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Hemgenix · 4.8 · 11 The safety of etranacogene dezaparvovec was evaluated in clinical studies involving 57 adult patients, who
Eintrag öffnenHemgenix · 4.8 · 12 c CTCAE Grade 1 d CTCAE Grade 2 e CTCAE Grade 3 f Adverse event data are derived from patients followed for
Eintrag öffnenHemgenix · 4.8 · An expected sustained humoral immune response to the infused AAV5 capsid was observed in all patients treated
Eintrag öffnenHemgenix · 4.8 · Description of selected adverse reactions
Eintrag öffnenHemgenix · 4.8 · Hepatic laboratory abnormalities Table 4 describes hepatic laboratory abnormalities following administration o
Eintrag öffnenHemgenix · 4.8 · Immunogenicity In the clinical studies with etranacogene dezaparvovec, no Factor IX inhibitor development was
Eintrag öffnenHemgenix · 4.8 · Infusion related reactions In the clinical studies with etranacogene dezaparvovec, infusion-related reactions
Eintrag öffnenHemgenix · 4.8 · Laboratory Parameter Increasesa Number of patients (%) N = 57f ALT increases > ULNb 23 (40.4%) c > ULN – 3.0 x
Eintrag öffnenHemgenix · 4.8 · MedDRA System Organ ADR Frequency per Class (SOC) (Preferred term) patient Nervous system disorders Headache V
Eintrag öffnenHemgenix · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenHemgenix · 4.8 · Reporting suspected adverse drug reactions after authorisation of the medicinal product is important. It allow
Eintrag öffnenHemgenix · 4.8 · Summary of the safety profile
Eintrag öffnenHemgenix · 4.8 · Table 3. Adverse drug reactions obtained from clinical studies with etranacogene dezaparvovec
Eintrag öffnenHemgenix · 4.8 · Table 4. Hepatic laboratory abnormalities in patients administered 2 x 1013 gc/kg body weight etranacogene dez
Eintrag öffnenHemgenix · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenHemgenix · 4.8 · The most frequently reported adverse drug reactions (ADRs) in clinical studies with etranacogene dezaparvovec
Eintrag öffnenHemgenix · 4.8 · Treatment-emergent transaminitis In the clinical studies, treatment-emergent adverse reactions of ALT increase
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