Nebenwirkungen · Caelyx pegylated liposomal
Caelyx pegylated liposomal 2 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 14
HOS-085582 · Präparat HOS-083155
In the pivotal phase III trial versus doxorubicin, 58/509 (11.4%) randomised subjects (10 treated with Caelyx pegylated liposomal at a dose of 50 mg/m2/every 4 weeks versus 48 treated with doxorubicin at a dose of 60 mg/m2/every 3 weeks) met the protocol-defined criteria for cardiac toxicity during treatment and/or follow-up. Cardiac toxicity was defined as a decrease of 20 points or greater from baseline if the resting LVEF remained in the normal range or a decrease of 10 points or greater if the LVEF became abnormal (less than the lower limit for normal). None of the 10 Caelyx pegylated liposomal subjects who had cardiac toxicity by LVEF criteria developed signs and symptoms of CHF. In contrast, 10 of 48 doxorubicin subjects who had cardiac toxicity by LVEF criteria also developed signs and symptoms of CHF.
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Version 2026-04-24T17:56:00Z · SHA-256 c7886f3f50305fcb29bfb2c8de51dd65f782908ce31d2fdd422d43a9ccecfc7e · Passage a4e119820e1014b2b017d9612601d0b00b306653b42c9800355888405308e040 · Zeichen 15780–16600 im Abschnitt