Database Study of Thalidomide (Thalidomide Celgene®) in Germany: Monitoring Off-Label Use

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:
  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:
  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:
  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.