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Venclyxto · 4.8 · In the AMPLIFY study, neutropenia/neutrophil count decreased/febrile neutropenia (all grades) was reported in
Eintrag öffnenVenclyxto · 4.8 · In the CAPTIVATE study, all-grade neutropenia/neutrophil count decreased was reported in 47% of patients in th
Eintrag öffnenVenclyxto · 4.8 · In the CLL14 study, neutropenia (all grades) was reported in 58% of patients in the venetoclax + obinutuzumab
Eintrag öffnenVenclyxto · 4.8 · In the M14-358 study, neutropenia was reported in 35% (all grades) and 35% (grade 3 or 4) of patients in the v
Eintrag öffnenVenclyxto · 4.8 · In the MURANO study, neutropenia (all grades) was reported in 61% of patients in the venetoclax + rituximab ar
Eintrag öffnenVenclyxto · 4.8 · In the VIALE-A study, discontinuations of venetoclax due to adverse reactions occurred in 24% of patients trea
Eintrag öffnenVenclyxto · 4.8 · In the VIALE-A study, grade ≥3 neutropenia was reported in 45% of patients. The following were also reported i
Eintrag öffnenVenclyxto · 4.8 · In the VIALE-A study, the most commonly occurring adverse reactions (≥20%) of any grade in patients receiving
Eintrag öffnenVenclyxto · 4.8 · In the initial Phase 1 dose-finding studies, which had a shorter (2 to 3 week) titration phase and higher star
Eintrag öffnenVenclyxto · 4.8 · In the open-label, randomised phase 3 study (AMPLIFY), the incidence of TLS was 0.3% (1/291) in patients treat
Eintrag öffnenVenclyxto · 4.8 · In the open-label, randomised phase 3 study (CLL14), the incidence of TLS was 1.4% (3/212) in patients treated
Eintrag öffnenVenclyxto · 4.8 · In the open-label, randomised phase 3 study (MURANO), the incidence of TLS was 3% (6/194) in patients treated
Eintrag öffnenVenclyxto · 4.8 · In the randomised, phase 3 study (VIALE-A) with venetoclax in combination with azacitidine the incidence of TL
Eintrag öffnenVenclyxto · 4.8 · In the venetoclax + ibrutinib arm in the GLOW study, all-grade neutropenia/neutrophil count decreased was repo
Eintrag öffnenVenclyxto · 4.8 · Neutropenia and infections
Eintrag öffnenVenclyxto · 4.8 · Neutropenia is an identified risk with Venclyxto treatment.
Eintrag öffnenVenclyxto · 4.8 · No adverse event of TLS was observed in the randomised phase 3 GLOW study.
Eintrag öffnenVenclyxto · 4.8 · Paediatric population The safety profile of venetoclax in paediatric patients is based on data from an open-la
Eintrag öffnenVenclyxto · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenVenclyxto · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
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