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Sutent · 4.8 · Gastrointestinal disorders Pancreatitis has been observed uncommonly (< 1%) in patients receiving sunitinib fo
Eintrag öffnenSutent · 4.8 · Hepatobiliary disorders Hepatic dysfunction has been reported and may include Liver Function Test abnormalitie
Eintrag öffnenSutent · 4.8 · Immune system disorders Hypersensitivity reactions, including angioedema, have been reported (see section 4.4)
Eintrag öffnenSutent · 4.8 · In GIST patients ‘cardiac failure’, ‘cardiac failure congestive’, or ‘left ventricular failure’ were reported
Eintrag öffnenSutent · 4.8 · In clinical trials, tumour haemorrhage was reported in approximately 2% of patients with GIST.
Eintrag öffnenSutent · 4.8 · In patients who received sunitinib in Phase 3 registrational studies, pulmonary events (i.e. dyspnoea, pleural
Eintrag öffnenSutent · 4.8 · In treatment-naïve MRCC patients receiving IFN-, 6 (2%) venous thromboembolic events were reported; 1 patient
Eintrag öffnenSutent · 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 öffnenSutent · 4.8 · Infections and Viral infectionsa Necrotising infestations Respiratory fasciitis* infectionsb,* Bacterial infec
Eintrag öffnenSutent · 4.8 · Infections and infestations Cases of serious infection (with or without neutropenia), including cases with fat
Eintrag öffnenSutent · 4.8 · Investigations Data from non clinical (in vitro and in vivo) studies, at doses higher than the recommended hum
Eintrag öffnenSutent · 4.8 · Long-term safety in MRCC The long-term safety of sunitinib in patients with MRCC was analysed across 9 complet
Eintrag öffnenSutent · 4.8 · Metabolism and nutrition disorders A higher incidence rate of hypoglycaemia events was reported in patients wi
Eintrag öffnenSutent · 4.8 · Musculoskeletal and connective tissue disorders Cases of myopathy and/or rhabdomyolysis, some with acute renal
Eintrag öffnenSutent · 4.8 · Nervous system Dizziness Neuropathy Cerebral Posterior Hyperammonaemic disorders Headache peripheral haemorrha
Eintrag öffnenSutent · 4.8 · Nervous system disorders In clinical studies of sunitinib and from postmarketing surveillance, there have been
Eintrag öffnenSutent · 4.8 · No cases with fatal outcome were reported in GIST, MRCC, and pNET registrational studies. Cases with fatal out
Eintrag öffnenSutent · 4.8 · Paediatric population The safety profile of sunitinib has been derived from a Phase 1 dose-escalation study, a
Eintrag öffnenSutent · 4.8 · Patients who presented with pulmonary embolism within the previous 12 months were excluded from sunitinib clin
Eintrag öffnenSutent · 4.8 · QTc interval prolongation was investigated in a trial in 24 patients, ages 20-87 years, with advanced malignan
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