Safety of dabigatran etexilate (DE) for treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from birth to less than 2 years of age: a prospective European non-interventional cohort study based on new data collection (1160.307)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  PRADAXA
• Study drug International non-proprietary name (INN) or common name:
  DABIGATRAN ETEXILATE
• Anatomical Therapeutic Chemical (ATC) code:
  (B01AE07) dabigatran etexilate

  dabigatran etexilate
• Medical condition to be studied:
  Embolism venous

Population studied

• Age groups:
  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)
• Estimated number of subjects:
  50

Study design details

• Main study objective:
  The objective of this study is to evaluate the safety of DE for the treatment of VTE and prevention of recurrent VTE in children from birth to < 2 years of age in a routine clinical practice setting.
• Outcomes:
  • The incidence of any bleeding events defined as Major Bleeding Events (MBE) or Non- Major Bleeding Events (Non-MBE). ; • Incidence of AEs. ; • Incidence of SAEs (see Sections 11.1 and 11.2).
• Data analysis plan:
  Safety outcomes from this single-arm study will be interpreted in the context of findings from the paediatric developmental program, i. e. acute VTE treatment (DIVERSITY) and secondary VTE prevention studies. As this is a descriptive non-interventional study, no hypotheses will be tested, rather, all variables will be presented using descriptive statistics (absolute and relative frequencies, means, standard deviations, medians, ranges, minimum and maximum values, 95% confidence intervals CI and incidences as appropriate for the nature of the variables (i.e. categorical or continuous)). Safety outcomes will be summarized as incidence with 95% CIs using Wilson method. All AE/ verbatim terms will be recorded and coded using the Medical Dictionary for Regulatory Activities (MedDRA). Concomitant medications will be recorded according to World Health Organisation Drug Dictionary (WHO-DD).