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Sunitinib Accord · 4.5 · If this is not possible, the dose of sunitinib may need to be reduced to a minimum of 37.5 mg daily for GIST a
Eintrag öffnenSunitinib Accord · 4.5 · Interaction studies have only been performed in adults.
Eintrag öffnenSunitinib Accord · 4.5 · Medicinal products that may decrease sunitinib plasma concentrations Effect of CYP3A4 inducers In healthy volu
Eintrag öffnenSunitinib Accord · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenSunitinib Accord · 4.8 Undesirable effects · 1
Eintrag öffnenSunitinib Accord · 4.8 · 10 System organ class Very common Common Uncommon Rare Not known
Eintrag öffnenSunitinib Accord · 4.8 · 11 System organ class Very common Common Uncommon Rare Not known
Eintrag öffnenSunitinib Accord · 4.8 · 12 Description of selected adverse reactions
Eintrag öffnenSunitinib Accord · 4.8 · 13 Nervous system disorders In clinical studies of sunitinib and from post-marketing surveillance, there have
Eintrag öffnenSunitinib Accord · 4.8 · 14 Venous thromboembolic events were reported for 1 (1.2%) patient in the sunitinib arm and 5 (6.1%) patients
Eintrag öffnenSunitinib Accord · 4.8 · 15 recognised as potentially significant changes. At approximately twice therapeutic concentrations, sunitinib
Eintrag öffnenSunitinib Accord · 4.8 · 16 A Phase 1/2 single-arm, study was conducted in 6 paediatric patients (aged 13 years to 16 years) with advan
Eintrag öffnenSunitinib Accord · 4.8 · A phase 1 dose-escalation study of oral sunitinib was conducted in 35 patients comprised of 30 paediatric pati
Eintrag öffnenSunitinib Accord · 4.8 · A phase 2 open-label study was conducted in 29 patients comprised of 27 paediatric patients (aged 3 years to 1
Eintrag öffnenSunitinib Accord · 4.8 · Additionally, thyroid-stimulating hormone (TSH) elevations were reported in 4 cytokine-refractory MRCC patient
Eintrag öffnenSunitinib Accord · 4.8 · Approximately 22.2% of patients with solid tumours, including GIST and MRCC, who received sunitinib in clinica
Eintrag öffnenSunitinib Accord · 4.8 · At therapeutic plasma concentrations, the maximum QTcF interval (Frederica’s correction) mean change from base
Eintrag öffnenSunitinib Accord · 4.8 · Bleeding events were reported in 18% of patients receiving sunitinib in a Phase 3 GIST study vs 17% of patient
Eintrag öffnenSunitinib Accord · 4.8 · Blood and lymphatic system disorders Decreased absolute neutrophil counts of Grade 3 and 4 severities, respect
Eintrag öffnenSunitinib Accord · 4.8 · Cardiac disorders In clinicalstudies, decreases in left ventricular ejection fraction (LVEF) of 20% and belo
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