A PROSPECTIVE NON-INTERVENTIONAL SAFETY STUDY IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA RECEIVING NILOTINIB IN DAILY PRACTICE ACCORDING TO UPDATED GUIDELINES

Study type

• Study topic:
  Disease /health condition

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

  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  Tasigna
• Study drug International non-proprietary name (INN) or common name:
  NILOTINIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XE08) nilotinib
• Medical condition to be studied:
  Chronic myeloid leukaemia

Population studied

• Short description of the study population:
  Patients with chronic myeloid leukemia receiving Nilotinib in daily practice.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Chronic myeloid leukaemia patients
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  This observational study will provide real-world safety data on CML patients exposed to nilotinib and therefore provide insights into disease management, efficacy as well as the safety profile of nilotinib and the adherence to current treatment recommendations (Baccarani et al. 2009, Valent et al. 2011, Rosti et al. 2011) in daily clinical practice.
• Outcomes:
  The main goal of this non-interventional study is to document the following parameters under specific conditions of daily clinical practice:• Safety and tolerability and all adverse events (AE, serious and non-serious) during treatment with nilotinib and adherence to current treatment recommendations in daily clinical practice, Clinical, cytogenetic, hematologic and molecular responses to nilotinib
• Data analysis plan:
  There are no predefined hypotheses regarding the incidence of specific safety outcomes, the magnitude of effectiveness or treatment practices. Descriptive statistical methods will be used for all variables of evaluation. Efficacy and safety variables will be presented descriptive and will be interpreted in comparison to historic controls and published data.

Documents

Study results

CAMN107AAT01_Redacted CSR