Feasibility of edoxaban for asymptomatic cancer-associated thrombosis in Japanese patients with gastrointestinal cancer: ExCAVE study

Table 2 Primary outcome

Outcome (n = 53)	No. of patients (%)
MB or CRNMB	6 (11.3)
MB	4 (7.5)
Criteria defining MB^a
Clinically overt and decrease in the hemoglobin level of ≥2 g/dL over 24 h	2 (3.8)
Clinically overt and transfusion of ≥2 units of packed red cells	2 (3.8)
Clinically overt and located at a critical site (e.g., intracranial, retroperitoneal)	2 (3.8)
Clinically overt and contributing to death	0 (0)
Sites of MB, no./total no. (%)
GI	3/4 (75)
Upper GI	1/4 (25)
Lower GI	1/4 (25)
Site unknown	1/4 (25)
Intracranial	1/4 (25)
Clinical presentation severity category^b, no./total no. (%)
Category 1	1/4 (25)
Category 2	1/4 (25)
Category 3	2/4 (50)
Category 4	0
CRNMB	2 (3.8)
Criteria defining CRNMB
Overt bleeding requiring medical intervention	0
Unscheduled contact with a physician	0
Interruption of edoxaban	2 (3.8)
Discomfort or impairment of activities of daily living	0
Site of CRNMB, no./total no. (%)
Gastrointestinal (stoma)	1 (50)
Genitourinary (vagina)	1 (50)

Abbreviations: CRNMB Clinically relevant non-major bleeding, GI Gastrointestinal, MB Major bleeding
^aOne patient had three reasons: decreased hemoglobin levels, transfusion of red cells, and critical site bleeding
^bClassification of the clinical presentation of major bleeding events: Category 1, bleeding events presenting without any clinical emergency; Category 2, all bleeding events requiring certain measures without necessitating urgent measures that could not be classified to any of the other three categories; Category 3, bleeding events causing a major medical emergency; such as hemodynamic instability, or cerebral bleeding presenting with neurologic symptoms; and Category 4, bleeding events that were fatal before or almost immediately after entering the hospital

ISSN: 1471-2407