A Study on Estimated Risks of Certain Adverse Events in Adults With Von Willebrand Disease (VWD) Treated With Veyvondi

Study Overview
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Brief Summary
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The main aim of this study is to estimate the risks of certain adverse events in adults with Von Willebrand Disease treated with VEYVONDI. No study medicines will be provided to participants in this study. Data from medical records of participants diagnosed with Von Willebrand Disease and treated with VEYVONDI will be evaluated during this study.

Official Title
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Estimating Risk of Selected Adverse Events in Patients With Von Willebrand Disease Treated With VEYVONDI® (Vonicog Alfa; Recombinant Von Willebrand Factor)

Conditions
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Von Willebrand Disease (VWD)

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Participants with 18 years of age or older Participants with diagnosis of congenital VWD. Participants received VEYVONDI with or without a FVIII concentrate. Participants must have at least 7 days of observation time after the index dose. Provides informed consent, if required, in accordance with local ethical and institutional requirements. All medical record data will be abstracted retrospectively; therefore, an exemption or waiver of informed consent will be sought from all associated independent ethics committees (IECs) and institutional review boards (IRBs). Exclusion criteria: History of any other coagulation or platelet disorder (including acquired VWD). History of neutralizing antibodies / inhibitors to VWF or FVIII.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants Diagnosed With VWD<br>Participants who have been diagnosed with VWD and prescribed VEYVONDI for the approved indications for the index infusion (first eligible VEYVONDI infusion) will be assessed using secondary data obtained from medical records to evaluate the safety of VEYVONDI in real-world clinical practice. All study data will be retrospectively abstracted from medical records by dedicated clinical research staff in partnership with the treating physician. The data window for this study will begin on 01 January 2019 and end one day before site activation at each site. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Hypersensitivity Reactions | Hypersensitivity reactions are acute events and are considered an adverse events of special interest (AESI) in this study if they occur within 7 days of the infusion (including the day of the initial VEYVONDI infusion). | From 01 January 2019 up to one day before site activation at each site (up to approximately 4 years) | 
| Percentage of Participants With Thromboembolic Events | Thrombotic events considered as an AESIs if diagnosed during the 30 days after a VEYVONDI infusion. Thromboembolic events include venous thrombosis, arterial thrombosis, pulmonary embolism, and cerebral artery thrombosis. | From 01 January 2019 up to one day before site activation at each site (up to approximately 4 years) | 
| Percentage of Participants With VWF or Factor VIII (FVIII) Inhibitor Formation | Percentage of participants with VWF or FVIII inhibitor formation will be reported. | From 01 January 2019 up to one day before site activation at each site (up to approximately 4 years) |