Table 1.

Clinical Study to Evaluate the Efficacy and Safety of NOACs in CAT Treatment

Clinical Study	Hokusai-VTE Cancer70	SELECT-D53	ADAM VTE71	Caravaggio72
Study design	Edoxaban vs LMWHs	Rivaroxaban vs LMWHs	Apixaban vs LMWHs	Apixaban vs LMWHs
Number of patients	522/524	203/203	145/142	576/579
Key inclusion criteria	≥18 years of age with cancer (active or diagnosed within 2 y)a and acute VTE	≥18 years of age, active cancerc,+acute VTE	≥18 years of age, with active cancerb + acute VTE	≥18 years of age with cancer (active or diagnosed within 2 y)c
NOACs	Edoxaban 60 mg QD after LMWHs for 5 daysc	Rivaroxaban 15 mg BID × 3 weeks → 20 mg QD	Apixaban 10 mg BID × 7 days → 5 mg BID	Apixaban 10 mg BID × 7 days→ 5 mg BID
Dalteparin	200 IU/kg QD × 1 month → 150 IU/kg QD	200 IU/kg QD × 1 month → 150 IU/kg QD	200 IU/kg QD × 1 month → 150 IU/kg QD	200 IU/kg QD × 1 month → 150 IU/kg QD
Treatment duration	6–12 months	6 months	6 months	6 months
Primary outcomes	Composite of recurrent VTE and major bleeding defined according to the ISTH criteria	Recurrent VTE and other sites of thrombosis	Major bleeding defined according to the ISTH criteria	Recurrent VTE and major bleeding defined according to the ISTH criteria
Major Conclusions	Recurrent VTE 7.9% vs 11.3%, Major bleeding 6.9% vs 4.0%	Recurrent VTE 11% vs 4.0%, Major bleeding 4.0% vs 6.0%	Recurrent VTE 0.7% vs 6.3%, Major bleeding 0.0% vs 1.4%	Recurrent VTE 5.6% vs 7.9%, Major bleeding 3.8% vs 4.0%

Notes: ^aActive cancer defined as diagnosed within 6 mo, treatment within 6 mo, recurrent/metastatic cancer, hematologic cancer not in complete remission. ^bActive cancer defined as any evidence of cancer on cross-sectional or positron emission tomography imaging, metastatic disease, and/or cancer-related surgery, chemotherapy, or radiation therapy within the prior 6 mo. ^cOr 30 mg 1×/d, if (i) body weight <60 kg, (ii) creatinine clearance of 30–50 mL/min, or (iii) concomitant therapy with a potent P-glycoprotein inhibitor.