Table 3.

Definitions Used for Bleeding Events

Study First Author (Ref. #); Year	Major Bleeding	CRNMB
CARAVAGGIO Agnelli et al. (12); 2020	Acute clinically overt bleeding associated with ≥1: 1) decrease in the hemoglobin level of at least 2 g/dl; 2) transfusion of ≥2 U of red cells; 3) bleeding occurring at a critical site (intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, or retroperitoneal); 4) bleeding resulting in surgical intervention, or fatal bleeding, all occurring during the trial drug period through 72 h after the last dose was administered	Acute clinically overt bleeding that does not meet the criteria for major bleeding and consists of: 1) any bleeding compromising hemodynamics; 2) spontaneous hematoma >25 cm2, or 100 cm2 if there was a traumatic cause; 3) intramuscular hematoma documented by ultrasonography; 4) epistaxis or gingival bleeding requiring tamponade or other medical intervention or bleeding from venipuncture for >5 min; 5) hematuria that was macroscopic and was spontaneous or lasted for >24 h after invasive procedures; 6) hemoptysis, hematemesis, or spontaneous rectal bleeding requiring endoscopy or other medical intervention; 7) or any other bleeding considered to have clinical consequences for a patient, such as medical intervention, the need for unscheduled contact (visit or telephone call) with a physician, or temporary cessation of a study drug, or associated with pain or impairment of activities of daily life
SELECT-D Young et al. (10); 2018	Acute, clinically overt bleeding accompanied by ≥1 of the following findings: a decrease in the hemoglobin level of ≥2 g/dl over a 24-h period, transfusion of ≥2 U of packed red cells, bleeding at a critical site (including intracranial, intraspinal, intraocular, pericardial, or retroperitoneal bleeding), or fatal bleeding	Acute, clinically overt episodes, such as wound hematoma, bruising, GI bleeding, hemoptysis, hematuria, or epistaxis that did not meet the criteria for major bleeding but were associated with medical intervention, unscheduled contact with a physician, interruption or discontinuation of a study drug, or discomfort or impairment of activities of daily life
Hokusai VTE Cancer Raskob et al. (9); 2018	Overt bleeding that was associated with a decrease in the hemoglobin level of ≥2 g/dl, led to a transfusion of ≥2 U of blood, occurred in a critical site, or contributed to death	Overt bleeding that did not meet the criteria for major bleeding but was associated with the use of medical intervention, contact with a physician, interruption of the assigned treatment, discomfort, or impairment of activities of daily living.
ADAM-VTE McBane et al. (11); 2020	Overt bleeding plus a hemoglobin decrease of ≥2 g/dl or transfusion of ≥2 U of packed red blood cells, or intracranial, intraspinal/epidural, intraocular, retroperitoneal, pericardial, intra-articular, or intramuscular with compartment syndrome, or fatal bleeding	Overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, an unscheduled contact with the health care team, or temporary anticoagulant cessation

GI = gastrointestinal; other abbreviations as in Table 1.