Prospective observational study to assess the long term safety profile of venetoclax in a Swedish cohort of Chronic Lymphocytic Leukaemia (CLL) patients

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Adverse events assessment

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  VENETOCLAX
• 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:
  3600

Study design details

• Main study objective:
  Main objective: To determine the incidence of selected adverse events (including Richter’s transformation) in CLL patients using venetoclax following long term use in the Real World.
• Outcomes:
  The primary outcome is the incidence of selected adverse events in CLL patients treated with venetoclax. Adverse events will be stratified by selected patient characteristics and risk factors. Information on adverse events will be captured via different sources (e.g. National Patient Register and Swedish Cancer Registry and EMRs).
• Data analysis plan:
  Statistical analysis will be conducted separately for each objective. Time-to-event and case mix methodologies will be applied, as necessary (e.g. primary objective and secondary objective b). Incidence rates of adverse events will be calculated per unit of observational time. Adverse events will be stratified by relevant patient characteristics and risk factors. Descriptive analysis of patient and clinical characteristics will also be performed.