Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.

Full analysis set (FAS) and analysed as randomised. FAS is defined as randomised and treated.

Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.

FAS and analysed as randomised.

Number of the participants with centrally confirmed symptomatic recurrent deep venous thrombotic (DVT) events during the intended treatment period were described.

FAS and analysed as randomised.

Number of participants with centrally confirmed symptomatic pulmonary embolism (PE) events during the intended treatment period were described.

FAS and analysed as randomised.

Number of participants with centrally confirmed unexplained deaths during the intended treatment period were described.

FAS and analysed as randomised.

Major bleeding events (MBE) had to fulfil at least 1 of the following criteria:

• Fatal bleeding
• Associated with a fall in haemoglobin of ≥2 g/dL
• Led to the transfusion of ≥2 units packed cells or whole blood
• Occurred in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal

Other clinically relevant bleeding was defined as overt bleeding not meeting the criteria for an MBE but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life.

Examples of these bleedings were:

• Bleeding that compromised haemodynamics
• Bleeding that led to hospitalisation

Trivial bleeding events were defined as all other bleeding events that did not fulfil the criteria of MBEs or CRBEs.

All bleeding events include MBEs, CRBEs, and trivial bleeding events.

FAS and analysed as treated. There were 3 participants who were randomised to placebo but treated with dabigatran only.

Cardiovascular events that occurred during the treatment period + 3 days were summarised by treatment groups.

FAS and analysed as treated. There were 3 participants who were randomised to placebo but treated with dabigatran only.

Number of participants with possible clinically significant abnormalities during the treatment period.

FAS - As Treated Assignment