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

Study type

• Study topic:
  Disease /health condition

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

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

Non-interventional study

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

Study drug and medical condition

• Medicinal product name:
  PRAXBIND
• Medicinal product name, other:
  PraxbindTM
• Study drug International non-proprietary name (INN) or common name:
  IDARUCIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (V03AB37) idarucizumab

  idarucizumab
• Medical condition to be studied:
  Brief resolved unexplained event

Population studied

• Short description of the study population:
  1. Patients treated with Pradaxa® (dabigatran etexilate) capsules with requirement of rapid reversal of the anticoagulant effects of dabigatran:;  For emergency surgery/urgent procedures; Or ;  In life-threatening or uncontrolled bleeding; 2. Written informed consent in accordance with International Conference on Harmonization Good Clinical Practice (GCP) guidelines and local legislation and/or regulations.; Exclusion criteria:;  Participation in a Praxbind® clinical trial
• 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:
  25

Study design details

• Study design:
  Multicenter, non-interventional, drug administration surveillance program
• 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.
• Setting:
  The study was performed in the Clinical Practice Setting. Participating hospitals had readiness for emergency services and access to Praxbind®.
• 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).