Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation

Data collection methods

Secondary data collection
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Single-arm descriptive observational study
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

100000157913
radium (223Ra) dichloride

Medical condition to be studied

Prostate cancer stage II
Population studied

Short description of the study population

Patients receiving Xofigo with data recorded at nuclear medicine centers in Sweden between 01 July 2014 and 30 June 2016 were included in the study

Age groups

Children (2 to < 12 years)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Prostate cancer patients

Estimated number of subjects

200
Study design details

Main study objective

To evaluate the extent of potential off-label use of Xofigo in Sweden

Outcomes

1.To evaluate the extent of potential off-label use of Xofigo in Sweden2.Proportion of being women of Xofigo use3.Proportion of being children of Xofigo use4.Proportion of bone metastasis but having a diagnosis of other cancer than mCRPV5.Dosage of Xofigo (kBq/kg)6.Proportion of participants of dose outside label recommendation

Data analysis plan

This is a single arm descriptive observational drug utilization study based on secondary data collection. This study is not aimed to confirm or reject pre-defined hypotheses. Statistical analyses will be descriptive in nature. All variables will be analyzed descriptively with appropriate statistical methods.
Documents
Study results

17399_EU-PAS_Abstract

English (61.73 KB - PDF)View document
Study report

17399_CSR_EU PAS register

English (321.1 KB - PDF)View document