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Abiraterone Accord · 4.8 · 31 * Cardiac failure also includes congestive heart failure, left ventricular dysfunction and ejection fractio
Eintrag öffnenAbiraterone Accord · 4.8 · 32 hepatic function were reported in 1.1% of patients treated with abiraterone acetate and 0.6% of patients tr
Eintrag öffnenAbiraterone Accord · 4.8 · 7 1 %, CTCAE (version 4.0) Grades 3 and 4 hypertension were observed in 7 % versus 5 %, and fluid retention (p
Eintrag öffnenAbiraterone Accord · 4.8 · 8 The following CTCAE (version 4.0) Grade 3 adverse reactions occurred in patients treated with abiraterone ac
Eintrag öffnenAbiraterone Accord · 4.8 · 9 In the 301 study, patients with baseline ALT and AST ≥ 2.5 x ULN in the absence of liver metastases and > 5
Eintrag öffnenAbiraterone Accord · 4.8 · A higher incidence of hypertension and hypokalemia was observed in the hormone sensitive population (study 301
Eintrag öffnenAbiraterone Accord · 4.8 · A higher incidence of hypertension and hypokalemia was observed in the hormone sensitive population (study 301
Eintrag öffnenAbiraterone Accord · 4.8 · Abiraterone acetate may cause hypertension, hypokalaemia and fluid retention as a pharmacodynamic consequence
Eintrag öffnenAbiraterone Accord · 4.8 · Adverse reactions observed during clinical studies and post-marketing experience are listed below by frequency
Eintrag öffnenAbiraterone Accord · 4.8 · Adverse reactions observed during clinical studies and post-marketing experience are listed below by frequency
Eintrag öffnenAbiraterone Accord · 4.8 · Description of selected adverse reactions Cardiovascular reactions The three Phase 3 studies excluded patients
Eintrag öffnenAbiraterone Accord · 4.8 · Description of selected adverse reactions Cardiovascular reactions The three Phase 3 studies excluded patients
Eintrag öffnenAbiraterone Accord · 4.8 · Hepatotoxicity Hepatotoxicity with elevated ALT, AST and total bilirubin has been reported in patients treated
Eintrag öffnenAbiraterone Accord · 4.8 · Hepatotoxicity Hepatotoxicity with elevated ALT, AST and total bilirubin has been reported in patients treated
Eintrag öffnenAbiraterone Accord · 4.8 · In clinical studies, the risk for hepatotoxicity was mitigated by exclusion of patients with baseline hepatiti
Eintrag öffnenAbiraterone Accord · 4.8 · In clinical studies, the risk for hepatotoxicity was mitigated by exclusion of patients with baseline hepatiti
Eintrag öffnenAbiraterone Accord · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenAbiraterone Accord · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenAbiraterone Accord · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenAbiraterone Accord · 4.8 · Summary of the safety profile In an analysis of adverse reactions of composite Phase 3 studies with abirateron
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