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Sutent · 4.8 · 13 capecitabine. Hyperthyroidism was reported in 4 (1.7%) patients on sunitinib and no patients on capecitabin
Eintrag öffnenSutent · 4.8 · 14 Thirteen patients (3%) receiving sunitinib in the Phase 3 treatment-naïve MRCC study and 4 patients (2%) on
Eintrag öffnenSutent · 4.8 · 15 Cases of ONJ have been reported in patients treated with Sutent, most of which occurred in patients who had
Eintrag öffnenSutent · 4.8 · 16 to those paediatric patients without previous exposure. In these paediatric patients without previous expos
Eintrag öffnenSutent · 4.8 · A Phase 1 dose-escalation study of oral sunitinib was conducted in 35 patients comprised of 30 paediatric pati
Eintrag öffnenSutent · 4.8 · A Phase 1/2 single-arm, study was conducted in 6 paediatric patients (aged 13 years to 16 years) with advanced
Eintrag öffnenSutent · 4.8 · A phase 2 open-label study was conducted in 29 patients comprised of 27 paediatric patients (aged 3 years to 1
Eintrag öffnenSutent · 4.8 · Additionally, thyroid-stimulating hormone (TSH) elevations were reported in 4 cytokine-refractory MRCC patient
Eintrag öffnenSutent · 4.8 · Approximately 22.2% of patients with solid tumours, including GIST and MRCC, who received sunitinib in clinica
Eintrag öffnenSutent · 4.8 · At therapeutic plasma concentrations, the maximum QTcF interval (Frederica’s correction) mean change from base
Eintrag öffnenSutent · 4.8 · Bleeding events were reported in 18% of patients receiving sunitinib in a Phase 3 GIST study vs 17% of patient
Eintrag öffnenSutent · 4.8 · Blood and lymphatic system disorders Decreased absolute neutrophil counts of Grade 3 and 4 severities, respect
Eintrag öffnenSutent · 4.8 · Cardiac disorders In clinical trials, decreases in left ventricular ejection fraction (LVEF) of 20% and belo
Eintrag öffnenSutent · 4.8 · Cases of fistula formation, sometimes associated with tumour necrosis and regression, in some cases with fatal
Eintrag öffnenSutent · 4.8 · Cases of pulmonary embolism were observed in approximately 3.1% of patients with GIST and in approximately 1.2
Eintrag öffnenSutent · 4.8 · Description of selected adverse reactions
Eintrag öffnenSutent · 4.8 · Endocrine disorders Hypothyroidism was reported as an adverse reaction in 7 patients (4%) receiving sunitinib
Eintrag öffnenSutent · 4.8 · Fatal events other than those listed in section 4.4 above or in section 4.8 below that were considered possibl
Eintrag öffnenSutent · 4.8 · Fatal gastrointestinal bleeding was reported in 0.98% of patients receiving placebo in the GIST Phase 3 study.
Eintrag öffnenSutent · 4.8 · Frequencies are defined as: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare
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