A Phase 4 Long-term Follow-up Study to Define the Safety Profile of Radium-223 Dichloride
A Phase 4 Long-term Follow-up Study to Define the Safety Profile of Radium-223 Dichloride
Patients will be followed up in this study after prior treatment with BAY88-8223 / Radium-223 dichloride / Xofigo.
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; to assess the incidence of bone fractures and bone associated events (e.g., osteoporosis); 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.
Inclusion Criteria:
Exclusion Criteria:
Barretos/SP, São Paulo 14784-400, Brazil
Zrifin, 7030000, Israel
Forlì Cesena, Emilia-Romagna 47014, Italy
Kita-Adachigun, Saitama 362-0806, Japan
Koto-ku, Tokyo 135-8550, Japan