Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (PPE).
This observational program is aimed at gaining tolerability and safety data with the routine
use of Caelyx in its labelled indication in ovarian cancer, focusing on infusion reaction
Data will be raised about the premedication routinely used for the prevention of side
effects caused by Caelyx. Premedications for infusion reactions include corticosteroids,
serotonin 3 (5HT3) antagonists, histamine 1 (H1) blockers, and histamine 2 (H2) blockers.
Premedications for PPE include oral dexamethasone and vitamin B6.
The management of infusion reactions and PPE will be recorded. A detailed record of the
medical history may reveal patient groups at a higher risk of experiencing these side
Observational Model: Case-Only, Time Perspective: Prospective
Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE)
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.
The observational program was conducted over a period of 2 years
Austria: Agency for Health and Food Safety