This is a multicenter, single-arm, non-interventional study (NIS) with a central registration system and an all-case surveillance system. The observation period is 48 weeks after the start of treatment with Fabhalta.
The observation period will be 48 weeks after the start of treatment with Fabhalta. For patients in whom treatment with Fabhalta is discontinued within 48 weeks after the start of the treatment, adverse events occurring by the last day of the treatment + 30 days and concomitant drugs will be monitored and recorded in CRFs.
Study Type
OBSERVATIONAL
Enrollment
100
Occurrence status of infections.
Type, incidence, seriousness, severity, clinical course, factors affecting onset (status of vaccination, name of vaccine administered, complications, baseline white blood cell count/neutrophil count, etc.), and causative organism (including serotype) of adverse events/adverse drug reactions of infections during the treatment period.
Time frame: 48weeks
Occurrence status of serious hemolysis after discontinuation of Fabhalta.
Number of patients with serious hemolysis after discontinuation of Fabhalta.
Time frame: 48weeks
Occurrence status of adverse events and adverse drug reactions.
Incidence of adverse events and adverse drug reactions during the treatment period.
Time frame: 48weeks
Incidence of breakthrough hemolysis and change of hemolysis-related markers and status of red blood cell transfusion-free.
Incidence of breakthrough hemolysis per year and change over time in hemolysis-related markers (LDH, Hb, etc.) and status of red blood cell transfusion-free up to Week 48.
Time frame: 48weeks
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