Table 5.

Definition of major and non-major bleeding events^a.

Major bleeding event

Clinically-relevant non-major bleeding event

Acute clinically overt bleeding accompanied by one or more of the following: Decrease in hemoglobin of 2 g/dl or more Transfusion of 2 or more units of packed red blood cells Bleeding that occurs in at least one of the following critical sites: intracranial, intra-spinal, intraocular (within the corpus), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal

Acute clinically overt bleeding that consists of one or more of the following: Bleeding that compromises hemodynamics Bleeding that leads to hospitalization Subcutaneous hematoma larger than 25 cm2, or 100 cm2 if due to a traumatic cause Intramuscular hematoma documented by ultrasonography Epistaxis that lasted for more than 5 min, was repetitive (two or more within 24 h), or led to an intervention Spontaneous gingival bleeding that lasts for more than 5 min Hematuria that was macroscopic and spontaneous or lasted for more than 24 h after instrumentation of the urogenital tract Macroscopic gastrointestinal hemorrhage, including at least one episode of rectal blood loss, if more than a few spots on toilet paper Hemoptysis, if more than a few speckles in the sputum and not occurring within the context of PE Any other bleeding considered to have clinical consequences

^aDefined by International Society on Thrombosis and Haemostasis guidelines.