GLORIA-AF Registry Program - Second and Third Phases

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01468701
• Collaborator: (none)
• Enrollment: 37,235
• Locations: 666
• Actual Duration (Months): 98.1
• Patients Per Site: 55.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into two protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Atrial Fibrillation

Study Design

• Study Type: Observational
• Actual Enrollment: 37235 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III)
• Actual Study Start Date: Nov 7, 2011
• Actual Primary Completion Date: Jan 10, 2020
• Actual Study Completion Date: Jan 10, 2020

Outcome Measures

Primary Outcome Measures

1. Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase II [From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.]

   Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.

2. Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase III [From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.]

   Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown cause of death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.

3. Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase II [From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.]

   Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.

4. Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase III [From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.]

   Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.

5. Incidence Rate of Stroke or Systemic Embolism - Phase III [From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.]

   Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.

6. Incidence Rate of Stroke - Phase II [From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.]

   Incidence rate of stroke on all eligible patients excluding prescribed but not taken set for Dabigatran etexilate (DE) of phase II only is presented. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.

7. Incidence Rate of Stroke - Phase III [From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.]

   Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.

8. Incidence Rate of Transient Ischaemic Attack (TIA) - Phase II [From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.]

   Incidence rate of transient ischaemic attack (TIA) on on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.

9. Incidence Rate of Transient Ischaemic Attack (TIA) - Phase III [From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.]

   Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.

10. Incidence Rate of Systemic Embolism (SE) - Phase II [From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.]

    Incidence rate of systemic embolism (SE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.

11. Incidence Rate of Systemic Embolism (SE) - Phase III [From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.]

    Incidence rate of systemic embolism (SE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.

12. Incidence Rate of Pulmonary Embolism (PE) - Phase II [From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.]

    Incidence rate of pulmonary embolism (PE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.

13. Incidence Rate of Pulmonary Embolism (PE) - Phase III [From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.]

    Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.

14. Incidence Rate of Major Bleeding Events (MBE) - Phase II [From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.]

    Incidence rate of major bleeding events (MBE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.

15. Incidence Rate of Major Bleeding Events (MBE) - Phase III [From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.]

    Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.

16. Incidence Rate of Life-threatening Bleeding Events - Phase II [From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.]

    Incidence rate of life-threatening bleeding events on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.

17. Incidence Rate of Life-threatening Bleeding Events - Phase III [From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.]

    Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.

18. Incidence Rate of Myocardial Infarction (MI) - Phase II [From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.]

    Incidence rate of myocardial infarction (MI) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.

19. Incidence Rate of Myocardial Infarction (MI) - Phase III [From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.]

    Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.

20. Incidence Rate of All-cause Death - Phase II [From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.]

    Incidence rate of all-cause death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.

21. Incidence Rate of All-cause Death - Phase III [From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.]

    Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.

22. Incidence Rate of Vascular Death - Phase II [From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.]

    Incidence rate of vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.

23. Incidence Rate of Vascular Death - Phase III [From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.]

    Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

1. Age =>18 years at enrollment

2. Male or female patient (or legally acceptable representative) willing and able to provide written informed consent

3. Patient newly diagnosed (< 3 months prior to baseline visit) with non-valvular AF and at risk for stroke.

Other inclusion criteria apply.

Exclusion criteria:

1. Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention;

2. Patients who have received more than 60 days of vitamin K antagonist (VKA) treatment in their lifetime;

3. AF with a generally reversible cause;

4. Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (for example, a VKA) is indicated Other exclusion criteria apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University South Alabama Medical Center	Mobile	Alabama	United States	38817
2	Black Warrior Research	Northport	Alabama	United States	35476
3	Scottsboro Quick Care Clinic	Scottsboro	Alabama	United States	35768
4	Alaska Heart Institute	Anchorage	Alaska	United States	99508
5	Phoenix Heart PLLC	Glendale	Arizona	United States	85306
6	Mercy Cinic Hot Springs Communities	Hot Springs	Arizona	United States	71913
7	Midwest Internal Medicine, PLLC	Lake Havasu City	Arizona	United States	86403
8	Sparks Regional Medical Center	Fort Smith	Arkansas	United States	72901
9	Dr. Michael A. Frais, Cardiologist, P.A.	Hot Springs	Arkansas	United States	71913
10	Cardiology and Medicine Clinic	Little Rock	Arkansas	United States	72204
11	Donald W. Reynolds Institute on Aging	Little Rock	Arkansas	United States	72205-7199
12	Arkansas Cardiology, PA	Little Rock	Arkansas	United States	72205
13	Diagnamics, Inc	Encinitas	California	United States	92024
14	Allianz Medical and Research Center	Fountain Valley	California	United States	92708
15	B&K Medical Research Center	Fresno	California	United States	93721
16	American Clinical Trials	Hawaiian Gardens	California	United States	90716
17	Scripps Clinic	La Jolla	California	United States	92037
18	La Mesa Cardiac Center	La Mesa	California	United States	91942
19	Los Alamitos Cardiovascular	Los Alamitos	California	United States	90720
20	VA Greater Los Angeles Healthcare System	Los Angeles	California	United States	90073
21	Mehrdad Kevin Ariani, MD, Incorporated	Northridge	California	United States	91325
22	VA Palo Alto Health Care System	Palo Alto	California	United States	94304
23	Eisenhower Desert Cardiology Center	Rancho Mirage	California	United States	92270
24	Ritchken and First MD's	San Diego	California	United States	92117
25	Coastal Heart Group Inc	Santa Ana	California	United States	92704
26	Pacific Heart and Vascular	Stockton	California	United States	95210
27	Southwest Heart Institute	Temecula	California	United States	92591
28	University of California Los Angeles	Torrance	California	United States	90509
29	Cardiology Associates Medical Group Inc	Ventura	California	United States	93003
30	Ventura Cardiology Consultants Medical Group, Inc	Ventura	California	United States	93003
31	Ventura Clinical Trials	Ventura	California	United States	93003
32	Office of Dr. David J Cislowski MD	Visalia	California	United States	93291
33	Aurora Denver Cardiology Associates, PC	Aurora	Colorado	United States	80012
34	Lynn Institute of the Rockies	Colorado Springs	Colorado	United States	80909
35	Pikes Peak Cardiology	Colorado Springs	Colorado	United States	80909
36	Denver Health Medical Center	Denver	Colorado	United States	80204
37	South Denver Cardiology Associates, PC	Littleton	Colorado	United States	80120
38	Connecticut Clinical Research, LLC	Bridgeport	Connecticut	United States	06606
39	Connecticut Heart and Vascular Center	Bridgeport	Connecticut	United States	06606
40	Bridgeport Hospital	Bridgeport	Connecticut	United States	06610
41	Cardiology Associates of Fairfield County	Norwalk	Connecticut	United States	06851
42	Norwalk Medical Group	Norwalk	Connecticut	United States	06851
43	Heart Specialists, PC of Southern CT	Shelton	Connecticut	United States	06484
44	Red Clay Research LLC.	Newark	Delaware	United States	19713
45	Howard University Hospital	Washington	District of Columbia	United States	20006
46	Cardiac Arrhythmia Center	Washington	District of Columbia	United States	20010
47	Medical Faculty Associates, Inc	Washington	District of Columbia	United States	20037
48	Aventura Institute for Cardiovascular Wellness, PA	Aventura	Florida	United States	33180
49	Bay Area Cardiology	Brandon	Florida	United States	33511
50	Tampa Bay Medical Research	Clearwater	Florida	United States	33761
51	Seidman Clinical Trials	Delray Beach	Florida	United States	33484
52	Universal Clinical Research Associates	Doral	Florida	United States	33166
53	Cardiovascular Research of North Florida LLC	Gainesville	Florida	United States	32605
54	Magi Research Clinic, Inc	Hialeah	Florida	United States	33013
55	Global Research Solutions Corporation	Hollywood	Florida	United States	33021
56	St. Vincent's Ambulatory Care	Jacksonville	Florida	United States	32216
57	Tenet Florida Physician Services	Jupiter	Florida	United States	33458
58	Watson Clinic Center for Research, Inc	Lakeland	Florida	United States	33805
59	A&L Clinical Research	Miami	Florida	United States	33126
60	Miami Center for Cardiovascular Disease	Miami	Florida	United States	33136
61	Global Research Solutions Corporation	Miami	Florida	United States	33144
62	Cardiovascular Research Center of South Florida	Miami	Florida	United States	33173
63	New Horizon Research Center	Miami	Florida	United States	33175
64	Sacred Heart Medical Specialty Group	Miramar Beach	Florida	United States	32550
65	Collier HMA Physician Management	Naples	Florida	United States	34119
66	Edgewater Medical Research	New Smyrna Beach	Florida	United States	32169
67	SouthEast Medical Centre	Oakland Park	Florida	United States	33309
68	Research One	Orlando	Florida	United States	32806
69	South Florida Research Solutions, LLC	Pembroke Pines	Florida	United States	33028
70	Langhorne Cardiology Consultants, Inc	Pensacola	Florida	United States	32501
71	VNH Heart Center Research	Port Charlotte	Florida	United States	33952
72	Brevard Cardiovascular Research Associates, Inc	Rockledge	Florida	United States	32955
73	Suncoast Cardiovascular Research Inc.	Saint Petersburg	Florida	United States	33701
74	Northside Hospital	Saint Petersburg	Florida	United States	33709
75	Alternative Solutions Medical Research and Prevention Center	Saint Petersburg	Florida	United States	33711
76	Velella Research, Inc	Sarasota	Florida	United States	34233
77	Cardiovascular Center of Sarasota	Sarasota	Florida	United States	34239
78	James C. Neiman, MD	Seminole	Florida	United States	33772
79	Tallahassee Research Instutite	Tallahassee	Florida	United States	32308
80	University of South Florida	Tampa	Florida	United States	33606
81	Indian River Medical Associates Cardiology	Vero Beach	Florida	United States	32960
82	Cardiology Partners Clinical Research Institute	Wellington	Florida	United States	33449
83	Executive Health and Research Associates	Atlanta	Georgia	United States	30342
84	Saint Joseph's Research Institute	Atlanta	Georgia	United States	30342
85	Atlanta Heart Specialists, LLC	Cumming	Georgia	United States	30041
86	William C McGarity, Jr, MD, PC	Decatur	Georgia	United States	30035
87	Coliseum Medical Center	Macon	Georgia	United States	31217
88	Kootenai Heart Clinics, LLC	Coeur d'Alene	Idaho	United States	83814
89	Northwest Heart Clinical Research, LLC	Arlington Heights	Illinois	United States	60005
90	Prairie Cardiovascular Memorial Hospital	Carbondale	Illinois	United States	62901
91	Captain James A. Lovell Federal Health Care Center	Chicago	Illinois	United States	60064
92	Medex Healthcare Research	Chicago	Illinois	United States	60602
93	John H. Stroger Jr. Hospital of Cook Country	Chicago	Illinois	United States	60612
94	University of Illinois at Chicago	Chicago	Illinois	United States	60612
95	North Shore Cardiology Consultants	Chicago	Illinois	United States	60631
96	University of Chicago	Chicago	Illinois	United States	60637
97	Northwestern University	Evanston	Illinois	United States	60208
98	Advanced Heart Care, LLC, Medicoricum, LLC	Fairview Heights	Illinois	United States	62208
99	Adventist Health Partners, Inc	Hinsdale	Illinois	United States	60521
100	Consultants in Cardiovascular Medicine	Melrose Park	Illinois	United States	60160
101	Koch Family Medicine	Morton	Illinois	United States	61550
102	Advanced Cardiovascular Consultants	Rock Island	Illinois	United States	61201
103	DuPage Medical Group	Winfield	Illinois	United States	60190
104	Hendricks Family Medicine	Brownsburg	Indiana	United States	46112
105	Parkview Research Center	Fort Wayne	Indiana	United States	46845
106	St. Vincent Medical Group	Indianapolis	Indiana	United States	46260
107	Beacon Medical Group Clinical Research	LaPorte	Indiana	United States	46350
108	Cardiology Associates of Northwest Indiana, PC	Munster	Indiana	United States	46321
109	Beacon Medical Group Clinical Research	South Bend	Indiana	United States	46601
110	McFarland Clinic PC	Ames	Iowa	United States	50010
111	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
112	Northeast Iowa Medical Education Foundation	Waterloo	Iowa	United States	50702
113	The Iowa Clinic, PC	West Des Moines	Iowa	United States	50266
114	Midwest Heart and Vascular Specialists	Overland Park	Kansas	United States	66211
115	Central Cardiology Associates	Elizabethtown	Kentucky	United States	42701
116	Robley Rex VA Medical Center	Louisville	Kentucky	United States	40206
117	Baptist Health Clinical Studies	Madisonville	Kentucky	United States	42431
118	Office of Dr. Paul McLaughlin, M.D.	Mount Sterling	Kentucky	United States	40353
119	Research Integrity, LLC	Owensboro	Kentucky	United States	42303
120	Cambridge Medical Trials	Alexandria	Louisiana	United States	71301
121	Cardiovascular Research Foundation of Louisiana	Baton Rouge	Louisiana	United States	70808
122	Grace Research, LLC	Bossier City	Louisiana	United States	71111
123	Heart Clinic of Hammond	Hammond	Louisiana	United States	70403
124	Cardiovascular Specialists of Southwest Louisiana, LLC	Lake Charles	Louisiana	United States	70601
125	Medpharmics, LLC	Metairie	Louisiana	United States	70006
126	LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
127	Advanced Cardiovascular Specialists	Shreveport	Louisiana	United States	71103
128	Louisiana Heart Center	Slidell	Louisiana	United States	70458
129	Southern Maine Health Care	Biddeford	Maine	United States	04005
130	Cardiac Consultants, LLC	Annapolis	Maryland	United States	21401
131	MedStar Health Research Institute	Baltimore	Maryland	United States	21218
132	MedStar Southern Maryland Hospital Center	Clinton	Maryland	United States	20735
133	Cardiovascular Specialists of Central Maryland	Columbia	Maryland	United States	21044
134	Delmarva Heart Research Foundation, Inc	Salisbury	Maryland	United States	21804
135	Peninsula Cardiology Associates	Salisbury	Maryland	United States	21804
136	Chesapeake Cardiovascular Associates	Towson	Maryland	United States	21204
137	Primary Care Cardiology Research, Inc	Ayer	Massachusetts	United States	01432
138	Genesys Research Institute, Incorporated	Brighton	Massachusetts	United States	02135
139	NECCR Internal Med and Cardio	Fall River	Massachusetts	United States	02720
140	Newton-Wellesley Hospital	Newton	Massachusetts	United States	02462
141	Endeavor Medical Research	Alpena	Michigan	United States	49707
142	McLaren Bay Region Medical Center	Bay City	Michigan	United States	48708
143	Henry Ford Hospital K-15	Detroit	Michigan	United States	48202
144	St. Vincent Consultants in Cardiovascular Disease, LLC	Erie	Michigan	United States	16502
145	Cardiology Consultants of East Michigan	Flint	Michigan	United States	48532
146	Genesys Heart Institute	Grand Blanc	Michigan	United States	48439
147	Regional Cardiology Associates	Grand Blanc	Michigan	United States	48439
148	Thoracic and Cardiovascular Healthcare Foundation	Lansing	Michigan	United States	48910
149	Upper Michigan Cardiovascular Associates, PC	Marquette	Michigan	United States	49855
150	McLaren-Macomb	Mount Clemens	Michigan	United States	48043
151	South Western Medical Clinic	Niles	Michigan	United States	49120
152	Providence Park Hospital	Novi	Michigan	United States	48374
153	Covenant Medical Center, Inc.	Saginaw	Michigan	United States	48602
154	MId-MIchigan Heart and Vascular Center	Saginaw	Michigan	United States	48604
155	Essentia Heart and Vascular Clinic	Duluth	Minnesota	United States	55805
156	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota	United States	55407
157	CentraCare Heart and Vascular Center	Saint Cloud	Minnesota	United States	56303
158	United Heart and Vascular Clinic	Saint Paul	Minnesota	United States	55102
159	The Center for Clinical Trials, Inc.	Biloxi	Mississippi	United States	39531
160	University Of Mississippi Medical Center	Jackson	Mississippi	United States	39216
161	Health Midwest Ventures Group, Inc	Kansas City	Missouri	United States	64132
162	Heartland Regional Medical Center	Saint Joseph	Missouri	United States	64506
163	Saint Louis University	Saint Louis	Missouri	United States	63110
164	Consult and Research Associates	Saint Louis	Missouri	United States	63122
165	Gateway Cardiology, PC	Saint Louis	Missouri	United States	63128
166	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
167	MidAmerica Cardiovascular Institute	Omaha	Nebraska	United States	68131
168	Meridian Clinical Research, LLC	Omaha	Nebraska	United States	68134
169	Board of Regents of the University of Nebraska	Omaha	Nebraska	United States	68198-7835
170	Alegent Health Heart and Vascular Specialists	Papillion	Nebraska	United States	68046
171	Renown Institute for Heart and Vascular Health	Reno	Nevada	United States	89502
172	VA Sierra Nevada Health Care System	Reno	Nevada	United States	89502
173	Medicor Cardiology	Bridgewater	New Jersey	United States	08807
174	Cooper University Hospital	Camden	New Jersey	United States	08014
175	Monmouth Cardiology Associates	Eatontown	New Jersey	United States	07724
176	Electrophysiology Associates of Northern New Jersey	Hackensack	New Jersey	United States	07601
177	Advocare Heights Primary Care	Haddon Heights	New Jersey	United States	08035
178	Associated Cardiovascular Consultants Lourdes	Hammonton	New Jersey	United States	08037
179	NJ Heart LLC	Linden	New Jersey	United States	07036
180	Garden State Heart Care, PC	Manalapan	New Jersey	United States	07726
181	Atlantic Cardiology, LLC	Neptune	New Jersey	United States	07753
182	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08901
183	Saint Joseph's Regional Medical Center	Paterson	New Jersey	United States	07503
184	The Valley Hospital	Ridgewood	New Jersey	United States	07450
185	Heart and Vascular Center of New Brunswick	Somerset	New Jersey	United States	08873
186	Central New Jersey Cardiology	South Plainfield	New Jersey	United States	07080
187	Associated Cardiovascular Consultants Lourdes	Voorhees	New Jersey	United States	08043
188	NJ Cardiology Associates	West Orange	New Jersey	United States	07052
189	Lovelace Scientific Resources, Inc.	Albuquerque	New Mexico	United States	87108
190	Albany Medical Center / Albany Medical College	Albany	New York	United States	12208
191	Cardiac Care and Vascular Medicine, PLLC	Bronx	New York	United States	10469
192	New York -Presbyterian Brooklyn Methodist Hospital	Brooklyn	New York	United States	11215
193	Community Cardiology	Camillus	New York	United States	13031
194	Bassett Medical Center	Cooperstown	New York	United States	13326
195	New York Hospital Queens	Flushing	New York	United States	11355
196	UHS Office of Clinical Trials	Johnson City	New York	United States	13790
197	Long Island Heart Associates	Mineola	New York	United States	11501
198	Chinatown Cardiology, PC	New York	New York	United States	10013
199	Lenox Hill Hospital	New York	New York	United States	10021
200	Saint Luke - Roosevelt Hospital Center	New York	New York	United States	10025
201	Saratoga Clinical Research, LLC	Saratoga Springs	New York	United States	12866
202	Stony Brook Cardiology/Electrophysiology	Stony Brook	New York	United States	11794-8167
203	SUNY Upstate Medical University	Syracuse	New York	United States	13202
204	New York Heart Center	Syracuse	New York	United States	13210
205	Great Lakes Medical Research	Westfield	New York	United States	14787
206	Cardiology Group of Western New York, PC	Williamsville	New York	United States	14221
207	Kernodle Clinic West	Burlington	North Carolina	United States	27215
208	Clinical Trials of America, Inc	Hickory	North Carolina	United States	28601
209	Carolina Cardiology Cornerstone	High Point	North Carolina	United States	27262
210	Profen Research Network at East Carolina Medical Associates	Jacksonville	North Carolina	United States	28546
211	Kannapolis Internal Medicine	Kannapolis	North Carolina	United States	28083
212	Clinical Trials of America, Inc	Lenoir	North Carolina	United States	28645
213	Pinehurst Medical Clinic, Inc	Pinehurst	North Carolina	United States	28374
214	Wake Heart Research	Raleigh	North Carolina	United States	27610
215	Wake Heart and Vascular Associates	Wilson	North Carolina	United States	27893
216	Lillestol Research, LLC	Fargo	North Dakota	United States	58103
217	Trinity Health Center Medical Arts	Minot	North Dakota	United States	58701
218	Aultman Hospital	Canton	Ohio	United States	44710
219	University of Cincinnati	Cincinnati	Ohio	United States	45267
220	The MetroHealth System	Cleveland	Ohio	United States	44109-1998
221	Mercy Health Fairfield Hospital	Fairfield	Ohio	United States	45014
222	Cleveland Cardiovascular Research Foundation	Fairview Park	Ohio	United States	44126
223	Emil Hayek, M.D., Inc	Hudson	Ohio	United States	44236
224	Innovation Center, Kettering Medical Center	Kettering	Ohio	United States	45429
225	RAS Health Ltd	Marion	Ohio	United States	43302
226	Frederick C Smith Clinic Inc	Marion	Ohio	United States	43342
227	Mound Family Practice	Miamisburg	Ohio	United States	45342
228	Heart House Research Foundation, LLC	Springfield	Ohio	United States	45504
229	Cardiovascular Research Center	Toledo	Ohio	United States	43608
230	Toledo Clinic Incorporated	Toledo	Ohio	United States	43623
231	Great Lakes Medical Research, LLC	Willoughby	Ohio	United States	44094
232	Ohio Heart Institute	Youngstown	Ohio	United States	44504
233	Oklahoma Foundation for Cardiovascular Research	Oklahoma City	Oklahoma	United States	73120
234	INTEGRIS Ambulatory Care Corporation	Yukon	Oklahoma	United States	73099
235	Good Samaritan Hospital Corvallis	Corvallis	Oregon	United States	97330
236	Fanno Creek Clinic, LLC	Portland	Oregon	United States	97219
237	Sacred Heart Medical Center at RiverBend	Springfield	Oregon	United States	97477
238	Abington Medical Specialists	Abington	Pennsylvania	United States	19003
239	Capital Area Research, LLC	Camp Hill	Pennsylvania	United States	17011
240	Preferred Primary Care Phys	Carnegie	Pennsylvania	United States	15106
241	Chambersburg Hospital	Chambersburg	Pennsylvania	United States	17201
242	Central Bucks Cardiology	Doylestown	Pennsylvania	United States	18901
243	Physician Specialist of Northern Lancaster County Medcl Grp	Ephrata	Pennsylvania	United States	17522
244	Harleysville Medical Associates	Harleysville	Pennsylvania	United States	19438
245	Lycoming Internal Medicine, Inc	Jersey Shore	Pennsylvania	United States	17740
246	Cardiology Consultants of Philadelphia	Lansdale	Pennsylvania	United States	19446-3748
247	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104-6205
248	Pennsylvania Cardiology Associates	Philadelphia	Pennsylvania	United States	19106
249	Einstein Medical Center Philadelphia	Philadelphia	Pennsylvania	United States	19141
250	Allegheny Neurology Associates	Pittsburgh	Pennsylvania	United States	15212
251	Grand View - Lehigh Valley Health Services	Sellersville	Pennsylvania	United States	18960
252	Warminster Medical Associates, PC	Warminster	Pennsylvania	United States	18974
253	Cardiology Consultants of Philadelphia	Yardley	Pennsylvania	United States	19067
254	Memorial Hospital of RI	Pawtucket	Rhode Island	United States	02860
255	South County Cardiology	Wakefield	Rhode Island	United States	02879
256	AnMed Health Clinical Research	Anderson	South Carolina	United States	29621
257	Internal Medicine Associates of Anderson, PA	Anderson	South Carolina	United States	29621
258	Lowcountry Medical Group, LLC	Beaufort	South Carolina	United States	29906
259	South Carolina Heart Center	Columbia	South Carolina	United States	29204
260	Piedmont Cardiology Associates, P.A.	Greenwood	South Carolina	United States	29646
261	Family Medicine of SayeBrook	Myrtle Beach	South Carolina	United States	29588
262	Black Hills Cardiovascular Research	Rapid City	South Dakota	United States	57701
263	Office of Yvonne Chester	Chattanooga	Tennessee	United States	37404
264	The Jackson Clinic, PA	Jackson	Tennessee	United States	38301
265	Center For Cardiovascular Research	Johnson City	Tennessee	United States	37604
266	PMG Research of Knoxville	Knoxville	Tennessee	United States	37912
267	Tennova Healthcare-Turkey Creek Medical Center	Knoxville	Tennessee	United States	37934
268	PMG Research of Knoxville	Knoxville	Tennessee	United States	37938
269	THV Research, LLC	Austin	Texas	United States	78745
270	Southeast Texas Clinical Research Center	Beaumont	Texas	United States	77702
271	Dallas VA Medical Center	Dallas	Texas	United States	75216
272	Heartplace	Dallas	Texas	United States	75226
273	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390-8837
274	Amir Malik Research	Fort Worth	Texas	United States	76104
275	State of the Heart Cardiology	Grapevine	Texas	United States	76051
276	Angiocardiac Care of Texas	Houston	Texas	United States	77025
277	Houston Methodist DeBakey Cardiology Associates	Houston	Texas	United States	77030
278	Barry Troyan, M.D, PA	Houston	Texas	United States	77043
279	Centex Studies, Inc.	Houston	Texas	United States	77062
280	Dairy Ashford Family Pratice	Houston	Texas	United States	77077
281	Cardiovascular Associates PLLC	Humble	Texas	United States	77338
282	Cardiology Center of Houston, PA	Katy	Texas	United States	77450
283	Texas Cardiology Research Center PLLC	Kingwood	Texas	United States	77339
284	Caprock Cardiac Center Research Institute	Lubbock	Texas	United States	79410
285	Mission Research Institute, LLC	New Braunfels	Texas	United States	78130
286	Mercury Medical ,LLC	San Antonio	Texas	United States	78229
287	Texas Medical Research Associates	San Antonio	Texas	United States	78238
288	Sealy Urgent Care Center and Medical Clinic	Sealy	Texas	United States	77474
289	Seguin Institute of Cardiovascular Research	Seguin	Texas	United States	78155
290	Sugarland Cardiology	Sugar Land	Texas	United States	77479
291	Cardiovascular Associates of East Texas, PA	Tyler	Texas	United States	75701
292	Trinity Clinic	Tyler	Texas	United States	75702
293	University of Texas Health Science Center at Tyler	Tyler	Texas	United States	75708
294	Providence Health Services of Waco	Waco	Texas	United States	76712
295	Hill County Primary Care	Whitney	Texas	United States	76692
296	Heart Center at Saint Mark's	Salt Lake City	Utah	United States	84124
297	Highland Clinical Research	Salt Lake City	Utah	United States	84124
298	Burke Internal Medicine and Research	Burke	Virginia	United States	22015
299	University of Virginia Health System	Charlottesville	Virginia	United States	22908
300	Cardiovascular Associates, Ltd	Chesapeake	Virginia	United States	23320
301	Cardiology Consultants of Danville, Inc	Danville	Virginia	United States	24541
302	Inova Research Center	Falls Church	Virginia	United States	22042
303	Virginia Heart	Falls Church	Virginia	United States	22042
304	Mary Washington Hospital Research Department	Fredericksburg	Virginia	United States	22401
305	Harrisonburg Medical Associates	Harrisonburg	Virginia	United States	22801
306	Manassas Clinical Research Center	Manassas	Virginia	United States	20110
307	Cardiovascular Associates of Virginia	Midlothian	Virginia	United States	23114
308	CJW Medical Center - Chippenham	Richmond	Virginia	United States	23225
309	Carilion Clinic	Roanoke	Virginia	United States	24014
310	Salem VA Medical Center	Salem	Virginia	United States	24153
311	Selma Medical Associates, Winchester	Winchester	Virginia	United States	22601
312	Sound Medical Research	Port Orchard	Washington	United States	98366
313	The Polyclinic	Seattle	Washington	United States	98133
314	Franciscan Heart and Vascular Associates	Tacoma	Washington	United States	98405
315	Cardiac and Thoracic Institute of Central Washington	Yakima	Washington	United States	98902
316	CAMC Clinical Trials Center	Charleston	West Virginia	United States	25304
317	University Cardiovascular Services	Huntington	West Virginia	United States	25701
318	St. Mary's Medical Center	Huntington	West Virginia	United States	25702
319	Mayo Clinic-Sparta	La Crosse	Wisconsin	United States	54601
320	Karim Bakhtiar MD, SC	Milwaukee	Wisconsin	United States	53215
321	Family Medical Clinic	Milwaukee	Wisconsin	United States	53216
322	Wheaton Franciscan	Milwaukee	Wisconsin	United States	53221
323	Milwaukee VA Medical Center	Milwaukee	Wisconsin	United States	53295
324	ProHealth Care Research Institute and Cardiology Associates	Waukesha	Wisconsin	United States	53188
325	Consultorios Hematologicos SRL	Buenos Aires		Argentina	1188
326	Clinica Coronel Suárez	Buenos Aires		Argentina	B7540GHD
327	Hospital Italiano de Buenos Aires	Buenos Aires		Argentina	C1181ACH
328	Instituto Cardiovascular de Buenos Aires	Buenos Aires		Argentina	C1428
329	Instituto Cardiovascular de Corrientes Juana Francisca Cabra	Corrientes		Argentina	C3400
330	Hospital Espanol de Mendonza	Godoy Cruz		Argentina	5501
331	Hospital Privado de Comunidad	Mar del Plata		Argentina	7602
332	DIM Clinica Privada	Ramos Mejía		Argentina	B1704ETD
333	Hospital Privado de Rosario	Rosario		Argentina	S2000GAP
334	Consultorio del Dr. Aiub	San Isidro		Argentina	1642
335	Sanatorio San Lucas	San Isidro		Argentina	B1642DJG
336	Unidad Coronaria San Geronimo S.R.L.	Santa Fe		Argentina	3000
337	Clinical Juncal	Temperley		Argentina	1834
338	Sanatorio 9 de Julio S.A.	Tucuman		Argentina	4000
339	Centro Privado de Cardiología	Tucumán		Argentina	T4000NIL
340	CEMEDIC - Centro de Especialidades Medicas	Villa Luro		Argentina	1407
341	Hospital Vera Cruz	Belo Horizonte		Brazil	30140-092
342	Clinica Procardio Ltda	Blumenau		Brazil	89010-500
343	Hospital do Coracao do Brasil	Brasilia		Brazil	70390-903
344	Instituto de Cardiologia do Distrito Federal	Brasilia		Brazil	70658-700
345	Hospital Angelina Caron	Campina Grande do Sul		Brazil	83430-000
346	Centro Especializado em Cardiol Loema Instituto de Pesq Clin	Campinas		Brazil	13010-001
347	HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas	Campinas		Brazil	13060-904
348	Hospital Nossa Senhora de Pompeia	Caxias do Sul		Brazil	95084-900
349	Irmandade da Santa Casa de Misericordia de Curitiba	Curitiba		Brazil	80010-030
350	Barroso e Sebba Ltda	Goiania		Brazil	74223-130
351	CLINICOR-Clinica de Exames Cardiolog e Ecografias S S LTDA	Maceio		Brazil	57051-500
352	Hospital São Vicente de Paulo	Passo Fundo		Brazil	99010-080
353	Hospital de Clínicas de Porto Alegre	Porto Alegre		Brazil	90035-903
354	Fundacao Universitaria de Cardiologia - Inst de Cardiologia	Porto Alegre		Brazil	90620-001
355	Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares	Recife		Brazil	50100-130
356	Hospital Copa D'or	Rio de Janeiro		Brazil	22031-011
357	Fundacao Pro-Coracao FUNDACOR	Rio de Janeiro		Brazil	22240-004
358	Instituto Cardiopulmonar da Bahia LTDA	Salvador		Brazil	40170-130
359	Fundacao Bahiana de Cardiologia	Salvador		Brazil	41810-010
360	Instituto de Ensino E Pesquisa Do Hospital Da Bahia	Salvador		Brazil	41810-011
361	Instituto de Molestias Cardiovasculares - IMC	Sao Jose do Rio Preto		Brazil	15015-210
362	Hcor - Hospital do Coracao	Sao Paulo		Brazil	04004-030
363	Instituto Dante Pazzanese de Cardiologia	Sao Paulo		Brazil	04012-180
364	Hospital Santa Marcelina	Sao Paulo		Brazil	08270-070
365	Hospital Sao Paulo UNIFESP	Sao Paulo		Brazil	4038-031
366	H.S.J. Beneficência Portuguesa - São Paulo	São Paulo		Brazil	01323-001
367	FGM - Clínica Paulista de Doenças Cardiovasculares	São Paulo		Brazil	01327-010
368	Hospital das Clinicas da Faculdade de Medicina - FMUSP	São Paulo		Brazil	05403-000
369	Instituto de Molestias Cardiovasculares Tatui SP	Tatui		Brazil	18270-170
370	Santa Casa de Votuporanga	Votuporanga		Brazil	15500-003
371	Foothills Medical Centre	Calgary	Alberta	Canada	T2N 2T9
372	University of Alberta Hospital (University of Alberta)	Edmonton	Alberta	Canada	T6G 2B7
373	North Road Clinical Research	Coquitlam	British Columbia	Canada	V3K 3V9
374	Kelowna General Hospital	Kelowna	British Columbia	Canada	V1Y 1E4
375	Crestwood Med & Dental Bldg	Richmond	British Columbia	Canada	V7C 3V3
376	Ocean West Research Clinic Inc.	Surrey	British Columbia	Canada	V3S 2N6
377	Victoria Cardiac Arrhythmia Trials Inc.	Victoria	British Columbia	Canada	V8T 1Z4
378	Q & T Research Chicoutimi Inc	Chicoutimi	Migration Data	Canada	G7H 7Y8
379	CardioVasc HR Inc.	St-Jean-sur-Richel	Migration Data	Canada	J3A 1C3
380	Saint John Regional Hospital	Saint John	New Brunswick	Canada	E2L 4L2
381	Eastern Health (MUN)	St. John's	Newfoundland and Labrador	Canada	A1B 3V6
382	Antigonish Medical Associates Inc.	Antigonish	Nova Scotia	Canada	B2G 2C7
383	QEII Health Sciences Centre	Halifax	Nova Scotia	Canada	B3H 3A7
384	Cambridge Cardiac Care Inc.	Cambridge	Ontario	Canada	N1R 6V6
385	West Lincoln Memorial Hospital	Grimsby	Ontario	Canada	L3M 1P3
386	Winterberry Family Medicine	Hamilton	Ontario	Canada	L8J 0B6
387	Hamilton Medical Research Group	Hamilton	Ontario	Canada	L8M 1K7
388	Hamilton General Hospital	Hamilton	Ontario	Canada	L8S 4T1
389	Victoria Hospital (LHSC)	London	Ontario	Canada	N6A 5A5
390	Mississauga Clinical Research Centre	MIssissauga	Ontario	Canada	L5B 2P7
391	SKDS Research Incorporated	Newmarket	Ontario	Canada	L3Y 5G8
392	M Heffernan Medicine Professional Corp.	Oakville	Ontario	Canada	L6K 3W7
393	Oshawa Clinic Cardiology Department, Oshawa, Courtice	Oshawa	Ontario	Canada	L1H 1B9
394	Ottawa Hospital - Civic Campus	Ottawa	Ontario	Canada	K1Y 4E9
395	University of Ottawa Heart Institute Cardiology Research	Ottawa	Ontario	Canada	K1Y 4W7
396	Aviva Clinical Trial Group Inc.	Stoney Creek	Ontario	Canada	L8J 2V8
397	SGH Medical Mall	Toronto	Ontario	Canada	M1P 2T7
398	Keele Medical Place	Toronto	Ontario	Canada	M3M 3E5
399	Toronto General Hospital	Toronto	Ontario	Canada	M4G 2C4
400	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8
401	Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8
402	Clinique de Cardiologie de Levis	Levis	Quebec	Canada	G6V 4Z5
403	CHUM Hotel Dieu	Montreal	Quebec	Canada	H2W 1T8
404	Recherche Clinique Sigma Inc.	Québec	Quebec	Canada	G1G 3Y8
405	IUCPQ (Laval University)	Sainte-Foy	Quebec	Canada	G1V 4G5
406	CHUS Fleurimont	Sherbrooke	Quebec	Canada	J1H 5N4
407	Baycole Research	Saskatoon	Saskatchewan	Canada	S7L 2W1
408	Hospital Clínico Fuerza Aérea de Chile	Santiago		Chile	7560171
409	Centro de Estudios Clinicos Barros Luco	Santiago		Chile	8910131
410	Hospital y CRS El Pino	Santiago		Chile
411	CECMI Ltda	Temuco		Chile	4813299
412	Clinica Tabancura	Vitacura		Chile	7650018
413	CINVEC - Centro de Investigacion Clinica V Reg.,Vina del Mar	Viña del Mar		Chile	2520997
414	Beijing AnZhen Hospital	Beijing		China	100029
415	Peking University First Hospital	Beijing		China	100034
416	Cardiovascular Institute and Fu Wai Hospital	Beijing		China	100037
417	Beijing Shijingshan Hospital	Beijing		China	100043
418	Beijing Tsinghua Changgung Hospital	Beijing		China	100044
419	Peking Union Medical College Hospital	Beijing		China	100730
420	First Hospital of Jilin University	Changchun		China	130021
421	Xiangya Hospital, Central South University	Changsha		China	410008
422	2nd Xiangya Hospital of Central South University	Changsha		China	410011
423	Chinese Traditional Medicine Hospital of Sichuna Provinc	Chengdu		China	610000
424	Center Hospital of Dalian	Dalian		China	116033
425	Foshan Hospital of Southern Medical University	Foshan		China	528000
426	Fujian Provincal Hospital	Fuzhou		China	350001
427	Guangdong Provincial People's Hospital	Guangzhou		China	510080
428	The First Afiliated Hospital, Sun Yet-sen University	Guangzhou		China	510080
429	Wu Jing Zong Dui Hospital of Guangdong Province	Guangzhou		China	510507
430	The First Affiliated Hospital of Jinan University	Guangzhou		China	510630
431	The Affiliated Hospital of Hangzhou Normal University	Hangzhou		China	310000
432	Hangzhou First People's Hospital	Hangzhou		China	310006
433	Shandong Jiaotong Hospital	Jinan		China	250000
434	Center Hospital of Jinan	Jinan		China	250013
435	Qianfoshan Hospital affiliated to Shandong University	Jinan		China	250014
436	Shandong Provincial Hospital	Jinan		China	250021
437	Jining No.1 people's hospital	Jining		China	272111
438	The Second Affiliated Hospital to Nanchang University	Nanchang		China	330006
439	Zhongda Hospital Southeast University	Nanjing		China	210009
440	The affiliated hospital of medicalcollege qingdao university	Qingdao		China	266003
441	QingDao Municipal Hospital	QingDao		China	266011
442	Qingdao Fuwai Hospital	Qingdao		China	266034
443	Qingdao Central Hospital	Qingdao		China	266042
444	Chinese People's Liberation Army 401 Hospital	Qingdao		China	266071
445	Huashan Hospital, Fudan University	Shanghai		China	200040
446	Shanghai Huadong Hospital	Shanghai		China	200040
447	Tongji Hospital, Tongji University	Shanghai		China	200065
448	Shanghai East Hospital, Tongji University China	Shanghai		China	200120
449	Renji Hospital Shanghai Jiaotong Univesrity School of Medicine	Shanghai		China	200127
450	Minhang District Central Hospital	Shanghai		China	201199
451	Songjiang Hospital	Shanghai		China	201600
452	Jiading Hospital	Shanghai		China	201800
453	Shengjing Hospital of China Medical University	Shenyang		China	110004
454	General Hospital of Shenyang Military Region	Shenyang		China	110015
455	People's Hospital of Liaoning Province	Shenyang		China	110016
456	The Forth People's Hospital of Shenzhen	Shenzhen		China	518033
457	The Second Hospital of Hebei Medical University	Shijiazhuang		China	050000
458	Hebei Provincial Tumor Hospital	Shijiazhuang		China	050011
459	SuZhou Kowloon Hospital	Suzhou		China	215021
460	The Central Hospital of Tai'an	Tai'an		China	250001
461	Shanxi Cardiovascular Hospital	Taiyuan		China	030024
462	Wu Jing Yi Xue Yuan Fu Shu Yi Yuan	Tianjin		China	300162
463	Wuhan Asia Heart Hospital	Wuhan		China	430022
464	Hubei Province Zhongshan Hospital	Wuhan		China	430032
465	First Affiliated Hospital of Xiamen University	Xiamen		China	361003
466	Xiamen Cardiovascular Hospital Xiamen University	Xiamen		China	361004
467	Xuzhou Central Hospital	Xuzhou		China	221009
468	Subei People's Hospital	Yangzhou		China	225001
469	zhengzhou No.7 people's Hospital	Zhengzhou		China	450006
470	Zhengzhou Central Hospital	Zhengzhou		China	450007
471	Zhengzhou People'S Hospital	Zhengzhou		China	450012
472	Yankuang Group General Hospital	Zoucheng		China	273500
473	Hospital Santa Clara E.S.E.	Bogota DC		Colombia
474	Fundacion Clinica Shaio	Bogota		Colombia
475	Fundacion Hospital Infantil Universitario de San José	Bogotá		Colombia	111221
476	Simedics Ips	Bogotá		Colombia
477	Centro Médico Julián Coronel	Cali -Valle Del Cauca		Colombia
478	Fundacion Valle de Lilly	Cali		Colombia
479	Centro de Diagnostico Cardilogico	Cartagena de Indias		Colombia
480	Fundacion Cardiovascular de Colombia	Floridablanca		Colombia	68004
481	Asociacion IPS Medicos Internistas de Caldas	Manizales		Colombia
482	Ces Cardiología	Medellin		Colombia
483	Ciclam Sas	Medellín		Colombia	5001000
484	Fundacion Cardiomet Centro de Investigaciones CEQUIN	Quindio		Colombia
485	Hospital Teodoro Maldonado Carbo	Guayaquil		Ecuador	190150
486	Unicormed SA	Guayaquil		Ecuador
487	Hospital INTERVASCU	Quito		Ecuador	170122
488	Princess Margaret Hospital	Hong Kong		Hong Kong	0
489	Queen Mary Hospital	Hong Kong		Hong Kong	0
490	Prince of Wales Hospital	Hong Kong		Hong Kong	999077
491	Asahi General Hospital	Chiba, Asahi		Japan	289-2511
492	Seikeikai New Tokyo Heart Clinic	Chiba, Matsudo		Japan	271-0077
493	Saiseikai Matsuyama Hospital	Ehime, Matsuyama		Japan	791-8026
494	Fukuiken Saiseikai Hospital	Fukui, Fukui		Japan	918-8503
495	Japanese Red Cross Fukuoka Hospital	Fukuoka, Fukuoka		Japan	815-8555
496	Aso Co.,Ltd Iizuka Hospital	Fukuoka, Iizuka		Japan	820-8505
497	Nakamura Cardiovascular Clinic	Fukuoka, Itoshima		Japan	819-1104
498	Fukuoka Tokushukai Medical Center	Fukuoka, Kasuga		Japan	816-0864
499	Shin Komonji Hospital	Fukuoka, Kitakyushu		Japan	800-0057
500	Fukuoka Shin Mizumaki Hospital	Fukuoka, Onga		Japan	807-0051
501	Matsuda Cardiovascular Clinic	Hokkaido, Sapporo		Japan	003-0026
502	Kobe City Medical Center General Hospital	Hyogo, Kobe		Japan	650-0047
503	Higashi Takarazuka Satoh Hospital	Hyogo, Takarazuka		Japan	665-0873
504	Houju Memorial Hospital	Isikawa, Nomi		Japan	923-1226
505	KKR Takamatsu Hospital	Kagawa , Takamatsu		Japan	760-0018
506	Kagawa Prefectural Shirotori Hospital	Kagawa, Higashikagawa		Japan	769-2788
507	Kokan Clinic	Kanagawa, Kawasaki		Japan	210-0852
508	Sekishinkai Kawasaki Saiwai Clinic	Kanagawa, Kawasaki		Japan	212-0016
509	Sagamihara Kyodo Hospital	Kanagawa, Sagamihara		Japan	252-5188
510	Social Medical Corporation Chikamorikai Chikamori Hospital	Kochi, Kochi		Japan	780-8522
511	Nakayama Clinic of I.M. and Cardiology, Kochi, Cardiology	Kochi, Kochi		Japan	781-5106
512	Sugimurakai Medical Association Sugimura Hospital	Kumamoto, Kumamoto		Japan	860-0811
513	Japan Community Health care Organization Kumamoto General Hospital	Kumamoto, Yatsushiro		Japan	866-8660
514	Uji-Tokushukai Medical Center	Kyoto, Uji		Japan	611-0041
515	Iida Municipal Hospital	Nagano, Iida		Japan	395-8502
516	Suwa Red Cross Hospital	Nagano, Suwa		Japan	392-8510
517	Tachikawa General Hospital	Niigata, Nagaoka		Japan	940-8621
518	Nozaki Tokushukai Hospital	Osaka, Daito		Japan	574-0074
519	Teramoto Memorial Hospital	Osaka, Kawachinagano		Japan	586-0017
520	Matsubara Tokushukai Hospital	Osaka, Matsubara		Japan	580-0032
521	Osaka Saiseikai Nakatsu Hospital	Osaka, Osaka		Japan	530-0012
522	Kitano Hospital	Osaka, Osaka		Japan	530-8480
523	Osaka Kaisei Hospital	Osaka, Osaka		Japan	532-0003
524	Ishinkai General Clinics	Osaka, Yao		Japan	581-0036
525	Medical corporation Chisei-kai Watanabe clinic	Saitama, Okegawa		Japan	363-0022
526	SAINO Clinic	Saitama, Tokorozawa		Japan	359-1141
527	Kusatsu Heart Center	Shiga, Kusatsu		Japan	525-0014
528	Shizuoka Tokushukai Hospital	Shizuoka, Shizuoka		Japan	421-0193
529	The Institute for Adult Deseases, Asahi Life Foundation	Tokyo, Chuo-ku		Japan	103-0002
530	Minamino Heart Clinic	Tokyo, Hachioji		Japan	192-0918
531	Shimizu Clinic	Tokyo, Kodaira		Japan	187-0003
532	The Cardiovascular Institute Hospital	Tokyo, Minato-ku		Japan	106-0031
533	YOGA Urban Clinic	Tokyo, Setagaya		Japan	158-0097
534	The University of Toyama Hospital	Toyama, Toyama		Japan	930-0194
535	Sejong General Hospital	Bucheon		Korea, Republic of	14754
536	Dong-A University Hospital	Busan		Korea, Republic of	49201
537	Kosin University Gospel Hospital	Busan		Korea, Republic of	602-702
538	Pusan National Univ. Hosp	Busan		Korea, Republic of	602-739
539	Inje University Haeundae Paik Hospital	Busan		Korea, Republic of	612-896
540	Inje University Busan Paik Hospital	Busan		Korea, Republic of	614-735
541	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of	41931
542	Kyungpook National Univ. Hosp	Daegu		Korea, Republic of	700-721
543	Daegu Fatima Hospital	Daegu		Korea, Republic of	701-724
544	Yeungnam University Medical Center	Daegu		Korea, Republic of	705-703
545	The Catholic University of Korea, Daejeon St.Mary's Hospital	Daejeon		Korea, Republic of	301-723
546	Eulji University Hospital	Daejeon		Korea, Republic of	302-799
547	Chonnam National University Hospital	Gwangju		Korea, Republic of	501-757
548	Wonkwang University Hospital	Iksan		Korea, Republic of	54538
549	Jeju National University Hospital	Jeju		Korea, Republic of	63241
550	Chonbuk National University Hospital	Jeonju		Korea, Republic of	54907
551	Gyeongsang National University Hospital	Jinju		Korea, Republic of	52727
552	Seoul National University Bundang Hospital	Seongnam		Korea, Republic of	13620
553	Kyung Hee University Medical Center	Seoul		Korea, Republic of	02447
554	Korea University Anam Hospital	Seoul		Korea, Republic of	02841
555	Kangdong Sacred Heart Hospital	Seoul		Korea, Republic of	05355
556	VHS Medical Center	Seoul		Korea, Republic of	05368
557	The Catholic University of Korea, Seoul St.Mary's Hospital	Seoul		Korea, Republic of	06591
558	Seoul National University Hospital	Seoul		Korea, Republic of	110-744
559	Severance Hospital	Seoul		Korea, Republic of	120-752
560	The Catholic University of Korea, Eunpyeong St. Mary's Hospital	Seoul		Korea, Republic of	130-709
561	Samsung Medical Center	Seoul		Korea, Republic of	135-710
562	Asan Medical Center	Seoul		Korea, Republic of	138-736
563	Ajou University Hospital	Suwon		Korea, Republic of	16499
564	Ulsan University Hospital	Ulsan		Korea, Republic of	682-714
565	Pusan National University Yangsan Hospital	Yangsan		Korea, Republic of	626-770
566	St.Charles Hospital	Baabda		Lebanon	50 Baabda
567	Makassed General Hospital	Beirut		Lebanon	11-6301
568	St. Georges Hospital	Beirut		Lebanon	166 378
569	Hotel Dieu de France Hospital	Beirut		Lebanon	166830
570	Rafik Hariri University Hospital	Beirut		Lebanon	5244
571	Al Rassoul Hospital, Beirut Cardiac Institute	Beirut		Lebanon
572	American University of Beirut Medical Center	Beirut		Lebanon
573	Bellvue Medical Center, Beirut	Beirut		Lebanon
574	Notre Dame de Secours Hospital	Byblos		Lebanon	3
575	Hammoud Hospital University Medical Center	Saida		Lebanon	652
576	Hospital General de Acapulco	Acapulco De Juárez, Guerrero		Mexico	39570
577	Hospital Cardiologica Aguascalientes	Aguascalientes		Mexico	20230
578	Christius Muguerza Hospital del Parque	Chihuahua		Mexico	31020
579	Centro Especializado de Investigación Medical Group Culiacan	Culiacan		Mexico	80200
580	Centro para el Desarrollo de la Medicina y de Asist Med Espe	Culiacan		Mexico	80230
581	Instituto Nacional de Cardiologia Ignacio Chavez	Distrito Federal		Mexico	14080
582	Unidad Coronariana del Hospital General de Durango	Durango		Mexico	34000
583	Centro de Investigación Especializada de Occidente S.C.	Guadalajara		Mexico	44160
584	Clínica de Estudios Médicos S.C.	Guadalajara		Mexico	44600
585	ICLE SC	Guadalajara		Mexico	44600
586	Private Practice	Guadalajara		Mexico	44670
587	Paracelsus S. A. de C.V.	Mexico		Mexico	03800
588	Clinica Miravalle	Monterrey, Nuevo Leon		Mexico	64000
589	Hospital Metropolitano "Dr Bernardo Sepulveda"	Monterrey		Mexico	66480
590	Unidad de Investigacion Clinica en Medicina, S.C.	Monterrrey		Mexico	64718
591	Consultorio Privado J Arturo Maldonado Villalon	Morelia, Michoacan		Mexico	58260
592	Centro Medico de las Americas	Mérida, Yucatán		Mexico	97000
593	Clinical Medical Research S.C	Orizaba		Mexico	94300
594	Instituto de Corazón de Querétaro	Querétaro		Mexico	76000
595	Cardioarritmias e Investigación S.C	San Luis Potosi		Mexico	78200
596	Plaza Medical	Tijuana		Mexico	22320
597	Servicios Diagnosticos en Medicina SC	Toluca, Estado De Mexico		Mexico	52140
598	iBiomed	Zapopan		Mexico	45030
599	Centro Medico Monte Carmelo	Arequipa		Peru	054
600	Hospital Nacional Daniel Alcides Carrion	Bellavista		Peru	Callao 2
601	EsSalud - Hospital Nacional IV Alberto Sabogal Sologuren	Callao		Peru	C2
602	Hospital Nacional Guillermo Almenara Irigoyen	La Victoria		Peru	Lima-13
603	Hospital Nacional Edgardo Rebaglini Martins	Lima		Peru	Lima-11
604	Clinica San Pablo	Lima		Peru	Lima-33
605	Centro de Investigación en Diabetes, Obesidad y Nutrición	Lince		Peru	Lima-14
606	Clinica Internacional	San Borja		Peru	LIMA 41
607	Clinica Vesalio	San Borja		Peru	lima-41
608	Clinica El Golf	San Isidro		Peru	Lima-27
609	Clinica Medica Cayetano Heredia	San Martin de Porres		Peru	Lima-31
610	Altaiskyi Reg.Cardiologic Dispensary,Cardiology Dept,Barnaul	Barnaul		Russian Federation	656055
611	Chelyabinsk State Med.Acad, Dept. of Clinical Pharmacology	Chelyabinsk		Russian Federation	454092
612	Chita State Med.Acad, Consultative-Diagnostic-Polyclinic	Chita		Russian Federation	672090
613	OJSC Municipal Instit.Dzerjinskiy City Hospital	Dzerjinskiy		Russian Federation	140 091
614	GBUZ SO Ural Institute of Cardiology, Ekaterinburg	Ekaterinburg		Russian Federation	620 144
615	Road Clin.Hosp.Irkutsk-Russian Railways,Cardio.&Therapy Dept	Irkutsk		Russian Federation	664005
616	City Clin.Hosp.#9,Intern.Diseases&Fam.Practice Dept, Izhevsk	Izhevsk		Russian Federation	426063
617	Res.Inst.-Compl.Iss.Cardi.Dis.	Kemerovo		Russian Federation	650002
618	Municipal Instit. City Hosp. No.2, Policlinic Dept,Krasnodar	Krasnodar		Russian Federation	350 012
619	GOU VPO MUZ City Clinical Hospital No. 20, Krasnoyarsk	Krasnoyarsk		Russian Federation	660014
620	Moscow 1st State Med.Univ.n.a.I.M.Sechenov	Moscow		Russian Federation	119992
621	Research Center n.a.A.N.Bakulev,Clin.-Diagnostic Dept,Moscow	Moscow		Russian Federation	121552
622	Russian Cardiology Research and Production Complex, Moscow	Moscow		Russian Federation	121552
623	Reg.Clin.Cardiological Dispen,Arrhythmology Dept,Novosibirsk	Novosibirsk		Russian Federation	630047
624	Omsk State Medical Acad.,Internal Diseases&Fam.Practice Dept	Omsk		Russian Federation	644043
625	Orenburg State Medical Academy of MoH, Therapy Department	Orenburg		Russian Federation	460 000
626	Instit.Healthcare,MedicalSanitary Unit 9,n.a.M.A.Tverie,Perm	Perm		Russian Federation	614990
627	Rostov Regional Clinical Hospital	Rostov-on-Don		Russian Federation	344015
628	Ryazan Reg.Clin.Hosp.Internal Diseases&Policlin.Therapy Dept	Ryazan		Russian Federation	390039
629	Samara Regional Clinical Cardiology Clinic, Day Hosp. Dept.	Samara		Russian Federation	443070
630	Samara State Medical University, Chair of Faculty Therapy	Samara		Russian Federation	443099
631	Municipal Instit.Healthcare,City Policlinic #6,Therapy Dept.	Saratov		Russian Federation	410015
632	Fed.Centre of Heart, Blood & Endocrinology n.a. V.A. Almazov	St. Petersburg		Russian Federation	197341
633	Pokrovskaya City Hospital, St.Petersburg	St. Petersburg		Russian Federation	199106
634	Primorskiy Regional Clinical Hospital No. 1	Vladivostok		Russian Federation	690091
635	King Fahad Military Hospital	Dammam		Saudi Arabia	9862
636	King Fahad Hufuf Hospital	Hufuf		Saudi Arabia	36441
637	Khamis Military Hospital	Jeddah		Saudi Arabia	21424
638	King Abdul Aziz University Hospital	Jeddah		Saudi Arabia	22254
639	Prince Salman Heart Center	Riyadh		Saudi Arabia	11525
640	King Salman Hospital	Riyadh		Saudi Arabia	11536
641	Tabuk Military Hospital	Tabuk		Saudi Arabia	71411
642	King Faisal Hospital	Taif		Saudi Arabia	21944
643	National University Hospital	Singapore		Singapore	119074
644	National Heart Center	Singapore		Singapore	169609
645	Novena Heart Centre	Singapore		Singapore	307506
646	National Neuroscience Institute	Singapore		Singapore	308433
647	Dr. N. Ranjith	Durban		South Africa	4052
648	Dr Mahesh Duki Research and Trial Site	Durban		South Africa	4339
649	LCS Clinical Research Unit	Johannesburg		South Africa	2021
650	Helderberg Research Institute	Somerset West, Cape Town		South Africa	7130
651	Dr. Moodley and Dr. Sarvan	Tongaat		South Africa	4400
652	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung		Taiwan	80756
653	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung		Taiwan	83301
654	Taichung Veterans General Hospital	Taichung		Taiwan	407
655	NCKUH	Tainan		Taiwan	704
656	National Taiwan University Hospital	Taipei		Taiwan	10002
657	Mackay Memorial Hospital	Taipei		Taiwan	10449
658	Cathay General Hospital	Taipei		Taiwan	106
659	Taipei Veterans General Hospital	Taipei		Taiwan	11217
660	Cheng Hsin General Hospital	Taipei		Taiwan	11220
661	Chang Gung Memorial Hospital(Linkou)	Taoyuan		Taiwan	330
662	Al Ain Hospital	Abu Dhabi		United Arab Emirates	1006
663	Sheikh Khalifa Medical City	Abu Dhabi		United Arab Emirates	51900
664	Dubai Hospital	Dubai		United Arab Emirates	7272
665	Al Qassimi Hospital	Sharjah		United Arab Emirates	PO BOX 2804
666	Instituto de Clinicas y Urologia Tamanaco	San Roman Caracas		Venezuela	1060

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

• Statistical Analysis Plan - Nov 9, 2018
• Study Protocol - Jun 7, 2013

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT01468701
• Other Study ID Numbers: 1160.129
• First Posted: Nov 9, 2011
• Last Update Posted: Mar 29, 2021
• Last Verified: Mar 1, 2021

• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

Participant Flow

Recruitment Details

GLORIA-AF was an international, multicentre, non-interventional study based on prospectively collected data for patients (pts) with newly diagnosed non-valvular atrial fibrillation (NVAF). In Ph II, pts baseline characteristics (BC), their antithrombotic treatment patterns and outcomes with 2 years of follow-up for dabigatran alone were collected prospectively. Ph III collected prospective data on pts BC, their treatments and outcomes with 3 years of follow-up for all pts in real-world setting.

Pre-assignment Detail

All patients were screened for eligibility prior to participation in the study. Patients attended a participating site which ensured that they (the patients) strictly met all inclusion and none of the exclusion criteria.

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase II)	Vitamin K Antagonist (VKA) - Baseline (Phase II)	Rivaroxaban - Baseline (Phase II)	Apixaban - Baseline (Phase II)	Acetylsalicylic Acid (ASA) - Baseline (Phase II)	Antiplts Other Than ASA - Baseline (Phase II)	No Treatment - Baseline (Phase II)	Combinations With Oral Anticoagulants - Baseline (Phase II)	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)	Rivaroxaban - Baseline (Phase III)	Apixaban - Baseline (Phase III)	Edoxaban - Baseline (Phase III)	Acetylsalicylic Acid (ASA) - Baseline (Phase III)	Antiplts Other Than ASA - Baseline (Phase III)	No Treatment - Baseline (Phase III)	Combinations With Oral Anticoagulants - Baseline (Phase III)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Vitamin K Antagonist (VKA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Rivaroxaban at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Apixaban at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Acetylsalicylic acid (ASA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Antiplts other than Acetylsalicylic acid (ASA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were not prescribed any antithrombotic treatments at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed combinations with oral anticoagulants treatments at baseline of Phase III were included in this group. Patients in this group were not included in the safety analysis as no specific treatment can be defined. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Vitamin K Antagonist (VKA) at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Rivaroxaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Apixaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Edoxaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Acetylsalicylic acid (ASA) at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Antiplatelets other than ASA at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may be used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were not prescribed any antithrombotic treatments at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed combinations with oral anticoagulants treatments at baseline of Phase III were included in this group. Patients in this group were not included in the safety analysis as no specific treatment can be defined. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Period Title: Overall Study
STARTED	4964	5103	1784	715	1736	128	1209	5	3879	4962	4054	4538	333	2182	214	1418	11
All Eligible Patient	4873	4963	1755	703	1714	126	1170	4	3839	4836	4015	4505	332	2163	213	1386	11
COMPLETED	3965	0	0	0	0	0	0	0	3219	3780	3256	3672	284	1712	151	1056	10
NOT COMPLETED	999	5103	1784	715	1736	128	1209	5	660	1182	798	866	49	470	63	362	1

Baseline Characteristics

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase II)	Vitamin K Antagonist (VKA) - Baseline (Phase II)	Rivaroxaban - Baseline (Phase II)	Apixaban - Baseline (Phase II)	Acetylsalicylic Acid (ASA) - Baseline (Phase II)	Antiplts Other Than ASA - Baseline (Phase II)	No Treatment - Baseline (Phase II)	Combinations With Oral Anticoagulants - Baseline (Phase II)	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)	Rivaroxaban - Baseline (Phase III)	Apixaban - Baseline (Phase III)	Edoxaban - Baseline (Phase III)	Acetylsalicylic Acid (ASA) - Baseline (Phase III)	Antiplts Other Than ASA - Baseline (Phase III)	No Treatment - Baseline (Phase III)	Combinations With Oral Anticoagulants - Baseline (Phase III)	Total
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Vitamin K Antagonist (VKA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Rivaroxaban at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Apixaban at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Acetylsalicylic acid (ASA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Antiplts other than Acetylsalicylic acid (ASA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were not prescribed any antithrombotic treatments at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed combinations with oral anticoagulants treatments at baseline of Phase II were included in this group. Patients in this group were not included in the safety analysis as no specific treatment can be defined. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Vitamin K Antagonist (VKA) at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Rivaroxaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Apixaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Edoxaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Acetylsalicylic acid (ASA) at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed Antiplatelets other than ASA at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may be used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were not prescribed any antithrombotic treatments at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed combinations with oral anticoagulants treatments at baseline of Phase III were included in this group. Patients in this group were not included in the safety analysis as no specific treatment can be defined. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Total of all reporting groups
Overall Participants	4873	4963	1755	703	1714	126	1170	4	3839	4836	4015	4505	332	2163	213	1386	11	36608
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	70.2 (10.4)	71.4 (10.6)	71.5 (10.6)	73.8 (10.0)	67.7 (12.4)	73.5 (10.7)	68.3 (12.5)	76.0 (8.3)	70.1 (10.2)	71.2 (10.3)	70.3 (10.2)	72.4 (10.1)	72.3 (9.4)	68.0 (11.8)	73.1 (10.8)	67.6 (12.2)	70.2 (12.1)	70.5 (10.8)
Sex: Female, Male (Count of Participants)
Female	2162 44.4%	2304 46.4%	773 44%	338 48.1%	778 45.4%	58 46%	553 47.3%	2 50%	1718 44.8%	2152 44.5%	1766 44%	2104 46.7%	139 41.9%	931 43%	92 43.2%	660 47.6%	6 54.5%	16536 45.2%
Male	2711 55.6%	2659 53.6%	982 56%	365 51.9%	936 54.6%	68 54%	617 52.7%	2 50%	2121 55.2%	2684 55.5%	2249 56%	2401 53.3%	193 58.1%	1232 57%	121 56.8%	726 52.4%	5 45.5%	20072 54.8%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	20 0.4%	14 0.3%	6 0.3%	0 0%	4 0.2%	0 0%	1 0.1%	0 0%	27 0.7%	32 0.7%	32 0.8%	21 0.5%	0 0%	7 0.3%	2 0.9%	3 0.2%	1 9.1%	170 0.5%
Asian	423 8.7%	797 16.1%	111 6.3%	93 13.2%	694 40.5%	43 34.1%	603 51.5%	0 0%	841 21.9%	760 15.7%	381 9.5%	413 9.2%	125 37.7%	916 42.3%	95 44.6%	593 42.8%	8 72.7%	6896 18.8%
Black/African American	40 0.8%	86 1.7%	42 2.4%	14 2%	44 2.6%	0 0%	23 2%	0 0%	47 1.2%	85 1.8%	72 1.8%	118 2.6%	2 0.6%	49 2.3%	2 0.9%	23 1.7%	0 0%	647 1.8%
Native Hawaiian/Other Pacific Islander	0 0%	3 0.1%	1 0.1%	0 0%	1 0.1%	0 0%	1 0.1%	0 0%	0 0%	0 0%	0 0%	1 0%	0 0%	2 0.1%	0 0%	0 0%	0 0%	9 0%
White	3372 69.2%	3590 72.3%	1375 78.3%	538 76.5%	863 50.4%	70 55.6%	497 42.5%	4 100%	2484 64.7%	3611 74.7%	3126 77.9%	3528 78.3%	203 61.1%	1057 48.9%	104 48.8%	708 51.1%	2 18.2%	25132 68.7%
Other	447 9.2%	262 5.3%	69 3.9%	24 3.4%	82 4.8%	10 7.9%	21 1.8%	0 0%	181 4.7%	144 3%	144 3.6%	79 1.8%	2 0.6%	57 2.6%	7 3.3%	32 2.3%	0 0%	1561 4.3%
Missing	571 11.7%	211 4.3%	151 8.6%	34 4.8%	26 1.5%	3 2.4%	24 2.1%	0 0%	259 6.7%	204 4.2%	260 6.5%	345 7.7%	0 0%	75 3.5%	3 1.4%	27 1.9%	0 0%	2193 6%

Outcome Measures

1. Primary Outcome

Title	Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase II
Description	Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.
Time Frame	From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Outcome Measure Data

Analysis Population Description

All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase II)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	4859
Number (95% Confidence Interval) [Events per 100 person-years]	2.06

2. Primary Outcome

Title	Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase III
Description	Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown cause of death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
Time Frame	From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Outcome Measure Data

Analysis Population Description

Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	3611	4413
Number (95% Confidence Interval) [Events per 100 person-years]	2.21	3.23

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dabigatran Etexilate - Baseline (Phase II), Vitamin K Antagonist (VKA) - Baseline (Phase III)
	Comments	A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.74
	Confidence Interval	(2-Sided) 95%; 0.60 to 0.90
	Parameter Dispersion	Type: Value:
	Estimation Comments	Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).

3. Primary Outcome

Title	Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase II
Description	Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.
Time Frame	From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Outcome Measure Data

Analysis Population Description

All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase II)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	4859
Number (95% Confidence Interval) [Events per 100 person-years]	1.74

4. Primary Outcome

Title	Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase III
Description	Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
Time Frame	From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Outcome Measure Data

Analysis Population Description

Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	3611	4413
Number (95% Confidence Interval) [Events per 100 person-years]	1.91	2.62

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dabigatran Etexilate - Baseline (Phase II), Vitamin K Antagonist (VKA) - Baseline (Phase III)
	Comments	A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95%; 0.63 to 0.98
	Parameter Dispersion	Type: Value:
	Estimation Comments	Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).

5. Primary Outcome

Title	Incidence Rate of Stroke or Systemic Embolism - Phase III
Description	Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Time Frame	From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Outcome Measure Data

Analysis Population Description

Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	3611	4413
Number (95% Confidence Interval) [Events per 100 person-years]	0.80	1.00

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dabigatran Etexilate - Baseline (Phase II), Vitamin K Antagonist (VKA) - Baseline (Phase III)
	Comments	A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95%; 0.57 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).

6. Primary Outcome

Title	Incidence Rate of Stroke - Phase II
Description	Incidence rate of stroke on all eligible patients excluding prescribed but not taken set for Dabigatran etexilate (DE) of phase II only is presented. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.
Time Frame	From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Outcome Measure Data

Analysis Population Description

All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase II)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	4859
Number (95% Confidence Interval) [Events per 100 person-years]	0.65

7. Primary Outcome

Title	Incidence Rate of Stroke - Phase III
Description	Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.
Time Frame	From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Outcome Measure Data

Analysis Population Description

Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	3611	4413
Number (95% Confidence Interval) [Events per 100 person-years]	0.77	0.96

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dabigatran Etexilate - Baseline (Phase II), Vitamin K Antagonist (VKA) - Baseline (Phase III)
	Comments	A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 95%; 0.57 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).

8. Primary Outcome

Title	Incidence Rate of Transient Ischaemic Attack (TIA) - Phase II
Description	Incidence rate of transient ischaemic attack (TIA) on on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Time Frame	From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Outcome Measure Data

Analysis Population Description

All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase II)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	4859
Number (95% Confidence Interval) [Events per 100 person-years]	0.21

9. Primary Outcome

Title	Incidence Rate of Transient Ischaemic Attack (TIA) - Phase III
Description	Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Time Frame	From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Outcome Measure Data

Analysis Population Description

Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	3611	4413
Number (95% Confidence Interval) [Events per 100 person-years]	0.29	0.32

10. Primary Outcome

Title	Incidence Rate of Systemic Embolism (SE) - Phase II
Description	Incidence rate of systemic embolism (SE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Time Frame	From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Outcome Measure Data

Analysis Population Description

All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase II)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	4859
Number (95% Confidence Interval) [Events per 100 person-years]	0.04

11. Primary Outcome

Title	Incidence Rate of Systemic Embolism (SE) - Phase III
Description	Incidence rate of systemic embolism (SE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Time Frame	From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Outcome Measure Data

Analysis Population Description

Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	3611	4413
Number (95% Confidence Interval) [Events per 100 person-years]	0.04	0.05

12. Primary Outcome

Title	Incidence Rate of Pulmonary Embolism (PE) - Phase II
Description	Incidence rate of pulmonary embolism (PE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Time Frame	From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Outcome Measure Data

Analysis Population Description

All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase II)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	4859
Number (95% Confidence Interval) [Events per 100 person-years]	0.07

13. Primary Outcome

Title	Incidence Rate of Pulmonary Embolism (PE) - Phase III
Description	Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Time Frame	From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Outcome Measure Data

Analysis Population Description

Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	3611	4413
Number (95% Confidence Interval) [Events per 100 person-years]	0.07	0.06

14. Primary Outcome

Title	Incidence Rate of Major Bleeding Events (MBE) - Phase II
Description	Incidence rate of major bleeding events (MBE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.
Time Frame	From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Outcome Measure Data

Analysis Population Description

All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase II)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	4859
Number (95% Confidence Interval) [Events per 100 person-years]	0.97

15. Primary Outcome

Title	Incidence Rate of Major Bleeding Events (MBE) - Phase III
Description	Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.
Time Frame	From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Outcome Measure Data

Analysis Population Description

Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	3611	4413
Number (95% Confidence Interval) [Events per 100 person-years]	0.69	1.44

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dabigatran Etexilate - Baseline (Phase II), Vitamin K Antagonist (VKA) - Baseline (Phase III)
	Comments	A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, abnormal kidney function, concomitant antiplatelets use and concomitant use of drugs related to bleeding.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.52
	Confidence Interval	(2-Sided) 95%; 0.38 to 0.73
	Parameter Dispersion	Type: Value:
	Estimation Comments	Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).

16. Primary Outcome

Title	Incidence Rate of Life-threatening Bleeding Events - Phase II
Description	Incidence rate of life-threatening bleeding events on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.
Time Frame	From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Outcome Measure Data

Analysis Population Description

All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase II)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	4859
Number (95% Confidence Interval) [Events per 100 person-years]	0.46

17. Primary Outcome

Title	Incidence Rate of Life-threatening Bleeding Events - Phase III
Description	Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.
Time Frame	From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Outcome Measure Data

Analysis Population Description

Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	3611	4413
Number (95% Confidence Interval) [Events per 100 person-years]	0.47	1.07

18. Primary Outcome

Title	Incidence Rate of Myocardial Infarction (MI) - Phase II
Description	Incidence rate of myocardial infarction (MI) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Time Frame	From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Outcome Measure Data

Analysis Population Description

All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase II)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	4859
Number (95% Confidence Interval) [Events per 100 person-years]	0.50

19. Primary Outcome

Title	Incidence Rate of Myocardial Infarction (MI) - Phase III
Description	Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Time Frame	From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Outcome Measure Data

Analysis Population Description

Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	3611	4413
Number (95% Confidence Interval) [Events per 100 person-years]	0.40	0.53

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dabigatran Etexilate - Baseline (Phase II), Vitamin K Antagonist (VKA) - Baseline (Phase III)
	Comments	A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, concomitant antiplatelets use, concomitant use of drugs related to bleeding, hypertension, and diabetes.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.60 to 1.57
	Parameter Dispersion	Type: Value:
	Estimation Comments	Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).

20. Primary Outcome

Title	Incidence Rate of All-cause Death - Phase II
Description	Incidence rate of all-cause death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Time Frame	From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Outcome Measure Data

Analysis Population Description

All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase II)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	4859
Number (95% Confidence Interval) [Events per 100 person-years]	2.48

21. Primary Outcome

Title	Incidence Rate of All-cause Death - Phase III
Description	Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Time Frame	From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Outcome Measure Data

Analysis Population Description

Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	3611	4413
Number (95% Confidence Interval) [Events per 100 person-years]	2.16	3.57

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dabigatran Etexilate - Baseline (Phase II), Vitamin K Antagonist (VKA) - Baseline (Phase III)
	Comments	A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.66
	Confidence Interval	(2-Sided) 95%; 0.54 to 0.80
	Parameter Dispersion	Type: Value:
	Estimation Comments	Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).

22. Primary Outcome

Title	Incidence Rate of Vascular Death - Phase II
Description	Incidence rate of vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Time Frame	From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Outcome Measure Data

Analysis Population Description

All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase II)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	4859
Number (95% Confidence Interval) [Events per 100 person-years]	0.85

23. Primary Outcome

Title	Incidence Rate of Vascular Death - Phase III
Description	Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Time Frame	From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Outcome Measure Data

Analysis Population Description

Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.

Arm/Group Title	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.	Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Measure Participants	3611	4413
Number (95% Confidence Interval) [Events per 100 person-years]	0.75	1.26

Adverse Events

Time Frame	Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Adverse Event Reporting Description	Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
Arm/Group Title	Dabigatran Etexilate - Baseline (Phase II)		Dabigatran Etexilate - at Least Once During Phase III of the Study		Vitamin K Antagonist (VKA) - at Least Once During Phase III of the Study		Rivaroxaban - at Least Once During Phase III of the Study		Apixaban - at Least Once During Phase III of the Study		Edoxaban - at Least Once During Phase III of the Study		Acetylsalicylic Acid (ASA) - at Least Once During Phase III of the Study		Antiplts Other Than ASA - at Least Once During Phase III of the Study
Arm/Group Description	Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.		All patients who received at least once dabigatran etexilate during phase III of the study were included in the group. Adverse events which happened when the patients received dabigatran etexilate were reported in this group. Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.		All patients who received at least once Vitamin K Antagonist (VKA) during phase III of the study were included in the group. Adverse events which happened when the patients received Vitamin K Antagonist (VKA) were reported in this group. Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.		All patients who received at least once Rivaroxaban during phase III of the study were included in the group. Adverse events which happened when the patients received Rivaroxaban were reported in this group. Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.		All patients who received at least once Apixaban during phase III of the study were included in the group. Adverse events which happened when the patients received Apixaban were reported in this group. Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.		All patients who received at least once Edoxaban during phase III of the study were included in the group. Adverse events which happened when the patients received Edoxaban were reported in this group. Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.		All patients who received at least once Acetylsalicylic acid (ASA) during phase III of the study were included in the group. Adverse events which happened when the patients received Acetylsalicylic acid (ASA) were reported in this group. Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.		All patients who received at least once Antiplts other than ASA during phase III of the study were included in the group. Adverse events which happened when the patients received Antiplts other than ASA were reported in this group. Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.
All Cause Mortality
	Dabigatran Etexilate - Baseline (Phase II)		Dabigatran Etexilate - at Least Once During Phase III of the Study		Vitamin K Antagonist (VKA) - at Least Once During Phase III of the Study		Rivaroxaban - at Least Once During Phase III of the Study		Apixaban - at Least Once During Phase III of the Study		Edoxaban - at Least Once During Phase III of the Study		Acetylsalicylic Acid (ASA) - at Least Once During Phase III of the Study		Antiplts Other Than ASA - at Least Once During Phase III of the Study
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	184/4943 (3.7%)		199/4477 (4.4%)		465/5894 (7.9%)		292/5177 (5.6%)		392/6024 (6.5%)		23/686 (3.4%)		469/6263 (7.5%)		46/780 (5.9%)
Serious Adverse Events
	Dabigatran Etexilate - Baseline (Phase II)		Dabigatran Etexilate - at Least Once During Phase III of the Study		Vitamin K Antagonist (VKA) - at Least Once During Phase III of the Study		Rivaroxaban - at Least Once During Phase III of the Study		Apixaban - at Least Once During Phase III of the Study		Edoxaban - at Least Once During Phase III of the Study		Acetylsalicylic Acid (ASA) - at Least Once During Phase III of the Study		Antiplts Other Than ASA - at Least Once During Phase III of the Study
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	985/4943 (19.9%)		118/4477 (2.6%)		296/5894 (5%)		185/5177 (3.6%)		217/6024 (3.6%)		16/686 (2.3%)		225/6263 (3.6%)		19/780 (2.4%)
Blood and lymphatic system disorders
Anaemia	12/4943 (0.2%)		6/4477 (0.1%)		16/5894 (0.3%)		12/5177 (0.2%)		19/6024 (0.3%)		2/636 (0.3%)		19/6263 (0.3%)		0/780 (0%)
Blood loss anaemia	0/4943 (0%)		2/4477 (0%)		9/5894 (0.2%)		4/5177 (0.1%)		4/6024 (0.1%)		1/636 (0.2%)		7/6263 (0.1%)		0/780 (0%)
Coagulopathy	0/4943 (0%)		0/4477 (0%)		2/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Eosinophilia	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hypochromic anaemia	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Iron deficiency anaemia	1/4943 (0%)		0/4477 (0%)		2/5894 (0%)		3/5177 (0.1%)		1/6024 (0%)		0/636 (0%)		2/6263 (0%)		0/780 (0%)
Microcytic anaemia	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		1/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Splenic haematoma	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Thrombocytopenia	0/4943 (0%)		1/4477 (0%)		1/5894 (0%)		1/5177 (0%)		1/6024 (0%)		0/636 (0%)		3/6263 (0%)		0/780 (0%)
Haemorrhagic disorder	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Leukocytosis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Normochromic anaemia	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Splenic lesion	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cardiac disorders
Acute myocardial infarction	11/4943 (0.2%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Angina pectoris	20/4943 (0.4%)		1/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Angina unstable	11/4943 (0.2%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Atrial fibrillation	159/4943 (3.2%)		0/4477 (0%)		3/5894 (0.1%)		2/5177 (0%)		1/6024 (0%)		0/636 (0%)		3/6263 (0%)		0/780 (0%)
Atrial flutter	9/4943 (0.2%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Atrial thrombosis	3/4943 (0.1%)		0/4477 (0%)		1/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Bradycardia	14/4943 (0.3%)		0/4477 (0%)		2/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Cardiac arrest	9/4943 (0.2%)		1/4477 (0%)		0/5894 (0%)		1/5177 (0%)		1/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Cardiac failure	67/4943 (1.4%)		3/4477 (0.1%)		4/5894 (0.1%)		0/5177 (0%)		2/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Cardiac failure congestive	41/4943 (0.8%)		1/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cardiac tamponade	1/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		2/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cardiac ventricular thrombosis	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cardiomyopathy alcoholic	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cardiopulmonary failure	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hypertensive cardiomyopathy	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Intracardiac thrombus	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Mitral valve incompetence	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Myocardial infarction	27/4943 (0.5%)		2/4477 (0%)		2/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		2/6263 (0%)		0/780 (0%)
Palpitations	9/4943 (0.2%)		0/4477 (0%)		1/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pericardial effusion	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pericardial haemorrhage	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		1/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Pericarditis	4/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Ventricular fibrillation	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Acute coronary syndrome	8/4943 (0.2%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Aortic valve incompetence	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Aortic valve stenosis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Arrhythmia	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Atrial tachycardia	5/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Atrioventricular block	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Atrioventricular block complete	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Atrioventricular block second degree	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Bradyarrhythmia	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cardiac disorder	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cardiac failure acute	6/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cardiac failure chronic	4/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cardio-respiratory arrest	5/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cardiogenic shock	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cardiomegaly	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cardiomyopathy	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Congestive cardiomyopathy	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Coronary artery disease	7/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Coronary artery stenosis	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Ischaemic cardiomyopathy	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Left ventricular failure	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Left ventricular hypertrophy	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Myocardial fibrosis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Myocardial ischaemia	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Nodal arrhythmia	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pericarditis constrictive	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Prinzmetal angina	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Right ventricular failure	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Sinoatrial block	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Sinus arrest	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Sinus bradycardia	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Sinus node dysfunction	16/4943 (0.3%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Supraventricular tachycardia	5/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Tachyarrhythmia	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Tachycardia	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Ventricular arrhythmia	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Ventricular extrasystoles	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Ventricular tachycardia	5/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Congenital, familial and genetic disorders
Haemorrhagic arteriovenous malformation	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Hypertrophic cardiomyopathy	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Ear and labyrinth disorders
Vertigo	3/4943 (0.1%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Vertigo positional	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Endocrine disorders
Hyperthyroidism	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hypothyroidism	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Thyroid mass	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Eye disorders
Eye haemorrhage	1/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		2/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Retinal artery embolism	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Retinal artery occlusion	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Retinal vascular occlusion	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Vitreous haemorrhage	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Open angle glaucoma	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Optic ischaemic neuropathy	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Gastrointestinal disorders
Abdominal pain	2/4943 (0%)		1/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		2/6263 (0%)		0/780 (0%)
Abdominal wall haematoma	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Acute abdomen	0/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Anal haemorrhage	2/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		2/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Barrett's oesophagus	0/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Colitis	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Colitis ischaemic	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		1/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Diarrhoea	5/4943 (0.1%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Diarrhoea haemorrhagic	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		2/6024 (0%)		0/636 (0%)		2/6263 (0%)		0/780 (0%)
Discoloured vomit	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Diverticulum intestinal	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Diverticulum intestinal haemorrhagic	3/4943 (0.1%)		0/4477 (0%)		2/5894 (0%)		0/5177 (0%)		1/6024 (0%)		1/636 (0.2%)		0/6263 (0%)		0/780 (0%)
Duodenal ulcer haemorrhage	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		2/6263 (0%)		0/780 (0%)
Duodenal varices	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Dyspepsia	1/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Gastric haemorrhage	2/4943 (0%)		2/4477 (0%)		1/5894 (0%)		1/5177 (0%)		2/6024 (0%)		0/636 (0%)		2/6263 (0%)		0/780 (0%)
Gastric ulcer	0/4943 (0%)		1/4477 (0%)		0/5894 (0%)		2/5177 (0%)		3/6024 (0%)		0/636 (0%)		3/6263 (0%)		0/780 (0%)
Gastric ulcer haemorrhage	1/4943 (0%)		1/4477 (0%)		2/5894 (0%)		3/5177 (0.1%)		3/6024 (0%)		1/636 (0.2%)		0/6263 (0%)		0/780 (0%)
Gastritis	1/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Gastroduodenal ulcer	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Gastrointestinal disorder	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Gastrointestinal haemorrhage	24/4943 (0.5%)		16/4477 (0.4%)		27/5894 (0.5%)		36/5177 (0.7%)		26/6024 (0.4%)		3/636 (0.5%)		43/6263 (0.7%)		4/780 (0.5%)
Gastrointestinal polyp haemorrhage	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Gastrointestinal vascular malformation haemorrhagic	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Gastrooesophageal reflux disease	0/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Haematemesis	2/4943 (0%)		0/4477 (0%)		2/5894 (0%)		2/5177 (0%)		1/6024 (0%)		0/636 (0%)		3/6263 (0%)		0/780 (0%)
Haematochezia	3/4943 (0.1%)		3/4477 (0.1%)		0/5894 (0%)		2/5177 (0%)		3/6024 (0%)		0/636 (0%)		4/6263 (0.1%)		0/780 (0%)
Haemorrhoidal haemorrhage	4/4943 (0.1%)		1/4477 (0%)		2/5894 (0%)		1/5177 (0%)		1/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Haemorrhoids	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hiatus hernia	1/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Intestinal haemorrhage	1/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Intestinal ischaemia	1/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Intra-abdominal haemorrhage	0/4943 (0%)		1/4477 (0%)		1/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Large intestinal ulcer	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Large intestine perforation	1/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Lower gastrointestinal haemorrhage	5/4943 (0.1%)		12/4477 (0.3%)		11/5894 (0.2%)		21/5177 (0.4%)		10/6024 (0.2%)		1/636 (0.2%)		20/6263 (0.3%)		3/780 (0.4%)
Mallory-Weiss syndrome	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Melaena	1/4943 (0%)		0/4477 (0%)		1/5894 (0%)		6/5177 (0.1%)		2/6024 (0%)		0/636 (0%)		2/6263 (0%)		0/780 (0%)
Mesenteric artery thrombosis	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Mesenteric haemorrhage	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Nausea	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Oesophageal ulcer haemorrhage	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pancreatitis	0/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pancreatitis acute	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Peptic ulcer	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		2/6263 (0%)		0/780 (0%)
Peritoneal haemorrhage	0/4943 (0%)		1/4477 (0%)		1/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Rectal haemorrhage	8/4943 (0.2%)		6/4477 (0.1%)		8/5894 (0.1%)		6/5177 (0.1%)		7/6024 (0.1%)		2/636 (0.3%)		8/6263 (0.1%)		1/780 (0.1%)
Rectal ulcer	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Retroperitoneal haematoma	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Retroperitoneal haemorrhage	0/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Small intestinal haemorrhage	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Upper gastrointestinal haemorrhage	6/4943 (0.1%)		8/4477 (0.2%)		18/5894 (0.3%)		8/5177 (0.2%)		12/6024 (0.2%)		0/636 (0%)		9/6263 (0.1%)		4/780 (0.5%)
Vomiting	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Vomiting projectile	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Duodenal ulcer	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Abdominal distension	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Abdominal incarcerated hernia	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Abdominal pain upper	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Anal fissure	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Chronic gastritis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Diaphragmatic hernia	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Dysphagia	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Faecaloma	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Faeces discoloured	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Gastritis erosive	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Ileus paralytic	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Inguinal hernia	4/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Intestinal infarction	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Intestinal obstruction	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Large intestinal haemorrhage	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Large intestine polyp	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Oesophagitis	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Rectal prolapse	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Tongue haematoma	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Tooth pulp haemorrhage	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
General disorders
Asthenia	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Chest pain	0/4943 (0%)		1/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Death	0/4943 (0%)		1/4477 (0%)		0/5894 (0%)		2/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		2/780 (0.3%)
Medical device site haematoma	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Multiple organ dysfunction syndrome	0/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Non-cardiac chest pain	0/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		2/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Oedema peripheral	0/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Puncture site haemorrhage	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Pyrexia	0/4943 (0%)		1/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		2/6263 (0%)		0/780 (0%)
Sudden death	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Suprapubic pain	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Vessel puncture site haematoma	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Asthenia	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cardiac death	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Catheter site haemorrhage	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Chest discomfort	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Chest pain	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Death	48/4943 (1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Fatigue	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Gait disturbance	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hernia	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Malaise	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Multiple organ dysfunction syndrome	6/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Non-cardiac chest pain	10/4943 (0.2%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Oedema peripheral	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Organ failure	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pain	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pyrexia	4/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Sudden cardiac death	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Sudden death	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Ulcer	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hepatobiliary disorders
Cholecystitis	3/4943 (0.1%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cholecystitis acute	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Drug-induced liver injury	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hepatic failure	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hepatic haematoma	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Acute hepatic failure	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Bile duct obstruction	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Biliary dyskinesia	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cholangitis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cholelithiasis	6/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Chronic hepatic failure	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hepatic cirrhosis	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hepatic congestion	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hepatic function abnormal	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Immune system disorders
Anaphylactic shock	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Infections and infestations
Bronchitis	4/4943 (0.1%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cellulitis	7/4943 (0.1%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cystitis	1/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Diverticulitis	1/4943 (0%)		1/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Diverticulitis intestinal haemorrhagic	0/4943 (0%)		0/4477 (0%)		2/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Empyema	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Gastroenteritis	5/4943 (0.1%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Haematoma infection	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		2/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Herpes zoster	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Infectious pleural effusion	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pneumonia	41/4943 (0.8%)		1/4477 (0%)		0/5894 (0%)		2/5177 (0%)		2/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Sepsis	9/4943 (0.2%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Urinary tract infection	7/4943 (0.1%)		1/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Urosepsis	3/4943 (0.1%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Lung abscess	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Subcutaneous abscess	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Appendicitis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Arthritis infective	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Clostridium difficile colitis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Clostridium difficile infection	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Diabetic foot infection	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Diarrhoea infectious	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Echinococciasis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Endocarditis	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Endocarditis bacterial	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Endophthalmitis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Erysipelas	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Infection	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Influenza	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Localised infection	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Lower respiratory tract infection	6/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Lyme disease	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Meningitis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Necrotising fasciitis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Paraspinal abscess	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Peritonitis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pneumonia haemophilus	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pneumonia staphylococcal	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Post procedural infection	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Post procedural sepsis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Postoperative wound infection	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pulmonary sepsis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pyelonephritis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Respiratory tract infection	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Septic arthritis streptococcal	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Septic shock	7/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Sinusitis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Streptococcal sepsis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Tracheobronchitis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Upper respiratory tract infection	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Viral infection	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Wound infection	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Injury, poisoning and procedural complications
Anaemia postoperative	1/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Contusion	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		2/6024 (0%)		0/636 (0%)		2/6263 (0%)		0/780 (0%)
Craniocerebral injury	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Extradural haematoma	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Facial bones fracture	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Fall	8/4943 (0.2%)		1/4477 (0%)		8/5894 (0.1%)		2/5177 (0%)		4/6024 (0.1%)		0/636 (0%)		5/6263 (0.1%)		0/780 (0%)
Femur fracture	5/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Head injury	2/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hip fracture	3/4943 (0.1%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Overdose	1/4943 (0%)		0/4477 (0%)		6/5894 (0.1%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		2/6263 (0%)		0/780 (0%)
Post procedural haematoma	0/4943 (0%)		0/4477 (0%)		2/5894 (0%)		0/5177 (0%)		2/6024 (0%)		0/636 (0%)		2/6263 (0%)		0/780 (0%)
Post procedural haematuria	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		1/6024 (0%)		0/636 (0%)		2/6263 (0%)		1/780 (0.1%)
Post procedural haemorrhage	2/4943 (0%)		1/4477 (0%)		3/5894 (0.1%)		5/5177 (0.1%)		1/6024 (0%)		0/636 (0%)		4/6263 (0.1%)		1/780 (0.1%)
Procedural haemorrhage	0/4943 (0%)		0/4477 (0%)		3/5894 (0.1%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Skin laceration	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		2/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Splenic injury	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Subcutaneous haematoma	0/4943 (0%)		0/4477 (0%)		2/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Subdural haematoma	4/4943 (0.1%)		4/4477 (0.1%)		13/5894 (0.2%)		0/5177 (0%)		2/6024 (0%)		0/636 (0%)		7/6263 (0.1%)		0/780 (0%)
Subdural haemorrhage	1/4943 (0%)		2/4477 (0%)		3/5894 (0.1%)		1/5177 (0%)		1/6024 (0%)		0/636 (0%)		2/6263 (0%)		0/780 (0%)
Tongue injury	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Toxicity to various agents	1/4943 (0%)		0/4477 (0%)		9/5894 (0.2%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		4/6263 (0.1%)		0/780 (0%)
Traumatic haematoma	1/4943 (0%)		1/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Traumatic haemorrhage	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Traumatic haemothorax	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Traumatic intracranial haemorrhage	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		1/636 (0.2%)		1/6263 (0%)		0/780 (0%)
Traumatic liver injury	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Traumatic renal injury	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Vascular pseudoaneurysm	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Wound haemorrhage	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Abdominal injury	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Accident	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Alcohol poisoning	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Ankle fracture	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Electric shock	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Face injury	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Femoral neck fracture	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Forearm fracture	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Humerus fracture	4/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Incisional hernia	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Intestinal anastomosis complication	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Ligament sprain	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Limb injury	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Patella fracture	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pocket erosion	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Procedural shock	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Road traffic accident	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Skin abrasion	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Spinal fracture	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Tendon injury	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Tendon rupture	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Upper limb fracture	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Wound secretion	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Investigations
Anticoagulation drug level above therapeutic	0/4943 (0%)		0/4477 (0%)		7/5894 (0.1%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Anticoagulation drug level below therapeutic	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Bleeding time prolonged	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Blood urine present	1/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Catheterisation cardiac	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Haemoglobin decreased	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		2/5177 (0%)		1/6024 (0%)		0/636 (0%)		2/6263 (0%)		0/780 (0%)
International normalised ratio increased	0/4943 (0%)		0/4477 (0%)		7/5894 (0.1%)		1/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Liver function test increased	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Occult blood	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Transaminases increased	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Blood creatinine increased	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Blood glucose increased	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Blood pressure increased	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
C-reactive protein increased	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Electrocardiogram QT prolonged	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Glomerular filtration rate decreased	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Haematocrit decreased	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Heart rate increased	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Troponin increased	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
White blood cell count increased	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Metabolism and nutrition disorders
Decreased appetite	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Dehydration	3/4943 (0.1%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hyperglycaemia	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hyperlipidaemia	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Diabetes mellitus	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Failure to thrive	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Fluid overload	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Fluid retention	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Gout	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hyperglycaemic hyperosmolar nonketotic syndrome	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hyperkalaemia	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hypoglycaemia	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hypokalaemia	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hyponatraemia	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Malnutrition	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Metabolic disorder	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Obesity	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Musculoskeletal and connective tissue disorders
Compartment syndrome	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		2/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Groin pain	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Haemarthrosis	0/4943 (0%)		1/4477 (0%)		2/5894 (0%)		2/5177 (0%)		1/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Haematoma muscle	1/4943 (0%)		0/4477 (0%)		5/5894 (0.1%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		2/6263 (0%)		0/780 (0%)
Muscle haemorrhage	0/4943 (0%)		0/4477 (0%)		2/5894 (0%)		1/5177 (0%)		4/6024 (0.1%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Osteoarthritis	12/4943 (0.2%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pain in extremity	1/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Arthralgia	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Arthritis	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Back pain	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Bursitis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Dupuytren's contracture	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Gouty arthritis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Muscular weakness	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Musculoskeletal chest pain	4/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Osteoporosis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Polymyalgia rheumatica	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Rhabdomyolysis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Rheumatoid arthritis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Rotator cuff syndrome	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Spinal osteoarthritis	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Spinal stenosis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Vertebral foraminal stenosis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Gastric cancer	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Gastrointestinal carcinoma	6/4943 (0.1%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Lung adenocarcinoma	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Lung neoplasm malignant	8/4943 (0.2%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Myelodysplastic syndrome	0/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Rectal cancer	0/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Sarcomatoid carcinoma	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Bladder cancer	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		1/780 (0.1%)
Acute leukaemia	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Acute myeloid leukaemia	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Adenocarcinoma	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Adenocarcinoma pancreas	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Basal cell carcinoma	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Bladder neoplasm	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Bladder transitional cell carcinoma	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Breast cancer	6/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Breast cancer metastatic	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Bronchial carcinoma	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Colon cancer	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Colon cancer metastatic	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Endometrial adenocarcinoma	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Gallbladder adenocarcinoma	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Gastrointestinal neoplasm	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Glioblastoma	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Glioblastoma multiforme	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Leukaemia	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Lung carcinoma cell type unspecified stage IV	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Lymphoma	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Malignant genitourinary tract neoplasm	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Malignant pleural effusion	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Malignant respiratory tract neoplasm	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Meningioma	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Metastases to bone	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Metastases to central nervous system	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Metastases to lung	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Metastases to lymph nodes	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Metastatic neoplasm	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Neoplasm malignant	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Non-Hodgkin's lymphoma	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Oesophageal carcinoma	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pancreatic carcinoma	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pancreatic carcinoma metastatic	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pituitary tumour benign	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Plasma cell myeloma	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Prostate cancer	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Prostate cancer metastatic	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Prostatic adenoma	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Rectal cancer stage IV	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Renal cancer	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Skin cancer	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Small cell lung cancer	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Squamous cell carcinoma	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Thyroid cancer	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Transitional cell carcinoma	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Transitional cell carcinoma metastatic	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Nervous system disorders
Ataxia	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Basal ganglia haemorrhage	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		1/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Brain injury	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Brain stem haemorrhage	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		1/636 (0.2%)		1/6263 (0%)		0/780 (0%)
Carotid artery stenosis	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Cerebellar haemorrhage	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cerebellar infarction	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cerebellar stroke	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cerebral haematoma	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cerebral haemorrhage	4/4943 (0.1%)		1/4477 (0%)		10/5894 (0.2%)		3/5177 (0.1%)		5/6024 (0.1%)		1/636 (0.2%)		5/6263 (0.1%)		0/780 (0%)
Cerebral infarction	7/4943 (0.1%)		1/4477 (0%)		1/5894 (0%)		1/5177 (0%)		2/6024 (0%)		0/636 (0%)		3/6263 (0%)		0/780 (0%)
Cerebrovascular accident	20/4943 (0.4%)		0/4477 (0%)		9/5894 (0.2%)		1/5177 (0%)		7/6024 (0.1%)		0/636 (0%)		5/6263 (0.1%)		0/780 (0%)
Dizziness	7/4943 (0.1%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Embolic stroke	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		1/5177 (0%)		0/6024 (0%)		2/636 (0.3%)		3/6263 (0%)		0/780 (0%)
Generalised tonic-clonic seizure	0/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Haemorrhage intracranial	2/4943 (0%)		1/4477 (0%)		10/5894 (0.2%)		4/5177 (0.1%)		2/6024 (0%)		0/636 (0%)		5/6263 (0.1%)		0/780 (0%)
Haemorrhagic stroke	1/4943 (0%)		2/4477 (0%)		7/5894 (0.1%)		4/5177 (0.1%)		5/6024 (0.1%)		0/636 (0%)		2/6263 (0%)		0/780 (0%)
Haemorrhagic transformation stroke	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		2/6263 (0%)		0/780 (0%)
Headache	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Intracranial haematoma	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Intraventricular haemorrhage	0/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Ischaemic cerebral infarction	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		1/780 (0.1%)
Ischaemic stroke	19/4943 (0.4%)		7/4477 (0.2%)		9/5894 (0.2%)		3/5177 (0.1%)		5/6024 (0.1%)		0/636 (0%)		6/6263 (0.1%)		2/780 (0.3%)
Lethargy	0/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Presyncope	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Subarachnoid haemorrhage	2/4943 (0%)		1/4477 (0%)		3/5894 (0.1%)		2/5177 (0%)		4/6024 (0.1%)		0/636 (0%)		2/6263 (0%)		0/780 (0%)
Syncope	18/4943 (0.4%)		0/4477 (0%)		1/5894 (0%)		2/5177 (0%)		1/6024 (0%)		0/636 (0%)		2/6263 (0%)		0/780 (0%)
Transient ischaemic attack	15/4943 (0.3%)		5/4477 (0.1%)		13/5894 (0.2%)		5/5177 (0.1%)		7/6024 (0.1%)		0/636 (0%)		5/6263 (0.1%)		0/780 (0%)
Vascular dementia	1/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Aphasia	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Autonomic nervous system imbalance	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Balance disorder	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Brain stem infarction	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cerebral ischaemia	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cerebrovascular disorder	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cognitive disorder	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Coma	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Complex regional pain syndrome	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Dementia	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Dysarthria	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Encephalitis autoimmune	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Encephalopathy	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Epilepsy	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hemiparesis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hepatic encephalopathy	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hydrocephalus	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hypoaesthesia	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Intracranial mass	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Lacunar stroke	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Metabolic encephalopathy	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Motor dysfunction	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Myelopathy	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Parkinson's disease	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Polyneuropathy	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Seizure	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Spinal cord haematoma	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Product Issues
Device battery issue	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Device dislocation	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Device loosening	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Device malfunction	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Psychiatric disorders
Anxiety	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Aggression	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Alcohol withdrawal syndrome	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Bipolar disorder	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Confusional state	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Delirium	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Derailment	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Homicidal ideation	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Mental status changes	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Restlessness	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Sleep disorder	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Stress	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Suicidal ideation	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Renal and urinary disorders
Acute kidney injury	5/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cystitis haemorrhagic	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Haematuria	4/4943 (0.1%)		3/4477 (0.1%)		12/5894 (0.2%)		10/5177 (0.2%)		5/6024 (0.1%)		0/636 (0%)		6/6263 (0.1%)		0/780 (0%)
Haemorrhage urinary tract	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hypertensive nephropathy	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Nephrotic syndrome	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Renal haematoma	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Renal infarct	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Renal injury	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Ureterolithiasis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Urinary retention	3/4943 (0.1%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Urogenital haemorrhage	0/4943 (0%)		1/4477 (0%)		7/5894 (0.1%)		1/5177 (0%)		2/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Calculus bladder	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Chronic kidney disease	4/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Dysuria	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hydronephrosis	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Nephrolithiasis	6/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Nephropathy	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Renal aneurysm	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Renal failure	12/4943 (0.2%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Renal impairment	4/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Tubulointerstitial nephritis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Urinary incontinence	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Reproductive system and breast disorders
Breast haematoma	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Metrorrhagia	0/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Postmenopausal haemorrhage	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Uterine haemorrhage	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		1/636 (0.2%)		0/6263 (0%)		0/780 (0%)
Vaginal haemorrhage	1/4943 (0%)		2/4477 (0%)		0/5894 (0%)		3/5177 (0.1%)		1/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Benign prostatic hyperplasia	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Breast hyperplasia	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Ovarian cyst	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Respiratory, thoracic and mediastinal disorders
Bronchiectasis	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Dyspnoea	23/4943 (0.5%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		4/6024 (0.1%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Epistaxis	0/4943 (0%)		3/4477 (0.1%)		19/5894 (0.3%)		8/5177 (0.2%)		8/6024 (0.1%)		1/636 (0.2%)		8/6263 (0.1%)		0/780 (0%)
Haemoptysis	5/4943 (0.1%)		1/4477 (0%)		5/5894 (0.1%)		1/5177 (0%)		5/6024 (0.1%)		0/636 (0%)		4/6263 (0.1%)		0/780 (0%)
Haemothorax	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Interstitial lung disease	1/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pleural effusion	1/4943 (0%)		0/4477 (0%)		1/5894 (0%)		1/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pulmonary embolism	6/4943 (0.1%)		1/4477 (0%)		2/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Respiratory failure	5/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Respiratory tract haemorrhage	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Acute pulmonary oedema	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Acute respiratory distress syndrome	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Acute respiratory failure	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Asthma	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Chronic obstructive pulmonary disease	19/4943 (0.4%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cough	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Dyspnoea exertional	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hypoxia	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pleurisy	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pneumonia aspiration	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pneumonitis	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pneumothorax spontaneous	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pulmonary fibrosis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pulmonary mass	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pulmonary oedema	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Pulmonary sarcoidosis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Respiratory disorder	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Sleep apnoea syndrome	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Skin and subcutaneous tissue disorders
Erythema	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Haemorrhage subcutaneous	0/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Skin ulcer	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		1/780 (0.1%)
Blister	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Cold sweat	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Rash	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Social circumstances
Alcoholic	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Vascular disorders
Aneurysm	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Aortic aneurysm rupture	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Arterial haemorrhage	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Deep vein thrombosis	0/4943 (0%)		1/4477 (0%)		1/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Embolism arterial	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Haematoma	0/4943 (0%)		1/4477 (0%)		10/5894 (0.2%)		1/5177 (0%)		4/6024 (0.1%)		0/636 (0%)		3/6263 (0%)		1/780 (0.1%)
Haemorrhage	0/4943 (0%)		3/4477 (0.1%)		8/5894 (0.1%)		4/5177 (0.1%)		10/6024 (0.2%)		0/636 (0%)		4/6263 (0.1%)		0/780 (0%)
Hypovolaemic shock	1/4943 (0%)		0/4477 (0%)		2/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Ischaemia	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Orthostatic hypotension	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		1/6024 (0%)		0/636 (0%)		1/6263 (0%)		0/780 (0%)
Peripheral embolism	1/4943 (0%)		1/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Peripheral ischaemia	2/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Shock haemorrhagic	1/4943 (0%)		1/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Subgaleal haematoma	0/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Venous haemorrhage	1/4943 (0%)		0/4477 (0%)		1/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Aortic stenosis	6/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Circulatory collapse	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hypertension	11/4943 (0.2%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hypertensive crisis	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Hypotension	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Peripheral arterial occlusive disease	3/4943 (0.1%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Peripheral artery occlusion	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Peripheral artery stenosis	2/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Peripheral venous disease	1/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/636 (0%)		0/6263 (0%)		0/780 (0%)
Other (Not Including Serious) Adverse Events
	Dabigatran Etexilate - Baseline (Phase II)		Dabigatran Etexilate - at Least Once During Phase III of the Study		Vitamin K Antagonist (VKA) - at Least Once During Phase III of the Study		Rivaroxaban - at Least Once During Phase III of the Study		Apixaban - at Least Once During Phase III of the Study		Edoxaban - at Least Once During Phase III of the Study		Acetylsalicylic Acid (ASA) - at Least Once During Phase III of the Study		Antiplts Other Than ASA - at Least Once During Phase III of the Study
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4943 (0%)		0/4477 (0%)		0/5894 (0%)		0/5177 (0%)		0/6024 (0%)		0/686 (0%)		0/6263 (0%)		0/780 (0%)

Limitations/Caveats

Phase II part of 1160.129 includes Phase II data from 1160.129, 1160.136 and 1160.171.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.