YERVOY Risk Minimisation Tool Evaluation Survey

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Knowledge and behavior survey of educational materials
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Survey, Assessment of risk management educational tools

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  IPILIMUMAB
• Medical condition to be studied:
  Malignant melanoma

Population studied

• Short description of the study population:
  HCPs prescribing Yevoy/ipilimumab; patients being treated with Yervoy/ipilimumab for advanced melanoma.
• 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:
  Malignant melanoma patients
• Estimated number of subjects:
  320

Study design details

• Main study objective:
  1) Determine the proportion of YERVOY HCPs and patients that are aware risk communications tools and how the tools were accessed 2) Determine who uses the RM communication tools, and how, when they are used and how often3) Determine the level of knowledge and comprehension of the key elements of important identified risks associated with YERVOY treat4) Evaluate HCP and Patient behaviours
• Data analysis plan:
  Descriptive statistics for discontinuous data will be used to examine the research questions. The data for the overall population if will be examined by users and non-users, university and community hospital HCPs, oncologists or dermatologists as the principal treating physician and individual countries. Data will be presented in a descriptive fashion with frequency distributions for responses, and 95% confidence intervals. In addition, correlation between the use of RM tools, knowledge of irARs and behaviours obtained from the surveys and the incidence of irARs collected through standard pharmacovigilance (spontaneous reports) will be explored