A Post-Authorisation Safety Study Patient Registry of Patients With Neuroblastoma Being Treated With Dinutuximab Beta

Summary

This is a non-interventional, multi-national, observational, prospective patient registry to further evaluate the effectiveness and safety of dinutuximab beta - a monoclonal immunoglobulin G 1 (IgG1) antibody, to obtain information on survival, pain severity and incidence of neuro-toxicity, visual impairment, capillary leak syndrome, cardiovascular events, hypersensitivity reactions and long-term safety.

Eligibility

Inclusion Criteria:

Patients meeting the following criteria will be considered for inclusion into the registry:

* Patients diagnosed with high-risk neuroblastoma and starting treatment with commercially available dinutuximab beta OR
* Patients diagnosed with high-risk neuroblastoma and starting treatment with dinutuximab beta in a clinical trial where dinutuximab beta is provided according to the country/regional marketing authorisation AND
* Appropriate consent/assent has been obtained for participation in the registry with a willingness to be followed up for up to 10 years.

Exclusion Criteria:

Patient will not be eligible for inclusion if the following criterion applies:

* Patients commencing dinutuximab beta within a clinical trial where the product is being provided outside of the country/regional marketing authorisation OR
* Appropriate consent/assent has not been obtained for participation in the registry or patient/legal representative is not willing for the patient be followed up for up to 10 years.

Conditions2

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