A cross-sectional study to evaluate the effectiveness of XALKORI Therapeutic Management Guide among physician prescribing XALKORI in Europe

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:
  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)
• 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.

Documents

Study results

Crizotinib A8081049 NI Study Report