Trial Outcomes & Findings for Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate (NCT NCT00262600)

NCT ID: NCT00262600

Last Updated: 2019-04-17

Results Overview

Time to first occurrence of stroke or systemic embolic event. Yearly event rate (%) = number of subjects with event / subject-years \* 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 18113 participants
• Primary outcome timeframe: 36 months
• Results posted on: 2019-04-17

Participant Flow

Participant milestones

Measure	Dabigatran 110 mg 110 mg twice daily, total daily dose 220 mg	Dabigatran 150 mg 150 mg twice daily, total daily dose 300 mg	Warfarin Target International Normalized Ratio (INR) of 2.0 to 3.0
Overall Study STARTED	6015	6076	6022
Overall Study COMPLETED	5780	5824	5756
Overall Study NOT COMPLETED	235	252	266

Reasons for withdrawal

Measure	Dabigatran 110 mg 110 mg twice daily, total daily dose 220 mg	Dabigatran 150 mg 150 mg twice daily, total daily dose 300 mg	Warfarin Target International Normalized Ratio (INR) of 2.0 to 3.0
Overall Study Lost to Follow-up	17	31	41
Overall Study Withdrawal by Subject	128	145	139
Overall Study Not Treated	32	17	24
Overall Study Other	58	59	62

Baseline Characteristics

Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate

Baseline characteristics by cohort

Measure	Dabigatran 110 mg n=6015 Participants 110 mg twice daily, total daily dose 220 mg	Dabigatran 150 mg n=6076 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=6022 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0	Total n=18113 Participants Total of all reporting groups
Age, Continuous	71.4 years STANDARD_DEVIATION 8.6 • n=5 Participants	71.5 years STANDARD_DEVIATION 8.8 • n=7 Participants	71.6 years STANDARD_DEVIATION 8.6 • n=5 Participants	71.5 years STANDARD_DEVIATION 8.7 • n=4 Participants
Age, Customized <65	998 Participants n=5 Participants	1030 Participants n=7 Participants	953 Participants n=5 Participants	2981 Participants n=4 Participants
Age, Customized 65<= and <75	2668 Participants n=5 Participants	2580 Participants n=7 Participants	2646 Participants n=5 Participants	7894 Participants n=4 Participants
Age, Customized >=75	2349 Participants n=5 Participants	2466 Participants n=7 Participants	2423 Participants n=5 Participants	7238 Participants n=4 Participants
Sex/Gender, Customized Male	3865 participants n=5 Participants	3840 participants n=7 Participants	3809 participants n=5 Participants	11514 participants n=4 Participants
Sex/Gender, Customized Female	2149 participants n=5 Participants	2236 participants n=7 Participants	2213 participants n=5 Participants	6598 participants n=4 Participants
Sex/Gender, Customized Missing	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5593 Participants n=5 Participants	5660 Participants n=7 Participants	5615 Participants n=5 Participants	16868 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	421 Participants n=5 Participants	416 Participants n=7 Participants	407 Participants n=5 Participants	1244 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White	4208 participants n=5 Participants	4268 participants n=7 Participants	4203 participants n=5 Participants	12679 participants n=4 Participants
Race/Ethnicity, Customized Black	52 participants n=5 Participants	57 participants n=7 Participants	67 participants n=5 Participants	176 participants n=4 Participants
Race/Ethnicity, Customized Asian	955 participants n=5 Participants	965 participants n=7 Participants	955 participants n=5 Participants	2875 participants n=4 Participants
Race/Ethnicity, Customized Other	799 participants n=5 Participants	786 participants n=7 Participants	797 participants n=5 Participants	2382 participants n=4 Participants
Race/Ethnicity, Customized Missing	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Region of Enrollment USA, Canada	2166 participants n=5 Participants	2200 participants n=7 Participants	2167 participants n=5 Participants	6533 participants n=4 Participants
Region of Enrollment Central Europe	707 participants n=5 Participants	706 participants n=7 Participants	706 participants n=5 Participants	2119 participants n=4 Participants
Region of Enrollment Western Europe	1544 participants n=5 Participants	1555 participants n=7 Participants	1552 participants n=5 Participants	4651 participants n=4 Participants
Region of Enrollment Latin America	320 participants n=5 Participants	320 participants n=7 Participants	316 participants n=5 Participants	956 participants n=4 Participants
Region of Enrollment Asia	923 participants n=5 Participants	933 participants n=7 Participants	926 participants n=5 Participants	2782 participants n=4 Participants
Region of Enrollment Other	355 participants n=5 Participants	362 participants n=7 Participants	355 participants n=5 Participants	1072 participants n=4 Participants
Smoking history Non-smoker	2941 participants n=5 Participants	2993 participants n=7 Participants	3006 participants n=5 Participants	8940 participants n=4 Participants
Smoking history Smoker	440 participants n=5 Participants	447 participants n=7 Participants	448 participants n=5 Participants	1335 participants n=4 Participants
Smoking history Ex-smoker	2633 participants n=5 Participants	2636 participants n=7 Participants	2567 participants n=5 Participants	7836 participants n=4 Participants
Smoking history Missing	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants
Regular Alcohol Consumption No	4017 participants n=5 Participants	4077 participants n=7 Participants	4040 participants n=5 Participants	12134 participants n=4 Participants
Regular Alcohol Consumption Yes	1996 participants n=5 Participants	1999 participants n=7 Participants	1981 participants n=5 Participants	5976 participants n=4 Participants
Regular Alcohol Consumption Missing	2 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants

PRIMARY outcome

Timeframe: 36 months

Population: Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.

Time to first occurrence of stroke or systemic embolic event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25

Outcome measures

Measure	Dabigatran 110 mg n=6015 Participants 110 mg twice daily, total daily dose 220 mg	Dabigatran 150 mg n=6076 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=6022 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0
Yearly Event Rate for Composite Endpoint of Stroke/SEE	1.54 yearly event rate (percentage)	1.11 yearly event rate (percentage)	1.71 yearly event rate (percentage)

SECONDARY outcome

Timeframe: 36 months

Population: Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.

Time to first occurrence of stroke, SEE or all cause death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25

Outcome measures

Measure	Dabigatran 110 mg n=6015 Participants 110 mg twice daily, total daily dose 220 mg	Dabigatran 150 mg n=6076 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=6022 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0
Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death	4.85 yearly event rate (percentage)	4.32 yearly event rate (percentage)	5.20 yearly event rate (percentage)

SECONDARY outcome

Timeframe: 36 months

Population: Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.

Time to first occurrence of stroke, systemic embolic event, pulmonary embolism, myocardial infarction including silent myocardial infarction or vascular death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25

Outcome measures

Measure	Dabigatran 110 mg n=6015 Participants 110 mg twice daily, total daily dose 220 mg	Dabigatran 150 mg n=6076 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=6022 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0
Yearly Event Rate: Composite of Stroke/SEE/PE/MI/Vascular Death	4.26 yearly event rate (percentage)	3.68 yearly event rate (percentage)	4.35 yearly event rate (percentage)

SECONDARY outcome

Timeframe: 36 months

Population: Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.

Yearly event rate of bleeds. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25

Major bleeds are adjudicated, whereas minor bleeds are investigator reported.

Outcome measures

Measure	Dabigatran 110 mg n=6015 Participants 110 mg twice daily, total daily dose 220 mg	Dabigatran 150 mg n=6076 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=6022 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0
Bleeding Events (Major and Minor) Major bleeds	2.99 yearly event rate (percentage)	3.55 yearly event rate (percentage)	3.81 yearly event rate (percentage)
Bleeding Events (Major and Minor) Minor bleeds	13.16 yearly event rate (percentage)	14.85 yearly event rate (percentage)	16.37 yearly event rate (percentage)

SECONDARY outcome

Timeframe: 36 months

Population: Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.

Patients with clinical relevant abnormalities for intracerebral hemorrhage, other intracranial hemorrhage (ICH)

Outcome measures

Measure	Dabigatran 110 mg n=5983 Participants 110 mg twice daily, total daily dose 220 mg	Dabigatran 150 mg n=6059 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=5998 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0
Clinical Relevant Abnormalities for Intracerebral Hemorrhage and Other Intracranial Hemorrhage (ICH) intracerebral hemorrhage	0.12 yearly event rate (percentage)]	0.10 yearly event rate (percentage)]	0.38 yearly event rate (percentage)]
Clinical Relevant Abnormalities for Intracerebral Hemorrhage and Other Intracranial Hemorrhage (ICH) intracranial hemorrhage (ICH)	0.23 yearly event rate (percentage)]	0.32 yearly event rate (percentage)]	0.76 yearly event rate (percentage)]

SECONDARY outcome

Timeframe: 36 months

Population: Safety set - all subjects who were randomized and received at least 1 dose of study drug

Number of subjects with abnormal liver function test (LFT), i.e., ALT/AST>3xULN and total bilirubin > 2 x ULN

Outcome measures

Measure	Dabigatran 110 mg n=5983 Participants 110 mg twice daily, total daily dose 220 mg	Dabigatran 150 mg n=6059 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=5998 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0
Abnormal Liver Function Test	11 participants	14 participants	21 participants

Adverse Events

Dabigatran 110 mg

Serious events: 1263 serious events

Other events: 2286 other events

Deaths: 0 deaths

Dabigatran 150 mg

Serious events: 1289 serious events

Other events: 2273 other events

Deaths: 0 deaths

Warfarin

Serious events: 1357 serious events

Other events: 2118 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dabigatran 110 mg n=5983 participants at risk 110 mg twice daily, total daily dose 220 mg	Dabigatran 150 mg n=6059 participants at risk 150 mg twice daily, total daily dose 300 mg	Warfarin n=5998 participants at risk Target International Normalized Ratio (INR) of 2.0 to 3.0
Cardiac disorders Coronary artery thrombosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Electromechanical dissociation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Intracardiac thrombus	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Coronary artery stenosis	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Coronary artery disease	0.15% 9/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.17% 10/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.18% 11/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Coronary artery occlusion	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Coronary artery perforation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Anaemia	0.57% 34/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.78% 47/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.55% 33/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Coagulopathy	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.20% 12/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Febrile neutropenia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Haemolysis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.10% 6/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.17% 10/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Hypereosinophilic syndrome	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Hypocoagulable state	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Iron deficiency anaemia	0.12% 7/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Leukocytosis	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Leukopenia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Lymphadenopathy	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Lymphatic disorder	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Microcytic anaemia	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Neutropenia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Pancytopenia	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Sideroblastic anaemia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Splenic haemorrhage	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Splenomegaly	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Spontaneous haematoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Blood and lymphatic system disorders Thrombocytopenia	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Acute coronary syndrome	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Acute left ventricular failure	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Acute myocardial infarction	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Angina pectoris	0.48% 29/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.50% 30/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.37% 22/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Angina unstable	0.12% 7/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.21% 13/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Aortic valve calcification	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Aortic valve disease	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Aortic valve incompetence	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Aortic valve sclerosis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Aortic valve stenosis	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Arrhythmia	0.10% 6/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Atrial fibrillation	1.1% 64/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.91% 55/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	1.2% 74/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Atrial flutter	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.17% 10/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Atrial thrombosis	0.12% 7/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Atrioventricular block	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Atrioventricular block complete	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Atrioventricular block first degree	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Atrioventricular block second degree	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Bradyarrhythmia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Bradycardia	0.33% 20/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.35% 21/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.33% 20/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Cardiac arrest	0.13% 8/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Cardiac asthma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Cardiac failure	0.85% 51/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	1.0% 62/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	1.1% 65/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Cardiac failure acute	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.12% 7/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Cardiac failure chronic	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Cardiac failure congestive	1.4% 83/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.96% 58/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	1.2% 73/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Cardiac perforation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Cardio-respiratory arrest	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Cardiogenic shock	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Cardiomegaly	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Cardiomyopathy	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Conduction disorder	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Congestive cardiomyopathy	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Cor pulmonale	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Left ventricular dysfunction	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Left ventricular failure	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Mitral valve incompetence	0.10% 6/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.17% 10/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Mitral valve prolapse	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Mitral valve stenosis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Myocardial infarction	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Myocardial ischaemia	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Nodal arrhythmia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Nodal rhythm	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Palpitations	0.12% 7/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Pericardial effusion	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Pericardial haemorrhage	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Pericarditis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Pericarditis constrictive	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Prinzmetal angina	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Restrictive cardiomyopathy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Right ventricular failure	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Sick sinus syndrome	0.13% 8/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Sinoatrial block	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Sinus arrest	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Sinus arrhythmia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Sinus bradycardia	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Stress cardiomyopathy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Supraventricular tachycardia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Tachyarrhythmia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Tachycardia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Torsade de pointes	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Tricuspid valve incompetence	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Ventricular arrhythmia	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Ventricular extrasystoles	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Ventricular fibrillation	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Ventricular hypokinesia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Ventricular tachyarrhythmia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Cardiac disorders Ventricular tachycardia	0.10% 6/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.17% 10/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Congenital, familial and genetic disorders Atrial septal defect	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Congenital, familial and genetic disorders Cerebral palsy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Congenital, familial and genetic disorders Congenital arterial malformation	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Congenital, familial and genetic disorders Diverticulitis Meckel's	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Congenital, familial and genetic disorders Exomphalos	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Congenital, familial and genetic disorders Gastrointestinal angiodysplasia	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Congenital, familial and genetic disorders Gastrointestinal angiodysplasia haemorrhagic	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Congenital, familial and genetic disorders Gastrointestinal arteriovenous malformation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Congenital, familial and genetic disorders Hydrocele	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Congenital, familial and genetic disorders Ventricular septal defect	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Ear and labyrinth disorders Deafness	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Ear and labyrinth disorders Deafness unilateral	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Ear and labyrinth disorders External ear pain	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Ear and labyrinth disorders Hearing impaired	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Ear and labyrinth disorders Meniere's disease	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Ear and labyrinth disorders Vertigo	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.23% 14/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Ear and labyrinth disorders Vertigo positional	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Ear and labyrinth disorders Vestibular disorder	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Enterovesical fistula	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Endocrine disorders Addison's disease	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Endocrine disorders Adrenal insufficiency	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Endocrine disorders Goitre	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Endocrine disorders Hyperparathyroidism	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Endocrine disorders Hyperthyroidism	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Endocrine disorders Hypothyroidism	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Endocrine disorders Thyroid mass	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Endocrine disorders Thyrotoxic crisis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Amaurosis fugax	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Blindness transient	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Cataract	0.12% 7/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.18% 11/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Conjunctival discolouration	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Conjunctival haemorrhage	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Dacryostenosis acquired	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Diabetic retinopathy	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Diplopia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Dry eye	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Eye haemorrhage	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Glaucoma	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Hyphaema	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Hypotony of eye	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Keratitis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Macular degeneration	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Necrotising retinitis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Optic neuropathy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Pseudophakia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Retinal detachment	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Retinal haemorrhage	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Retinal tear	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Retinitis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Uveitis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Vision blurred	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Visual acuity reduced	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Visual impairment	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Eye disorders Vitreous haemorrhage	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Abdominal distension	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Abdominal hernia	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Abdominal mass	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Abdominal pain	0.18% 11/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.28% 17/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Abdominal pain upper	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Acute abdomen	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Alcoholic pancreatitis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Anal fissure	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Anal polyp	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Appendiceal mucocoele	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Ascites	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Coeliac disease	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Colitis	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Colitis ischaemic	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Colonic obstruction	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Colonic polyp	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Colonic stenosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Constipation	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Crohn's disease	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Diarrhoea	0.13% 8/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.12% 7/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.33% 20/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Diverticular perforation	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Diverticulitis intestinal haemorrhagic	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Diverticulum	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Duodenal ulcer	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Duodenal ulcer perforation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Duodenitis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Duodenitis haemorrhagic	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Dyskinesia oesophageal	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Burns third degree	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Dyspepsia	0.10% 6/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Dysphagia	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Enteritis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Enterocele	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Enterocolitis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Faecaloma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Faeces discoloured	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Gastric disorder	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Gastric perforation	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Gastric polyps	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Gastric stenosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Gastric ulcer	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Gastric ulcer perforation	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Gastritis	0.10% 6/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Gastritis erosive	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Gastritis haemorrhagic	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Gastrointestinal dysplasia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.64% 38/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.91% 55/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.68% 41/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Gastrointestinal obstruction	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Gastrointestinal perforation	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Gastrointestinal ulcer	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Gingival bleeding	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Haematemesis	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Haematochezia	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Haemorrhagic erosive gastritis	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Haemorrhoids	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Hernial eventration	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Hiatus hernia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Hiatus hernia, obstructive	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Ileus	0.13% 8/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Ileus paralytic	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Inguinal hernia	0.25% 15/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.26% 16/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.20% 12/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Inguinal hernia, obstructive	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Intestinal fistula	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Intestinal haemorrhage	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Intestinal infarction	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Intestinal ischaemia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Intestinal mass	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Intestinal obstruction	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Intestinal perforation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Intra-abdominal haematoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Intussusception	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Large intestinal haemorrhage	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Large intestine perforation	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.13% 8/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.20% 12/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Malabsorption	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Mallory-Weiss syndrome	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Melaena	0.12% 7/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.17% 10/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Melanosis coli	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Mouth ulceration	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Nausea	0.18% 11/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.12% 7/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.15% 9/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Odynophagia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Oesophageal mass	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Oesophageal perforation	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Oesophageal spasm	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Oesophageal ulcer	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Oesophageal ulcer haemorrhage	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Oesophagitis	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Oral discomfort	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Pancreatic cyst	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Pancreatic insufficiency	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Pancreatic mass	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Pancreatitis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Pancreatitis acute	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Paraesthesia oral	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Peptic ulcer	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Periodontal disease	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Periodontitis	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Peritoneal cyst	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Peritoneal haemorrhage	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Peritonitis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Pharyngoesophageal diverticulum	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Pneumoperitoneum	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Presbyoesophagus	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Proctitis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Rectal haemorrhage	0.25% 15/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.21% 13/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.15% 9/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Rectal lesion	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Rectal prolapse	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Rectal ulcer	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Salivary gland cyst	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Small intestinal obstruction	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Stress ulcer	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Subileus	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Umbilical hernia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.13% 8/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.21% 13/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.20% 12/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Volvulus	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Vomiting	0.28% 17/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.15% 9/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Adhesion	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Adverse drug reaction	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Asthenia	0.20% 12/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.17% 10/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.25% 15/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Chest discomfort	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Chest pain	0.48% 29/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.74% 45/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.77% 46/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Chills	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Condition aggravated	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Cyst	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Death	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Discomfort	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Drug withdrawal syndrome	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Fatigue	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.20% 12/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Feeling abnormal	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Gait disturbance	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders General physical health deterioration	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Generalised oedema	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Hernia	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Hernia obstructive	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Hyperthermia	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Hypothermia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Impaired healing	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Implant site inflammation	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Inflammation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Injection site haemorrhage	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Ischaemic ulcer	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Malaise	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Mass	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Mechanical complication of implant	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Mucosal inflammation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Multi-organ failure	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Necrosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Non-cardiac chest pain	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Oedema	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Oedema peripheral	0.17% 10/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.22% 13/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Pain	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Pelvic mass	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Polyp	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Pyrexia	0.18% 11/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.21% 13/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.23% 14/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Sudden cardiac death	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Systemic inflammatory response syndrome	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Ulcer	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Bile duct stone	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Biliary colic	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Biliary dilatation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Cholangitis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Cholangitis acute	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Cholecystitis	0.13% 8/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.15% 9/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Cholecystitis acute	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Cholelithiasis	0.12% 7/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.12% 7/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Cholestasis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Cytolytic hepatitis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Gallbladder disorder	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Hepatic cirrhosis	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Hepatic failure	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Hepatic function abnormal	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Hepatic lesion	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Hepatic steatosis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Hepatitis	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Jaundice	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Jaundice cholestatic	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Hepatobiliary disorders Liver disorder	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Immune system disorders Amyloidosis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Immune system disorders Anaphylactic reaction	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Immune system disorders Anaphylactic shock	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Immune system disorders Drug hypersensitivity	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Immune system disorders Hypersensitivity	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Immune system disorders Primary amyloidosis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Abdominal abscess	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Abdominal wall abscess	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Abscess	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Abscess intestinal	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Abscess limb	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Acute sinusitis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Acute tonsillitis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Alpha haemolytic streptococcal infection	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Anal abscess	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Appendiceal abscess	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Appendicitis	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.18% 11/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.12% 7/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Appendicitis perforated	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Arthritis bacterial	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Arthritis infective	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Bacteraemia	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Bacterial sepsis	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Biliary tract infection	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Bronchiectasis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Bronchitis	0.18% 11/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.21% 13/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.18% 11/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Bronchitis bacterial	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Bronchopneumonia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Bursitis infective	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Carbuncle	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Catheter sepsis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Cellulitis	0.35% 21/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.38% 23/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.33% 20/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Cellulitis of male external genital organ	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Cellulitis staphylococcal	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Cervicitis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Cholecystitis infective	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Chronic sinusitis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Clostridial infection	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Clostridium difficile colitis	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Creutzfeldt-Jakob disease	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Cystitis	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Dengue fever	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Device related infection	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Diabetic gangrene	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Diarrhoea infectious	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Disseminated tuberculosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Diverticulitis	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.20% 12/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Empyema	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Endocarditis	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Endocarditis bacterial	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Endophthalmitis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Enterococcal bacteraemia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Enterococcal sepsis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Epiglottitis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Erysipelas	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.12% 7/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Escherichia bacteraemia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Escherichia sepsis	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Eye infection viral	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Gangrene	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Gastroenteritis	0.18% 11/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.21% 13/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Gastroenteritis norovirus	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Gastroenteritis salmonella	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Gastroenteritis viral	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Gastrointestinal infection	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Groin abscess	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Haematoma infection	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Helicobacter infection	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Helminthic infection	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Herpes zoster	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Herpes zoster ophthalmic	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Histoplasmosis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Implant site cellulitis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Implant site infection	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Incision site cellulitis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Incision site infection	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Infected cyst	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Infected skin ulcer	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Infection	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Influenza	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Infusion site infection	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Intervertebral discitis	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Intestinal gangrene	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Jejunal gangrene	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Keratitis herpetic	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Liver abscess	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Lobar pneumonia	0.10% 6/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Localised infection	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Lower respiratory tract infection	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Lung infection	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Mastoiditis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Mediastinitis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Meningitis bacterial	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Meningitis viral	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Necrotising fasciitis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Oesophageal candidiasis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Osteomyelitis	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Osteomyelitis acute	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Osteomyelitis chronic	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Osteomyelitis salmonella	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Otitis media	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Parotitis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Pelvic abscess	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Pelvic infection	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Peridiverticular abscess	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Periorbital abscess	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Perirectal abscess	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Peritoneal infection	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Peritonsillar abscess	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Pharyngeal abscess	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Pharyngitis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Pharyngitis streptococcal	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Pneumocystis jiroveci pneumonia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Pneumonia	1.2% 74/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	1.2% 70/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	1.0% 62/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Pneumonia bacterial	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Pneumonia primary atypical	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Pneumonia streptococcal	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Pneumonia viral	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Post procedural infection	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Postoperative abscess	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Postoperative wound infection	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Proteus infection	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Psoas abscess	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Pulmonary sepsis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Pulmonary tuberculosis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Pyelonephritis	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Pyelonephritis acute	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Pyonephrosis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Pyothorax	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Respiratory tract infection	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Salmonella bacteraemia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Scrotal abscess	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Sepsis	0.32% 19/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.28% 17/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.32% 19/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Sepsis syndrome	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Septic shock	0.17% 10/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Sinusitis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Skin infection	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Staphylococcal infection	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Staphylococcal sepsis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Staphylococcal skin infection	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Streptococcal bacteraemia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Streptococcal sepsis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Subacute endocarditis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Subcutaneous abscess	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Superinfection	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Tinea pedis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Tonsillitis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Tooth abscess	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Toxoplasmosis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Tracheobronchitis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Tuberculosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Upper respiratory tract infection	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Urinary tract infection	0.30% 18/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.21% 13/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.35% 21/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Urinary tract infection bacterial	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Urosepsis	0.17% 10/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Vestibular neuronitis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Viral infection	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations West Nile viral infection	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Wound infection	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Wound infection staphylococcal	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Cardiac pacemaker malfunction	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Accidental exposure	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Accidental overdose	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Adrenal haematoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Agitation postoperative	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Anaemia postoperative	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Anastomotic complication	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Ankle fracture	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Back injury	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Bladder injury	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Brain contusion	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Brain herniation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Cartilage injury	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Cataract operation complication	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Collapse of lung	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Complication of device insertion	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Compression fracture	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Concussion	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Confusion postoperative	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Contusion	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Device breakage	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Device dislocation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Device electrical finding	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Device failure	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Device lead damage	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Drug administration error	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Drug toxicity	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Excoriation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Eye injury	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Face injury	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Facial bones fracture	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Failure to capture	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Fall	0.37% 22/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.48% 29/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.72% 43/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Femoral neck fracture	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Femur fracture	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Flail chest	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Fracture	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Gastroenteritis radiation	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Graft complication	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Hand fracture	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Head injury	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Heart injury	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Heat exhaustion	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Hip fracture	0.13% 8/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Humerus fracture	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Iatrogenic injury	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Implantable defibrillator malfunction	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications In-stent coronary artery restenosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Incision site haematoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Injury	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Joint dislocation	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Throat cancer	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Joint injury	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Joint sprain	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Laceration	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Laryngeal injury	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Limb crushing injury	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Limb injury	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Lower limb fracture	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Lung injury	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Meniscus lesion	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Multiple drug overdose	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Multiple fractures	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Multiple injuries	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Muscle injury	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Narcotic intoxication	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Nerve root injury	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Operative haemorrhage	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Overdose	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Pacemaker complication	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Pancreatic injury	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Patella fracture	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Pelvic fracture	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Pocket erosion	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Post concussion syndrome	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Post procedural fistula	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Post procedural haematoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Post procedural haematuria	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Postoperative ileus	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Postoperative thoracic procedure complication	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Pubic rami fracture	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Renal injury	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Respiratory fume inhalation disorder	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Retinal scar	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Rib fracture	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Road traffic accident	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Scapula fracture	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Scrotal haematoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Seroma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Skin laceration	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Soft tissue injury	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Spinal compression fracture	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Spinal fracture	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Splenic haematoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Splenic injury	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Splenic rupture	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Subcutaneous haematoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Subdural haematoma	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.18% 11/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.33% 20/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Subdural haemorrhage	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Therapeutic agent toxicity	0.10% 6/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.15% 9/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Thrombosis in device	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Tibia fracture	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Transurethral resection syndrome	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Traumatic brain injury	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Traumatic haematoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Traumatic haemorrhage	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Underdose	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Upper limb fracture	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Vaccination complication	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Vascular bypass dysfunction	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Ventriculoperitoneal shunt malfunction	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Vertebral injury	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Wound	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Wound complication	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Wound dehiscence	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Injury, poisoning and procedural complications Wrist fracture	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Alanine aminotransferase increased	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Anticoagulation drug level above therapeutic	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Arteriogram coronary	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Aspartate aminotransferase increased	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Biopsy	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Biopsy breast	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Biopsy endometrium	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Biopsy lung	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Biopsy prostate	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Blood albumin decreased	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Blood calcium decreased	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Blood creatinine increased	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Blood glucose increased	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Blood osmolarity decreased	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Blood potassium increased	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Blood pressure decreased	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Blood pressure increased	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Blood urea increased	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Blood uric acid increased	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Blood urine present	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Brain natriuretic peptide increased	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Carbohydrate antigen 125 increased	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Cardiac electrophysiologic study	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Cardiac stress test	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Cardiac stress test abnormal	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Catheterisation cardiac	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Chest X-ray abnormal	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Coagulation factor increased	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Coagulation test abnormal	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Coagulation time prolonged	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Colonoscopy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Colonoscopy abnormal	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Creatinine renal clearance decreased	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Echocardiogram abnormal	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Electroencephalogram abnormal	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Glycosylated haemoglobin increased	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Haematocrit decreased	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Haemoglobin decreased	0.12% 7/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.20% 12/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.17% 10/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Heart rate increased	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Hepatic enzyme increased	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations International normalised ratio increased	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.32% 19/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Intraocular pressure increased	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Liver function test abnormal	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Lymphocyte count increased	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Megakaryocytes decreased	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Occult blood positive	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Oesophagogastroduodenoscopy	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Platelet count decreased	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Precancerous cells present	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Prostatic specific antigen	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Prostatic specific antigen increased	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Prothrombin time prolonged	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Sinus rhythm	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Troponin increased	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Tumour marker increased	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Urine output decreased	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Venous pressure jugular increased	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Weight decreased	0.10% 6/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations Weight increased	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Investigations White blood cell count increased	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Anorexia	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Cachexia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Dehydration	0.25% 15/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.36% 22/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.52% 31/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Diabetes mellitus	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.12% 7/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Diabetic foot	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Fluid overload	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Gout	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.12% 7/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Hyperglycaemia	0.10% 6/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.12% 7/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Hyperkalaemia	0.30% 18/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.20% 12/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Hypernatraemia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Hypoalbuminaemia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Hypocalcaemia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Hypoglycaemia	0.17% 10/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.18% 11/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.20% 12/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Hypokalaemia	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.17% 10/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Hyponatraemia	0.15% 9/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.15% 9/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.17% 10/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Ketoacidosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Ketosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Malnutrition	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Metabolic acidosis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Metabolic disorder	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Obesity	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Starvation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Tetany	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Arthralgia	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.12% 7/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.18% 11/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Arthritis	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Arthritis reactive	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Articular disc disorder	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Back pain	0.23% 14/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.28% 17/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.15% 9/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Bursitis	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Diabetic amyotrophy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Fasciitis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Fistula	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Foot deformity	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Jaw cyst	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Joint swelling	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Loose body in joint	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.15% 9/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Monarthritis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Muscle tightness	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Muscular weakness	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Nodule on extremity	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.37% 22/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.21% 13/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.35% 21/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Pain in extremity	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Periarthritis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Shoulder deformity	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Synovial cyst	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Tendonitis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Vertebral column mass	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Abdominal neoplasm	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acoustic neuroma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell small lymphocytic lymphoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign bone neoplasm	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.13% 8/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.21% 13/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.23% 14/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer stage III	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Small intestinal resection	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder papilloma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma recurrent	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer metastatic	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone neoplasm malignant	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain cancer metastatic	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.22% 13/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.28% 17/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.17% 10/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer in situ	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage IV	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast neoplasm	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cardiac fibroma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cardiac neoplasm malignant	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cardiac neoplasm unspecified	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Central nervous system leukaemia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Choroid melanoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.32% 19/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.28% 17/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage 0	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage I	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage IV	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ependymoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer metastatic	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer non-resectable	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric adenoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer stage II	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric neoplasm	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal cancer metastatic	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal neoplasm	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal tract adenoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrooesophageal cancer	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Head and neck cancer	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharyngeal cancer	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Inflammatory carcinoma of the breast	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Inflammatory myofibroblastic tumour	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal adenocarcinoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Keratoacanthoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Langerhans' cell granulomatosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large cell carcinoma of the respiratory tract stage unspecified	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer recurrent	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer stage 0	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal neoplasm	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma recurrent	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia monocytic	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liposarcoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage II	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage III	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.33% 20/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.23% 14/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage IV	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage unspecified	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphocytic lymphoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.13% 8/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma stage III	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of renal pelvis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant palate neoplasm	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant peritoneal neoplasm	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mantle cell lymphoma recurrent	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma benign	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to eye	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to kidney	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to pleura	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spleen	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to the mediastinum	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic carcinoid tumour	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic gastric cancer	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm prostate	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma recurrent	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal neoplasm	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oncologic complication	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal cancer stage unspecified	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian neoplasm	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.12% 7/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraneoplastic syndrome	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penis carcinoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Peritoneal neoplasm	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Phaeochromocytoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.42% 25/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.53% 32/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.48% 29/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland neoplasm	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell carcinoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer stage unspecified	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.17% 10/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.25% 15/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.17% 10/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.10% 6/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Superficial spreading melanoma stage unspecified	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-cell lymphoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testicular cancer metastatic	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour flare	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour invasion	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urethral cancer	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urethral papilloma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urinary bladder adenoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Altered state of consciousness	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Amnesia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Amyotrophic lateral sclerosis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Anoxic encephalopathy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Aphasia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Ataxia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Balance disorder	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Basilar artery occlusion	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Burning sensation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Carotid arteriosclerosis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Carotid artery disease	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Carotid artery stenosis	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.12% 7/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Carotid artery thrombosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Carpal tunnel syndrome	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Cerebellar haemorrhage	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Cerebellar infarction	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Cerebral atrophy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Cerebral circulatory failure	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Cerebral haematoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Cerebral haemorrhage	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.22% 13/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Cerebral hypoperfusion	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Cerebral infarction	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Cerebral ischaemia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Cerebrovascular accident	0.12% 7/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Cerebrovascular disorder	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Cerebrovascular insufficiency	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Cervical myelopathy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Cervicobrachial syndrome	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Cognitive disorder	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Coma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Complex partial seizures	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Convulsion	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Dementia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Dementia Alzheimer's type	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Depressed level of consciousness	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Dizziness	0.25% 15/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.30% 18/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.30% 18/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Dysarthria	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Embolic stroke	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Encephalitis	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Encephalopathy	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Epilepsy	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Facial palsy	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Frontotemporal dementia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Global amnesia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Grand mal convulsion	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Guillain-Barre syndrome	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Haemorrhage intracranial	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Haemorrhagic stroke	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.15% 9/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Headache	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Hemiparesis	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Hepatic encephalopathy	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Hydrocephalus	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Hyperaesthesia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Hypoaesthesia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Hypoglycaemic coma	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Hypoxic encephalopathy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Intracranial aneurysm	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Ischaemic stroke	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Lacunar infarction	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Lethargy	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Loss of consciousness	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Memory impairment	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Metabolic encephalopathy	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Monoparesis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Myoclonus	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Narcolepsy	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Nerve compression	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Neuralgia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Neuritis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Neurological decompensation	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Neuropathy peripheral	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Normal pressure hydrocephalus	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Paraesthesia	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Paralysis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Parkinson's disease	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Parkinsonism	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Peripheral paralysis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Post herpetic neuralgia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Post-traumatic headache	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Posterior interosseous syndrome	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Presyncope	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.12% 7/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Pseudoparalysis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Radial nerve palsy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Radicular syndrome	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Restless legs syndrome	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Sciatica	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Somnolence	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Speech disorder	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Spinal claudication	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Spinal cord compression	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Subarachnoid haemorrhage	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Subdural hygroma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Syncope	0.55% 33/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.51% 31/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.57% 34/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Tension headache	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Toxic encephalopathy	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Transient ischaemic attack	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Tremor	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Unresponsive to stimuli	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Vascular dementia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Vascular encephalopathy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Visual field defect	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Wernicke's encephalopathy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Adjustment disorder	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Agitation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Alcohol abuse	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Alcohol withdrawal syndrome	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Alcoholism	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Anxiety	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Apathy	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Bereavement reaction	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Completed suicide	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Confusional state	0.12% 7/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.17% 10/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Delirium	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Delusion	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Delusional disorder, unspecified type	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Depression	0.10% 6/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Drug abuse	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Hallucination	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Hallucination, auditory	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Major depression	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Mania	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Mental status changes	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.15% 9/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Panic attack	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Post-traumatic stress disorder	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Psychotic disorder	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Sleep disorder	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Somatisation disorder	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Somatoform disorder	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Suicidal ideation	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Suicide attempt	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Psychiatric disorders Withdrawal syndrome	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Acute prerenal failure	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Azotaemia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Bladder mass	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Bladder neck obstruction	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Bladder obstruction	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Bladder prolapse	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Bladder tamponade	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Calculus bladder	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Calculus ureteric	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Calculus urinary	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Diabetic nephropathy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Dysuria	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Haematuria	0.27% 16/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.23% 14/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.25% 15/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Haemorrhage urinary tract	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Hydronephrosis	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Nephritis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Nephrolithiasis	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Nephropathy	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Nephrosclerosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Nephrotic syndrome	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Obstructive uropathy	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Pelvi-ureteric obstruction	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Renal artery stenosis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Renal colic	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Renal cyst	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Renal disorder	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Renal failure	0.25% 15/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.31% 19/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.45% 27/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Renal failure acute	0.70% 42/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.63% 38/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.58% 35/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Renal failure chronic	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Renal impairment	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Renal mass	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Renal pain	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Renal tubular necrosis	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Stress urinary incontinence	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Tubulointerstitial nephritis	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Urethral haemorrhage	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Urethral obstruction	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Urethral stenosis	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Urinary bladder haemorrhage	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Urinary bladder polyp	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Urinary retention	0.10% 6/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.12% 7/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Breast mass	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Colpocele	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Cystocele	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Epididymitis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Gynaecomastia	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Ovarian cyst	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Ovarian mass	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Pelvic haematoma	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Prostatic disorder	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Prostatic obstruction	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Prostatism	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Prostatitis	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Rectocele	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Scrotal haematocoele	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Uterine enlargement	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Uterine prolapse	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Vaginal disorder	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Vaginal haemorrhage	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Vaginal polyp	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Reproductive system and breast disorders Vaginal prolapse	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Acute interstitial pneumonitis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Allergic cough	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Alveolitis allergic	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Asthma	0.12% 7/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Bronchial secretion retention	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.40% 24/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.23% 14/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.33% 20/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Cough	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Diaphragmatic rupture	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.64% 38/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.71% 43/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.75% 45/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Emphysema	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Eosinophilic pneumonia acute	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.10% 6/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.17% 10/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.28% 17/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.12% 7/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.15% 9/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Hydropneumothorax	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Hypoventilation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Mediastinal mass	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Nasal turbinate hypertrophy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Nocturnal dyspnoea	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Pharyngeal mass	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Pickwickian syndrome	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.37% 22/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.28% 17/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.35% 21/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.13% 8/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Productive cough	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.12% 7/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.12% 7/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.15% 9/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Pulmonary toxicity	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.15% 9/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.25% 15/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.25% 15/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Restrictive pulmonary disease	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Wegener's granulomatosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Blister	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Campbell de Morgan spots	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Diabetic bullosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Diabetic ulcer	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Drug eruption	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Dry gangrene	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Eczema	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Eczema nummular	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Erythema	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Erythema multiforme	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Leukocytoclastic vasculitis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Pemphigoid	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Pemphigus	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Photosensitivity allergic reaction	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Rash	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Rash erythematous	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Skin ulcer	0.10% 6/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Social circumstances Joint prosthesis user	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Social circumstances Refusal of treatment by patient	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Social circumstances Walking disability	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Alcohol rehabilitation	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Aortic aneurysm repair	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Aortic valve repair	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Aortic valve replacement	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Arthrodesis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Artificial urinary sphincter implant	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Bladder neoplasm surgery	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Bladder operation	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Cardiac ablation	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Cardiac operation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Cardiac pacemaker battery replacement	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Cardiac pacemaker insertion	0.15% 9/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.12% 7/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.17% 10/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Cardiac pacemaker replacement	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Cardiac pacemaker revision	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Cardioversion	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Cataract operation	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Chemotherapy	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Cholecystectomy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Colon operation	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Contraceptive diaphragm	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Coronary angioplasty	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Coronary artery bypass	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Craniotomy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Debridement	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Dupuytren's contracture operation	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Endarterectomy	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Eventration procedure	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Explorative laparotomy	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Eye operation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Gamma radiation therapy to prostate	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Gastrointestinal tube insertion	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Heart valve operation	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Hepatectomy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Hernia repair	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures High frequency ablation	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Hip arthroplasty	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Hospitalisation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Hysterectomy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Hysterosalpingo-oophorectomy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Implantable defibrillator insertion	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Incisional hernia repair	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Inguinal hernia repair	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Internal fixation of fracture	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Knee arthroplasty	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Laparoscopic surgery	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Malignant tumour excision	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Mass excision	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Mastectomy	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Medical device implantation	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Medical device removal	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Mitral valve repair	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Mitral valve replacement	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Nerve block	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Open reduction of fracture	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Osteosynthesis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Patellectomy	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Pleurodesis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Polymedication	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Prostatic operation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Radiotherapy	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Resuscitation	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Shoulder arthroplasty	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Skin neoplasm excision	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Spinal laminectomy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Stent placement	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Sternotomy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Surgery	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Tendon operation	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Thoracotomy	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Thyroidectomy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Toe amputation	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Transfusion	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Transurethral prostatectomy	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Umbilical hernia repair	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Uterine dilation and curettage	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Surgical and medical procedures Wound drainage	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Accelerated hypertension	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Aneurysm	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Angiodysplasia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Aortic aneurysm	0.13% 8/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.15% 9/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Aortic aneurysm rupture	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Aortic calcification	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Aortic dissection	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Aortic occlusion	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Aortic rupture	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Aortic stenosis	0.18% 11/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.08% 5/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Aortic thrombosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Arterial occlusive disease	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Arterial stenosis limb	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Arterial thrombosis limb	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Arteriosclerosis	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Arteriosclerosis obliterans	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Bleeding varicose vein	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Circulatory collapse	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Deep vein thrombosis	0.12% 7/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Embolism	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Exsanguination	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Extremity necrosis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Femoral arterial stenosis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Femoral artery occlusion	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Haematoma	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.12% 7/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.22% 13/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Haemorrhage	0.12% 7/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.15% 9/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.13% 8/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Hypertension	0.27% 16/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.17% 10/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.17% 10/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Hypertensive crisis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Hypertensive emergency	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Hypotension	0.28% 17/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.15% 9/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.23% 14/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Hypovolaemic shock	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Iliac artery occlusion	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Iliac artery stenosis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Intermittent claudication	0.05% 3/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Ischaemia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Jugular vein distension	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Leriche syndrome	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Lymphangiectasia	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Orthostatic hypotension	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Peripheral arterial occlusive disease	0.07% 4/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.05% 3/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.07% 4/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Peripheral artery aneurysm	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Peripheral embolism	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Peripheral ischaemia	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Peripheral vascular disorder	0.08% 5/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.10% 6/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Phlebitis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Phlebitis deep	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Shock haemorrhagic	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Subclavian artery thrombosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Subclavian vein thrombosis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Temporal arteritis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Thrombophlebitis	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Thrombosis	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Varicose vein	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Varicose vein ruptured	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Vascular insufficiency	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Vascular occlusion	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Vasculitis	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Venous haemorrhage	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Venous insufficiency	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Venous thrombosis	0.02% 1/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Venous thrombosis limb	0.03% 2/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.00% 0/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.02% 1/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Vascular disorders Wound haemorrhage	0.00% 0/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	0.03% 2/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.

Other adverse events

Measure	Dabigatran 110 mg n=5983 participants at risk 110 mg twice daily, total daily dose 220 mg	Dabigatran 150 mg n=6059 participants at risk 150 mg twice daily, total daily dose 300 mg	Warfarin n=5998 participants at risk Target International Normalized Ratio (INR) of 2.0 to 3.0
Gastrointestinal disorders Diarrhoea	5.8% 347/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	5.9% 360/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	5.1% 308/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Gastrointestinal disorders Dyspepsia	6.1% 362/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	5.7% 344/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	1.4% 83/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Chest pain	4.3% 258/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	5.1% 310/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	4.9% 296/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Fatigue	6.1% 367/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	6.0% 361/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	5.7% 341/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
General disorders Oedema peripheral	7.3% 436/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	7.2% 439/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	7.3% 440/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Infections and infestations Nasopharyngitis	5.3% 315/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	5.1% 309/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	5.5% 327/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Back pain	4.7% 281/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	4.5% 272/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	5.4% 322/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Nervous system disorders Dizziness	7.4% 442/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	7.3% 440/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	8.9% 536/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Cough	5.3% 318/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	5.1% 308/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	5.7% 343/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.7% 460/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	8.0% 483/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	8.4% 506/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.
Musculoskeletal and connective tissue disorders Arthralgia	4.1% 246/5983 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	5.1% 306/6059 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.	5.3% 318/5998 • 36 months Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin.

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