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Leqembi · 4.8 · Description of selected adverse reactions
Eintrag öffnenLeqembi · 4.8 · In Study 301, ARIA-E was observed in 9% (67/757) of patients on lecanemab compared with 1% (10/764) of patient
Eintrag öffnenLeqembi · 4.8 · In Study 301, symptomatic ARIA occurred in 2% (16/757) patients on lecanemab who are non- carriers and heteroz
Eintrag öffnenLeqembi · 4.8 · In the indicated population, the most common adverse reactions were infusion-related reaction (26%), ARIA-H (1
Eintrag öffnenLeqembi · 4.8 · Incidence of ARIA in the Indicated Population
Eintrag öffnenLeqembi · 4.8 · Including asymptomatic radiographic events, ARIA was observed in 17% (128/757) of patients on lecanemab compar
Eintrag öffnenLeqembi · 4.8 · Infusion related reactions
Eintrag öffnenLeqembi · 4.8 · Infusion-related reactions were observed in Study 301 in 26% (237/898) patients treated with lecanemab and 75%
Eintrag öffnenLeqembi · 4.8 · Intracerebral Haemorrhage in the Indicated Population The incidence of intracerebral haemorrhage was 0.3% (1/2
Eintrag öffnenLeqembi · 4.8 · Intracerebral haemorrhages greater than 1 cm in diameter were reported in 0.5% (4/757) patients in Study 301 a
Eintrag öffnenLeqembi · 4.8 · Isolated ARIA-H was observed in 8% (61/757) of patients on lecanemab and 6% (45/764) of patients on placebo, o
Eintrag öffnenLeqembi · 4.8 · Of the patients treated with lecanemab 31% (278/898) were non-carriers, 53% (479/898) were heterozygotes and 1
Eintrag öffnenLeqembi · 4.8 · Recurrence of ARIA in the Indicated Population ARIA-E was observed in 9% (67/757) of patients on lecanemab, of
Eintrag öffnenLeqembi · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenLeqembi · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenLeqembi · 4.8 · Seizures including status epilepticus have been reported with lecanemab treatment in the clinical trials.
Eintrag öffnenLeqembi · 4.8 · Summary of the safety profile
Eintrag öffnenLeqembi · 4.8 · Table 2: Adverse reactions System Organ Class Adverse reaction Frequency category (SOC) Immune system Hypersen
Eintrag öffnenLeqembi · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenLeqembi · 4.8 · The adverse reactions are presented as MedDRA preferred terms under the MedDRA System Organ Class. Adverse rea
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