A Dose Response Study of Dabigatran Etexilate(BIBR 1048) in Pharmacodynamics and Safety in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin

Frequency (Occurrence Rates) of Major Bleeding Event

The percentage of patients with major bleeding event. Major bleeding was defined as any bleed fulfilling one of the following conditions: * Fatal or life-threatening * Retroperitoneal, intracranial, intraocular, or intraspinal bleeding (verified by objective testing) * Bleeding requiring surgical treatment * Clinically overt bleeding leading to a transfusion (erythrocyte component transfusion or whole blood transfusion) of 4.5 units (equal to 2 units in EU/US) or more * Clinically overt bleeding leading to a fall in haemoglobin of at least 2 g/dL

Time frame: upto 15 weeks

Frequency (Occurrence Rates) of Clinically Relevant Bleeding Event

The percentage of patients with clinically relevant bleeding event. Any bleed that did not qualify as a major bleed was defined as a minor bleed; minor bleed which fulfilled one of the criteria below was defined as a clinically relevant bleeding event: * A skin haematoma of at least 25 sqcm * Spontaneous nose bleed lasting for more than 5 minutes * Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours) * Spontaneous rectal bleeding (more than spotting on toilet paper) * Gingival bleeding lasting for more than 5 minutes * Bleeding leading to hospitalisation * Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US) * Any other bleeding considered clinically relevant by the investigator

Time frame: upto 15 weeks

Frequency (Occurrence Rates) of Nuisance Bleeding Event

The percentage of patients with nuisance bleeding event Any bleed that did not qualify as a major bleed was defined as a minor bleed; all minor bleeding events not fulfilling one of the criteria below was defined as a nuisance bleeding event: * A skin haematoma of at least 25 sqcm * Spontaneous nose bleed lasting for more than 5 minutes * Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours) * Spontaneous rectal bleeding (more than spotting on toilet paper) * Gingival bleeding lasting for more than 5 minutes * Bleeding leading to hospitalisation * Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US) * Any other bleeding considered clinically relevant by the investigator