The purpose of this observational study is to describe the incidence of adverse events among patients treated with Refacto AF in usual health care settings in Germany and Austria.
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
Study Type
OBSERVATIONAL
Enrollment
101
Patients will be treated with intravenous infusion of ReFacto AF per dosing and frequency as prescribed by the subjects' treating physician. ReFacto AF® will be prescribed in the context of routine clinical practice in Germany and Austria, respectively
LKH - Univ. Klinikum Graz,Abt. fur Hamatologie
Graz, Austria
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to last visit (up to 87 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Time frame: Baseline until last visit (up to 87 months)
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; cancer; congenital anomaly. AEs included both serious and non-serious adverse events. Relatedness of AEs with Refacto AF was assessed by the investigator.
Time frame: Baseline until last visit (up to 87 months)
Number of Participants With Factor VIII (FVIII) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay
FVIII inhibitor development was defined as measured inhibitor titer of greater than (\>) 0.6 Bethesda Units (BU) using the Nijmegen-modified Bethesda assay.
Time frame: Baseline until last visit (up to 87 months)
Mean Total Number of Bleeding Episodes in Participants
Participants documented all bleeding episodes in a diary during the study.
Time frame: Baseline until last visit (up to 87 months)
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Allgemeines Krankenhaus Linz, Kinderklinik
Linz, Austria
Universitaetsklinik fuer Innere Medizin 1
Vienna, Austria
Sonnengesundheitszentrum
München, Bavaria, Germany
Werlhof-Institut für Haemostaseologie GmbH
Hanover, Lower Saxony, Germany
Vivantes Klinikum im Friedrichshain
Berlin, Germany
Klinikum Bremen Mitte
Bremen, Germany
CRC Coagulation Research Centre GmbH
Duisburg, Germany
Universitaetsklinikum Duesseldorf, Klinik f. Kinder-Onkologie, Haematologie u. Klinische Immunologie
Düsseldorf, Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, Germany
...and 14 more locations
Mean Total Number of Bleeding Episodes Per Year in Participants
Participants documented all bleeding episodes in a diary during the study. Mean total number of bleeding episodes per year was calculated as: mean total number of bleeding episodes divided by duration of observation period (in years) for bleeding documentation.
Time frame: Baseline until last visit (up to 87 months)
Number of Participants With Change From Baseline Status in Days Missed From School or Work
Change from baseline status in days missed from school or work was categorized in 3 categories: Improvement, unchanged and worsening. Improvement defined as a decrease in number of days missed by participants from school/work as compared to baseline; worsening was defined as an increase in number of days missed by participants from school/work as compared to baseline; unchanged was defined as no change in number of days missed by participants from school/work as compared to baseline. In this outcome measure, number of participants with change from baseline status (as improved, worsen, unchanged) in days missed from school/work were reported.
Time frame: Baseline until last visit (up to 87 months)
Participant Assessment of Satisfaction With Treatment Handling
Participants evaluated their satisfaction with handing (administration) of Refacto AF and rated it in 4 categories as: very satisfied, satisfied, unsatisfied and very unsatisfied.
Time frame: End of study visit (any time up to 87 months)
Investigator Assessment of Treatment Satisfaction of Participants
Investigator assessed the treatment satisfaction of participants and categorized as very satisfied, satisfied, unsatisfied, or very unsatisfied.
Time frame: End of study visit (any time up to 87 months)