Trial Outcomes & Findings for PETRO Stroke Prevention in Patients With AF by Treatment With Dabigatran, With and Without Aspirin, Compared to Warfarin (NCT NCT01227629)

NCT ID: NCT01227629

Last Updated: 2014-05-05

Results Overview

Retroperitoneal, intracranial, intraocular, or intraspinal bleeding, or requiring surgical treatment, or leading to a transfusion of 2 units or more, or leading to a fall in hemoglobin of 20g/L or more

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 502 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2014-05-05

Participant Flow

Participant milestones

Measure	BIBR 1048 50 mg b.i.d bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 qd (once daily) oral
Overall Study STARTED	58	20	27	99	34	33	98	33	30	70
Overall Study COMPLETED	56	18	26	91	32	32	90	27	24	68
Overall Study NOT COMPLETED	2	2	1	8	2	1	8	6	6	2

Reasons for withdrawal

Measure	BIBR 1048 50 mg b.i.d bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 qd (once daily) oral
Overall Study Adverse Event	2	2	1	6	1	1	6	6	4	0
Overall Study Protocol Violation	0	0	0	1	0	0	0	0	0	0
Overall Study Lost to Follow-up	0	0	0	0	1	0	0	0	0	0
Overall Study Withdrawal by Subject	0	0	0	0	0	0	2	0	0	1
Overall Study Other	0	0	0	1	0	0	0	0	2	1

Baseline Characteristics

PETRO Stroke Prevention in Patients With AF by Treatment With Dabigatran, With and Without Aspirin, Compared to Warfarin

Baseline characteristics by cohort

Measure	BIBR 1048 50 mg b.i.d n=58 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=20 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=27 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=99 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=34 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=98 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=30 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=70 Participants qd (once daily) oral	Total n=502 Participants Total of all reporting groups
Age, Continuous	69.0 Years STANDARD_DEVIATION 8.8 • n=5 Participants	70.1 Years STANDARD_DEVIATION 9.4 • n=7 Participants	71.6 Years STANDARD_DEVIATION 8.1 • n=5 Participants	69.7 Years STANDARD_DEVIATION 7.7 • n=4 Participants	72.1 Years STANDARD_DEVIATION 9.0 • n=21 Participants	69.7 Years STANDARD_DEVIATION 8.0 • n=8 Participants	69.0 Years STANDARD_DEVIATION 9.1 • n=8 Participants	71.8 Years STANDARD_DEVIATION 7.2 • n=24 Participants	68.6 Years STANDARD_DEVIATION 7.1 • n=42 Participants	69.0 Years STANDARD_DEVIATION 8.3 • n=42 Participants	69.7 Years STANDARD_DEVIATION 8.3 • n=42 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants	8 Participants n=21 Participants	8 Participants n=8 Participants	19 Participants n=8 Participants	7 Participants n=24 Participants	2 Participants n=42 Participants	11 Participants n=42 Participants	91 Participants n=42 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	16 Participants n=7 Participants	22 Participants n=5 Participants	84 Participants n=4 Participants	26 Participants n=21 Participants	25 Participants n=8 Participants	79 Participants n=8 Participants	26 Participants n=24 Participants	28 Participants n=42 Participants	59 Participants n=42 Participants	411 Participants n=42 Participants
Baseline documentation regarding the atrial fibrillation Persistent	20 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	43 Participants n=4 Participants	13 Participants n=21 Participants	10 Participants n=8 Participants	37 Participants n=8 Participants	14 Participants n=24 Participants	12 Participants n=42 Participants	27 Participants n=42 Participants	195 Participants n=42 Participants
Baseline documentation regarding the atrial fibrillation Permanent	23 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	35 Participants n=4 Participants	11 Participants n=21 Participants	16 Participants n=8 Participants	37 Participants n=8 Participants	10 Participants n=24 Participants	14 Participants n=42 Participants	26 Participants n=42 Participants	192 Participants n=42 Participants
Baseline documentation regarding the atrial fibrillation Paroxysmal	15 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	21 Participants n=4 Participants	10 Participants n=21 Participants	7 Participants n=8 Participants	24 Participants n=8 Participants	9 Participants n=24 Participants	4 Participants n=42 Participants	17 Participants n=42 Participants	115 Participants n=42 Participants
Baseline documentation regarding stroke No	54 Participants n=5 Participants	18 Participants n=7 Participants	24 Participants n=5 Participants	93 Participants n=4 Participants	30 Participants n=21 Participants	30 Participants n=8 Participants	91 Participants n=8 Participants	31 Participants n=24 Participants	26 Participants n=42 Participants	62 Participants n=42 Participants	459 Participants n=42 Participants
Baseline documentation regarding stroke Yes	4 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=8 Participants	7 Participants n=8 Participants	2 Participants n=24 Participants	4 Participants n=42 Participants	8 Participants n=42 Participants	43 Participants n=42 Participants
Baseline documentation regarding transient ischemic attack No	49 Participants n=5 Participants	20 Participants n=7 Participants	25 Participants n=5 Participants	88 Participants n=4 Participants	31 Participants n=21 Participants	31 Participants n=8 Participants	90 Participants n=8 Participants	30 Participants n=24 Participants	26 Participants n=42 Participants	63 Participants n=42 Participants	453 Participants n=42 Participants
Baseline documentation regarding transient ischemic attack Yes	9 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	8 Participants n=8 Participants	3 Participants n=24 Participants	4 Participants n=42 Participants	7 Participants n=42 Participants	49 Participants n=42 Participants
Baseline documentation regarding transient ischemic attack or stroke No	45 Participants n=5 Participants	18 Participants n=7 Participants	23 Participants n=5 Participants	82 Participants n=4 Participants	27 Participants n=21 Participants	28 Participants n=8 Participants	85 Participants n=8 Participants	28 Participants n=24 Participants	22 Participants n=42 Participants	57 Participants n=42 Participants	415 Participants n=42 Participants
Baseline documentation regarding transient ischemic attack or stroke Yes	13 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	17 Participants n=4 Participants	7 Participants n=21 Participants	5 Participants n=8 Participants	13 Participants n=8 Participants	5 Participants n=24 Participants	8 Participants n=42 Participants	13 Participants n=42 Participants	87 Participants n=42 Participants
Baseline documentation regarding hypertension No	17 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	21 Participants n=4 Participants	13 Participants n=21 Participants	14 Participants n=8 Participants	24 Participants n=8 Participants	8 Participants n=24 Participants	10 Participants n=42 Participants	21 Participants n=42 Participants	146 Participants n=42 Participants
Baseline documentation regarding hypertension Yes	41 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants	78 Participants n=4 Participants	21 Participants n=21 Participants	19 Participants n=8 Participants	74 Participants n=8 Participants	25 Participants n=24 Participants	20 Participants n=42 Participants	49 Participants n=42 Participants	356 Participants n=42 Participants
Baseline documentation regarding symptomatic heart failure No	41 Participants n=5 Participants	12 Participants n=7 Participants	17 Participants n=5 Participants	73 Participants n=4 Participants	20 Participants n=21 Participants	21 Participants n=8 Participants	85 Participants n=8 Participants	20 Participants n=24 Participants	20 Participants n=42 Participants	46 Participants n=42 Participants	355 Participants n=42 Participants
Baseline documentation regarding symptomatic heart failure Yes	17 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	26 Participants n=4 Participants	14 Participants n=21 Participants	12 Participants n=8 Participants	13 Participants n=8 Participants	13 Participants n=24 Participants	10 Participants n=42 Participants	24 Participants n=42 Participants	147 Participants n=42 Participants
Baseline documentation regarding left ventricular dysfunction No	41 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants	68 Participants n=4 Participants	22 Participants n=21 Participants	19 Participants n=8 Participants	78 Participants n=8 Participants	20 Participants n=24 Participants	14 Participants n=42 Participants	44 Participants n=42 Participants	337 Participants n=42 Participants
Baseline documentation regarding left ventricular dysfunction Yes	17 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	31 Participants n=4 Participants	12 Participants n=21 Participants	14 Participants n=8 Participants	20 Participants n=8 Participants	13 Participants n=24 Participants	16 Participants n=42 Participants	26 Participants n=42 Participants	165 Participants n=42 Participants
Baseline documentation regarding symptomatic heart failure or left ventricular dysfunction No	35 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants	55 Participants n=4 Participants	15 Participants n=21 Participants	17 Participants n=8 Participants	71 Participants n=8 Participants	14 Participants n=24 Participants	12 Participants n=42 Participants	34 Participants n=42 Participants	277 Participants n=42 Participants
Baseline documentation regarding symptomatic heart failure or left ventricular dysfunction Yes	23 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants	44 Participants n=4 Participants	19 Participants n=21 Participants	16 Participants n=8 Participants	27 Participants n=8 Participants	19 Participants n=24 Participants	18 Participants n=42 Participants	36 Participants n=42 Participants	225 Participants n=42 Participants
Coronary Artery Disease no	39 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	55 participants n=4 Participants	3 participants n=21 Participants	4 participants n=8 Participants	62 participants n=8 Participants	2 participants n=24 Participants	1 participants n=42 Participants	28 participants n=42 Participants	196 participants n=42 Participants
Coronary Artery Disease yes	19 participants n=5 Participants	19 participants n=7 Participants	26 participants n=5 Participants	44 participants n=4 Participants	31 participants n=21 Participants	29 participants n=8 Participants	36 participants n=8 Participants	31 participants n=24 Participants	29 participants n=42 Participants	42 participants n=42 Participants	306 participants n=42 Participants
D-dimer at baseline N=(56;19;25;88;29;32;85;31;29;63;457)	106.8 ng/ml STANDARD_DEVIATION 104.1 • n=5 Participants	104.5 ng/ml STANDARD_DEVIATION 62.9 • n=7 Participants	176.9 ng/ml STANDARD_DEVIATION 389.9 • n=5 Participants	100.8 ng/ml STANDARD_DEVIATION 94.5 • n=4 Participants	120.3 ng/ml STANDARD_DEVIATION 95.4 • n=21 Participants	96.3 ng/ml STANDARD_DEVIATION 64.3 • n=8 Participants	146.8 ng/ml STANDARD_DEVIATION 210.9 • n=8 Participants	119.4 ng/ml STANDARD_DEVIATION 95.5 • n=24 Participants	83.8 ng/ml STANDARD_DEVIATION 48.8 • n=42 Participants	139.9 ng/ml STANDARD_DEVIATION 251.9 • n=42 Participants	120.9 ng/ml STANDARD_DEVIATION 173.7 • n=42 Participants
Soluble fibrin at baseline N=(53;16;23;88;27;29;92;30;25;65;448)	4.9 µg/ml STANDARD_DEVIATION 4.4 • n=5 Participants	5.3 µg/ml STANDARD_DEVIATION 7.9 • n=7 Participants	5.4 µg/ml STANDARD_DEVIATION 5.9 • n=5 Participants	5.8 µg/ml STANDARD_DEVIATION 8.8 • n=4 Participants	9.1 µg/ml STANDARD_DEVIATION 15.5 • n=21 Participants	7.6 µg/ml STANDARD_DEVIATION 14.8 • n=8 Participants	7.4 µg/ml STANDARD_DEVIATION 11.5 • n=8 Participants	9.2 µg/ml STANDARD_DEVIATION 26.0 • n=24 Participants	6.5 µg/ml STANDARD_DEVIATION 9.2 • n=42 Participants	7.2 µg/ml STANDARD_DEVIATION 10.4 • n=42 Participants	6.8 µg/ml STANDARD_DEVIATION 11.9 • n=42 Participants
Thromboxane B2 (TXB2) measured at baseline N=(53;20;23;93;30;30;90;31;30;67;467)	3968.5 pg/mg Creatinine STANDARD_DEVIATION 2530.4 • n=5 Participants	3795.9 pg/mg Creatinine STANDARD_DEVIATION 2252.9 • n=7 Participants	4705.6 pg/mg Creatinine STANDARD_DEVIATION 3047.5 • n=5 Participants	4138.1 pg/mg Creatinine STANDARD_DEVIATION 2184.6 • n=4 Participants	4485.7 pg/mg Creatinine STANDARD_DEVIATION 2147.8 • n=21 Participants	4084.9 pg/mg Creatinine STANDARD_DEVIATION 2253.5 • n=8 Participants	3619.0 pg/mg Creatinine STANDARD_DEVIATION 2020.6 • n=8 Participants	4450.8 pg/mg Creatinine STANDARD_DEVIATION 2653.7 • n=24 Participants	3735.6 pg/mg Creatinine STANDARD_DEVIATION 2440.6 • n=42 Participants	4177.9 pg/mg Creatinine STANDARD_DEVIATION 2661.2 • n=42 Participants	4051.6 pg/mg Creatinine STANDARD_DEVIATION 2367.7 • n=42 Participants
ECT at baseline N=(57;20;27;98;34;33;95;33;29;56;482)	32.3 seconds STANDARD_DEVIATION 2.0 • n=5 Participants	31.8 seconds STANDARD_DEVIATION 1.9 • n=7 Participants	31.9 seconds STANDARD_DEVIATION 2.2 • n=5 Participants	31.9 seconds STANDARD_DEVIATION 2.2 • n=4 Participants	32.0 seconds STANDARD_DEVIATION 1.9 • n=21 Participants	32.6 seconds STANDARD_DEVIATION 2.4 • n=8 Participants	33.6 seconds STANDARD_DEVIATION 13.3 • n=8 Participants	31.9 seconds STANDARD_DEVIATION 1.8 • n=24 Participants	32.2 seconds STANDARD_DEVIATION 2.6 • n=42 Participants	32.0 seconds STANDARD_DEVIATION 2.4 • n=42 Participants	32.4 seconds STANDARD_DEVIATION 6.2 • n=42 Participants
aPTT at baseline N=(57;20;27;98;34;33;96;33;29;57;484)	32.5 seconds STANDARD_DEVIATION 3.0 • n=5 Participants	31.2 seconds STANDARD_DEVIATION 3.5 • n=7 Participants	32.4 seconds STANDARD_DEVIATION 3.6 • n=5 Participants	34.2 seconds STANDARD_DEVIATION 15.2 • n=4 Participants	33.5 seconds STANDARD_DEVIATION 7.6 • n=21 Participants	34.2 seconds STANDARD_DEVIATION 6.7 • n=8 Participants	32.8 seconds STANDARD_DEVIATION 5.7 • n=8 Participants	32.6 seconds STANDARD_DEVIATION 3.4 • n=24 Participants	32.9 seconds STANDARD_DEVIATION 6.7 • n=42 Participants	33.2 seconds STANDARD_DEVIATION 3.7 • n=42 Participants	33.1 seconds STANDARD_DEVIATION 8.2 • n=42 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: All treated patients. No statistical comparisons were performed, due to the extremely small number of events.

Retroperitoneal, intracranial, intraocular, or intraspinal bleeding, or requiring surgical treatment, or leading to a transfusion of 2 units or more, or leading to a fall in hemoglobin of 20g/L or more

Outcome measures

Measure	BIBR 1048 50 mg b.i.d n=59 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=21 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=27 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=100 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=36 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=105 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=34 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=30 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=70 Participants qd (once daily) oral	D300bid Dabigatran 300 mg twice daily	D300qd Dabigatran 300 mg once daily	D300bid + ASA81qd Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin, Dosed to Target INR 2.0 to 3.0 Warfarin once daily
Number of Participants With Fatal or Life-threatening Major Bleeding Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 12 weeks

Population: All treated patients. No statistical comparisons were performed, due to the small number of events per group

Haematuria, rectal bleeding, gingival bleeding, skin hematoma of 25cm^2 or more, nose bleed of more than 5 minutes duration, bleeding leading to a hospitalization, leading to a transfusion of less than 2 units or any other clinically relevant bleeding

Outcome measures

Measure	BIBR 1048 50 mg b.i.d n=59 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=21 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=27 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=100 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=36 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=105 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=34 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=30 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=70 Participants qd (once daily) oral	D300bid Dabigatran 300 mg twice daily	D300qd Dabigatran 300 mg once daily	D300bid + ASA81qd Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin, Dosed to Target INR 2.0 to 3.0 Warfarin once daily
Number of Participants With Minor/Relevant Bleeding Events	0 Participants	1 Participants	1 Participants	9 Participants	2 Participants	2 Participants	6 Participants	4 Participants	3 Participants	4 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 12 weeks

Population: All treated patients. No statistical comparisons were performed, due to the small number of events per group

All bleeding events not fulfilling one of the criteria for major bleeding event or minor/relevant bleeding events.

Outcome measures

Measure	BIBR 1048 50 mg b.i.d n=59 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=21 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=27 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=100 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=36 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=105 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=34 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=30 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=70 Participants qd (once daily) oral	D300bid Dabigatran 300 mg twice daily	D300qd Dabigatran 300 mg once daily	D300bid + ASA81qd Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin, Dosed to Target INR 2.0 to 3.0 Warfarin once daily
Number of Participants With Minor/Nuisance Bleeding Events	2 Participants	1 Participants	2 Participants	6 Participants	6 Participants	5 Participants	9 Participants	7 Participants	9 Participants	9 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.

Combination of ischemic stroke (fatal or non fatal), transient ischemic attack, systemic thromboembolism, myocardial infarction (fatal or non fatal), other major adverse cardiac event and all cause mortality

Outcome measures

Measure	BIBR 1048 50 mg b.i.d n=58 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=20 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=27 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=99 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=34 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=98 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=30 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=70 Participants qd (once daily) oral	D300bid Dabigatran 300 mg twice daily	D300qd Dabigatran 300 mg once daily	D300bid + ASA81qd Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin, Dosed to Target INR 2.0 to 3.0 Warfarin once daily
Number of Participants With Thromboembolic Events: Composite Endpoint	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.

Occurence of an ischemic stroke (fatal or non-fatal)

Outcome measures

Measure	BIBR 1048 50 mg b.i.d n=58 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=20 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=27 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=99 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=34 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=98 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=30 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=70 Participants qd (once daily) oral	D300bid Dabigatran 300 mg twice daily	D300qd Dabigatran 300 mg once daily	D300bid + ASA81qd Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin, Dosed to Target INR 2.0 to 3.0 Warfarin once daily
Number of Participants With Thromboembolic Events: Ischemic Stroke None	58 Participants	19 Participants	27 Participants	99 Participants	34 Participants	33 Participants	98 Participants	33 Participants	30 Participants	70 Participants	—	—	—	—	—	—	—
Number of Participants With Thromboembolic Events: Ischemic Stroke Fatal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—
Number of Participants With Thromboembolic Events: Ischemic Stroke Non-Fatal	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—
Number of Participants With Thromboembolic Events: Ischemic Stroke Both	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.

Occurence of a transient ischemic attack

Outcome measures

Measure	BIBR 1048 50 mg b.i.d n=58 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=20 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=27 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=99 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=34 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=98 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=30 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=70 Participants qd (once daily) oral	D300bid Dabigatran 300 mg twice daily	D300qd Dabigatran 300 mg once daily	D300bid + ASA81qd Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin, Dosed to Target INR 2.0 to 3.0 Warfarin once daily
Thromboembolic Events: Number of Participants With Transient Ischemic Attack	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.

Occurence of a systemic thromboembolism

Outcome measures

Measure	BIBR 1048 50 mg b.i.d n=58 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=20 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=27 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=99 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=34 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=98 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=30 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=70 Participants qd (once daily) oral	D300bid Dabigatran 300 mg twice daily	D300qd Dabigatran 300 mg once daily	D300bid + ASA81qd Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin, Dosed to Target INR 2.0 to 3.0 Warfarin once daily
Thromboembolic Events: Number of Participants With Systemic Thromboembolism	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.

Occurence of a myocardial infarction

Outcome measures

Measure	BIBR 1048 50 mg b.i.d n=58 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=20 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=27 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=99 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=34 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=98 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=30 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=70 Participants qd (once daily) oral	D300bid Dabigatran 300 mg twice daily	D300qd Dabigatran 300 mg once daily	D300bid + ASA81qd Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin, Dosed to Target INR 2.0 to 3.0 Warfarin once daily
Thromboembolic Events: Number of Participants With Myocardial Infarction None	58 Participants	20 Participants	27 Participants	99 Participants	34 Participants	33 Participants	98 Participants	33 Participants	30 Participants	70 Participants	—	—	—	—	—	—	—
Thromboembolic Events: Number of Participants With Myocardial Infarction Fatal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—
Thromboembolic Events: Number of Participants With Myocardial Infarction Non-Fatal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—
Thromboembolic Events: Number of Participants With Myocardial Infarction Both	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.

Occurence of other major adverse cardiac events

Outcome measures

Measure	BIBR 1048 50 mg b.i.d n=58 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=20 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=27 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=99 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=34 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=98 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=30 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=70 Participants qd (once daily) oral	D300bid Dabigatran 300 mg twice daily	D300qd Dabigatran 300 mg once daily	D300bid + ASA81qd Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin, Dosed to Target INR 2.0 to 3.0 Warfarin once daily
Thromboembolic Events: Number of Participants With Other Major Cardiac Events	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.

Occurence of death by all causes

Outcome measures

Measure	BIBR 1048 50 mg b.i.d n=58 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=20 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=27 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=99 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=34 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=98 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=30 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=70 Participants qd (once daily) oral	D300bid Dabigatran 300 mg twice daily	D300qd Dabigatran 300 mg once daily	D300bid + ASA81qd Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin, Dosed to Target INR 2.0 to 3.0 Warfarin once daily
Thromboembolic Events: Number of Participants Who Died	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: All randomised patients, only per-protocol data included.

Difference in D-dimer from baseline to last available value

Outcome measures

Measure	BIBR 1048 50 mg b.i.d n=55 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=19 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=26 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=87 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=29 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=32 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=88 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=29 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=29 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=63 Participants qd (once daily) oral	D300bid Dabigatran 300 mg twice daily	D300qd Dabigatran 300 mg once daily	D300bid + ASA81qd Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin, Dosed to Target INR 2.0 to 3.0 Warfarin once daily
D-dimer: Difference From Baseline	22.3 ng/ml Standard Deviation 65.4	12.3 ng/ml Standard Deviation 25.3	50.2 ng/ml Standard Deviation 182.8	8.1 ng/ml Standard Deviation 41.6	29.1 ng/ml Standard Deviation 90.4	8.6 ng/ml Standard Deviation 49.2	4.2 ng/ml Standard Deviation 95.8	11.3 ng/ml Standard Deviation 82.2	-7.9 ng/ml Standard Deviation 40.9	-5.8 ng/ml Standard Deviation 50.6	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: All randomised patients, only per-protocol data included.

Difference from baseline to visit 7

Outcome measures

Measure	BIBR 1048 50 mg b.i.d n=52 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=15 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=25 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=88 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=25 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=24 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=83 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=27 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=20 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=54 Participants qd (once daily) oral	D300bid Dabigatran 300 mg twice daily	D300qd Dabigatran 300 mg once daily	D300bid + ASA81qd Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin, Dosed to Target INR 2.0 to 3.0 Warfarin once daily
Soluble Fibrin: Difference From Baseline	3.2 µg/ml Standard Deviation 22.0	0.9 µg/ml Standard Deviation 2.3	1.2 µg/ml Standard Deviation 8.4	0.3 µg/ml Standard Deviation 5.1	-2.0 µg/ml Standard Deviation 9.9	-1.3 µg/ml Standard Deviation 8.8	2.3 µg/ml Standard Deviation 26.8	-0.7 µg/ml Standard Deviation 4.6	-1.9 µg/ml Standard Deviation 12.0	0.1 µg/ml Standard Deviation 4.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: All treated patients. No statistical comparisons due to high variability

Difference from baseline to visit 7

Outcome measures

Measure	BIBR 1048 50 mg b.i.d n=44 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=17 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=19 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=73 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=25 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=27 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=73 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=25 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=25 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=51 Participants qd (once daily) oral	D300bid Dabigatran 300 mg twice daily	D300qd Dabigatran 300 mg once daily	D300bid + ASA81qd Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin, Dosed to Target INR 2.0 to 3.0 Warfarin once daily
11-dehydrothromboxane B2 (TXB2): Difference From Baseline	596.5 pg/mg Creatinine Standard Deviation 2896.3	-1816.8 pg/mg Creatinine Standard Deviation 2186.1	-2779.8 pg/mg Creatinine Standard Deviation 2953.3	922.0 pg/mg Creatinine Standard Deviation 3874.0	-1988.6 pg/mg Creatinine Standard Deviation 2187.5	-1125.9 pg/mg Creatinine Standard Deviation 3566.6	1059.7 pg/mg Creatinine Standard Deviation 2216.8	-1822.6 pg/mg Creatinine Standard Deviation 2381.7	-1337.8 pg/mg Creatinine Standard Deviation 2279.2	203.5 pg/mg Creatinine Standard Deviation 2109.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: All treated patients. No statistical comparisons due to high variability

Outcome measures

Measure	BIBR 1048 50 mg b.i.d n=56 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=19 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=26 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=94 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=34 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=86 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=29 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=27 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=27 Participants qd (once daily) oral	D300bid Dabigatran 300 mg twice daily	D300qd Dabigatran 300 mg once daily	D300bid + ASA81qd Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin, Dosed to Target INR 2.0 to 3.0 Warfarin once daily
Ecarin Clotting Time (ECT): Difference From Baseline	9.7 seconds Standard Deviation 8.2	12.0 seconds Standard Deviation 10.7	12.0 seconds Standard Deviation 9.6	31.9 seconds Standard Deviation 26.2	42.5 seconds Standard Deviation 29.2	32.7 seconds Standard Deviation 23.1	63.6 seconds Standard Deviation 44.8	70.8 seconds Standard Deviation 60.3	74.0 seconds Standard Deviation 70.5	3.1 seconds Standard Deviation 2.5	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: All treated patients. No statistical comparisons due to high variability

Outcome measures

Measure	BIBR 1048 50 mg b.i.d n=56 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=19 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=26 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=92 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=87 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=29 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=27 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=27 Participants qd (once daily) oral	D300bid Dabigatran 300 mg twice daily	D300qd Dabigatran 300 mg once daily	D300bid + ASA81qd Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin, Dosed to Target INR 2.0 to 3.0 Warfarin once daily
Activated Partial Thromboplastin Time (aPTT): Difference From Baseline	6.4 seconds Standard Deviation 5.6	8.3 seconds Standard Deviation 6.1	8.8 seconds Standard Deviation 9.4	13.5 seconds Standard Deviation 18.3	24.9 seconds Standard Deviation 26.1	14.5 seconds Standard Deviation 11.5	25.0 seconds Standard Deviation 12.4	23.4 seconds Standard Deviation 12.7	27.2 seconds Standard Deviation 24.2	8.8 seconds Standard Deviation 6.7	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: All treated patients

The values of the trough plasma concentration of dabigatran (BIBR 953) are the by-patient geometric means of week 1, 4 and 12.

Outcome measures

Measure	BIBR 1048 50 mg b.i.d n=58 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=20 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=27 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=99 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=34 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=97 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=30 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=70 Participants qd (once daily) oral	D300bid Dabigatran 300 mg twice daily	D300qd Dabigatran 300 mg once daily	D300bid + ASA81qd Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin, Dosed to Target INR 2.0 to 3.0 Warfarin once daily
Trough Plasma Concentration of Dabigatran (BIBR 953)	29.1 ng/ml Standard Deviation 16.6	30.4 ng/ml Standard Deviation 16.6	31.8 ng/ml Standard Deviation 20.0	82.8 ng/ml Standard Deviation 54.3	103.2 ng/ml Standard Deviation 69.0	90.1 ng/ml Standard Deviation 52.5	188.0 ng/ml Standard Deviation 117.3	203.7 ng/ml Standard Deviation 123.9	207.6 ng/ml Standard Deviation 108.7	NA ng/ml Standard Deviation NA	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: All treated patients. No statistical comparisons due to extremely small number of cases

Increase of AST to more than two times the baseline value

Outcome measures

Measure	BIBR 1048 50 mg b.i.d n=58 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=20 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=27 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=99 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=34 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=98 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=30 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=70 Participants qd (once daily) oral	D300bid Dabigatran 300 mg twice daily	D300qd Dabigatran 300 mg once daily	D300bid + ASA81qd Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin, Dosed to Target INR 2.0 to 3.0 Warfarin once daily
Number of Participants With Increase of Aspartat-Aminotransferase (AST) to >2*Baseline Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Increase of Aspartat-Aminotransferase (AST) to >2*Baseline No	57 Participants	20 Participants	24 Participants	93 Participants	32 Participants	31 Participants	95 Participants	31 Participants	30 Participants	68 Participants	—	—	—	—	—	—	—
Number of Participants With Increase of Aspartat-Aminotransferase (AST) to >2*Baseline Yes	1 Participants	0 Participants	3 Participants	6 Participants	2 Participants	2 Participants	2 Participants	1 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: All treated patients. No statistical comparisons due to extremely small number of cases

Increase of AP to more than two times the baseline value

Outcome measures

Measure	BIBR 1048 50 mg b.i.d n=58 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=20 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=27 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=99 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=34 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=98 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=30 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=70 Participants qd (once daily) oral	D300bid Dabigatran 300 mg twice daily	D300qd Dabigatran 300 mg once daily	D300bid + ASA81qd Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin, Dosed to Target INR 2.0 to 3.0 Warfarin once daily
Number of Participants With Increase of Alkaline Phosphatase (AP) to >2*Baseline Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Increase of Alkaline Phosphatase (AP) to >2*Baseline No	58 Participants	20 Participants	27 Participants	98 Participants	33 Participants	33 Participants	97 Participants	32 Participants	29 Participants	69 Participants	—	—	—	—	—	—	—
Number of Participants With Increase of Alkaline Phosphatase (AP) to >2*Baseline Yes	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: All treated patients. No statistical comparisons due to extremely small number of cases

Increase of Bilirubin to more than two times the baseline value

Outcome measures

Measure	BIBR 1048 50 mg b.i.d n=58 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=20 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=27 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=99 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=34 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=98 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=30 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=70 Participants qd (once daily) oral	D300bid Dabigatran 300 mg twice daily	D300qd Dabigatran 300 mg once daily	D300bid + ASA81qd Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin, Dosed to Target INR 2.0 to 3.0 Warfarin once daily
Number of Participants With Increase of Bilirubin to >2*Baseline No	55 Participants	18 Participants	25 Participants	86 Participants	31 Participants	33 Participants	88 Participants	29 Participants	29 Participants	63 Participants	—	—	—	—	—	—	—
Number of Participants With Increase of Bilirubin to >2*Baseline Yes	3 Participants	2 Participants	2 Participants	13 Participants	3 Participants	0 Participants	9 Participants	3 Participants	1 Participants	6 Participants	—	—	—	—	—	—	—
Number of Participants With Increase of Bilirubin to >2*Baseline Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: All treated patients. No statistical comparisons due to extremely small number of cases

Number of Participants with Increase of ALT to more than two times the baseline value

Outcome measures

Measure	BIBR 1048 50 mg b.i.d n=58 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=20 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=27 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=99 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=34 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=98 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=30 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=70 Participants qd (once daily) oral	D300bid Dabigatran 300 mg twice daily	D300qd Dabigatran 300 mg once daily	D300bid + ASA81qd Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin, Dosed to Target INR 2.0 to 3.0 Warfarin once daily
Number of Participants With Increase of Alanine-Aminotransferase (ALT) to >2*Baseline Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With Increase of Alanine-Aminotransferase (ALT) to >2*Baseline No	55 Participants	18 Participants	26 Participants	95 Participants	33 Participants	32 Participants	93 Participants	31 Participants	30 Participants	64 Participants	—	—	—	—	—	—	—
Number of Participants With Increase of Alanine-Aminotransferase (ALT) to >2*Baseline Yes	3 Participants	2 Participants	1 Participants	4 Participants	1 Participants	1 Participants	4 Participants	1 Participants	0 Participants	5 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: Treated patients(Numbers of patients for adverse events are counted for each treatment and are in their sum greater than the total number of patients randomized as 14 patients on Dabigatran with ASA changed treatment,12 patients down titrated Dabigatran bid to qd of which one did the down titration at the same time as the stop of the ASA treatment)

Total number of patients with any adverse event of worst intensity 'mild', 'moderate' and 'severe'.

Outcome measures

Measure	BIBR 1048 50 mg b.i.d n=59 Participants bid (twice daily) oral	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n=1 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n=21 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d n=27 Participants bid (twice daily) oral	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n=100 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n=3 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d n=36 Participants bid (twice daily) oral	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n=1 Participants bid (twice daily) oral + qd (once daily) oral	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n=33 Participants bid (twice daily) oral + qd (once daily) oral	Warfarin, Dosed to Target INR 2.0 to 3.0 n=1 Participants qd (once daily) oral	D300bid n=105 Participants Dabigatran 300 mg twice daily	D300qd n=3 Participants Dabigatran 300 mg once daily	D300bid + ASA81qd n=34 Participants Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd n=2 Participants Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd n=30 Participants Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd n=1 Participants Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin, Dosed to Target INR 2.0 to 3.0 n=70 Participants Warfarin once daily
Severity of Adverse Events Mild	24 participants	0 participants	9 participants	16 participants	54 participants	1 participants	23 participants	0 participants	17 participants	0 participants	47 participants	1 participants	23 participants	2 participants	23 participants	1 participants	30 participants
Severity of Adverse Events Moderate	13 participants	0 participants	6 participants	7 participants	19 participants	0 participants	9 participants	0 participants	4 participants	0 participants	23 participants	0 participants	5 participants	1 participants	11 participants	1 participants	14 participants
Severity of Adverse Events Severe	3 participants	0 participants	1 participants	1 participants	4 participants	0 participants	2 participants	0 participants	1 participants	0 participants	6 participants	0 participants	1 participants	0 participants	2 participants	0 participants	2 participants

Adverse Events

D50bid

Serious events: 5 serious events

Other events: 20 other events

Deaths: 0 deaths

D50qd

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

D50bid + ASA81qd

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

D50bid + ASA325qd

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

D150bid

Serious events: 10 serious events

Other events: 43 other events

Deaths: 0 deaths

D150qd

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

D150bid + ASA81qd

Serious events: 4 serious events

Other events: 19 other events

Deaths: 0 deaths

D150qd + ASA81qd

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

D150bid + ASA325qd

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

D150qd + ASA325qd

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

D300bid

Serious events: 3 serious events

Other events: 35 other events

Deaths: 0 deaths

D300qd

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

D300bid + ASA81qd

Serious events: 4 serious events

Other events: 20 other events

Deaths: 0 deaths

D300qd + ASA81qd

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

D300bid + ASA325qd

Serious events: 4 serious events

Other events: 18 other events

Deaths: 0 deaths

D300qd + ASA325qd

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Warfarin

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	D50bid n=59 participants at risk Dabigatran 50 mg twice daily	D50qd n=1 participants at risk Dabigatran 50 mg once daily	D50bid + ASA81qd n=21 participants at risk Dabigatran 50 mg twice daily + ASA 81 mg once daily	D50bid + ASA325qd n=27 participants at risk Dabigatran 50 mg twice daily + ASA 325 mg once daily	D150bid n=100 participants at risk Dabigatran 150 mg twice daily	D150qd n=3 participants at risk Dabigatran 150 mg once daily	D150bid + ASA81qd n=36 participants at risk Dabigatran 150 mg twice daily + ASA 81 mg once daily	D150qd + ASA81qd n=1 participants at risk Dabigatran 150 mg once daily + ASA 81 mg once daily	D150bid + ASA325qd n=33 participants at risk Dabigatran 150 mg twice daily + ASA 325 mg once daily	D150qd + ASA325qd n=1 participants at risk Dabigatran 150 mg once daily + ASA 325 mg once daily	D300bid n=105 participants at risk Dabigatran 300 mg twice daily	D300qd n=3 participants at risk Dabigatran 300 mg once daily	D300bid + ASA81qd n=34 participants at risk Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd n=2 participants at risk Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd n=30 participants at risk Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd n=1 participants at risk Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin n=70 participants at risk Warfarin once daily
Renal and urinary disorders Renal infarct	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	4.8% 1/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Cardiac disorders Acute coronary syndrome	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	4.8% 1/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 1/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Cardiac disorders Angina pectoris	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.0% 1/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Cardiac disorders Atrial fibrillation	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.8% 1/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.95% 1/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 1/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.4% 1/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Cardiac disorders Atrial thrombosis	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	4.8% 1/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Cardiac disorders Cardiac failure	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.0% 1/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.6% 2/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Cardiac disorders Cardiac failure congestive	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.8% 1/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Cardiac disorders Ventricular fibrillation	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.0% 1/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Cardiac disorders Ventricular tachycardia	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.0% 1/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Gastrointestinal disorders Abdominal pain	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.8% 1/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Gastrointestinal disorders Dyspepsia	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.0% 1/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Gastrointestinal disorders Gastric ulcer	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 1/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 1/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.3% 1/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Gastrointestinal disorders Ileus	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.7% 1/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.3% 1/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 1/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Gastrointestinal disorders Pancreatitis	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.8% 1/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.3% 1/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
General disorders Asthenia	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.8% 1/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
General disorders Chest pain	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.0% 1/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Hepatobiliary disorders Cholecystitis	1.7% 1/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.8% 1/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Hepatobiliary disorders Cholelithiasis	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.0% 1/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Infections and infestations Diverticulitis	1.7% 1/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Infections and infestations Pneumonia	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.0% 2/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.8% 1/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Infections and infestations Urinary tract infection	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.8% 1/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Injury, poisoning and procedural complications Implantable defibrillator malfunction	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.0% 1/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.4% 1/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Investigations Alanine aminotransferase increased	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.0% 1/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Investigations Blood pressure systolic inspiratory decreased	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.0% 1/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.8% 1/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.8% 1/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.0% 1/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.0% 2/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.3% 1/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Nervous system disorders Cerebrovascular accident	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	4.8% 1/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Nervous system disorders Epilepsy	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.95% 1/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Nervous system disorders Paraesthesia	1.7% 1/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Nervous system disorders Syncope	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.95% 1/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.3% 1/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.8% 1/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Skin and subcutaneous tissue disorders Skin discolouration	1.7% 1/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Surgical and medical procedures Hip arthroplasty	1.7% 1/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Vascular disorders Circulatory collapse	1.7% 1/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Vascular disorders Hypotension	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.0% 1/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Vascular disorders Peripheral embolism	1.7% 1/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.

Other adverse events

Measure	D50bid n=59 participants at risk Dabigatran 50 mg twice daily	D50qd n=1 participants at risk Dabigatran 50 mg once daily	D50bid + ASA81qd n=21 participants at risk Dabigatran 50 mg twice daily + ASA 81 mg once daily	D50bid + ASA325qd n=27 participants at risk Dabigatran 50 mg twice daily + ASA 325 mg once daily	D150bid n=100 participants at risk Dabigatran 150 mg twice daily	D150qd n=3 participants at risk Dabigatran 150 mg once daily	D150bid + ASA81qd n=36 participants at risk Dabigatran 150 mg twice daily + ASA 81 mg once daily	D150qd + ASA81qd n=1 participants at risk Dabigatran 150 mg once daily + ASA 81 mg once daily	D150bid + ASA325qd n=33 participants at risk Dabigatran 150 mg twice daily + ASA 325 mg once daily	D150qd + ASA325qd n=1 participants at risk Dabigatran 150 mg once daily + ASA 325 mg once daily	D300bid n=105 participants at risk Dabigatran 300 mg twice daily	D300qd n=3 participants at risk Dabigatran 300 mg once daily	D300bid + ASA81qd n=34 participants at risk Dabigatran 300 mg twice daily + ASA 81 mg once daily	D300qd + ASA81qd n=2 participants at risk Dabigatran 300 mg once daily + ASA 81 mg once daily	D300bid + ASA325qd n=30 participants at risk Dabigatran 300 mg twice daily + ASA 325 mg once daily	D300qd + ASA325qd n=1 participants at risk Dabigatran 300 mg once daily + ASA 325 mg once daily	Warfarin n=70 participants at risk Warfarin once daily
Renal and urinary disorders Haematuria	1.7% 1/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	7.0% 7/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.8% 1/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.9% 2/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.3% 1/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Gastrointestinal disorders Abdominal distension	1.7% 1/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	9.5% 2/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.0% 1/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	100.0% 1/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Respiratory, thoracic and mediastinal disorders Cough	1.7% 1/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.0% 3/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	8.3% 3/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.0% 1/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 3/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 1/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	50.0% 1/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.3% 1/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.4% 1/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Gastrointestinal disorders Abdominal pain	1.7% 1/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.0% 1/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.9% 2/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	50.0% 1/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.4% 1/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Cardiac disorders Angina pectoris	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.7% 1/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.0% 1/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.95% 1/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.9% 2/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.4% 1/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Eye disorders Conjunctival haemorrhage	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.6% 2/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 1/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Eye disorders Eye haemorrhage	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.6% 2/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.9% 2/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 1/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Gastrointestinal disorders Abdominal pain upper	3.4% 2/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.0% 1/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	8.3% 3/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.0% 1/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 3/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.3% 1/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Gastrointestinal disorders Constipation	3.4% 2/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	4.8% 1/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	14.8% 4/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.8% 1/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.0% 1/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 2/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Gastrointestinal disorders Diarrhoea	5.1% 3/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	9.5% 2/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	11.1% 3/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.0% 3/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.6% 2/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	6.1% 2/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 3/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	6.7% 2/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.4% 1/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Gastrointestinal disorders Dry mouth	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.95% 1/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	6.7% 2/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Gastrointestinal disorders Dyspepsia	1.7% 1/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	4.8% 1/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.7% 1/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.0% 3/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	8.3% 3/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	6.1% 2/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.7% 6/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 1/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	6.7% 2/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Gastrointestinal disorders Gingival bleeding	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.7% 1/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.0% 1/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.0% 1/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.95% 1/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.9% 2/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.0% 1/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 1/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	6.7% 2/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.4% 1/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.9% 2/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Gastrointestinal disorders Nausea	3.4% 2/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	9.5% 2/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	4.0% 4/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.8% 1/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.0% 1/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.95% 1/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.9% 2/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	50.0% 1/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.3% 1/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Gastrointestinal disorders Vomiting	1.7% 1/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	7.4% 2/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	50.0% 1/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
General disorders Chest pain	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	9.5% 2/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.0% 2/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 3/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.9% 2/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.4% 1/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
General disorders Fatigue	1.7% 1/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	7.4% 2/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.0% 5/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.8% 1/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 3/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	14.7% 5/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	50.0% 1/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.3% 1/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	4.3% 3/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
General disorders Sensation of pressure	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	50.0% 1/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Infections and infestations Influenza	1.7% 1/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.9% 2/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.3% 1/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Infections and infestations Nasopharyngitis	3.4% 2/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.7% 1/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.6% 2/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 3/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.3% 1/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Infections and infestations Urinary tract infection	1.7% 1/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	4.8% 1/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.0% 2/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	33.3% 1/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.6% 2/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.0% 1/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.95% 1/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.3% 1/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.4% 1/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Injury, poisoning and procedural complications Contusion	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.0% 2/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	6.1% 2/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 3/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.9% 2/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	10.0% 3/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	8.6% 6/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Investigations Alanine aminotransferase increased	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.95% 1/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	50.0% 1/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Investigations Aspartate aminotransferase increased	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.95% 1/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	50.0% 1/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	9.5% 2/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.0% 1/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.95% 1/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 2/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	50.0% 1/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.7% 1/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	4.0% 4/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.6% 2/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.9% 2/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.4% 1/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Musculoskeletal and connective tissue disorders Pain in extremity	3.4% 2/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	9.5% 2/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.6% 2/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Nervous system disorders Dizziness	5.1% 3/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	4.8% 1/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	11.1% 3/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	4.0% 4/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.6% 2/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.0% 1/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.8% 4/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.9% 2/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	50.0% 1/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	16.7% 5/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	100.0% 1/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 2/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Nervous system disorders Headache	3.4% 2/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	4.8% 1/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	14.8% 4/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.0% 2/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.6% 2/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 3/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 1/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 2/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.0% 1/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.0% 1/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.8% 4/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.9% 2/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	6.7% 2/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	7.1% 5/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	6.1% 2/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 1/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	6.7% 2/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 2/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Skin and subcutaneous tissue disorders Exanthem	0.00% 0/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	33.3% 1/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Vascular disorders Haematoma	1.7% 1/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.0% 2/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.8% 1/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	3.0% 1/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.95% 1/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	2.9% 1/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	6.7% 2/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Vascular disorders Hypertension	1.7% 1/59 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	4.8% 1/21 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/27 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	5.0% 5/100 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/36 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/33 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/105 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/3 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/34 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/2 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	6.7% 2/30 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	0.00% 0/1 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.	1.4% 1/70 • 12 weeks Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
• Publication restrictions are in place

Restriction type: OTHER