The drug use-results survey (All-Case Surveillance) on Prizbind® for Intravenous Solution 2.5 g in Japan (PMS for idarucizumab)

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

  Disease epidemiology

  Drug utilisation

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Upper gastrointestinal haemorrhage

Population studied

• Short description of the study population:
  Japanese subjects with upper gastrointestinal haemorrhage treated with Prizbind (Intravenous Solution 2.5 g) under clinical condition.
• 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)
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  Study to to evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under Japanese clinical condition
• Outcomes:
  Any suspected ADRs (primary outcome), Serious AEs, and AEs for important potential risks(hypersensitivity, thrombotic event), Reversal of anticoagulation as measured by coagulation test
• Data analysis plan:
  Analyses are descriptive in nature including means, standard deviation, min, Q1, medians, Q3, max, frequency and percentages