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Arsenic trioxide Accord · 4.8 · All grades Grades ≥ 3 Infections and infestations Herpes zoster Common Not known Sepsis Not known Not known Pn
Eintrag öffnenArsenic trioxide Accord · 4.8 · Description of selected adverse reactions
Eintrag öffnenArsenic trioxide Accord · 4.8 · Differentiation syndrome During arsenic trioxide treatment, 14 of the 52 patients in the APL studies in the re
Eintrag öffnenArsenic trioxide Accord · 4.8 · Haematological and gastrointestinal toxicity In newly diagnosed patients with low to intermediate risk APL, ga
Eintrag öffnenArsenic trioxide Accord · 4.8 · Hepatotoxicity (grade 3-4) In newly diagnosed patients with low to intermediate risk APL 63.2 % developed grad
Eintrag öffnenArsenic trioxide Accord · 4.8 · In a phase 3, multicentre, non-inferiority trial comparing all-trans-retinoic acid (ATRA) plus chemotherapy wi
Eintrag öffnenArsenic trioxide Accord · 4.8 · In general, treatment-emergent adverse events tended to decrease over time, in relapsed/refractory APL patient
Eintrag öffnenArsenic trioxide Accord · 4.8 · In newly diagnosed patients with low to intermediate risk APL, differentiation syndrome was observed in 19 % i
Eintrag öffnenArsenic trioxide Accord · 4.8 · In newly diagnosed patients, with low to intermediate risk APL, QTc prolongation was observed in 15.6 %. In on
Eintrag öffnenArsenic trioxide Accord · 4.8 · In post marketing experience, a differentiation syndrome, like retinoic acid syndrome, has also been reported
Eintrag öffnenArsenic trioxide Accord · 4.8 · Mortality in the pivotal studies in the relapsed setting from disseminated intravascular coagulation (DIC) ass
Eintrag öffnenArsenic trioxide Accord · 4.8 · Peripheral neuropathy Peripheral neuropathy, characterised by paraesthesia/dysaesthisia, is a common and well
Eintrag öffnenArsenic trioxide Accord · 4.8 · QT interval prolongation Arsenic trioxide can cause QT interval prolongation (see section 4.4). QT prolongatio
Eintrag öffnenArsenic trioxide Accord · 4.8 · Related adverse reactions of CTC grade 3 and 4 occurred in 37% of relapsed/refractory APL patients in clinical
Eintrag öffnenArsenic trioxide Accord · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenArsenic trioxide Accord · 4.8 · Serious adverse reactions were common (1-10%) and not unexpected in the relapsed/refractory population. Those
Eintrag öffnenArsenic trioxide Accord · 4.8 · Summary of the safety profile
Eintrag öffnenArsenic trioxide Accord · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenArsenic trioxide Accord · 4.8 · The following undesirable effects have been reported in the APL0406 study in newly diagnosed patients and in c
Eintrag öffnenArsenic trioxide Accord · 4.8 · Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
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