Nebenwirkungen · Kisqali
Kisqali 200 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16
HOS-136291 · Präparat HOS-097860
A central analysis of ECG data showed 10 patients (0.4%) and 4 patients (0.2%) with at least one post- baseline QTcF interval >480 msec for the Kisqali plus AI arm and the AI alone arm, respectively. Among the patients who had QTcF interval prolongation of >480 msec in the Kisqali plus AI arm, the median time to onset was 15 days and these changes were reversible with dose interruption and/or dose adjustment. QTcF interval >60 msec change from baseline was observed in 19 patients (0.8%) in the Kisqali plus AI arm and post-baseline QTcF interval >500 msec was observed in 3 patients (0.1%) in the Kisqali plus AI arm.
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Version 2026-08-19T11:22:00Z · SHA-256 808e9743b462916472557a0fc0a032e5a4cdf4c2e48d8fd0f992823e92cc05c1 · Passage a48e906a8f948503c3fda799aadfcfa648f1012648670117611d9131db92d36b · Zeichen 14572–15194 im Abschnitt