Cross-sectional Study Evaluating the Effectiveness of the Venetoclax Patient Card Among Adult Patients in Europe

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medicinal product name:
  VENCLYXTO
• Study drug International non-proprietary name (INN) or common name:
  VENETOCLAX
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XX52) venetoclax

  venetoclax
• Medical condition to be studied:
  Tumour lysis syndrome

Population studied

• Short description of the study population:
  Patients initiating venetoclax for the treatment of CLL in the past 8 weeks will be targeted ; for participation in the study. Patients will be identified and recruited through clinical sites. Countries ; are anticipated to include France, Germany, Spain, Poland, and the UK.
• 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

• Study design:
  This study will be a cross-sectional survey of knowledge of the risks and safe use of venetoclax as outlined in the PC among adult patients who have recently received venetoclax for treatment of CLL per standard of care.
• 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.