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).