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

 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 CEC^a

 Major

Overt: fatal, symptomatic in a critical area/organ, causing a ≥ 2 g/dL fall in haemoglobin and/or ≥6.0% fall in haematocrit^b

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 cells^b

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 criteria^b

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/CRNM^b

Overt: other; does not fulfil the criteria for major/CRNM^b

Not specified