International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed.

A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells.

All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug).

Treated set - The treated set includes all patients who received at least one dose of study medication.

Number of Participants with Composite of Cardiovascular death (CVD) with non fatal myocardial infarction (MI) and non haemorrhagic stroke and All cause death (ACD), non fatal MI, severe recurrent ischaemia (SRI) and non haemorrhagic stroke during six months treatment

Treated set

Number of Participants with individual occurrence of death (cardiovascular and all-cause), non-fatal MI, severe recurrent ischaemia and non-haemorrhagic stroke during six months of treatment.

Treated set

Full analysis set - The full analysis set includes all randomised and treated patients who had at least one post-dose assessment of D-dimer available.

Change from baseline in log10 D-dimer concentration after 1 and 4 weeks of dabigatran etexilate treatment compared to placebo. The standard deviation is the geometric standard deviation.

Full Analysis Set (FAS)

International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed.

A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells.

All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds (CRBE) and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug).

Treated set

Number of patients with possible clinically significant abnormalities. Clinically significant abnormalities refers to the increase or decrease from baseline.

Treated set