2 |
*
No grade 5 events were reported.
Table summarizes the frequency of specific adverse events, regardless of causality, in CTCL patients using the National Cancer Institute-Common Terminology Criteria for Adverse Events, version 3.0 (Olsen et al 2001; Foss et al 2005).