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Casgevy · 4.8 · Adverse reactions are listed by MedDRA body system organ class and by frequency. Frequencies are defined as: v
Eintrag öffnenCasgevy · 4.8 · Cardiac disorders Tachycardia †
Eintrag öffnenCasgevy · 4.8 · Immune system disorders Haemophagocytic lymphohistiocytosis
Eintrag öffnenCasgevy · 4.8 · In study 111, the median (min, max) time to neutrophil engraftment in patients with TDT was 29 (12, 56) days (
Eintrag öffnenCasgevy · 4.8 · In study 111, the median (min, max) time to platelet engraftment in patients with TDT was 44 (20, 200) days (n
Eintrag öffnenCasgevy · 4.8 · In study 121, the median (min, max) time to neutrophil engraftment in patients with SCD was 27 (15, 40) days (
Eintrag öffnenCasgevy · 4.8 · In study 121, the median (min, max) time to platelet engraftment for patients with SCD was 35 (23, 126) days (
Eintrag öffnenCasgevy · 4.8 · Metabolism and nutrition Hypocalcaemia † disorders
Eintrag öffnenCasgevy · 4.8 · Nervous system disorders Headache †, paraesthesia
Eintrag öffnenCasgevy · 4.8 · Neutrophil engraftment
Eintrag öffnenCasgevy · 4.8 · Neutrophil engraftment was defined as 3 consecutive measurements of absolute neutrophil count (ANC) ≥ 500 cell
Eintrag öffnenCasgevy · 4.8 · One (2.3%) patient with SCD died due to a COVID-19 infection and subsequent respiratory failure. The event was
Eintrag öffnenCasgevy · 4.8 · Paediatric population
Eintrag öffnenCasgevy · 4.8 · Platelet engraftment
Eintrag öffnenCasgevy · 4.8 · Platelet engraftment was defined as 3 consecutive measurements of platelet counts ≥ 20 × 109/L in patients wit
Eintrag öffnenCasgevy · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenCasgevy · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenCasgevy · 4.8 · Respiratory, thoracic and Acute respiratory distress syndrome, idiopathic mediastinal disorders pneumonia synd
Eintrag öffnenCasgevy · 4.8 · Serious adverse reactions attributed to Casgevy occurred in 2 (3.7%) patients with TDT: 1 (1.9%) patient with
Eintrag öffnenCasgevy · 4.8 · Summary of the safety profile
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