Last updated on May 2018

Radium-223 Dichloride Long-term Follow-up Program

Brief description of study

Patients will be followed up in this study after prior treatment with BAY 88-8223 / Radium-223 dichloride / Xofigo.

Detailed Study Description

This long-term follow up study will enroll subjects who will be transferred from selected interventional, company sponsored trials with radium-223 dichloride (feeder trials).

The primary objectives are to define the long term safety profile of radium-223 dichloride (for up to 7 years after the last dose of radium-223 dichloride); to assess the incidence of leukemia, myelodysplastic syndrome, aplastic anemia, and primary bone cancer or any other new primary malignancy; and, in subjects who receive cytotoxic chemotherapy, to assess the incidence of febrile neutropenia and hemorrhage during their chemotherapy treatment and for up to 6 months thereafter at a frequency based on local clinical practice.

Clinical Study Identifier: NCT02312960

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