Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Other

If ‘other’, further details on the scope of the study

Evaluation of XGEVA off-label use

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

XGEVA

Medical condition to be studied

Off label use
Population studied

Short description of the study population

Patients with a treatment code for XGEVA in the Northern Jutland Region during the first 1-year period after the initial market availability of XGEVA.

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
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)

Estimated number of subjects

108
Study design details

Main study objective

This study will evaluate off-label use of XGEVA® (denosumab) in Denmark during the first 1-year post XGEVA market availability, defined as 12 months after RADS opinion on 24th January 2013.

Outcomes

On or off label individual prescription type.On or off label patient treatment. Type of off-label use.Off-label use stratified by administering department

Data analysis plan

Primary statistical analysis will be based on data of off-label use after the initial market availability of XGEVA in Denmark. Stratified analysis will be done for data accumulated during the first year of commercial availability. Additional analyses will stratify 12-month periods into 6-month intervals. Study population will be characterized with regard to demographic factors, diagnoses and treatments using descriptive statistics. Categorical variables will be summarized in frequency tables and numeric variables as the number of observations, mean, standard deviation, quartiles, and median.
Documents
Study results
English (27.41 KB - PDF)View document