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:
  Disease /health condition

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

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Prizbind® for Intravenous Solution 2.5 g
• Study drug International non-proprietary name (INN) or common name:
  IDARUCIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (V03AB37) idarucizumab

  idarucizumab
• 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

• Study design:
  Non-interventional study based on newly collected data
• 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