Evaluation of the Effectiveness of Risk Minimization Measures: A Survey Among Pharmacists to Assess the Impact of the RMP Material for Patients on Promoting the Proper use of NINLARO in Japan

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Study drug and medical condition

• Name of medicine:
  NINLARO
• Study drug International non-proprietary name (INN) or common name:
  IXAZOMIB CITRATE
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XG03) ixazomib

  ixazomib
• Medical condition to be studied:
  Plasma cell myeloma refractory

Population studied

• Age groups:
  • 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:
  300

Study design details

• Main study objective:
  The primary objective of this study is to assess the frequency of pharmacists who have provided patients with the contents of the RMP material for patients.
• Outcomes:
  The primary outcome will assess the number of participants who have provided patients with the contents of the RMP material. The secondary outcomes will assess the number of pharmacists who received RMP material for patients, and understand the proper NINLARO dosing schedule and its importance of providing.
• Data analysis plan:
  For each question in the web-based questionnaire, the number and/or percentage of participants who responded for each answer option will be calculated. Cross-tabulations will also be performed between participants' backgrounds and/or questions, as appropriate.