Long Term Post Marketing Drug Use Result Survey for Blinatumomab in Japan (20180238) (Blinatumomab Long Term PMS Japan)

Study type

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

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  BLINCYTO
• Study drug International non-proprietary name (INN) or common name:
  BLINATUMOMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01FX07) blinatumomab

  blinatumomab
• Medical condition to be studied:
  B precursor type acute leukaemia

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • 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:
  40

Study design details

• Main study objective:
  To investigate the incidence of CTCAE grade ≥ 3 events of each safety specification of the Japan Risk Management Plan (neurologic events, infections, cytokine release syndrome, tumor lysis syndrome, myelosuppression and Pancreatitis) in patients receiving long term administration of blinatumomab
• Outcomes:
  The incidence of CTCAE grade ≥ 3 events of each safety specification
• Data analysis plan:
  The number of patients and the incidence rates of CTCAE grade ≥ 3 events are tabulated for each safety specifications and other adverse drug reactions during the survey.