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Table 4 Classification of risk factors for venous thrombosis at baseline

From: Rivaroxaban versus standard anticoagulation for acute venous thromboembolism in childhood. Design of the EINSTEIN-Jr phase III study

  Subgroup Requirement
Provoked by persistent risk factor
 Active cancer – n (%) • Hematologic malignancies • Solid tumors Diagnosed, or treated within 3 months, or presence of metastases
 Major organ disease – n (%) • Cardiac • Gastrointestinal • Renal • Neurological Exclude major infectious disease
 Major congenital venous anomaly – n (%)   Venous anomaly in relation to location of index event
 Known inherited thrombophilia – n (%) • Antithrombin, protein C or protein S deficiency • Factor V Leiden, or prothrombin mutation • Homozygous • Heterozygous At baseline or confirmed after randomization
Acquired thrombophilia – n (%)   Antiphospholipid syndrome. At baseline or confirmed after randomization
Family history of venous thrombosis – n (%)   First degree (parent or sibling)
Morbid obesity – n (%)   Body mass index > 35 kg/m2
Provoked by transient risk factor
 Major surgery – n (%)   Timeframe: within 1 month
 Major trauma – n (%)   Timeframe: within 1 month
 Major infectious disease – n (%) • Systemic • Local Timeframe: within 1 month Local infection in anatomical relation with index event
 Prolonged immobilization – n (%)   Timeframe: within 1 month Duration immobilization > 1 week
 Central venous catheter – n (%)   Timeframe: within 1 month Location of index event related to central venous catheter
 Use of estrogens or progestins – n (%)   
 Puerperium– n (%)   Puerperium ends 6 weeks after birth
Etiology of index venous thrombosis
 Unprovoked – n (%)  Provoked by persistent risk factor – n (%)  Provoked by transient risk factor – n (%)  Provoked by persistent and transient risk factor – n (%)   
Number of risk factors – n (%)  0  1  ≥2