Drug Utilization Study of ZALTRAP® (aflibercept) Using European Databases (Zaltrap Utilization Study)

Study type

• Study topic:
  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:
  Zaltrap
• Study drug International non-proprietary name (INN) or common name:
  AFLIBERCEPT
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XX44) aflibercept
• Medical condition to be studied:
  Colorectal neoplasm

  Colorectal cancer metastatic

Population studied

• Short description of the study population:
  Patients from the EU5 for whom the physician reported the receipt of at least one dose of ZALTRAP, as a current therapy.
• Age groups:
  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)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  - To evaluate the frequency distribution of cancer type(s) among patients who receive treatment containing ZALTRAP in the five largest national markets in Europe (EU5): United Kingdom (UK), France, Germany, Italy, and Spain.; - To describe different treatment combinations among patients who receive therapy containing ZALTRAP in the EU5.; - To evaluate the proportion of ZALTRAP patients with observed intravitreal use in England.
• Data analysis plan:
  Descriptive statistics will be provided

Documents

Study results

Zaltrap DUS Study Final Report