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Evoltra · 4.8 · Adverse reactions considered to be related to clofarabine reported at frequencies ≥ 1/1,000 (i.e. in > 1/115 p
Eintrag öffnenEvoltra · 4.8 · Blood and lymphatic system disorders The most frequent haematological laboratory abnormalities observed in pat
Eintrag öffnenEvoltra · 4.8 · Capillary leak syndrome cases reported during the post-marketing period have been associated with a fatal outc
Eintrag öffnenEvoltra · 4.8 · Cardiac disorders Fifty percent of patients experienced at least one cardiac disorders adverse event. Eleven e
Eintrag öffnenEvoltra · 4.8 · Description of selected adverse reactions
Eintrag öffnenEvoltra · 4.8 · During the post-marketing period prolonged cytopaenias (thrombocytopaenia, anaemia, neutropaenia and leukopaen
Eintrag öffnenEvoltra · 4.8 · During the post-marketing period, bacterial, fungal and viral infections have been reported and may be fatal.
Eintrag öffnenEvoltra · 4.8 · Gastrointestinal disorders Occurrences of enterocolitis, including neutropaenic colitis, caecitis, and C. diff
Eintrag öffnenEvoltra · 4.8 · Hepato-biliary disorders The liver is a potential target organ for clofarabine toxicity and 25.2% of patients
Eintrag öffnenEvoltra · 4.8 · In addition, 50/113 patients receiving clofarabine had at least severely (at least US NCI CTC Grade 3) elevate
Eintrag öffnenEvoltra · 4.8 · Infections and infestations Forty-eight percent of patients had one or more ongoing infections prior to receiv
Eintrag öffnenEvoltra · 4.8 · Nearly all patients (98%) experienced at least one adverse event considered by the study investigator to be re
Eintrag öffnenEvoltra · 4.8 · Patients with advanced stages of ALL or AML may have confounding medical conditions that make causality of adv
Eintrag öffnenEvoltra · 4.8 · Pericardial effusion and pericarditis were reported as an adverse event in 9% (10/115) of patients. Three of t
Eintrag öffnenEvoltra · 4.8 · Renal and urinary disorders Forty-one patients of 115 (35.7%) experienced at least one renal and urinary disor
Eintrag öffnenEvoltra · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenEvoltra · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenEvoltra · 4.8 · Skin and subcutaneous disorders Stevens - Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), includi
Eintrag öffnenEvoltra · 4.8 · Summary of the safety profile
Eintrag öffnenEvoltra · 4.8 · Tabulated list of adverse reactions
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