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 use of data
Non-interventional study

Non-interventional study design

Cross-sectional
Study drug and medical condition

Name of medicine, other

Thalidomide Celgene

Medical condition to be studied

Plasma cell myeloma
Population studied

Short description of the study population

Myeloma patients with off-label use of thalidomide in 2009 and 2010.

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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

Plasma cell myeloma patients

Estimated number of subjects

200
Study design details

Main study objective

The objectives of this study were to determine off-label use of thalidomide by indication in the years 2009 (subproject 1) and 2010 (subproject 2) and to investigate probable indications for thalidomide use in off-label users. On-label and off-label users of thalidomide were characterised. Furthermore, the incidence rates of thalidomide use were investigated.

Outcomes

frequency of off-label use

Data analysis plan

Descriptive analyses were conducted for all users of thalidomide with respect to demographic characteristics, i.e. sex, age and federal state of residence, death and frequency of dispensations. Incidence rates of thalidomide use by sex, age and federal state of residence were determined. Prevalence and incidence rates of thalidomide use were calculated with 95% confidence intervals. Demographics and comorbidities are determined for patient with off-label use.