REVIEU - A multinational, retrospective, observational drug utilisation study of REVOLADE™ (eltrombopag) In selected countries in the European Union (201108)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective review of medical records

Study drug and medical condition

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

Population studied

• Short description of the study population:
  Patients being treated with REVOLADE at approximately 18-21 hospital/ward or office based sites in selected European countries including France, Germany, Spain, Italy and Greece.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  450

Study design details

• Main study objective:
  To determine indications for use among REVOLADE users within several EU countries utilizing real-world data obtained in medical records, to document REVOLADE utilisation patterns, classified according to the medical conditions and the patient age categories for which REVOLADE is being prescribed in selected European countries, and to characterize the patients who are prescribed REVOLADE.
• Outcomes:
  Patient age, patient gender, diagnosis for which REVOLADE was prescribed, and REVOLADE dose, Treatment(s) preceding REVOLADE prescription, concomitant treatment(s) initiated with REVOLADE, and platelet counts
• Data analysis plan:
  Continuous variables will be reported as mean, standard deviation, median and range. Categorical variables will be summarised as number and proportion of the total study population (counting missing data as a class), and by subgroups, where appropriate. Confidence intervals (as 95% CI) will be calculated using the method outlined by Newcombe, 1998 for the key variables.