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Table 2 Definitions of VTE and bleeding events in ETNA-VTE-Europe, PREFER in VTE and Hokusai-VTE studies

From: Design and rationale of the non-interventional, edoxaban treatment in routiNe clinical prActice in patients with venous ThromboEmbolism in Europe (ETNA-VTE-Europe) study

  ETNA-VTE-Europe PREFER in VTE [13, 14] Hokusai-VTE [6, 15]
VTE
 Baseline Confirmed first time/recurrent distal/proximal acute symptomatic DVT and/or PE Confirmed first time/recurrent distal/proximal acute symptomatic DVT and/or PE Confirmed first time/recurrent proximal acute symptomatic DVT and/or PE
 Recurrent (during study) VTE, as adjudicated by an independent CEC DVT or PE, as diagnosed by investigator (not adjudicated) DVT, new non-fatal symptomatic/fatal PE, as adjudicated by an independent CECa
Bleeding
 Major Overt: fatal, symptomatic in a critical area/organ, causing a ≥ 2 g/dL fall in haemoglobin and/or ≥6.0% fall in haematocritb Overt: fatal, symptomatic in a critical area/organ, causing a ≥ 20 g L−1 fall in haemoglobin or transfusion of ≥ 2 units of whole blood or red cellsb Overt: fatal, occurs in a critical site, associated with a ≥ 2 g/dL decrease in haemoglobin or requires a transfusion of ≥ 2 units of blood
 Life-threatening Major: intracranial or associated with haemodynamic compromise requiring intervention Not specified Not specified
 CRNM Overt: requires medical attention but does not fulfil major bleeding criteriab Overt: does not meet major bleeding criteria but prompts a clinical response (hospital admission/physician-guided treatment/change in antithrombotic therapy)b Overt: associated with the need for medical intervention, contact with a physician, interruption of study drug, or discomfort/impairment of ADL, but does not fulfil major bleeding criteria
 Minor Overt: other; does not fulfil the criteria for major/CRNMb Overt: other; does not fulfil the criteria for major/CRNMb Not specified
  1. Legend: DVT, deep-vein thrombosis; PE, pulmonary embolism; VTE, venous thromboembolism; CRNM, clinically relevant non-major; CEC, clinical events committee; ADL, activities of daily living. aMembers unaware of treatment allocation. bAs defined by the International Society of Thrombosis and Haemostasis (2005) [11]. Items in bold reflect differences compared to ETNA-VTE-Europe