Study type

Study topic

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

ZALTRAP

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

AFLIBERCEPT

Anatomical Therapeutic Chemical (ATC) code

(L01XX44) aflibercept
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

  • Paediatric Population (< 18 years)
    • Neonate
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • 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

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