Radium-223 Dichloride Long-term Follow-up Program

Study Overview
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Brief Summary
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Patients will be followed up in this study after prior treatment with BAY88-8223 / Radium-223 dichloride / Xofigo .

Detailed Description
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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.

Official Title
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A Phase 4 Long-term Follow-up Study to Define the Safety Profile of Radium-223 Dichloride

Conditions
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Neoplasm Metastasis / Bone and Bones

Intervention / Treatment
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* Other: Data Collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br>The subjects previously enrolled in a selected radium-223 dichloride feeder trial, their treating health care professional, or caregiver will be contacted in 6-month intervals for follow up and query. | Other: Data Collection<br>* No study treatment will be provided in this long term follow up study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of radium-223 dichloride related Adverse Events |  | Up to 7 years | 
| Severity of radium-223 dichloride related Adverse Events | Severity will be measured as per guidelines by Common Terminology Criteria for Adverse Events; Version 4.03 (CTCAE) | Up to 7 years | 
| Incidence of radium-223 dichloride related Serious Adverse Events |  | Up to 7 years | 
| Incidence of placebo-related Adverse Events |  | Up to 7 years | 
| Severity of placebo-related Adverse Events |  | Up to 7 years | 
| Incidence of placebo-related Serious Adverse Events |  | Up to 7 years | 
| Incidence of leukemia |  | Up to 7 years | 
| Incidence of myelodysplastic syndrome |  | Up to 7 years | 
| Incidence of aplastic anemia |  | Up to 7 years | 
| Incidence of primary bone cancer |  | Up to 7 years | 
| Incidence of any other new primary malignancy |  | Up to 7 years | 
| Incidence of bone fractures |  | Up to 7 years | 
| Incidence of bone-associated events |  | Up to 7 years | 
| Incidence of febrile neutropenia in subjects who receive cytotoxic chemotherapy |  | Up to 7 years | 
| Incidence of hemorrhage in subjects who receive cytotoxic chemotherapy |  | Up to 7 years |