A cross-sectional survey of patients and caregivers receiving Blincyto in routine clinical practice in Europe to evaluate the effectiveness of additional risk minimisation measures

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• 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

• Study drug International non-proprietary name (INN) or common name:
  BLINATUMOMAB
• Medical condition to be studied:
  Acute lymphocytic leukaemia

Population studied

• Short description of the study population:
  1. Patient/caregiver completing questionnaire is 18 years of age or older.; 2. Patient and/or caregiver of a patient with Ph- R/R B-precursor ALL who has received Blincyto as an outpatient.; 3. Patient/caregiver completing questionnaire can read and understand the native language of the country in which the study is being conducted.
• 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:
  100

Study design details

• Main study objective:
  The primary objectives of the study are to describe receipt of the educational materials and knowledge about the patient/caregiver educational materials, among patients with Ph– R/R B-precursor ALL receiving Blincyto and their caregivers.
• Outcomes:
  Proportion of subject who received the brochure, a mean score of knowledge questions answered correctly, Behaviour, understanding and usage
• Data analysis plan:
  Categorical data will be summarized by counts and percentages. Continuous data will be summarized using number, mean, standard deviation (SD), median, quartiles, minimum and maximum and in the case of non-normally distributed data, median, range and interquartile range. 95% confidence intervals will be presented to three decimalplaces. The statistical analysis will include a summary of the study conduct, a descriptive analysis and the analysis of the objectives.

Documents

Study results

20150228 Observational Research Study Report Published Report_Redacted