• *

    Major bleeding in nonsurgical patients was defined as2

    1. Fatal bleeding, and/or
    2. Symptomatic bleeding in critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome, and/or
    3. Bleeding causing a fall in haemoglobin level of 20 g/L-1 (1.24 mml/L-1) or more, or leading to transfusing of 2 or more units of whole blood or red cells.
  • Clinically relevant bleeding is defined as the composite of major and clinically relevant nonmajor bleeding. Clinically relevant nonmajor bleeding was defined as overt bleeding not meeting the criteria for major bleeding* but associated with medical intervention, unscheduled contact (visit or telephone call) with a physician, (temporary) cessation of study treatment, or associated with any other discomfort such as pain, or impairment of activities of daily life.3

  • Following initial use of parenteral anticoagulant for at least 5 days.3