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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
255
No study treatment will be provided in this long term follow up study.
Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs)
Adverse events considered related to radium-223 dichloride or placebo (received in the feeder studies), first arising or worsening on or after the date the participant signed the 16996 informed consent.
Time frame: Up to 7 years
Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs)
Severity will be measured as per guidelines by Common Terminology Criteria for Adverse Events; Version 4.03 (CTCAE)
Time frame: Up to 7 years
Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events
Serious adverse events considered related to radium-223 dichloride or placebo (received in the feeder studies), first arising or worsening on or after the date the participant signed the 16996 informed consent.
Time frame: Up to 7 years
Number of Participants With Leukemia
Time frame: Up to 7 years
Number of Participants With Myelodysplastic Syndrome
Time frame: Up to 7 years
Number of Participants With Aplastic Anemia
Time frame: Up to 7 years
Number of Participants With Primary Bone Cancer
Time frame: Up to 7 years
Number of Participants With Any Other New Primary Malignancy
Time frame: Up to 7 years
Number of Participants With Bone Fractures
Time frame: Up to 7 years
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Unnamed facility
Anchorage, Alaska, United States
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Tucson, Arizona, United States
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Plantation, Florida, United States
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Indianapolis, Indiana, United States
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Ashland, Kentucky, United States
Unnamed facility
New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Detroit, Michigan, United States
...and 107 more locations
Number of Participants With Bone-associated Events
Time frame: Up to 7 years
Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy
Time frame: Up to 7 years
Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy
Time frame: Up to 7 years