All Case Post Marketing Drug Use Result Survey for Blinatumomab in Japan (20170655) (Blinatumomab All Case PMS Japan)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective observational study

Study drug and medical condition

• Name of medicine:
  BLINCYTO
• Medical condition to be studied:
  B precursor type acute leukaemia

Population studied

• Short description of the study population:
  The study population included patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) received treatment with blinatumomab in a real world medical practice in Japan.
• Age groups:
  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)

  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:
  Patients with relapsed or refractory B-cell acute lymphoblastic leukemia
• Estimated number of subjects:
  390

Study design details

• Main study objective:
  To explore the risk factors of neurologic events, and evaluate the treatments taken against CRS and the incidence of each safety specification
• Outcomes:
  Risk factors of neurologic events, treatments taken against CRS, incidence of each safety specification
• Data analysis plan:
  The odds ratio and 95% confidence interval of high-risk population for low risk population in neurological events are calculated. Also, the treatment for CRS are tabulated. The number of patients and the incidence rates are tabulated for each safety specifications and all adverse drug reactions during the survey.

Documents

Study results

20170655 ORSR Abstract_Redacted