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Table 6. Randomized trial of non-vitamin K oral anticoagulants for patients with cancer associated thrombosis152,154-156.

Hokusai VTE Cancer SELECT-D ADAM VTE Caravaggio
NCT02073682 ISRCTN86712308 NCT02585713 NCT03045406
Publication year 2018 2018 2020 2020
Patient no. 1050 406 300 1170
Study arm treatment Edoxaban 60 mg (30 mg in patients with CrCl of 30 to 50 mL/min or weight of 60 kg or less or in those receiving concomitant treatment with potent P-glycoprotein inhibitors) once daily after 5-day low-molecular-weight heparin lead-in Rivaroxaban, 15 mg twice daily for the first 3 weeks followed by 20 mg once daily Apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily Apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily
Control arm treatment Dalteparin 200 IU/kg once daily for 30 days then 150 IU/kg once daily Dalteparin 200 IU/kg once daily for 30 days then 150 IU/kg once daily Dalteparin 200 IU/kg once daily for the first month followed by 150 IU/kg Dalteparin 200 IU/kg once daily for the first month followed by 150 IU/kg
Study duration 12 months 6 months 6 months 6 months
Specific exclusion ECOG performance status > 2 Weight < 40 kg CrCl < 30 mL/min ECOG performance status > 2
CrCl < 30 mL/min ECOG performance status > 2 Concomitant use of strong CYP3A4 inducers CrCl < 30 mL/min
Concomitant use of P-glycoprotein inhibitors Concomitant use of strong CYP3A4 inhibitors or inducers or P-glycoprotein inhibitors or inducers Concomitant use of strong CYP3A4 inhibitors or inducers or P-glycoprotein inhibitors or inducers
Thrombocytopenia (< 50000/μL) Primary esophageal or gastro-esophageal cancer Thrombocytopenia (< 75000/μL)
Primary endpoint Recurrent VTE or major bleeding Recurrent VTE Major bleeding Recurrent VTE

CrCl, creatinine clearance; CYP, cytochrome P-450; ECOG, Eastern Cooperative Oncology Group; VTE, venous thromboembolism.