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Cabazitaxel Accord · 4.8 · Haematuria In the pooled analysis, haematuria all grades frequency was 18.8% at 25 mg/m2 (see section 5.1). Co
Eintrag öffnenCabazitaxel Accord · 4.8 · Hypoaesthesia 18 (1.6) 1 (<0.1) Dizziness 63 (5.8) 0 Headache 56 (5.1) 1 (<0.1) Lethargy 15 (1.4) 1 (<0.1) Sci
Eintrag öffnenCabazitaxel Accord · 4.8 · Neutropenia, and associated clinical events The use of G-CSF has been shown to limit the incidence and severit
Eintrag öffnenCabazitaxel Accord · 4.8 · Other laboratory abnormalities In pooled analysis, the incidence of grade ≥3 anaemia, increased AST, ALT, and
Eintrag öffnenCabazitaxel Accord · 4.8 · Other special populations
Eintrag öffnenCabazitaxel Accord · 4.8 · Paediatric population See section 4.2
Eintrag öffnenCabazitaxel Accord · 4.8 · Paraesthesia 46 (4.2) 0
Eintrag öffnenCabazitaxel Accord · 4.8 · Renal and urinary disorders Cystitis due to radiation recall phenomenon, including haemorrhagic cystitis, were
Eintrag öffnenCabazitaxel Accord · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenCabazitaxel Accord · 4.8 · Summary of safety profile The safety of cabazitaxel in combination with prednisone or prednisolone was evaluat
Eintrag öffnenCabazitaxel Accord · 4.8 · System Organ Adverse reaction All grades n (%) Grade>3 Class n (%) Very Common Uncommon common Infections and
Eintrag öffnenCabazitaxel Accord · 4.8 · Table 2: Reported adverse reactions and haematological abnormalities with cabazitaxel in combination with pred
Eintrag öffnenCabazitaxel Accord · 4.8 · Tabulated list of adverse reactions Adverse reactions are listed in table 2 according to MedDRA system organ c
Eintrag öffnenCabazitaxel Accord · 4.8 · The incidences from the pooled analysis of these 3 trials are presented below and in the tabulated list. The m
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