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. Author manuscript; available in PMC: 2024 Jun 1.
Published in final edited form as: J Thromb Haemost. 2023 Mar 14;21(6):1666–1673. doi: 10.1016/j.jtha.2023.03.004

Table 4:

Safety outcomes for pediatric VTE treatment or prevention clinical trials

2011 Definitions 2022 Update Comments regarding changes
Primary Major bleeding Clinically relevant bleeding, defined as a composite of:

  1. Major bleeding

  2. Clinically relevant non-major bleeding

  1. Updated definitions of major and CRNM bleeding summarized in Table 3

  2. Include CRNM bleeding as part of composite primary outcome
Secondary

  1. Clinically relevant non-major bleeding

  2. Minor bleeding

  1. Each component of the primary outcome (Major and CRNM bleeding)

  2. Patient important bleeding without intervention

  3. Minor bleeding

  4. All bleeding

  1. Includes all bleeding and each category of bleeding reported individually

  2. New bleeding category created (see Table 3)

VTE: venous thromboembolism; CRNM: clinically relevant non-major