Cross-sectional Study Evaluating the Effectiveness of the Venetoclax Patient Card Among Adult Patients 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 patients’ knowledge of the following: ? TLS as a risk of venetoclax treatment for CLL ? Symptoms of TLS ? Steps to take to reduce the risk of TLS ? Actions to take if symptoms of TLS appear To assess patients’ use of the PC, including the following: ? Whether the patient keeps the PC on their person ? Whether the PC is shared with all medical providers when seeking care
• 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 patients overall and stratified by country and other identified variables of interest. Analysis tables will include the frequency and percentage of patients who select each response to each individual question.