Cross-sectional Study Evaluating the Effectiveness of Venetoclax Risk-Minimisation Measures Among Haematologists in Europe

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Name of medicine:
  Venclyxto
• Medical condition to be studied:
  Chronic lymphocytic leukaemia

Population studied

• 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:
  200

Study design details

• Main study objective:
  To assess haematologists' knowledge of the following: - TLS as a risk of venetoclax treatment for CLL - Signs/symptoms of TLS - The importance of strict adherence to venetoclax dose titration and TLS risk-minimisation measures as outlined in the SmPC for all patients.
• Data analysis plan:
  The analyses will be descriptive in nature and will include distributions of the responses to all of the individual questions and, if appropriate, summary measures across logical groupings of questions. Descriptive tables will be generated for the physicians overall and stratified by country and other identified variables of interest. Analysis tables will include the frequency and percentage of physicians who select each response to each individual question.