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Bayer AG Gebäude W 11 51368 Leverkusen, Germany http://www.bayer.de
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Bayer AG

Phase-III-Studie mit Radium-223-dichlorid in Kombination mit Abirateronacetat und Prednison/Prednisolon für Patienten mit metastasiertem kastrationsresistentem Prostatakrebs vorzeitig entblindet

Entscheidung folgt einer Empfehlung eines unabhängigen Datenüberwachungsgremiums

(PresseBox) (Berlin, )
Ein unabhängiges Datenüberwachungsgremium (Independent Data Monitoring Committee, IDMC) hat empfohlen, eine Phase-III-Studie mit Radium-223-dichlorid (Radium-223) in Kombination mit Abirateronacetat und Prednison/Prednisolon bei Prostatakrebs zu entblinden. Grund für diese Empfehlung ist ein beobachtetes Ungleichgewicht in Bezug auf vermehrte Knochenbrüche und Todesfälle im Behandlungsarm mit Radium-223 in Kombination mit Abirateronacetat und Prednison/Prednisolon bei Patienten mit asymptomatischem oder leicht symptomatischem, chemotherapienaiven, metastatasiertem kastrationsresistentem Prostatakrebs (mCRPC). Bayer entblindet die Studie jetzt, um die Ergebnisse sorgfältig zu analysieren, und führt das Studienmonitoring gemäß Studienprotokoll fort. Daten aus anderen Studien, in denen diese Kombinationstherapie untersucht wurde, zeigten keine neuen Sicherheitssignale.

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