A Drug Utilization Study of Radium-223 in Sweden

Completed

• Conditions: Neoplasms
• Interventions: Other: Radium-223 dichloride (Xofigo, BAY88-8223)

• Registration Number: NCT02331303
• Lead Sponsor: Bayer

Brief Summary

The objective of this study is to evaluate the extent of potential off-label use of Xofigo in Sweden.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-02
• Study First Submitted QC: 2015-01-02
• Study First Posted: 2015-01-06
• Study Start: 2015-04-15
• Primary Completion: 2017-12-19
• Study Completion: 2017-12-19
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

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Exclusion Criteria

• Patients receiving Xofigo in a clinical trial will not be included in this study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group1	Radium-223 dichloride (Xofigo, BAY88-8223)	This is a single-arm descriptive observational drug utilization study based on secondary data collection of patients treated with Xofigo in Sweden. This study will include patients receiving treatment of Xofigo at certified nuclear medicine centers across Sweden during a two year period.

Primary Outcome Measures

Name	Time	Method
Dosage of Xofigo (kBq/kg)	Up to 2 years
Proportion of being women of Xofigo use	Up to 2 years
Proportion of bone metastasis but having a diagnosis of other cancer than mCRPV	Up to 2 years
Proportion of participants of dose outside label recommendation	Up to 2 years
Proportion of men with metastatic castration resistant prostate cancer (mCRPC) of Xofigo use	Up to 2 years
Proportion of being children of Xofigo use	Up to 2 years