Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Other

If ‘other’, further details on the scope of the study

Evaluate the effectiveness of physician educational materials and assess whether physicians would provide patients with patient educational materials.

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Cross-sectional
Study drug and medical condition

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

CRIZOTINIB
Population studied

Short description of the study population

Physicians who have prescribed XALKORI per SmPC at least once within 12 months prior to taking the survey.

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)

Estimated number of subjects

150
Study design details

Main study objective

The overall objective of this study is to evaluate the effectiveness of the XALKORI TMG and PIB implemented to mitigate the risks of visual disorders, QTc prolongation, bradycardia, hepatotoxicity, neutropenia and leukopenia, and ILD/pneumonitis in 6 countries including Belgium, Denmark, France, Germany, Italy, and the Netherlands in the European Union (EU).

Data analysis plan

The survey population will include all physicians who are screened and eligible for this study. All statistical analyses in this study will be descriptive. All variables collected are categorical. Frequencies and percentages, with 95% CIs where appropriate, will be presented. Country specific analyses will be presented. Additional exploratory analyses and sensitivity analyses may be conducted.