No patients were screened in the study.

The study is designed to collect and evaluate Dabigatran Etexilate (DE) safety in the context of routine anticoagulation care provided in the European Union (EU)/European Economic Area (EEA) for children under 2 years of age.

The non-interventional study will be conducted in paediatric hospitals or paediatric departments of EEA member states where Venous thromboembolism (VTE) patients of the evaluated age group are treated.

Inclusion criteria:

• Written informed consent from parents/care givers

• Children from birth to less than 2 years of age

• Initiation of Dabigatran Etexilate (DE) administration:

  • for treatment of Venous thromboembolism (VTE) or/and
  • prevention of recurrent VTE due to presence of unresolved clinical VTE risk factor(s).

Exclusion criteria:

• Participation in any Randomised Clinical Trial or use of any investigational product
• Any contraindications to DE according to the EU Summary of Product Characteristics (SmPC)

Paediatric patients from birth to < 2 years of age considered by investigator after screening as eligible for Dabigatran Etexilate (DE) treatment of acute Venous thromboembolism (VTE) or secondary prevention of recurrent VTE will be enrolled in the Post-Authorization Safety Study (PASS).

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.

For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.