Secondary Prevention of Venous Thrombo Embolism (VTE).

DVT at 18 Months

Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.

Time frame: 18 months

Symptomatic Pulmonary Embolism (PE) at 36 Months

Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.

Time frame: 36 months

Symptomatic Pulmonary Embolism (PE) at 18 Months

Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.

Time frame: 18 months

Deaths Related to VTE at 36 Months

Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.

Time frame: 36 months

Deaths Related to VTE at 18 Months

Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.

Time frame: 18 months

Deaths of All Causes at 36 Months

Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.

Time frame: 36 months

Deaths of All Causes at 18 Months

Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.

Time frame: 18 months

Number of Participants With Bleeding Events

MBE (major bleeding event) if it fulfilled at least one of the following criteria * Fatal bleeding * Symptomatic bleeding in a critical area or organ. * Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells. Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria * Spontaneous skin haematoma ≥25 cm2 * Spontaneous nose bleed \>5 min duration * Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting \>24 h * Spontaneous rectal bleeding * Gingival bleeding \>5 min * Bleeding leading to hospitalisation or requiring surgical treatment * Bleeding leading to a transfusion of \<2 units of whole blood or red cells * Any other bleeding event considered clinically relevant by the investigator

Time frame: first intake of study drug until 6 days following last intake of study drug

Laboratory Analysis

Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: ≥3 x ULN (AST, ALT), ≥2 x ULN (AP), and ≥2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality).

Time frame: 18 months + 30 days follow up

Number of Participants With Definite Acute Coronary Syndrome (ACS)

All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner.

Time frame: day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination