An observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices.

The primary objective of this study is to characterize the safety of Blincyto in routine clinical practice. Blincyto effectiveness, medication errors, and utilisation; and select healthcare resource use while using Blincyto will also be described. Safety and effectiveness of Blincyto in specified subgroups of patients will also be assessed.

Inclusion Criteria:

- Medical records of patients initiating Blincyto after country-specific reimbursement in routine clinical practice will be eligible for extraction.

Exclusion Criteria:

• Medical records of patients who have participated in Blincyto clinical trials will be excluded since their treatment will be prescribed by the study protocol unless the patient is receiving new Blincyto treatment outside the clinical trial.
• Medical records of patients participating in other Amgen non-interventional prospective studies in which safety endpoints are collected will be excluded.
• Medical records of patients who have received Blincyto via an expanded access/compassionate use program will be excluded.
• In countries where patient informed consent is required for access to their medical records, any patient who does not provide informed consent will be excluded.

The study population will include patients receiving Blincyto at participating clinical centres after country-specific reimbursement of Blincyto in the Europe.

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.