Trial Condition(s):
Neoplasms
A Drug Utilization Study of Radium-223 in Sweden
Bayer Identifier:
17399
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
The objective of this study is to evaluate the extent of potential off-label use of Xofigo in Sweden.
Inclusion Criteria
- Patients receiving Xofigo with data recorded at nuclear medicine centers in Sweden between 01 July 2014 and 30 June 2016 will be included in the study
Exclusion Criteria
- Patients receiving Xofigo in a clinical trial will not be included in this study
Trial Summary
Enrollment Goal
37
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
Status
| Locations | Status | |
|---|---|---|
Locations Investigative Site Stockholm, Sweden | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Drug Utilization Study of Xofigo Use in Sweden
Trial Type:
Observational
Intervention Type:
Other
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Proportion of men with metastatic castration resistant prostate cancer (mCRPC) of Xofigo useTimeframe: Up to 2 years
- Proportion of being women of Xofigo useTimeframe: Up to 2 years
- Proportion of being children of Xofigo useTimeframe: Up to 2 years
- Proportion of bone metastasis but having a diagnosis of other cancer than mCRPVTimeframe: Up to 2 years
- Dosage of Xofigo (kBq/kg)Timeframe: Up to 2 years
- Proportion of participants of dose outside label recommendationTimeframe: Up to 2 years
Additional Information
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