Radium-223 Dichloride Long-term Follow-up Program
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/6/2019 |
Start Date: | December 18, 2014 |
End Date: | September 15, 2025 |
Contact: | Bayer Clinical Trials Contact |
Email: | clinical-trials-contact@bayer.com |
Phone: | (+)1-888-84 22937 |
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 BAY 88-8223 /
Radium-223 dichloride / Xofigo .
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.
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:
- Subject was previously enrolled in a selected company sponsored feeder trial, and has
received at least 1 dose of radium 223 dichloride or placebo in the feeder trial
Exclusion Criteria:
- Not applicable to this follow up study
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