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Cabometyx · 4.8 · 15 In the HCC study (CELESTIAL), hepatic encephalopathy (hepatic encephalopathy, encephalopathy, hyperammonaem
Eintrag öffnenCabometyx · 4.8 · 16 Haemorrhage (see section 4.4) In the RCC study (METEOR), the incidence of severe haemorrhagic events (Grade
Eintrag öffnenCabometyx · 4.8 · 17 compared to adults. The increased rates for these Preferred Terms (PTs) concern any grade as well as grade
Eintrag öffnenCabometyx · 4.8 · Cabozantinib as monotherapy Summary of safety profile The most common serious adverse drug reactions in the RC
Eintrag öffnenCabometyx · 4.8 · Cabozantinib in combination with nivolumab in first-line advanced RCC Summary of safety profile When cabozanti
Eintrag öffnenCabometyx · 4.8 · Description of selected adverse reactions Data for the following reactions are based on patients who received
Eintrag öffnenCabometyx · 4.8 · Diarrhoea (see section 4.4) In the RCC study (METEOR), diarrhoea was reported in 74% of cabozantinib-treated R
Eintrag öffnenCabometyx · 4.8 · Elevated liver enzymes when cabozantinib is combined with nivolumab in RCC In a clinical study of previously u
Eintrag öffnenCabometyx · 4.8 · Fistulas (see section 4.4) In the RCC study (METEOR), fistulas were reported in 1.2% (4/331) of cabozantinib-t
Eintrag öffnenCabometyx · 4.8 · Gastrointestinal (GI) perforation (see section 4.4) In the RCC study (METEOR), GI perforations were reported i
Eintrag öffnenCabometyx · 4.8 · Hepatic encephalopathy (see section 4.4)
Eintrag öffnenCabometyx · 4.8 · Hypothyroidism In the RCC study (METEOR), the incidence of hypothyroidism was 21% (68/331). In the treatment-n
Eintrag öffnenCabometyx · 4.8 · In a dataset of cabozantinib 40 mg once daily in combination with nivolumab 240 mg every two weeks in RCC (n =
Eintrag öffnenCabometyx · 4.8 · In combination with nivolumab in advanced RCC in first-line treatment (CA2099ER) the incidence of fistula was
Eintrag öffnenCabometyx · 4.8 · In study ADVL1211, a limited dose-escalation study of cabozantinib in paediatric and adolescent patients with
Eintrag öffnenCabometyx · 4.8 · In study ADVL1622 of cabozantinib in children and young adults with the following solid tumour strata: Ewing s
Eintrag öffnenCabometyx · 4.8 · Paediatric population (see section 5.1)
Eintrag öffnenCabometyx · 4.8 · Physeal widening has been observed in children with open growth plates when treated with cabozantinib.
Eintrag öffnenCabometyx · 4.8 · Posterior reversible encephalopathy syndrome (PRES) (see section 4.4) No case of PRES was reported in the METE
Eintrag öffnenCabometyx · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
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