Post marketing surveillance program of PraxbindTM use in (PraxbindTM India PMS program)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Post Marketing Surveillance

Study drug and medical condition

• Name of medicine, other:
  PraxbindTM
• Medical condition to be studied:
  Brief resolved unexplained event

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:
  25

Study design details

• Main study objective:
  The main objective of the PraxbindTM drug administrationsurveillance program is to evaluate the prescription patterns of useof PraxbindTM in a clinical practice setting, with special focus onADRs and fatal AEs.
• Outcomes:
  Primary outcomesAny suspected ADRs and fatal AEs, with special focus on hypersensitivity and thrombotic event, occurred within 7 days after PraxbindTM administration. Secondary outcomesPercentage of patients who either received PraxbindTM for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding at the end of 2 years.
• Data analysis plan:
  All variables will be presented using descriptive statistics (absolute and relative frequencies, means, standard deviations, medians, quartiles, minimum and maximum values, 95% CIs) as appropriate for the nature of the variables (i.e. categorical or continuous).