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Vidaza · 4.8 · All 28 patients experienced at least 1 adverse event and 17 (60.7%) experienced at least 1 treatment- related
Eintrag öffnenVidaza · 4.8 · All 7 patients experienced at least 1 treatment-related adverse event. The most commonly reported adverse even
Eintrag öffnenVidaza · 4.8 · Bleeding Bleeding may occur with patients receiving azacitidine. Serious adverse reactions such as gastrointes
Eintrag öffnenVidaza · 4.8 · Cardiac events Data from a clinical study allowing enrolment of patients with known history of cardiovascular
Eintrag öffnenVidaza · 4.8 · Description of selected adverse reactions
Eintrag öffnenVidaza · 4.8 · Elderly population There is limited safety information available with azacitidine in patients ≥ 85 years (with
Eintrag öffnenVidaza · 4.8 · Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100);
Eintrag öffnenVidaza · 4.8 · Haematologic adverse reactions The most commonly reported (≥ 10%) haematological adverse reactions associated
Eintrag öffnenVidaza · 4.8 · Hepatic adverse reactions Patients with extensive tumour burden due to metastatic disease have been reported t
Eintrag öffnenVidaza · 4.8 · Hypersensitivity Serious hypersensitivity reactions have been reported in patients receiving azacitidine. In c
Eintrag öffnenVidaza · 4.8 · In Study AZA-AML-004, 7 paediatric patients (aged 2 to 12 years) were treated with Vidaza for AML in molecular
Eintrag öffnenVidaza · 4.8 · Infections Myelosuppression may lead to neutropenia and an increased risk of infection. Serious adverse reacti
Eintrag öffnenVidaza · 4.8 · No new safety signals were identified in the limited number of paediatric patients treated with Vidaza during
Eintrag öffnenVidaza · 4.8 · Paediatric population In Study AZA-JMML-001, 28 paediatric patients (1 month to less than 18 years of age) wer
Eintrag öffnenVidaza · 4.8 · Renal adverse reactions Renal abnormalities, ranging from elevated serum creatinine and haematuria to renal tu
Eintrag öffnenVidaza · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenVidaza · 4.8 · Skin and subcutaneous tissue adverse reactions The majority of skin and subcutaneous adverse reactions were as
Eintrag öffnenVidaza · 4.8 · Summary of the safety profile
Eintrag öffnenVidaza · 4.8 · System Organ Very common Common Uncommon Rare Not Known Class Infections and pneumonia* sepsis* necrotising in
Eintrag öffnenVidaza · 4.8 · Table 1: Adverse reactions reported in patients with MDS or AML treated with azacitidine (clinical studies and
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