Last reviewed · How we verify
Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (PPE).
The purpose of this study is to evaluate the safety and tolerability of Caelyx in women with advanced ovarian cancer, focusing on infusion reactions and palmar-plantar erythrodysesthesia.
Details
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Status | COMPLETED |
| Enrolment | 224 |
| Start date | 2005-02 |
| Completion | 2008-12 |
Conditions
- Ovarian Neoplasms
Interventions
- Caelyx (Pegylated Lyposomal Doxorubicin)
Primary outcomes
- Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) — The observational program was conducted over a period of 2 years
Definitions in assessment of adverse event severity: Mild: awareness of sign, symptom, or event, but easily tolerated. Moderate: discomfort enough to cause interference with usual activity and may warrant intervention. Severe: incapacitating with inability to do usual activities or significantly affects clinical status, and warrants intervention.