Prescribing Patterns of Lipegfilgrastim (Lonquex®) in the European Union

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  LIPEGFILGRASTIM

Population studied

• 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:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  The primary objective is to quantify the extent of off-label Lipegfilgrastim use in routine clinical practice in several countries in the European Union (EU).
• Outcomes:
  The primary endpoint of this study is off-label use of Lipegfilgrastim as documented in the most recent chemotherapy cycle with administration of Lipefilgrastim.
• Data analysis plan:
  There will be descriptive data analysis. Off-label use will be described by type and frequency. Study results will be quantified in terms of incidence of off-label lipegfilgrastim use per 1,000 investigated population. The rates and 95% confidence intervals of off-label use stratified by sex, age-group, center clinical setting, country and possibly, depending on the numbers in the sub-category, type of off-label use will be reported per 1,000 investigated population. Similarly, rates per 1000 and 95% CI will be provided for the authorized lipegfilgrastim use by sex, age-group, center clinical setting, and country.