TABLE 1

The six VTE-BLEED items with corresponding weights and the predictive value of VTE-BLEED for the end-points of intracranial haemorrhage (ICH), fatal bleeding and ICH or fatal bleeding during stable anticoagulant therapy in the combined RE-COVER trials, the HOKUSAI-VTE study and the pooled data from both studies

Item	Score	Study	OR (95%CI)	Chi²	I²
The six VTE-BLEED items
Active cancer^#	2
Male with uncontrolled arterial hypertension^¶	1
Anaemia⁺	1.5
History of bleeding^§	1.5
Age ≥60 years	1.5
Renal dysfunction^ƒ	1.5
Classification of patients with VTE-BLEED
Low bleeding risk	Total score <2
High bleeding risk	Total score ≥2
End-point
ICH		RE-COVER	4.4 (0.74–26)
		HOKUSAI-VTE	3.8 (1.5–10)
		Pooled data	4.0 (1.7–9.3)	0.02	0%
Fatal bleeding		RE-COVER	4.4 (0.74–26)
		HOKUSAI-VTE	6.7 (1.3–35)
		Pooled data	5.6 (1.7–19)	0.12	0%
ICH or fatal bleeding		RE-COVER	4.9 (1.2–21)
		HOKUSAI-VTE	4.6 (1.8–12)
		Pooled data	4.7 (2.2–10)	0	0%

^#: cancer diagnosed within the 6 months before diagnosis of venous thromboembolism (VTE) (excluding basal-cell or squamous-cell carcinoma of the skin), recently recurrent or progressive cancer or any cancer that required anti-cancer treatment within 6 months before the VTE was diagnosed; ^¶: males with uncontrolled arterial hypertension were defined by values of systolic blood pressure ≥140 mmHg at baseline; ⁺: haemoglobin <13 g·dL⁻¹ in men or <12 g·dL⁻¹ in women; ^§: including prior major or non-major clinically relevant bleeding event, rectal bleeding, frequent nose bleeding, or haematuria; ^ƒ: estimated glomerular filtration rate (eGFR) <60 mL·min⁻¹ defined the presence of renal dysfunction, eGFR was calculated at baseline using the Cockcroft–Gault formulas, which include serum creatinine, age and body weight.