Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).

All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients.

Full Analysis Set (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for distal and proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died)

Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee

Full Analysis Set - major (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died by a Venous Thromboembolic Event-related death)

Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee

Full Analysis Set - pDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis)

Total Deep Vein Thrombosis as adjudicated by the VTE events committee

Full Analysis Set - tDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram, or had confirmed symptomatic Deep Vein Thrombosis)

Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee

Full Analysis Set - op (all patients who are treated and operated)

Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee

Full Analysis Set - op

All cause death, as adjudicated by the VTE events committee

Full Analysis Set - op

Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).

Patients with any data available during follow-up

Major bleeding events were defined as

• fatal
• clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected
• clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected
• symptomatic retroperitoneal, intracranial, intraocular or intraspinal
• requiring treatment cessation
• leading to re-operation

Clinically-relevant was defined as

• spontaneous skin hematoma greater than or equal to 25 cm²
• wound hematoma greater than or equal to 100 cm²
• spontaneous nose bleed lasting longer than 5 min
• macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention
• spontaneous rectal bleeding (more than a spot on toilet paper)
• gingival bleeding lasting longer than 5 min
• any other bleeding event considered clinically relevant by the investigator

Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.

Treated set