Survey of Physicians, Pharmacists, and Nurses Involved in the Prescribing, Preparation and Administration of Blincyto in Europe to Evaluate the Effectiveness of Additional Risk Minimization Measures (20150163)

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:
  Philadelphia chromosome negative

Population studied

• Short description of the study population:
  Physicians, nurses, or pharmacists who have managed, administered, or prepared Blincyto for at least 1 adult patient (≥ 18 years of age at Blincyto initiation) with; Philadephia chromosome-negative relapsed or refractory B-precursor.
• 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:
  The primary objectives of the study are to describe the receipt of the Blincyto brochures, and knowledge and behaviours outlined in the Blincyto brochures among physicians, nurses and pharmacists
• Outcomes:
  Proportion of subject who received the brochure, a mean score of knowledge questions answered correctly, a mean score of behavior questions with correct responses, Understanding and usage of the brochures
• 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. All 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

20150163 Observational Research Study Report Published Report (1)_Redacted