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Zaltrap · 4.8 · Gastrointestinal perforation GI perforation including fatal GI perforation has been reported in patients treat
Eintrag öffnenZaltrap · 4.8 · Given the similar ADA assay results in patients treated with placebo or ZALTRAP, the actual incidence of immun
Eintrag öffnenZaltrap · 4.8 · Haemorrhage Patients treated with ZALTRAP have an increased risk of haemorrhage, including severe and sometime
Eintrag öffnenZaltrap · 4.8 · Hypersensitivity reactions In the pivotal study of MCRC patients, severe hypersensitivity reactions have been
Eintrag öffnenZaltrap · 4.8 · Hypertension In the pivotal study of MCRC patients, hypertension (all grades) has been reported in 41.2 % of p
Eintrag öffnenZaltrap · 4.8 · Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity with ZALTRAP.
Eintrag öffnenZaltrap · 4.8 · In the pivotal MCRC study, anaemia, nausea, vomiting, constipation, alopecia, increased alkaline phosphatase,
Eintrag öffnenZaltrap · 4.8 · Infections Infections occurred at a higher frequency in patients receiving the ZALTRAP/FOLFIRI regimen (46.2 %
Eintrag öffnenZaltrap · 4.8 · Neutropenia and neutropenic complications In the pivotal study of MCRC patients, neutropenia (all grades) has
Eintrag öffnenZaltrap · 4.8 · Other special populations Elderly Of the 611 patients treated with the ZALTRAP/FOLFIRI regimen in the pivotal
Eintrag öffnenZaltrap · 4.8 · Overall across all clinical oncology studies, similar incidence of low titre anti-drug antibody (ADA) response
Eintrag öffnenZaltrap · 4.8 · Paediatric population The safety in paediatric patients has not been established.
Eintrag öffnenZaltrap · 4.8 · Posterior reversible encephalopathy syndrome (PRES) PRES was not reported in the pivotal Phase III study of MC
Eintrag öffnenZaltrap · 4.8 · Proteinuria In the pivotal study of MCRC patients, proteinuria (compiled from clinical and laboratory data) wa
Eintrag öffnenZaltrap · 4.8 · Rare Ejection fraction decreased Nervous system disorders Very common Headache Common Headache Uncommon PRES (
Eintrag öffnenZaltrap · 4.8 · Renal impairment In patients receiving ZALTRAP, the adverse reactions in patients with mild renal impairment a
Eintrag öffnenZaltrap · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenZaltrap · 4.8 · Skin and subcutaneous tissue disorders Very common Palmar-Plantar Erythrodysaesthesia syndrome Common Skin hyp
Eintrag öffnenZaltrap · 4.8 · Summary of the safety profile The safety of ZALTRAP in combination with FOLFIRI was evaluated in 1,216 patient
Eintrag öffnenZaltrap · 4.8 · System Organ Class Adverse Reaction Frequency Category All grades Grades ≥3 Infections and infestations Very c
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