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Azacitidine Accord · 4.8 · Description of selected adverse reactions
Eintrag öffnenAzacitidine Accord · 4.8 · Description of selected adverse reactions Haematologic adverse reactions The most commonly reported (≥ 10%) ha
Eintrag öffnenAzacitidine Accord · 4.8 · Dose interruptions due to an adverse reaction occurred in 36.4% of patients who received Azacitidine Accord. A
Eintrag öffnenAzacitidine Accord · 4.8 · Dose reductions due to an adverse reaction period occurred in 14% of patients who received Azacitidine Accord.
Eintrag öffnenAzacitidine Accord · 4.8 · Elderly population There is limited safety information available with azacitidine in patients ≥85 years (with
Eintrag öffnenAzacitidine Accord · 4.8 · Frequencies are defined as: very common (≥ 1/10), common (≥1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100);
Eintrag öffnenAzacitidine Accord · 4.8 · Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100);
Eintrag öffnenAzacitidine Accord · 4.8 · Gastrointestinal adverse reactions The most commonly reported gastrointestinal adverse reactions associated wi
Eintrag öffnenAzacitidine Accord · 4.8 · Gastrointestinal toxicity Gastrointestinal toxicities were the most frequent adverse reactions in patients tre
Eintrag öffnenAzacitidine Accord · 4.8 · Haematological toxicity New or worsening Grade 3 or higher neutropenia (41.1%), thrombocytopenia (22.5%), or f
Eintrag öffnenAzacitidine Accord · 4.8 · Hepatic adverse reactions Patients with extensive tumour burden due to metastatic disease have been reported t
Eintrag öffnenAzacitidine Accord · 4.8 · Hypersensitivity Serious hypersensitivity reactions have been reported in patients receiving azacitidine. In c
Eintrag öffnenAzacitidine Accord · 4.8 · In Study AZA-AML-004, 7 paediatric patients (aged 2 to 12 years) were treated with azacitidine for AML in mole
Eintrag öffnenAzacitidine Accord · 4.8 · No new safety signals were identified in the limited number of paediatric patients treated with azacitidine du
Eintrag öffnenAzacitidine Accord · 4.8 · Paediatric population In Study AZA-JMML-001, 28 paediatric patients (1 month to less than 18 years of age) wer
Eintrag öffnenAzacitidine Accord · 4.8 · Renal adverse reactions Renal abnormalities, ranging from elevated serum creatinine and haematuria to renal tu
Eintrag öffnenAzacitidine Accord · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenAzacitidine Accord · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenAzacitidine Accord · 4.8 · Skin and subcutaneous tissue adverse reactions The majority of skin and subcutaneous adverse reactions were as
Eintrag öffnenAzacitidine Accord · 4.8 · Summary of the safety profile
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