Program to evaluate the Tasigna (nilotinib) educational materials: survey to patients and physicians in five EU countries

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• 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:
  NILOTINIB

Population studied

• Short description of the study population:
  Patients and physicians in five largest European countries (France, Germany, Italy, Spain and the United Kingdom).; Participating physicians must meet the following criteria at the study start:; 1. Oncology-haematology specialist.; 2. Have prescribed Tasigna in the preceding 12 months at the time of survey.; Included patients must meet the following criteria:; 1. CML patient who has been prescribed Tasigna within 12 months of the date the patient starts the survey.; 2. Provides informed consent in accordance with local national requirements (where required).
• 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:
  150

Study design details

• Main study objective:
  The objective of the proposed survey is to evaluate the effectiveness of the educational material for healthcare professionals and patients/caregivers used as part of the Tasigna® risk management plan.
• Data analysis plan:
  The following metrics will be reported as part of this analysis. All data will be reported by country and for all countries in aggregate:• Number of patients and HCPs receiving survey invitations • Number of patients and HCPs who met eligibility criteria• Number of completed patient and HCP surveys by internet• Description of survey participants’ characteristics o Patients• Gender, Age• Length of CML treatment(s)o HCPs• Medical specialty (if other than hematologists attend CML patients)• Type of institution• Gender, Age• Prescribing level• Frequency distribution of responses to each question in each survey• Percent of respondents indicating correct response to each key risk message and 95% confidence intervals of the estimates

Documents

Study results

CAMN107A2001 CSR EuPAS6073_Redacted