The purpose of this study is to collect data on adverse events from third party registries that include information about adverse events from patients with haemophilia B treated with nonacog beta pegol. The third party registries include PedNet Haemophilia Registry (PedNet) and the European Haemophilia Safety Surveillance System (EUHASS). Data from national and international registries in countries where nonacog beta pegol has been approved and marketed could be included in the data collection.
Study Type
OBSERVATIONAL
Enrollment
10
Treatment with commercially available nonacog beta pegol according to routine clinical practice at the discretion of the treating physician.
PedNet Haemophilia Registry
Baarn, Netherlands
European Haemophilia Safety Surveillance Registry
Sheffield, United Kingdom
Adverse Drug Reactions (ADRs) reported to the registries with suspected relation to nonacog beta pegol in patients with haemophilia B
Number of events (renal, hepatic, neurodevelopmental, neurocognitive, neurologic or psychiatric events)
Time frame: From start of data collection (week 0) to end of data collection (after 9 years)
Other ADRs reported to the registries during the study period with suspected relation to nonacog beta pegol in patients with haemophilia B
Number of events (de novo FIX inhibitors more than or equal to 0.6 Bethesda units); anaphylaxis and other allergic reactions; thromboembolic events)
Time frame: From start of data collection (week 0) to end of data collection (after 9 years)
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