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Sunitinib Accord · 4.8 · Cases of ONJ have been reported in patients treated with sunitinib, most of which occurred in patients who had
Eintrag öffnenSunitinib Accord · 4.8 · Cases of fistula formation, sometimes associated with tumour necrosis and regression, in some cases with fatal
Eintrag öffnenSunitinib Accord · 4.8 · Cases of pulmonary embolism were observed in approximately 3.1% of patients with GIST and in approximately 1.2
Eintrag öffnenSunitinib Accord · 4.8 · Endocrine disorders Hypothyroidism was reported as an adverse reaction in 7 patients (4%) receiving sunitinib
Eintrag öffnenSunitinib Accord · 4.8 · Fatal events other than those listed in section 4.4 above or in section 4.8 below that were considered possibl
Eintrag öffnenSunitinib Accord · 4.8 · Fatal gastrointestinal bleeding was reported in 0.98% of patients receiving placebo in the GIST Phase 3 study.
Eintrag öffnenSunitinib Accord · 4.8 · Frequencies are defined as: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare
Eintrag öffnenSunitinib Accord · 4.8 · Gastrointestinal disorders Pancreatitis has been observed uncommonly (< 1%) in patients receiving sunitinib fo
Eintrag öffnenSunitinib Accord · 4.8 · Hepatobiliary disorders Hepatic dysfunction has been reported and may include Liver Function Test abnormalitie
Eintrag öffnenSunitinib Accord · 4.8 · Immune system disorders Hypersensitivity reactions, including angioedema, have been reported (see section 4.4)
Eintrag öffnenSunitinib Accord · 4.8 · In GIST patients ‘cardiac failure’, ‘cardiac failure congestive’, or ‘left ventricular failure’ were reported
Eintrag öffnenSunitinib Accord · 4.8 · In clinicalstudies, tumour haemorrhage was reported in approximately 2% of patients with GIST.
Eintrag öffnenSunitinib Accord · 4.8 · In patients who received sunitinib in Phase 3 registrational studies, pulmonary events (i.e. dyspnoea, pleural
Eintrag öffnenSunitinib Accord · 4.8 · In treatment-naïve MRCC patients receiving IFN-, 6 (2%) venous thromboembolic events were reported; 1 patient
Eintrag öffnenSunitinib Accord · 4.8 · Increases in the QTc interval to over 500 msec were reported in 0.5%, and changes from baseline in excess of 6
Eintrag öffnenSunitinib Accord · 4.8 · Infections and Viral infections* Necrotising infestations Respiratory fasciitis* infectionsb,* Bacterial infec
Eintrag öffnenSunitinib Accord · 4.8 · Infections and infestations Cases of serious infection (with or without neutropenia), including cases with fat
Eintrag öffnenSunitinib Accord · 4.8 · Investigations Data from non clinical (in vitro and in vivo) studies, at doses higher than the recommended hum
Eintrag öffnenSunitinib Accord · 4.8 · Long-term safety in MRCC The long-term safety of sunitinib in patients with MRCC was analysed across 9 complet
Eintrag öffnenSunitinib Accord · 4.8 · Metabolism and nutrition disorders A higher incidence rate of hypoglycaemia events was reported in patients wi
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