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Halaven · 4.8 · Elderly population Of the 1559 breast cancer patients treated with the recommended dose of eribulin, 283 patie
Eintrag öffnenHalaven · 4.8 · Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to
Eintrag öffnenHalaven · 4.8 · Hepatotoxicity In some patients with normal/abnormal liver enzymes prior treatment with eribulin, increased le
Eintrag öffnenHalaven · 4.8 · In Study 113 (Phase 1), the most frequently reported adverse drug reactions were white blood cell count decrea
Eintrag öffnenHalaven · 4.8 · In Study 213 (Phase 1/2), the most frequently reported adverse drug reactions were neutropenia (Phase 1) and d
Eintrag öffnenHalaven · 4.8 · In Study 223 (Phase 2), the most frequently reported adverse drug reactions were neutrophil count decreased, a
Eintrag öffnenHalaven · 4.8 · Neutropenia The neutropenia observed was reversible and not cumulative; the mean time to nadir was 13 days and
Eintrag öffnenHalaven · 4.8 · Overall, the safety profiles in the breast cancer and soft tissue sarcoma patient populations were similar.
Eintrag öffnenHalaven · 4.8 · Paediatric population Three open-label studies, Studies 113, 213 and 223, were conducted in paediatric patient
Eintrag öffnenHalaven · 4.8 · Patients with hepatic impairment Patients with ALT or AST > 3 x ULN experienced a higher incidence of Grade 4
Eintrag öffnenHalaven · 4.8 · Peripheral neuropathy In the 1559 breast cancer patients the most common adverse reaction resulting in discont
Eintrag öffnenHalaven · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenHalaven · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenHalaven · 4.8 · Special populations
Eintrag öffnenHalaven · 4.8 · Summary of safety profile
Eintrag öffnenHalaven · 4.8 · System Organ Adverse Reactions – all Grades Class Very Common Common Uncommon Rare or not (Frequency %) (Frequ
Eintrag öffnenHalaven · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenHalaven · 4.8 · The most commonly reported adverse reactions related to HALAVEN, are bone marrow suppression manifested as neu
Eintrag öffnenHalaven · 4.8 · The safety of eribulin monotherapy was evaluated in 43 paediatric patients who received up to 1.58 mg/m2 on Da
Eintrag öffnenHalaven · 4.8 · The safety profile of eribulin as monotherapy or in combination with irinotecan hydrochloride in this paediatr
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