RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT00808067

Collaborator

(none)

5,897

Enrollment

567

Locations

Arms

Duration (Months)

10.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purposes of this study are:

To evaluate the long-term safety of dabigatran etexilate
To assess the effect of a knowledge translation intervention on patient outcomes

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: dabigatran dose 1 Drug: dabigatran dose 2	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

5897 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed the RE-LY Trial and a Cluster Randomised Trial to Assess the Effect of a Knowledge Translation Intervention on Patient Outcomes

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dabigatran dose 1 dabigatran high dose twice daily	Drug: dabigatran dose 1 dabigatran high dose twice daily
Experimental: dabigatran dose 2 dabigatran low dose twice daily	Drug: dabigatran dose 2 dabigatran low dose twice daily

Arm

Intervention/Treatment

Experimental: dabigatran dose 1

dabigatran high dose twice daily

Drug: dabigatran dose 1

dabigatran high dose twice daily

Experimental: dabigatran dose 2

dabigatran low dose twice daily

Drug: dabigatran dose 2

dabigatran low dose twice daily

Outcome Measures

Primary Outcome Measures

Major Bleeding, Annualized Rate of Subjects With Major Bleeds [up to 43 months]
Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Major bleeding must have satisfied one or more of the following criteria: Bleeding associated with a reduction in hemoglobin of at least 20 g/L Required transfusion of at least 2 units of blood or packed cells Symptomatic bleeding in a critical area or organ: intraocular, intraspinal, intramuscular with compartment syndrome, retroperitoneal, intra-articular, pericardial, gastrointestinal Major bleed were classified as life-threatening if they met one or more of the following criteria: Reduction in hemoglobin of at least 50 g/L Transfusion of at least 4 units of blood or packed cells Symptomatic intracranial bleeding, either subdural or intracerebral Associated with hypotension requiring use of intravenous inotropic agents Required surgical intervention to stop bleeding Resulted in death

Secondary Outcome Measures

Stroke, Annualized Rate of Subjects With Stroke [up to 43 months]
Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Stroke was an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke was categorized as ischemic or hemorrhagic or cause unknown based on computerized tomography (CT), magnetic resonance (MR) scanning or autopsy. Fatal stroke was defined as death from any cause within 30 days of stroke. Severity of stroke was assessed by modified Rankin score at discharge from hospital
Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE [up to 43 months]
Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Systemic embolism was an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts), and was to be documented by angiography, surgery, scintigraphy, or autopsy.
Pulmonary Embolism (PE), Annualized Rate of Subjects With PE [up to 43 months]
Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Pulmonary Embolism was generally documented by one of the following: an intraluminal filling defect in segmental or more proximal branches on spiral CT scan an intraluminal filling defect or an extension of an existing defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS) inconclusive spiral CT, pulmonary angiography or lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasound or venography.
Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI [up to 43 months]
Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. a. In subjects not undergoing PCI or CABG a subject should have fulfilled at least 2 of the following: i. Typical prolonged severe chest pain or related symptoms or signs suggestive of MI. ii. Elevation of troponin or CK-MB to more than upper level of normal (ULN) or, if CK-MB was elevated at baseline, re-elevation to more than 50% increase above the previous level. iii. Development of significant Q-waves in at least 2 adjacent ECG leads. b. After percutaneous coronary intervention (within 24h). c. After coronary artery bypass grafting (within 72h). d. Silent myocardial infarction. e. Myocardial infarction could also have been demonstrated at autopsy.
Deep Vein Thrombosis, Annualized Rate of Subjects With DVT [up to 43 months]
Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Deep Vein Thrombosis (DVT) was generally documented by one of the following: abnormal compression ultrasound (CUS), an intraluminal filling defect on venography.
Death, Annualized Rate of Subject Death [up to 43 months]
Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Deaths were classified as being vascular (sudden/arrhythmic, pump failure death, or other vascular, including bleeding) or non-vascular, due to other specified causes (e.g., malignancy), or of unknown etiology.
Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) [up to 43 months]
Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death [up to 43 months]
Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death [up to 43 months]
Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed [up to 43 months]
Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Annualized Rate of Subjects With Minor Bleeds [up to 43 months]
Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. Minor bleeds were classified as associated with study medication discontinuation (temporary or permanent) or not.
Annualized Rate of Subjects With Any Bleeds (Major Plus Minor) [up to 43 months]
Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH) [up to 43 months]
Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Participation in RE-LY, requires long term anticoagulation, provides written informed consent

Exclusion criteria:

Permanent discontinuation of dabigatran during RE-LY

Contacts and Locations

Locations

	Site	City	State	Country
1	1160.71.0046 Boehringer Ingelheim Investigational Site	Birmingham	Alabama	United States
2	1160.71.0057 Boehringer Ingelheim Investigational Site	Birmingham	Alabama	United States
3	1160.71.0211 Boehringer Ingelheim Investigational Site	Birmingham	Alabama	United States
4	1160.71.0115 Boehringer Ingelheim Investigational Site	Mobile	Alabama	United States
5	1160.71.0104 Boehringer Ingelheim Investigational Site	Lake Havasu City	Arizona	United States
6	1160.71.0185 Boehringer Ingelheim Investigational Site	Tucson	Arizona	United States
7	1160.71.0038 Boehringer Ingelheim Investigational Site	Hot Springs	Arkansas	United States
8	1160.71.0302 Boehringer Ingelheim Investigational Site	Jonesboro	Arkansas	United States
9	1160.71.0191 Boehringer Ingelheim Investigational Site	Little Rock	Arkansas	United States
10	1160.71.0213 Boehringer Ingelheim Investigational Site	Little Rock	Arkansas	United States
11	1160.71.0441 Boehringer Ingelheim Investigational Site	Carmichael	California	United States
12	1160.71.0333 Boehringer Ingelheim Investigational Site	Fullerton	California	United States
13	1160.71.0384 Boehringer Ingelheim Investigational Site	La Jolla	California	United States
14	1160.71.0246 Boehringer Ingelheim Investigational Site	Lancaster	California	United States
15	1160.71.0070 Boehringer Ingelheim Investigational Site	Merced	California	United States
16	1160.71.0349 Boehringer Ingelheim Investigational Site	Oakland	California	United States
17	1160.71.0016 Boehringer Ingelheim Investigational Site	Oceanside	California	United States
18	1160.71.0459 Boehringer Ingelheim Investigational Site	Pasadena	California	United States
19	1160.71.0270 Boehringer Ingelheim Investigational Site	Poway	California	United States
20	1160.71.0135 Boehringer Ingelheim Investigational Site	Riverside	California	United States
21	1160.71.0300 Boehringer Ingelheim Investigational Site	Sacramento	California	United States
22	1160.71.0284 Boehringer Ingelheim Investigational Site	San Diego	California	United States
23	1160.71.0379 Boehringer Ingelheim Investigational Site	Walnut Creek	California	United States
24	1160.71.0321 Boehringer Ingelheim Investigational Site	Colorado Springs	Colorado	United States
25	1160.71.0449 Boehringer Ingelheim Investigational Site	Colorado Springs	Colorado	United States
26	1160.71.0360 Boehringer Ingelheim Investigational Site	Denver	Colorado	United States
27	1160.71.0413 Boehringer Ingelheim Investigational Site	Denver	Colorado	United States
28	1160.71.0362 Boehringer Ingelheim Investigational Site	Fort Collins	Colorado	United States
29	1160.71.0278 Boehringer Ingelheim Investigational Site	Bridgeport	Connecticut	United States
30	1160.71.0482 Boehringer Ingelheim Investigational Site	Guilford	Connecticut	United States
31	1160.71.0382 Boehringer Ingelheim Investigational Site	Boynton Beach	Florida	United States
32	1160.71.0056 Boehringer Ingelheim Investigational Site	Brandon	Florida	United States
33	1160.71.0296 Boehringer Ingelheim Investigational Site	Clearwater	Florida	United States
34	1160.71.0327 Boehringer Ingelheim Investigational Site	Coral Springs	Florida	United States
35	1160.71.0376 Boehringer Ingelheim Investigational Site	Daytona Beach	Florida	United States
36	1160.71.0074 Boehringer Ingelheim Investigational Site	Fort Myers	Florida	United States
37	1160.71.0089 Boehringer Ingelheim Investigational Site	Jacksonville	Florida	United States
38	1160.71.0232 Boehringer Ingelheim Investigational Site	Jacksonville	Florida	United States
39	1160.71.0427 Boehringer Ingelheim Investigational Site	Jacksonville	Florida	United States
40	1160.71.0012 Boehringer Ingelheim Investigational Site	Lakeland	Florida	United States
41	1160.71.0034 Boehringer Ingelheim Investigational Site	Miami	Florida	United States
42	1160.71.0227 Boehringer Ingelheim Investigational Site	Orlando	Florida	United States
43	1160.71.0095 Boehringer Ingelheim Investigational Site	Ormond Beach	Florida	United States
44	1160.71.0037 Boehringer Ingelheim Investigational Site	Pensacola	Florida	United States
45	1160.71.0137 Boehringer Ingelheim Investigational Site	Port Charlotte	Florida	United States
46	1160.71.0417 Boehringer Ingelheim Investigational Site	Port Charlotte	Florida	United States
47	1160.71.0332 Boehringer Ingelheim Investigational Site	Rockledge	Florida	United States
48	1160.71.0385 Boehringer Ingelheim Investigational Site	Sarasota	Florida	United States
49	1160.71.0015 Boehringer Ingelheim Investigational Site	St. Petersburg	Florida	United States
50	1160.71.0339 Boehringer Ingelheim Investigational Site	St. Petersburg	Florida	United States
51	1160.71.0019 Boehringer Ingelheim Investigational Site	Vero Beach	Florida	United States
52	1160.71.0159 Boehringer Ingelheim Investigational Site	Atlanta	Georgia	United States
53	1160.71.0021 Boehringer Ingelheim Investigational Site	Augusta	Georgia	United States
54	1160.71.0161 Boehringer Ingelheim Investigational Site	Conyers	Georgia	United States
55	1160.71.0218 Boehringer Ingelheim Investigational Site	Cicero	Illinois	United States
56	1160.71.0438 Boehringer Ingelheim Investigational Site	Maywood	Illinois	United States
57	1160.71.0331 Boehringer Ingelheim Investigational Site	Melrose Park	Illinois	United States
58	1160.71.0364 Boehringer Ingelheim Investigational Site	Normal	Illinois	United States
59	1160.71.0109 Boehringer Ingelheim Investigational Site	North Chicago	Illinois	United States
60	1160.71.0152 Boehringer Ingelheim Investigational Site	Oak Lawn	Illinois	United States
61	1160.71.0198 Boehringer Ingelheim Investigational Site	Rockford	Illinois	United States
62	1160.71.0433 Boehringer Ingelheim Investigational Site	Winfield	Illinois	United States
63	1160.71.0377 Boehringer Ingelheim Investigational Site	Fort Wayne	Indiana	United States
64	1160.71.0288 Boehringer Ingelheim Investigational Site	Indianapolis	Indiana	United States
65	1160.71.0352 Boehringer Ingelheim Investigational Site	Indianapolis	Indiana	United States
66	1160.71.0436 Boehringer Ingelheim Investigational Site	Indianapolis	Indiana	United States
67	1160.71.0235 Boehringer Ingelheim Investigational Site	South Bend	Indiana	United States
68	1160.71.0268 Boehringer Ingelheim Investigational Site	Dubuque	Iowa	United States
69	1160.71.0001 Boehringer Ingelheim Investigational Site	West Des Moines	Iowa	United States
70	1160.71.0357 Boehringer Ingelheim Investigational Site	West Des Moines	Iowa	United States
71	1160.71.0422 Boehringer Ingelheim Investigational Site	Lexington	Kentucky	United States
72	1160.71.0178 Boehringer Ingelheim Investigational Site	Louisville	Kentucky	United States
73	1160.71.0397 Boehringer Ingelheim Investigational Site	Louisville	Kentucky	United States
74	1160.71.0310 Boehringer Ingelheim Investigational Site	Owensboro	Kentucky	United States
75	1160.71.0144 Boehringer Ingelheim Investigational Site	Baton Rouge	Louisiana	United States
76	1160.71.0018 Boehringer Ingelheim Investigational Site	Lafayette	Louisiana	United States
77	1160.71.0132 Boehringer Ingelheim Investigational Site	New Iberia	Louisiana	United States
78	1160.71.0096 Boehringer Ingelheim Investigational Site	Auburn	Maine	United States
79	1160.71.0114 Boehringer Ingelheim Investigational Site	Annapolis	Maryland	United States
80	1160.71.0023 Boehringer Ingelheim Investigational Site	Baltimore	Maryland	United States
81	1160.71.0047 Boehringer Ingelheim Investigational Site	Baltimore	Maryland	United States
82	1160.71.0079 Boehringer Ingelheim Investigational Site	Baltimore	Maryland	United States
83	1160.71.0186 Boehringer Ingelheim Investigational Site	Baltimore	Maryland	United States
84	1160.71.0194 Boehringer Ingelheim Investigational Site	Baltimore	Maryland	United States
85	1160.71.0255 Boehringer Ingelheim Investigational Site	Bel Air	Maryland	United States
86	1160.71.0398 Boehringer Ingelheim Investigational Site	Columbia	Maryland	United States
87	1160.71.0177 Boehringer Ingelheim Investigational Site	Rockville	Maryland	United States
88	1160.71.0073 Boehringer Ingelheim Investigational Site	Salisbury	Maryland	United States
89	1160.71.0207 Boehringer Ingelheim Investigational Site	Salisbury	Maryland	United States
90	1160.71.0196 Boehringer Ingelheim Investigational Site	Takoma Park	Maryland	United States
91	1160.71.0187 Boehringer Ingelheim Investigational Site	Towson	Maryland	United States
92	1160.71.0052 Boehringer Ingelheim Investigational Site	Westminster	Maryland	United States
93	1160.71.0443 Boehringer Ingelheim Investigational Site	Haverhill	Massachusetts	United States
94	1160.71.0452 Boehringer Ingelheim Investigational Site	Haverhill	Massachusetts	United States
95	1160.71.0029 Boehringer Ingelheim Investigational Site	Natick	Massachusetts	United States
96	1160.71.0003 Boehringer Ingelheim Investigational Site	North Dartmouth	Massachusetts	United States
97	1160.71.0308 Boehringer Ingelheim Investigational Site	Worcester	Massachusetts	United States
98	1160.71.0154 Boehringer Ingelheim Investigational Site	Grand Blanc	Michigan	United States
99	1160.71.0205 Boehringer Ingelheim Investigational Site	Lapeer	Michigan	United States
100	1160.71.0279 Boehringer Ingelheim Investigational Site	Muskegon	Michigan	United States
101	1160.71.0445 Boehringer Ingelheim Investigational Site	Petoskey	Michigan	United States
102	1160.71.0274 Boehringer Ingelheim Investigational Site	Rochester Hills	Michigan	United States
103	1160.71.0165 Boehringer Ingelheim Investigational Site	Saginaw	Michigan	United States
104	1160.71.0020 Boehringer Ingelheim Investigational Site	Troy	Michigan	United States
105	1160.71.0188 Boehringer Ingelheim Investigational Site	Ypsilanti	Michigan	United States
106	1160.71.0202 Boehringer Ingelheim Investigational Site	Minneapolis	Minnesota	United States
107	1160.71.0101 Boehringer Ingelheim Investigational Site	St. Paul	Minnesota	United States
108	1160.71.0086 Boehringer Ingelheim Investigational Site	Gulfport	Mississippi	United States
109	1160.71.0119 Boehringer Ingelheim Investigational Site	Tupelo	Mississippi	United States
110	1160.71.0055 Boehringer Ingelheim Investigational Site	Columbia	Missouri	United States
111	1160.71.0257 Boehringer Ingelheim Investigational Site	Kansas City	Missouri	United States
112	1160.71.0336 Boehringer Ingelheim Investigational Site	St. Charles	Missouri	United States
113	1160.71.0249 Boehringer Ingelheim Investigational Site	St. Louis	Missouri	United States
114	1160.71.0027 Boehringer Ingelheim Investigational Site	Kalispell	Montana	United States
115	1160.71.0110 Boehringer Ingelheim Investigational Site	Omaha	Nebraska	United States
116	1160.71.0346 Boehringer Ingelheim Investigational Site	Henderson	Nevada	United States
117	1160.71.0430 Boehringer Ingelheim Investigational Site	Las Vegas	Nevada	United States
118	1160.71.0142 Boehringer Ingelheim Investigational Site	Browns Mills	New Jersey	United States
119	1160.71.0221 Boehringer Ingelheim Investigational Site	Cherry Hill	New Jersey	United States
120	1160.71.0248 Boehringer Ingelheim Investigational Site	Flemington	New Jersey	United States
121	1160.71.0478 Boehringer Ingelheim Investigational Site	Oakland	New Jersey	United States
122	1160.71.0392 Boehringer Ingelheim Investigational Site	Ocean	New Jersey	United States
123	1160.71.0254 Boehringer Ingelheim Investigational Site	Westwood	New Jersey	United States
124	1160.71.0472 Boehringer Ingelheim Investigational Site	Woodland Park	New Jersey	United States
125	1160.71.0476 Boehringer Ingelheim Investigational Site	Albany	New York	United States
126	1160.71.0113 Boehringer Ingelheim Investigational Site	Bronx	New York	United States
127	1160.71.0281 Boehringer Ingelheim Investigational Site	Bronx	New York	United States
128	1160.71.0044 Boehringer Ingelheim Investigational Site	Cortlandt Manor	New York	United States
129	1160.71.0229 Boehringer Ingelheim Investigational Site	Mineola	New York	United States
130	1160.71.0451 Boehringer Ingelheim Investigational Site	Mineola	New York	United States
131	1160.71.0183 Boehringer Ingelheim Investigational Site	New Rochelle	New York	United States
132	1160.71.0210 Boehringer Ingelheim Investigational Site	Northport	New York	United States
133	1160.71.0075 Boehringer Ingelheim Investigational Site	Poughkeepsie	New York	United States
134	1160.71.0414 Boehringer Ingelheim Investigational Site	Troy	New York	United States
135	1160.71.0356 Boehringer Ingelheim Investigational Site	Watertown	New York	United States
136	1160.71.0064 Boehringer Ingelheim Investigational Site	Yonkers	New York	United States
137	1160.71.0353 Boehringer Ingelheim Investigational Site	Asheville	North Carolina	United States
138	1160.71.0080 Boehringer Ingelheim Investigational Site	Charlotte	North Carolina	United States
139	1160.71.0350 Boehringer Ingelheim Investigational Site	Gastonia	North Carolina	United States
140	1160.71.0173 Boehringer Ingelheim Investigational Site	High Point	North Carolina	United States
141	1160.71.0006 Boehringer Ingelheim Investigational Site	Pinehurst	North Carolina	United States
142	1160.71.0002 Boehringer Ingelheim Investigational Site	Statesville	North Carolina	United States
143	1160.71.0069 Boehringer Ingelheim Investigational Site	Statesville	North Carolina	United States
144	1160.71.0102 Boehringer Ingelheim Investigational Site	Grand Forks	North Dakota	United States
145	1160.71.0222 Boehringer Ingelheim Investigational Site	Jamestown	North Dakota	United States
146	1160.71.0203 Boehringer Ingelheim Investigational Site	Akron	Ohio	United States
147	1160.71.0434 Boehringer Ingelheim Investigational Site	Canal Fulton	Ohio	United States
148	1160.71.0402 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio	United States
149	1160.71.0426 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio	United States
150	1160.71.0479 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio	United States
151	1160.71.0263 Boehringer Ingelheim Investigational Site	Cleveland	Ohio	United States
152	1160.71.0480 Boehringer Ingelheim Investigational Site	Cleveland	Ohio	United States
153	1160.71.0267 Boehringer Ingelheim Investigational Site	Columbus	Ohio	United States
154	1160.71.0035 Boehringer Ingelheim Investigational Site	Dayton	Ohio	United States
155	1160.71.0150 Boehringer Ingelheim Investigational Site	Fairview Park	Ohio	United States
156	1160.71.0201 Boehringer Ingelheim Investigational Site	Kettering	Ohio	United States
157	1160.71.0223 Boehringer Ingelheim Investigational Site	Lorain	Ohio	United States
158	1160.71.0214 Boehringer Ingelheim Investigational Site	Lyndhurst	Ohio	United States
159	1160.71.0275 Boehringer Ingelheim Investigational Site	Sandusky	Ohio	United States
160	1160.71.0103 Boehringer Ingelheim Investigational Site	Westlake	Ohio	United States
161	1160.71.0435 Boehringer Ingelheim Investigational Site	Tulsa	Oklahoma	United States
162	1160.71.0139 Boehringer Ingelheim Investigational Site	Corvallis	Oregon	United States
163	1160.71.0325 Boehringer Ingelheim Investigational Site	Eugene	Oregon	United States
164	1160.71.0133 Boehringer Ingelheim Investigational Site	Springfield	Oregon	United States
165	1160.71.0301 Boehringer Ingelheim Investigational Site	Allentown	Pennsylvania	United States
166	1160.71.0295 Boehringer Ingelheim Investigational Site	Camp Hill	Pennsylvania	United States
167	1160.71.0294 Boehringer Ingelheim Investigational Site	Hershey	Pennsylvania	United States
168	1160.71.0369 Boehringer Ingelheim Investigational Site	Jenkintown	Pennsylvania	United States
169	1160.71.0431 Boehringer Ingelheim Investigational Site	Lancaster	Pennsylvania	United States
170	1160.71.0168 Boehringer Ingelheim Investigational Site	Langhorne	Pennsylvania	United States
171	1160.71.0293 Boehringer Ingelheim Investigational Site	Meadowbrook	Pennsylvania	United States
172	1160.71.0394 Boehringer Ingelheim Investigational Site	Norristown	Pennsylvania	United States
173	1160.71.0466 Boehringer Ingelheim Investigational Site	Pittsburgh	Pennsylvania	United States
174	1160.71.0208 Boehringer Ingelheim Investigational Site	Sellersville	Pennsylvania	United States
175	1160.71.0465 Boehringer Ingelheim Investigational Site	Uniontown	Pennsylvania	United States
176	1160.71.0032 Boehringer Ingelheim Investigational Site	Wynnewood	Pennsylvania	United States
177	1160.71.0067 Boehringer Ingelheim Investigational Site	Wyomissing	Pennsylvania	United States
178	1160.71.0007 Boehringer Ingelheim Investigational Site	Beaufort	South Carolina	United States
179	1160.71.0383 Boehringer Ingelheim Investigational Site	Charleston	South Carolina	United States
180	1160.71.0313 Boehringer Ingelheim Investigational Site	Greenville	South Carolina	United States
181	1160.71.0166 Boehringer Ingelheim Investigational Site	Spartanburg	South Carolina	United States
182	1160.71.0008 Boehringer Ingelheim Investigational Site	Summerville	South Carolina	United States
183	1160.71.0084 Boehringer Ingelheim Investigational Site	Chattanooga	Tennessee	United States
184	1160.71.0474 Boehringer Ingelheim Investigational Site	Clinton	Tennessee	United States
185	1160.71.0062 Boehringer Ingelheim Investigational Site	Germantown	Tennessee	United States
186	1160.71.0370 Boehringer Ingelheim Investigational Site	Johnson City	Tennessee	United States
187	1160.71.0395 Boehringer Ingelheim Investigational Site	Nashville	Tennessee	United States
188	1160.71.0129 Boehringer Ingelheim Investigational Site	Austin	Texas	United States
189	1160.71.0410 Boehringer Ingelheim Investigational Site	Austin	Texas	United States
190	1160.71.0156 Boehringer Ingelheim Investigational Site	Dallas	Texas	United States
191	1160.71.0315 Boehringer Ingelheim Investigational Site	Fort Worth	Texas	United States
192	1160.71.0447 Boehringer Ingelheim Investigational Site	Houston	Texas	United States
193	1160.71.0483 Boehringer Ingelheim Investigational Site	Killeen	Texas	United States
194	1160.71.0335 Boehringer Ingelheim Investigational Site	Lubbock	Texas	United States
195	1160.71.0269 Boehringer Ingelheim Investigational Site	San Antonio	Texas	United States
196	1160.71.0307 Boehringer Ingelheim Investigational Site	San Antonio	Texas	United States
197	1160.71.0285 Boehringer Ingelheim Investigational Site	San Marcos	Texas	United States
198	1160.71.0367 Boehringer Ingelheim Investigational Site	Tyler	Texas	United States
199	1160.71.0453 Boehringer Ingelheim Investigational Site	Charlottesville	Virginia	United States
200	1160.71.0053 Boehringer Ingelheim Investigational Site	Chesapeake	Virginia	United States
201	1160.71.0428 Boehringer Ingelheim Investigational Site	Fredericksburg	Virginia	United States
202	1160.71.0311 Boehringer Ingelheim Investigational Site	Harrisonburg	Virginia	United States
203	1160.71.0292 Boehringer Ingelheim Investigational Site	Newport News	Virginia	United States
204	1160.71.0220 Boehringer Ingelheim Investigational Site	Salem	Virginia	United States
205	1160.71.0224 Boehringer Ingelheim Investigational Site	Suffolk	Virginia	United States
206	1160.71.0317 Boehringer Ingelheim Investigational Site	Winchester	Virginia	United States
207	1160.71.0050 Boehringer Ingelheim Investigational Site	Bellingham	Washington	United States
208	1160.71.0040 Boehringer Ingelheim Investigational Site	Burien	Washington	United States
209	1160.71.0250 Boehringer Ingelheim Investigational Site	Spokane	Washington	United States
210	1160.71.0256 Boehringer Ingelheim Investigational Site	Tacoma	Washington	United States
211	1160.71.0024 Boehringer Ingelheim Investigational Site	Wenatchee	Washington	United States
212	1160.71.0169 Boehringer Ingelheim Investigational Site	Clarksburg	West Virginia	United States
213	1160.71.0365 Boehringer Ingelheim Investigational Site	Huntington	West Virginia	United States
214	1160.71.0099 Boehringer Ingelheim Investigational Site	Madison	Wisconsin	United States
215	1160.71.0072 Boehringer Ingelheim Investigational Site	Milwaukee	Wisconsin	United States
216	1160.71.0461 Boehringer Ingelheim Investigational Site	Milwaukee	Wisconsin	United States
217	1160.71.0508 Boehringer Ingelheim Investigational Site	Coffs Harbour	New South Wales	Australia
218	1160.71.0510 Boehringer Ingelheim Investigational Site	Gosford	New South Wales	Australia
219	1160.71.0506 Boehringer Ingelheim Investigational Site	Milton	Queensland	Australia
220	1160.71.0509 Boehringer Ingelheim Investigational Site	Ashford	South Australia	Australia
221	1160.71.0507 Boehringer Ingelheim Investigational Site	Launceston	Tasmania	Australia
222	1160.71.0504 Boehringer Ingelheim Investigational Site	Box Hill	Victoria	Australia
223	1160.71.0501 Boehringer Ingelheim Investigational Site	Geelong	Victoria	Australia
224	1160.71.0543 Boehringer Ingelheim Investigational Site	Graz		Austria
225	1160.71.0549 Boehringer Ingelheim Investigational Site	Linz		Austria
226	1160.71.0541 Boehringer Ingelheim Investigational Site	Wien		Austria
227	1160.71.0542 Boehringer Ingelheim Investigational Site	Wien		Austria
228	1160.71.0545 Boehringer Ingelheim Investigational Site	Wien		Austria
229	1160.71.0547 Boehringer Ingelheim Investigational Site	Wien		Austria
230	1160.71.0548 Boehringer Ingelheim Investigational Site	Wien		Austria
231	1160.71.0550 Boehringer Ingelheim Investigational Site	Wr. Neustadt		Austria
232	1160.71.0564 Boehringer Ingelheim Investigational Site	Aalst		Belgium
233	1160.71.0572 Boehringer Ingelheim Investigational Site	Brasschaat		Belgium
234	1160.71.0571 Boehringer Ingelheim Investigational Site	Brussel		Belgium
235	1160.71.0581 Boehringer Ingelheim Investigational Site	Bruxelles		Belgium
236	1160.71.0585 Boehringer Ingelheim Investigational Site	Bruxelles		Belgium
237	1160.71.0563 Boehringer Ingelheim Investigational Site	Edegem		Belgium
238	1160.71.0578 Boehringer Ingelheim Investigational Site	Genk		Belgium
239	1160.71.0587 Boehringer Ingelheim Investigational Site	Genk		Belgium
240	1160.71.0574 Boehringer Ingelheim Investigational Site	Gent		Belgium
241	1160.71.0588 Boehringer Ingelheim Investigational Site	Gilly		Belgium
242	1160.71.0568 Boehringer Ingelheim Investigational Site	Hasselt		Belgium
243	1160.71.0561 Boehringer Ingelheim Investigational Site	Leuven		Belgium
244	1160.71.0579 Boehringer Ingelheim Investigational Site	Liège		Belgium
245	1160.71.0567 Boehringer Ingelheim Investigational Site	Oostende		Belgium
246	1160.71.0570 Boehringer Ingelheim Investigational Site	Roeselare		Belgium
247	1160.71.0566 Boehringer Ingelheim Investigational Site	Tienen		Belgium
248	1160.71.0562 Boehringer Ingelheim Investigational Site	Turnhout		Belgium
249	1160.71.0644 Boehringer Ingelheim Investigational Site	Campinas		Brazil
250	1160.71.0650 Boehringer Ingelheim Investigational Site	Curitiba		Brazil
251	1160.71.0651 Boehringer Ingelheim Investigational Site	Curitiba		Brazil
252	1160.71.0652 Boehringer Ingelheim Investigational Site	Goiania		Brazil
253	1160.71.0646 Boehringer Ingelheim Investigational Site	Sao Jose do Riio Preto		Brazil
254	1160.71.0647 Boehringer Ingelheim Investigational Site	São José do Rio Preto		Brazil
255	1160.71.0643 Boehringer Ingelheim Investigational Site	São Paulo		Brazil
256	1160.71.0620 Boehringer Ingelheim Investigational Site	Pleven		Bulgaria
257	1160.71.0611 Boehringer Ingelheim Investigational Site	Sofia		Bulgaria
258	1160.71.0612 Boehringer Ingelheim Investigational Site	Sofia		Bulgaria
259	1160.71.0615 Boehringer Ingelheim Investigational Site	Sofia		Bulgaria
260	1160.71.0617 Boehringer Ingelheim Investigational Site	Sofia		Bulgaria
261	1160.71.0618 Boehringer Ingelheim Investigational Site	Sofia		Bulgaria
262	1160.71.0625 Boehringer Ingelheim Investigational Site	Sofia		Bulgaria
263	1160.71.0694 Boehringer Ingelheim Investigational Site	Calgary	Alberta	Canada
264	1160.71.0696 Boehringer Ingelheim Investigational Site	Calgary	Alberta	Canada
265	1160.71.0680 Boehringer Ingelheim Investigational Site	Coquitlam	British Columbia	Canada
266	1160.71.0712 Boehringer Ingelheim Investigational Site	Coquitlam	British Columbia	Canada
267	1160.71.0706 Boehringer Ingelheim Investigational Site	Kelowna	British Columbia	Canada
268	1160.71.0725 Boehringer Ingelheim Investigational Site	Nanaimo	British Columbia	Canada
269	1160.71.0691 Boehringer Ingelheim Investigational Site	New Westminster	British Columbia	Canada
270	1160.71.0714 Boehringer Ingelheim Investigational Site	Victoria	British Columbia	Canada
271	1160.71.0701 Boehringer Ingelheim Investigational Site	Portage la Prairie	Manitoba	Canada
272	1160.71.0703 Boehringer Ingelheim Investigational Site	Halifax	Nova Scotia	Canada
273	1160.71.0674 Boehringer Ingelheim Investigational Site	Burlington	Ontario	Canada
274	1160.71.0702 Boehringer Ingelheim Investigational Site	Cambridge	Ontario	Canada
275	1160.71.0720 Boehringer Ingelheim Investigational Site	Cambridge	Ontario	Canada
276	1160.71.0692 Boehringer Ingelheim Investigational Site	Grimsby	Ontario	Canada
277	1160.71.0697 Boehringer Ingelheim Investigational Site	Hamilton	Ontario	Canada
278	1160.71.0710 Boehringer Ingelheim Investigational Site	Hamilton	Ontario	Canada
279	1160.71.0719 Boehringer Ingelheim Investigational Site	Hamilton	Ontario	Canada
280	1160.71.0721 Boehringer Ingelheim Investigational Site	Hamilton	Ontario	Canada
281	1160.71.0708 Boehringer Ingelheim Investigational Site	Mississauga	Ontario	Canada
282	1160.71.0688 Boehringer Ingelheim Investigational Site	Newmarket	Ontario	Canada
283	1160.71.0672 Boehringer Ingelheim Investigational Site	Oshawa	Ontario	Canada
284	1160.71.0687 Boehringer Ingelheim Investigational Site	Ottawa	Ontario	Canada
285	1160.71.0679 Boehringer Ingelheim Investigational Site	Scarborough	Ontario	Canada
286	1160.71.0723 Boehringer Ingelheim Investigational Site	Scarborough	Ontario	Canada
287	1160.71.0715 Boehringer Ingelheim Investigational Site	Sudbury	Ontario	Canada
288	1160.71.0690 Boehringer Ingelheim Investigational Site	Thunder Bay	Ontario	Canada
289	1160.71.0684 Boehringer Ingelheim Investigational Site	Toronto	Ontario	Canada
290	1160.71.0718 Boehringer Ingelheim Investigational Site	Toronto	Ontario	Canada
291	1160.71.0686 Boehringer Ingelheim Investigational Site	Windsor	Ontario	Canada
292	1160.71.0683 Boehringer Ingelheim Investigational Site	Montreal	Quebec	Canada
293	1160.71.0705 Boehringer Ingelheim Investigational Site	Montreal	Quebec	Canada
294	1160.71.0709 Boehringer Ingelheim Investigational Site	Montreal	Quebec	Canada
295	1160.71.0716 Boehringer Ingelheim Investigational Site	Montreal	Quebec	Canada
296	1160.71.0717 Boehringer Ingelheim Investigational Site	Quebec City	Quebec	Canada
297	1160.71.0699 Boehringer Ingelheim Investigational Site	St. Charles-Borromee	Quebec	Canada
298	1160.71.0713 Boehringer Ingelheim Investigational Site	St. George-de-Beauce	Quebec	Canada
299	1160.71.0675 Boehringer Ingelheim Investigational Site	St. Hyacinthe	Quebec	Canada
300	1160.71.0673 Boehringer Ingelheim Investigational Site	Saskatoon	Saskatchewan	Canada
301	1160.71.0678 Boehringer Ingelheim Investigational Site	Saskatoon	Saskatchewan	Canada
302	1160.71.0700 Boehringer Ingelheim Investigational Site	Quebec		Canada
303	1160.71.0771 Boehringer Ingelheim Investigational Site	Beijing		China
304	1160.71.0772 Boehringer Ingelheim Investigational Site	Beijing		China
305	1160.71.0773 Boehringer Ingelheim Investigational Site	Beijing		China
306	1160.71.0774 Boehringer Ingelheim Investigational Site	Beijing		China
307	1160.71.0776 Boehringer Ingelheim Investigational Site	Haerbin		China
308	1160.71.0784 Boehringer Ingelheim Investigational Site	Hangzhou		China
309	1160.71.0778 Boehringer Ingelheim Investigational Site	QingDao		China
310	1160.71.0781 Boehringer Ingelheim Investigational Site	Shanghai		China
311	1160.71.0782 Boehringer Ingelheim Investigational Site	Shanghai		China
312	1160.71.0777 Boehringer Ingelheim Investigational Site	Shenyang		China
313	1160.71.0780 Boehringer Ingelheim Investigational Site	Shijiazhuang		China
314	1160.71.0816 Boehringer Ingelheim Investigational Site	Modrice		Czech Republic
315	1160.71.0820 Boehringer Ingelheim Investigational Site	Ostrava 1		Czech Republic
316	1160.71.0818 Boehringer Ingelheim Investigational Site	Pardubice		Czech Republic
317	1160.71.0814 Boehringer Ingelheim Investigational Site	Plzen-Bory		Czech Republic
318	1160.71.0811 Boehringer Ingelheim Investigational Site	Praha 5		Czech Republic
319	1160.71.0812 Boehringer Ingelheim Investigational Site	Praha 6		Czech Republic
320	1160.71.0813 Boehringer Ingelheim Investigational Site	Praha 9		Czech Republic
321	1160.71.0817 Boehringer Ingelheim Investigational Site	Pribram		Czech Republic
322	1160.71.0819 Boehringer Ingelheim Investigational Site	Usti nad Orlici		Czech Republic
323	1160.71.0837 Boehringer Ingelheim Investigational Site	Aalborg		Denmark
324	1160.71.0835 Boehringer Ingelheim Investigational Site	Aarhus C		Denmark
325	1160.71.0838 Boehringer Ingelheim Investigational Site	Frederikssund		Denmark
326	1160.71.0833 Boehringer Ingelheim Investigational Site	Helsingør		Denmark
327	1160.71.0834 Boehringer Ingelheim Investigational Site	Herlev		Denmark
328	1160.71.0841 Boehringer Ingelheim Investigational Site	Horsens		Denmark
329	1160.71.0832 Boehringer Ingelheim Investigational Site	Hvidovre		Denmark
330	1160.71.0840 Boehringer Ingelheim Investigational Site	Køge		Denmark
331	1160.71.0831 Boehringer Ingelheim Investigational Site	Odense		Denmark
332	1160.71.0839 Boehringer Ingelheim Investigational Site	Roskilde		Denmark
333	1160.71.0836 Boehringer Ingelheim Investigational Site	Svendborg		Denmark
334	1160.71.0851 Boehringer Ingelheim Investigational Site	Helsinki		Finland
335	1160.71.0859 Boehringer Ingelheim Investigational Site	Jyväskylä		Finland
336	1160.71.0854 Boehringer Ingelheim Investigational Site	Oulu		Finland
337	1160.71.0858 Boehringer Ingelheim Investigational Site	Pori		Finland
338	1160.71.0852 Boehringer Ingelheim Investigational Site	Tampere		Finland
339	1160.71.0853 Boehringer Ingelheim Investigational Site	Turku		Finland
340	1160.71.875A Boehringer Ingelheim Investigational Site	ABBEVILLE cedex		France
341	1160.71.882D Boehringer Ingelheim Investigational Site	Angers		France
342	1160.71.882G Boehringer Ingelheim Investigational Site	Angers		France
343	1160.71.879F Boehringer Ingelheim Investigational Site	Besle Sur Vilaine		France
344	1160.71.887A Boehringer Ingelheim Investigational Site	Cholet		France
345	1160.71.882K Boehringer Ingelheim Investigational Site	Château Gontier		France
346	1160.71.879C Boehringer Ingelheim Investigational Site	Derval		France
347	1160.71.882H Boehringer Ingelheim Investigational Site	Feneu		France
348	1160.71.888A Boehringer Ingelheim Investigational Site	GRENOBLE Cédex 9		France
349	1160.71.879B Boehringer Ingelheim Investigational Site	La Chapelle sur Erdre		France
350	1160.71.874A Boehringer Ingelheim Investigational Site	Langres		France
351	1160.71.884A Boehringer Ingelheim Investigational Site	Laval		France
352	1160.71.880B Boehringer Ingelheim Investigational Site	Le Mesnil en Valée		France
353	1160.71.880A Boehringer Ingelheim Investigational Site	Murs Erigne		France
354	1160.71.879A Boehringer Ingelheim Investigational Site	Nantes		France
355	1160.71.879H Boehringer Ingelheim Investigational Site	Nantes		France
356	1160.71.879S Boehringer Ingelheim Investigational Site	Nantes		France
357	1160.71.880J Boehringer Ingelheim Investigational Site	Parcay les Pins		France
358	1160.71.871A Boehringer Ingelheim Investigational Site	Paris		France
359	1160.71.879E Boehringer Ingelheim Investigational Site	Saint Aubin Des Chateaux		France
360	1160.71.880D Boehringer Ingelheim Investigational Site	Segre		France
361	1160.71.882A Boehringer Ingelheim Investigational Site	Tierce		France
362	1160.71.882B Boehringer Ingelheim Investigational Site	Tierce		France
363	1160.71.882C Boehringer Ingelheim Investigational Site	Tierce		France
364	1160.71.879G Boehringer Ingelheim Investigational Site	Vieillevigne		France
365	1160.71.880E Boehringer Ingelheim Investigational Site	Vihiers		France
366	1160.71.0932 Boehringer Ingelheim Investigational Site	Berlin		Germany
367	1160.71.0948 Boehringer Ingelheim Investigational Site	Berlin		Germany
368	1160.71.0962 Boehringer Ingelheim Investigational Site	Berlin		Germany
369	1160.71.0940 Boehringer Ingelheim Investigational Site	Bochum		Germany
370	1160.71.0972 Boehringer Ingelheim Investigational Site	Dortmund		Germany
371	1160.71.0934 Boehringer Ingelheim Investigational Site	Essen		Germany
372	1160.71.0931 Boehringer Ingelheim Investigational Site	Frankfurt am Main		Germany
373	1160.71.0943 Boehringer Ingelheim Investigational Site	Heidelberg		Germany
374	1160.71.0963 Boehringer Ingelheim Investigational Site	Köln		Germany
375	1160.71.0946 Boehringer Ingelheim Investigational Site	Lahr		Germany
376	1160.71.0944 Boehringer Ingelheim Investigational Site	Limburg		Germany
377	1160.71.0951 Boehringer Ingelheim Investigational Site	Mainz		Germany
378	1160.71.0933 Boehringer Ingelheim Investigational Site	Mannheim		Germany
379	1160.71.0945 Boehringer Ingelheim Investigational Site	Mannheim		Germany
380	1160.71.0970 Boehringer Ingelheim Investigational Site	Mannheim		Germany
381	1160.71.0937 Boehringer Ingelheim Investigational Site	Witten		Germany
382	1160.71.0966 Boehringer Ingelheim Investigational Site	Wuppertal		Germany
383	1160.71.0901 Boehringer Ingelheim Investigational Site	Athens		Greece
384	1160.71.0914 Boehringer Ingelheim Investigational Site	Kalamaria-Thessaloniki		Greece
385	1160.71.0904 Boehringer Ingelheim Investigational Site	Larissa		Greece
386	1160.71.0910 Boehringer Ingelheim Investigational Site	Thiva		Greece
387	1160.71.0903 Boehringer Ingelheim Investigational Site	Trikala		Greece
388	1160.71.0905 Boehringer Ingelheim Investigational Site	Voula - Athens		Greece
389	1160.71.1003 Boehringer Ingelheim Investigational Site	Kowloon		Hong Kong
390	1160.71.1004 Boehringer Ingelheim Investigational Site	Kowloon		Hong Kong
391	1160.71.1011 Boehringer Ingelheim Investigational Site	Budapest		Hungary
392	1160.71.1012 Boehringer Ingelheim Investigational Site	Budapest		Hungary
393	1160.71.1013 Boehringer Ingelheim Investigational Site	Budapest		Hungary
394	1160.71.1014 Boehringer Ingelheim Investigational Site	Budapest		Hungary
395	1160.71.1015 Boehringer Ingelheim Investigational Site	Budapest		Hungary
396	1160.71.1016 Boehringer Ingelheim Investigational Site	Budapest		Hungary
397	1160.71.1020 Boehringer Ingelheim Investigational Site	Gyongyos		Hungary
398	1160.71.1017 Boehringer Ingelheim Investigational Site	Komarom		Hungary
399	1160.71.1018 Boehringer Ingelheim Investigational Site	Pecs		Hungary
400	1160.71.1056 Boehringer Ingelheim Investigational Site	Ahmedabad-52		India
401	1160.71.1057 Boehringer Ingelheim Investigational Site	Ahmedabad		India
402	1160.71.1065 Boehringer Ingelheim Investigational Site	Bangalore		India
403	1160.71.1062 Boehringer Ingelheim Investigational Site	Hyderabad		India
404	1160.71.1073 Boehringer Ingelheim Investigational Site	Jaipur, Rajasthan		India
405	1160.71.1067 Boehringer Ingelheim Investigational Site	Kerala		India
406	1160.71.1068 Boehringer Ingelheim Investigational Site	Kottayam		India
407	1160.71.1055 Boehringer Ingelheim Investigational Site	Lucknow, Uttar Pradesh		India
408	1160.71.1051 Boehringer Ingelheim Investigational Site	Ludhiana		India
409	1160.71.1072 Boehringer Ingelheim Investigational Site	Mysore		India
410	1160.71.1059 Boehringer Ingelheim Investigational Site	Nagpur-12		India
411	1160.71.1052 Boehringer Ingelheim Investigational Site	New Delhi		India
412	1160.71.1070 Boehringer Ingelheim Investigational Site	Pune, Maharashtra		India
413	1160.71.1110 Boehringer Ingelheim Investigational Site	Afula		Israel
414	1160.71.1121 Boehringer Ingelheim Investigational Site	Afula		Israel
415	1160.71.1111 Boehringer Ingelheim Investigational Site	Ashkelon		Israel
416	1160.71.1117 Boehringer Ingelheim Investigational Site	Givatayim		Israel
417	1160.71.1112 Boehringer Ingelheim Investigational Site	Hadera		Israel
418	1160.71.1091 Boehringer Ingelheim Investigational Site	Haifa		Israel
419	1160.71.1113 Boehringer Ingelheim Investigational Site	Haifa		Israel
420	1160.71.1114 Boehringer Ingelheim Investigational Site	Haifa		Israel
421	1160.71.1116 Boehringer Ingelheim Investigational Site	Haifa		Israel
422	1160.71.1118 Boehringer Ingelheim Investigational Site	Haifa		Israel
423	1160.71.1105 Boehringer Ingelheim Investigational Site	Holon		Israel
424	1160.71.1101 Boehringer Ingelheim Investigational Site	Jerusalem		Israel
425	1160.71.1104 Boehringer Ingelheim Investigational Site	Jerusalem		Israel
426	1160.71.1106 Boehringer Ingelheim Investigational Site	Jerusalem		Israel
427	1160.71.1119 Boehringer Ingelheim Investigational Site	Kfar Saba		Israel
428	1160.71.1096 Boehringer Ingelheim Investigational Site	Petah Tikva		Israel
429	1160.71.1093 Boehringer Ingelheim Investigational Site	Ramat Gan		Israel
430	1160.71.1094 Boehringer Ingelheim Investigational Site	Ramat Gan		Israel
431	1160.71.1095 Boehringer Ingelheim Investigational Site	Ramat Gan		Israel
432	1160.71.1100 Boehringer Ingelheim Investigational Site	Rehovot		Israel
433	1160.71.1103 Boehringer Ingelheim Investigational Site	Safed		Israel
434	1160.71.1120 Boehringer Ingelheim Investigational Site	Tel Aviv		Israel
435	1160.71.1122 Boehringer Ingelheim Investigational Site	Tel Aviv		Israel
436	1160.71.1107 Boehringer Ingelheim Investigational Site	Tel-Aviv		Israel
437	1160.71.1108 Boehringer Ingelheim Investigational Site	Tel-Aviv		Israel
438	1160.71.1109 Boehringer Ingelheim Investigational Site	Tel-Aviv		Israel
439	1160.71.1169 Boehringer Ingelheim Investigational Site	Arezzo		Italy
440	1160.71.1172 Boehringer Ingelheim Investigational Site	Ascoli Piceno		Italy
441	1160.71.1170 Boehringer Ingelheim Investigational Site	Sassari		Italy
442	1160.71.1585 Boehringer Ingelheim Investigational Site	Busan		Korea, Republic of
443	1160.71.1586 Boehringer Ingelheim Investigational Site	Cheonan-si		Korea, Republic of
444	1160.71.1584 Boehringer Ingelheim Investigational Site	Daegu		Korea, Republic of
445	1160.71.1591 Boehringer Ingelheim Investigational Site	Daegu		Korea, Republic of
446	1160.71.1590 Boehringer Ingelheim Investigational Site	Gwangju		Korea, Republic of
447	1160.71.1581 Boehringer Ingelheim Investigational Site	Incheon		Korea, Republic of
448	1160.71.1582 Boehringer Ingelheim Investigational Site	Seoul		Korea, Republic of
449	1160.71.1583 Boehringer Ingelheim Investigational Site	Seoul		Korea, Republic of
450	1160.71.1589 Boehringer Ingelheim Investigational Site	Seoul		Korea, Republic of
451	1160.71.1592 Boehringer Ingelheim Investigational Site	Seoul		Korea, Republic of
452	1160.71.1593 Boehringer Ingelheim Investigational Site	Seoul		Korea, Republic of
453	1160.71.1291 Boehringer Ingelheim Investigational Site	Kuala Lumpur		Malaysia
454	1160.71.1292 Boehringer Ingelheim Investigational Site	Kuala Lumpur		Malaysia
455	1160.71.1337 Boehringer Ingelheim Investigational Site	's Hertogenbosch		Netherlands
456	1160.71.1344 Boehringer Ingelheim Investigational Site	Almelo		Netherlands
457	1160.71.1331 Boehringer Ingelheim Investigational Site	Amsterdam		Netherlands
458	1160.71.1336 Boehringer Ingelheim Investigational Site	Apeldoorn		Netherlands
459	1160.71.1332 Boehringer Ingelheim Investigational Site	Breda		Netherlands
460	1160.71.1349 Boehringer Ingelheim Investigational Site	Den Helder		Netherlands
461	1160.71.1345 Boehringer Ingelheim Investigational Site	Deventer		Netherlands
462	1160.71.1360 Boehringer Ingelheim Investigational Site	Dirksland		Netherlands
463	1160.71.1340 Boehringer Ingelheim Investigational Site	Ede		Netherlands
464	1160.71.1358 Boehringer Ingelheim Investigational Site	Eindhoven		Netherlands
465	1160.71.1338 Boehringer Ingelheim Investigational Site	Enschede		Netherlands
466	1160.71.1343 Boehringer Ingelheim Investigational Site	Goes		Netherlands
467	1160.71.1347 Boehringer Ingelheim Investigational Site	Gorinchem		Netherlands
468	1160.71.1333 Boehringer Ingelheim Investigational Site	Groningen		Netherlands
469	1160.71.1361 Boehringer Ingelheim Investigational Site	Heerlen		Netherlands
470	1160.71.1339 Boehringer Ingelheim Investigational Site	Hengelo		Netherlands
471	1160.71.1346 Boehringer Ingelheim Investigational Site	Hilversum		Netherlands
472	1160.71.1356 Boehringer Ingelheim Investigational Site	Hoorn		Netherlands
473	1160.71.1359 Boehringer Ingelheim Investigational Site	Maastricht		Netherlands
474	1160.71.1341 Boehringer Ingelheim Investigational Site	Meppel		Netherlands
475	1160.71.1354 Boehringer Ingelheim Investigational Site	Rotterdam		Netherlands
476	1160.71.1351 Boehringer Ingelheim Investigational Site	Sneek		Netherlands
477	1160.71.1353 Boehringer Ingelheim Investigational Site	Tiel		Netherlands
478	1160.71.1352 Boehringer Ingelheim Investigational Site	Tilburg		Netherlands
479	1160.71.1350 Boehringer Ingelheim Investigational Site	Veldhoven		Netherlands
480	1160.71.1342 Boehringer Ingelheim Investigational Site	Velp		Netherlands
481	1160.71.1348 Boehringer Ingelheim Investigational Site	Zwijndrecht		Netherlands
482	1160.71.1396 Boehringer Ingelheim Investigational Site	Gjøvik		Norway
483	1160.71.1393 Boehringer Ingelheim Investigational Site	Moss		Norway
484	1160.71.1395 Boehringer Ingelheim Investigational Site	Nordbyhagen		Norway
485	1160.71.1391 Boehringer Ingelheim Investigational Site	Oslo		Norway
486	1160.71.1397 Boehringer Ingelheim Investigational Site	Oslo		Norway
487	1160.71.1394 Boehringer Ingelheim Investigational Site	RUD		Norway
488	1160.71.1422 Boehringer Ingelheim Investigational Site	Ermita Manila		Philippines
489	1160.71.1421 Boehringer Ingelheim Investigational Site	Manila		Philippines
490	1160.71.1424 Boehringer Ingelheim Investigational Site	Pasig City		Philippines
491	1160.71.1423 Boehringer Ingelheim Investigational Site	Quezon City		Philippines
492	1160.71.1425 Boehringer Ingelheim Investigational Site	Quezon City		Philippines
493	1160.71.1436 Boehringer Ingelheim Investigational Site	Gdynia		Poland
494	1160.71.1437 Boehringer Ingelheim Investigational Site	Gdynia		Poland
495	1160.71.1438 Boehringer Ingelheim Investigational Site	Gdynia		Poland
496	1160.71.1433 Boehringer Ingelheim Investigational Site	Pulawy		Poland
497	1160.71.1431 Boehringer Ingelheim Investigational Site	Warsaw		Poland
498	1160.71.1432 Boehringer Ingelheim Investigational Site	Warsaw		Poland
499	1160.71.1434 Boehringer Ingelheim Investigational Site	Zabrze		Poland
500	1160.71.1456 Boehringer Ingelheim Investigational Site	Amadora		Portugal
501	1160.71.1451 Boehringer Ingelheim Investigational Site	Carnaxide		Portugal
502	1160.71.1454 Boehringer Ingelheim Investigational Site	Coimbra		Portugal
503	1160.71.1459 Boehringer Ingelheim Investigational Site	Coimbra		Portugal
504	1160.71.1457 Boehringer Ingelheim Investigational Site	Covilhã		Portugal
505	1160.71.1455 Boehringer Ingelheim Investigational Site	Porto		Portugal
506	1160.71.1471 Boehringer Ingelheim Investigational Site	Bucharest		Romania
507	1160.71.1472 Boehringer Ingelheim Investigational Site	Bucharest		Romania
508	1160.71.1501 Boehringer Ingelheim Investigational Site	Moscow		Russian Federation
509	1160.71.1503 Boehringer Ingelheim Investigational Site	Moscow		Russian Federation
510	1160.71.1504 Boehringer Ingelheim Investigational Site	Moscow		Russian Federation
511	1160.71.1505 Boehringer Ingelheim Investigational Site	Moscow		Russian Federation
512	1160.71.1507 Boehringer Ingelheim Investigational Site	Moscow		Russian Federation
513	1160.71.1508 Boehringer Ingelheim Investigational Site	Moscow		Russian Federation
514	1160.71.1509 Boehringer Ingelheim Investigational Site	Moscow		Russian Federation
515	1160.71.1510 Boehringer Ingelheim Investigational Site	Moscow		Russian Federation
516	1160.71.1511 Boehringer Ingelheim Investigational Site	Moscow		Russian Federation
517	1160.71.1512 Boehringer Ingelheim Investigational Site	St. Petersburg		Russian Federation
518	1160.71.1513 Boehringer Ingelheim Investigational Site	St. Petersburg		Russian Federation
519	1160.71.1514 Boehringer Ingelheim Investigational Site	St. Petersburg		Russian Federation
520	1160.71.1531 Boehringer Ingelheim Investigational Site	Singapore		Singapore
521	1160.71.1548 Boehringer Ingelheim Investigational Site	Banska Bystrica		Slovakia
522	1160.71.1541 Boehringer Ingelheim Investigational Site	Bratislava		Slovakia
523	1160.71.1542 Boehringer Ingelheim Investigational Site	Bratislava		Slovakia
524	1160.71.1543 Boehringer Ingelheim Investigational Site	Bratislava		Slovakia
525	1160.71.1550 Boehringer Ingelheim Investigational Site	Kosice		Slovakia
526	1160.71.1547 Boehringer Ingelheim Investigational Site	Zilina		Slovakia
527	1160.71.1633 Boehringer Ingelheim Investigational Site	Göteborg		Sweden
528	1160.71.1627 Boehringer Ingelheim Investigational Site	Malmö		Sweden
529	1160.71.1625 Boehringer Ingelheim Investigational Site	Norrköping		Sweden
530	1160.71.1628 Boehringer Ingelheim Investigational Site	Nässjö		Sweden
531	1160.71.1626 Boehringer Ingelheim Investigational Site	Stockholm		Sweden
532	1160.71.1634 Boehringer Ingelheim Investigational Site	Stockholm		Sweden
533	1160.71.1624 Boehringer Ingelheim Investigational Site	Umeå		Sweden
534	1160.71.1621 Boehringer Ingelheim Investigational Site	Uppsala		Sweden
535	1160.71.1635 Boehringer Ingelheim Investigational Site	Uppsala		Sweden
536	1160.71.1622 Boehringer Ingelheim Investigational Site	Västerås		Sweden
537	1160.71.1623 Boehringer Ingelheim Investigational Site	Örebro		Sweden
538	1160.71.1652 Boehringer Ingelheim Investigational Site	Basel		Switzerland
539	1160.71.1655 Boehringer Ingelheim Investigational Site	Bellinzona		Switzerland
540	1160.71.1651 Boehringer Ingelheim Investigational Site	Bern		Switzerland
541	1160.71.1654 Boehringer Ingelheim Investigational Site	Lugano		Switzerland
542	1160.71.1680 Boehringer Ingelheim Investigational Site	Changhua		Taiwan
543	1160.71.1683 Boehringer Ingelheim Investigational Site	Hualien		Taiwan
544	1160.71.1682 Boehringer Ingelheim Investigational Site	Kaohsiung		Taiwan
545	1160.71.1679 Boehringer Ingelheim Investigational Site	Taichung		Taiwan
546	1160.71.1681 Boehringer Ingelheim Investigational Site	Tainan		Taiwan
547	1160.71.1671 Boehringer Ingelheim Investigational Site	Taipei		Taiwan
548	1160.71.1672 Boehringer Ingelheim Investigational Site	Taipei		Taiwan
549	1160.71.1673 Boehringer Ingelheim Investigational Site	Taipei		Taiwan
550	1160.71.1674 Boehringer Ingelheim Investigational Site	Taipei		Taiwan
551	1160.71.1675 Boehringer Ingelheim Investigational Site	Taipei		Taiwan
552	1160.71.1676 Boehringer Ingelheim Investigational Site	Taipei		Taiwan
553	1160.71.1677 Boehringer Ingelheim Investigational Site	Taipei		Taiwan
554	1160.71.1678 Boehringer Ingelheim Investigational Site	Taoyuan		Taiwan
555	1160.71.1701 Boehringer Ingelheim Investigational Site	Bangkok		Thailand
556	1160.71.1703 Boehringer Ingelheim Investigational Site	Chiang Mai		Thailand
557	1160.71.1704 Boehringer Ingelheim Investigational Site	Khon Kaen		Thailand
558	1160.71.1744 Boehringer Ingelheim Investigational Site	Birmingham		United Kingdom
559	1160.71.1746 Boehringer Ingelheim Investigational Site	Chertsey		United Kingdom
560	1160.71.1745 Boehringer Ingelheim Investigational Site	County Armagh		United Kingdom
561	1160.71.1755 Boehringer Ingelheim Investigational Site	Kirkcaldy, Fife		United Kingdom
562	1160.71.1741 Boehringer Ingelheim Investigational Site	London		United Kingdom
563	1160.71.1742 Boehringer Ingelheim Investigational Site	Newcastle upon Tyne		United Kingdom
564	1160.71.1751 Boehringer Ingelheim Investigational Site	Newport		United Kingdom
565	1160.71.1752 Boehringer Ingelheim Investigational Site	Northampton		United Kingdom
566	1160.71.1743 Boehringer Ingelheim Investigational Site	Romford, Essex		United Kingdom
567	1160.71.1748 Boehringer Ingelheim Investigational Site	York		United Kingdom

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT00808067

Other Study ID Numbers:

1160.71
2008-005248-17

First Posted:

Dec 15, 2008

Last Update Posted:

Jun 9, 2014

Last Verified:

Mar 1, 2014

Additional relevant MeSH terms:

Atrial Fibrillation

Dabigatran

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail	A total of 5897 subjects were enrolled (rolled over from RE-LY trial), and 5891 were entered in this study. There were 8 subjects not treated; therefore 5883 subjects comprise the 'started' treatment group.

Arm/Group Title	Dabigatran 110 mg	Dabigatran 150 mg
Arm/Group Description	Dabigatran etexilate 110 mg twice daily	Dabigatran etexilate 150 mg twice daily
Period Title: Overall Study
STARTED	2927	2956
COMPLETED	2446	2438
NOT COMPLETED	481	518

Baseline Characteristics

Arm/Group Title	Dabigatran 110 mg	Dabigatran 150 mg	Total
Arm/Group Description	Dabigatran etexilate 110 mg twice daily	Dabigatran etexilate 150 mg twice daily	Total of all reporting groups
Overall Participants	2914	2937	5851
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.1 (8.4)	73.1 (8.4)	73.1 (8.4)
Sex: Female, Male (Count of Participants)
Female	1000 34.3%	1026 34.9%	2026 34.6%
Male	1914 65.7%	1911 65.1%	3825 65.4%

Outcome Measures

1. Primary Outcome

Title	Major Bleeding, Annualized Rate of Subjects With Major Bleeds
Description	Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Major bleeding must have satisfied one or more of the following criteria: Bleeding associated with a reduction in hemoglobin of at least 20 g/L Required transfusion of at least 2 units of blood or packed cells Symptomatic bleeding in a critical area or organ: intraocular, intraspinal, intramuscular with compartment syndrome, retroperitoneal, intra-articular, pericardial, gastrointestinal Major bleed were classified as life-threatening if they met one or more of the following criteria: Reduction in hemoglobin of at least 50 g/L Transfusion of at least 4 units of blood or packed cells Symptomatic intracranial bleeding, either subdural or intracerebral Associated with hypotension requiring use of intravenous inotropic agents Required surgical intervention to stop bleeding Resulted in death
Time Frame	up to 43 months

Outcome Measure Data

Analysis Population Description
SAF-FAS interval

Arm/Group Title	Dabigatran 110 mg	Dabigatran 150 mg
Arm/Group Description	Dabigatran etexilate 110 mg twice daily	Dabigatran etexilate 150 mg twice daily
Measure Participants	2914	2937
Number [percentage of subject-years]	2.79	3.59

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dabigatran 110 mg, Dabigatran 150 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0055
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95% 0.64 to 0.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Stroke, Annualized Rate of Subjects With Stroke
Description	Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Stroke was an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke was categorized as ischemic or hemorrhagic or cause unknown based on computerized tomography (CT), magnetic resonance (MR) scanning or autopsy. Fatal stroke was defined as death from any cause within 30 days of stroke. Severity of stroke was assessed by modified Rankin score at discharge from hospital
Time Frame	up to 43 months

Outcome Measure Data

Analysis Population Description
SAF-FAS interval

Arm/Group Title	Dabigatran 110 mg	Dabigatran 150 mg
Arm/Group Description	Dabigatran etexilate 110 mg twice daily	Dabigatran etexilate 150 mg twice daily
Measure Participants	2914	2937
Number [percentage of subject-years]	1.39	1.26

3. Secondary Outcome

Title	Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE
Description	Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Systemic embolism was an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts), and was to be documented by angiography, surgery, scintigraphy, or autopsy.
Time Frame	up to 43 months

Outcome Measure Data

Analysis Population Description
SAF-FAS interval

Arm/Group Title	Dabigatran 110 mg	Dabigatran 150 mg
Arm/Group Description	Dabigatran etexilate 110 mg twice daily	Dabigatran etexilate 150 mg twice daily
Measure Participants	2914	2937
Number [percentage of subject-years]	0.25	0.23

4. Secondary Outcome

Title	Pulmonary Embolism (PE), Annualized Rate of Subjects With PE
Description	Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Pulmonary Embolism was generally documented by one of the following: an intraluminal filling defect in segmental or more proximal branches on spiral CT scan an intraluminal filling defect or an extension of an existing defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS) inconclusive spiral CT, pulmonary angiography or lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasound or venography.
Time Frame	up to 43 months

Outcome Measure Data

Analysis Population Description
SAF-FAS interval

Arm/Group Title	Dabigatran 110 mg	Dabigatran 150 mg
Arm/Group Description	Dabigatran etexilate 110 mg twice daily	Dabigatran etexilate 150 mg twice daily
Measure Participants	2914	2937
Number [percentage of subject-years]	0.10	0.12

5. Secondary Outcome

Title	Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI
Description	Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. a. In subjects not undergoing PCI or CABG a subject should have fulfilled at least 2 of the following: i. Typical prolonged severe chest pain or related symptoms or signs suggestive of MI. ii. Elevation of troponin or CK-MB to more than upper level of normal (ULN) or, if CK-MB was elevated at baseline, re-elevation to more than 50% increase above the previous level. iii. Development of significant Q-waves in at least 2 adjacent ECG leads. b. After percutaneous coronary intervention (within 24h). c. After coronary artery bypass grafting (within 72h). d. Silent myocardial infarction. e. Myocardial infarction could also have been demonstrated at autopsy.
Time Frame	up to 43 months

Outcome Measure Data

Analysis Population Description
SAF-FAS interval

Arm/Group Title	Dabigatran 110 mg	Dabigatran 150 mg
Arm/Group Description	Dabigatran etexilate 110 mg twice daily	Dabigatran etexilate 150 mg twice daily
Measure Participants	2914	2937
Number [percentage of subject-years]	0.72	0.66

6. Secondary Outcome

Title	Deep Vein Thrombosis, Annualized Rate of Subjects With DVT
Description	Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Deep Vein Thrombosis (DVT) was generally documented by one of the following: abnormal compression ultrasound (CUS), an intraluminal filling defect on venography.
Time Frame	up to 43 months

Outcome Measure Data

Analysis Population Description
SAF-FAS interval

Arm/Group Title	Dabigatran 110 mg	Dabigatran 150 mg
Arm/Group Description	Dabigatran etexilate 110 mg twice daily	Dabigatran etexilate 150 mg twice daily
Measure Participants	2914	2937
Number [percentage of subject-years]	0.06	0.11

7. Secondary Outcome

Title	Death, Annualized Rate of Subject Death
Description	Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Deaths were classified as being vascular (sudden/arrhythmic, pump failure death, or other vascular, including bleeding) or non-vascular, due to other specified causes (e.g., malignancy), or of unknown etiology.
Time Frame	up to 43 months

Outcome Measure Data

Analysis Population Description
SAF-FAS interval

Arm/Group Title	Dabigatran 110 mg	Dabigatran 150 mg
Arm/Group Description	Dabigatran etexilate 110 mg twice daily	Dabigatran etexilate 150 mg twice daily
Measure Participants	2914	2937
Number [percentage of subject-years]	3.18	2.99

8. Secondary Outcome

Title	Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE)
Description	Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time Frame	up to 43 months

Outcome Measure Data

Analysis Population Description
SAF-FAS interval

Arm/Group Title	Dabigatran 110 mg	Dabigatran 150 mg
Arm/Group Description	Dabigatran etexilate 110 mg twice daily	Dabigatran etexilate 150 mg twice daily
Measure Participants	2914	2937
Number [percentage of subject-years]	1.60	1.47

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dabigatran 110 mg, Dabigatran 150 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.5119
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.09
	Confidence Interval	(2-Sided) 95% 0.84 to 1.42
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death
Description	Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time Frame	up to 43 months

Outcome Measure Data

Analysis Population Description
SAF-FAS interval

Arm/Group Title	Dabigatran 110 mg	Dabigatran 150 mg
Arm/Group Description	Dabigatran etexilate 110 mg twice daily	Dabigatran etexilate 150 mg twice daily
Measure Participants	2914	2937
Number [percentage of subject-years]	4.40	4.02

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dabigatran 110 mg, Dabigatran 150 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.2371
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.10
	Confidence Interval	(2-Sided) 95% 0.94 to 1.29
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death
Description	Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time Frame	up to 43 months

Outcome Measure Data

Analysis Population Description
SAF-FAS interval

Arm/Group Title	Dabigatran 110 mg	Dabigatran 150 mg
Arm/Group Description	Dabigatran etexilate 110 mg twice daily	Dabigatran etexilate 150 mg twice daily
Measure Participants	2914	2937
Number [percentage of subject-years]	3.51	3.32

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dabigatran 110 mg, Dabigatran 150 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.5052
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95% 0.89 to 1.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed
Description	Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time Frame	up to 43 months

Outcome Measure Data

Analysis Population Description
SAF-FAS interval

Arm/Group Title	Dabigatran 110 mg	Dabigatran 150 mg
Arm/Group Description	Dabigatran etexilate 110 mg twice daily	Dabigatran etexilate 150 mg twice daily
Measure Participants	2914	2937
Number [percentage of subject-years]	6.65	7.14

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dabigatran 110 mg, Dabigatran 150 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.2241
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.93
	Confidence Interval	() 95% 0.82 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Annualized Rate of Subjects With Minor Bleeds
Description	Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. Minor bleeds were classified as associated with study medication discontinuation (temporary or permanent) or not.
Time Frame	up to 43 months

Outcome Measure Data

Analysis Population Description
SAF-FAS interval

Arm/Group Title	Dabigatran 110 mg	Dabigatran 150 mg
Arm/Group Description	Dabigatran etexilate 110 mg twice daily	Dabigatran etexilate 150 mg twice daily
Measure Participants	2914	2937
Number [percentage of subject-years]	7.49	8.98

13. Secondary Outcome

Title	Annualized Rate of Subjects With Any Bleeds (Major Plus Minor)
Description	Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time Frame	up to 43 months

Outcome Measure Data

Analysis Population Description
SAF-FAS interval

Arm/Group Title	Dabigatran 110 mg	Dabigatran 150 mg
Arm/Group Description	Dabigatran etexilate 110 mg twice daily	Dabigatran etexilate 150 mg twice daily
Measure Participants	2914	2937
Number [percentage of subject-years]	9.44	11.20

14. Secondary Outcome

Title	Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH)
Description	Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time Frame	up to 43 months

Outcome Measure Data

Analysis Population Description
SAF-FAS interval

Arm/Group Title	Dabigatran 110 mg	Dabigatran 150 mg
Arm/Group Description	Dabigatran etexilate 110 mg twice daily	Dabigatran etexilate 150 mg twice daily
Measure Participants	2914	2937
Number [percentage of subject-years]	0.28	0.33

Adverse Events

	Dabigatran 110 mg		Dabigatran 150 mg
Time Frame	Up to 43 months
Adverse Event Reporting Description

Arm/Group Title	Dabigatran 110 mg		Dabigatran 150 mg
Arm/Group Description	Dabigatran etexilate 110 mg twice daily		Dabigatran etexilate 150 mg twice daily
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Dabigatran 110 mg		Dabigatran 150 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1028/2914 (35.3%)		1106/2937 (37.7%)
Blood and lymphatic system disorders
Anaemia	23/2914 (0.8%)		36/2937 (1.2%)
Coagulopathy	1/2914 (0%)		2/2937 (0.1%)
Disseminated intravascular coagulation	2/2914 (0.1%)		0/2937 (0%)
Haemolytic anaemia	1/2914 (0%)		1/2937 (0%)
Haemorrhagic anaemia	1/2914 (0%)		4/2937 (0.1%)
Heparin-induced thrombocytopenia	0/2914 (0%)		1/2937 (0%)
Iron deficiency anaemia	4/2914 (0.1%)		1/2937 (0%)
Leukopenia	0/2914 (0%)		1/2937 (0%)
Lymphadenopathy	1/2914 (0%)		0/2937 (0%)
Microcytic anaemia	1/2914 (0%)		0/2937 (0%)
Neutropenia	0/2914 (0%)		1/2937 (0%)
Polycythaemia	1/2914 (0%)		0/2937 (0%)
Thrombocytopenia	5/2914 (0.2%)		5/2937 (0.2%)
Cardiac disorders
Acute coronary syndrome	2/2914 (0.1%)		6/2937 (0.2%)
Acute left ventricular failure	0/2914 (0%)		1/2937 (0%)
Acute myocardial infarction	1/2914 (0%)		0/2937 (0%)
Angina pectoris	34/2914 (1.2%)		36/2937 (1.2%)
Angina unstable	2/2914 (0.1%)		13/2937 (0.4%)
Aortic valve stenosis	1/2914 (0%)		1/2937 (0%)
Arrhythmia	5/2914 (0.2%)		4/2937 (0.1%)
Arteriosclerosis coronary artery	1/2914 (0%)		2/2937 (0.1%)
Atrial fibrillation	84/2914 (2.9%)		95/2937 (3.2%)
Atrial flutter	4/2914 (0.1%)		6/2937 (0.2%)
Atrial tachycardia	1/2914 (0%)		1/2937 (0%)
Atrial thrombosis	1/2914 (0%)		2/2937 (0.1%)
Atrioventricular block	1/2914 (0%)		1/2937 (0%)
Atrioventricular block complete	2/2914 (0.1%)		4/2937 (0.1%)
Bradyarrhythmia	3/2914 (0.1%)		6/2937 (0.2%)
Bradycardia	19/2914 (0.7%)		23/2937 (0.8%)
Cardiac arrest	7/2914 (0.2%)		9/2937 (0.3%)
Cardiac failure	70/2914 (2.4%)		87/2937 (3%)
Cardiac failure acute	1/2914 (0%)		0/2937 (0%)
Cardiac failure chronic	3/2914 (0.1%)		3/2937 (0.1%)
Cardiac failure congestive	68/2914 (2.3%)		71/2937 (2.4%)
Cardiac valve disease	1/2914 (0%)		0/2937 (0%)
Cardio-respiratory arrest	2/2914 (0.1%)		2/2937 (0.1%)
Cardiogenic shock	0/2914 (0%)		1/2937 (0%)
Cardiomyopathy	0/2914 (0%)		2/2937 (0.1%)
Chronotropic incompetence	1/2914 (0%)		0/2937 (0%)
Coronary artery disease	14/2914 (0.5%)		12/2937 (0.4%)
Coronary artery occlusion	0/2914 (0%)		2/2937 (0.1%)
Coronary artery stenosis	0/2914 (0%)		2/2937 (0.1%)
Dressler's syndrome	0/2914 (0%)		1/2937 (0%)
Left ventricular dysfunction	0/2914 (0%)		3/2937 (0.1%)
Left ventricular failure	1/2914 (0%)		0/2937 (0%)
Mitral valve incompetence	7/2914 (0.2%)		5/2937 (0.2%)
Mitral valve stenosis	2/2914 (0.1%)		0/2937 (0%)
Myocardial infarction	3/2914 (0.1%)		2/2937 (0.1%)
Myocardial ischaemia	3/2914 (0.1%)		1/2937 (0%)
Palpitations	4/2914 (0.1%)		5/2937 (0.2%)
Pericardial effusion	3/2914 (0.1%)		0/2937 (0%)
Pericarditis	1/2914 (0%)		0/2937 (0%)
Right ventricular failure	1/2914 (0%)		2/2937 (0.1%)
Sick sinus syndrome	13/2914 (0.4%)		10/2937 (0.3%)
Sinus arrest	0/2914 (0%)		1/2937 (0%)
Sinus bradycardia	0/2914 (0%)		1/2937 (0%)
Sinus tachycardia	1/2914 (0%)		0/2937 (0%)
Tachycardia	2/2914 (0.1%)		5/2937 (0.2%)
Tricuspid valve incompetence	0/2914 (0%)		1/2937 (0%)
Ventricular arrhythmia	7/2914 (0.2%)		8/2937 (0.3%)
Ventricular fibrillation	4/2914 (0.1%)		6/2937 (0.2%)
Ventricular tachycardia	7/2914 (0.2%)		6/2937 (0.2%)
Ear and labyrinth disorders
Deafness	0/2914 (0%)		2/2937 (0.1%)
Hearing impaired	1/2914 (0%)		0/2937 (0%)
Vertigo	6/2914 (0.2%)		4/2937 (0.1%)
Vertigo positional	2/2914 (0.1%)		0/2937 (0%)
Endocrine disorders
Addison's disease	0/2914 (0%)		1/2937 (0%)
Goitre	1/2914 (0%)		1/2937 (0%)
Hyperparathyroidism	0/2914 (0%)		1/2937 (0%)
Hyperthyroidism	2/2914 (0.1%)		0/2937 (0%)
Eye disorders
Amaurosis fugax	1/2914 (0%)		0/2937 (0%)
Blepharochalasis	0/2914 (0%)		1/2937 (0%)
Blindness	1/2914 (0%)		0/2937 (0%)
Cataract	8/2914 (0.3%)		10/2937 (0.3%)
Diplopia	1/2914 (0%)		0/2937 (0%)
Eye haemorrhage	0/2914 (0%)		2/2937 (0.1%)
Glaucoma	1/2914 (0%)		0/2937 (0%)
Macular pseudohole	0/2914 (0%)		1/2937 (0%)
Optic ischaemic neuropathy	1/2914 (0%)		0/2937 (0%)
Retinal detachment	2/2914 (0.1%)		0/2937 (0%)
Retinal haemorrhage	0/2914 (0%)		1/2937 (0%)
Retinal vein occlusion	1/2914 (0%)		1/2937 (0%)
Scotoma	1/2914 (0%)		0/2937 (0%)
Ulcerative keratitis	0/2914 (0%)		1/2937 (0%)
Visual impairment	0/2914 (0%)		1/2937 (0%)
Gastrointestinal disorders
Abdominal distension	1/2914 (0%)		0/2937 (0%)
Abdominal hernia	1/2914 (0%)		1/2937 (0%)
Abdominal mass	1/2914 (0%)		0/2937 (0%)
Abdominal pain	29/2914 (1%)		27/2937 (0.9%)
Abdominal pain upper	1/2914 (0%)		0/2937 (0%)
Anal fistula	1/2914 (0%)		0/2937 (0%)
Ascites	1/2914 (0%)		0/2937 (0%)
Colitis	1/2914 (0%)		2/2937 (0.1%)
Colitis ischaemic	1/2914 (0%)		1/2937 (0%)
Colonic obstruction	0/2914 (0%)		1/2937 (0%)
Colonic polyp	11/2914 (0.4%)		4/2937 (0.1%)
Constipation	2/2914 (0.1%)		1/2937 (0%)
Dental caries	0/2914 (0%)		1/2937 (0%)
Diarrhoea	8/2914 (0.3%)		3/2937 (0.1%)
Diverticulum	0/2914 (0%)		3/2937 (0.1%)
Diverticulum intestinal	1/2914 (0%)		2/2937 (0.1%)
Diverticulum intestinal haemorrhagic	0/2914 (0%)		3/2937 (0.1%)
Duodenal polyp	1/2914 (0%)		0/2937 (0%)
Duodenal ulcer	4/2914 (0.1%)		4/2937 (0.1%)
Duodenal ulcer haemorrhage	0/2914 (0%)		1/2937 (0%)
Duodenal ulcer perforation	1/2914 (0%)		0/2937 (0%)
Dyspepsia	7/2914 (0.2%)		12/2937 (0.4%)
Dysphagia	3/2914 (0.1%)		1/2937 (0%)
Enterocolitis	0/2914 (0%)		1/2937 (0%)
Gastric haemorrhage	1/2914 (0%)		2/2937 (0.1%)
Gastric ulcer	8/2914 (0.3%)		5/2937 (0.2%)
Gastric ulcer perforation	0/2914 (0%)		1/2937 (0%)
Gastritis	8/2914 (0.3%)		7/2937 (0.2%)
Gastritis erosive	0/2914 (0%)		2/2937 (0.1%)
Gastritis haemorrhagic	0/2914 (0%)		4/2937 (0.1%)
Gastrointestinal haemorrhage	20/2914 (0.7%)		20/2937 (0.7%)
Gastrointestinal mucosal disorder	0/2914 (0%)		1/2937 (0%)
Gingival bleeding	1/2914 (0%)		0/2937 (0%)
Haematemesis	0/2914 (0%)		1/2937 (0%)
Haematochezia	3/2914 (0.1%)		1/2937 (0%)
Haemorrhoidal haemorrhage	1/2914 (0%)		2/2937 (0.1%)
Hiatus hernia	0/2914 (0%)		2/2937 (0.1%)
Ileus	6/2914 (0.2%)		7/2937 (0.2%)
Inguinal hernia	13/2914 (0.4%)		7/2937 (0.2%)
Inguinal hernia, obstructive	1/2914 (0%)		1/2937 (0%)
Intestinal haemorrhage	0/2914 (0%)		1/2937 (0%)
Intestinal ischaemia	2/2914 (0.1%)		3/2937 (0.1%)
Intestinal obstruction	8/2914 (0.3%)		2/2937 (0.1%)
Large intestinal obstruction	0/2914 (0%)		1/2937 (0%)
Large intestinal ulcer	1/2914 (0%)		0/2937 (0%)
Lower gastrointestinal haemorrhage	1/2914 (0%)		6/2937 (0.2%)
Melaena	6/2914 (0.2%)		5/2937 (0.2%)
Mesenteric artery stenosis	1/2914 (0%)		0/2937 (0%)
Nausea	3/2914 (0.1%)		1/2937 (0%)
Obstruction gastric	1/2914 (0%)		0/2937 (0%)
Odynophagia	0/2914 (0%)		2/2937 (0.1%)
Oesophageal achalasia	0/2914 (0%)		1/2937 (0%)
Oesophageal obstruction	0/2914 (0%)		1/2937 (0%)
Oesophageal rupture	0/2914 (0%)		1/2937 (0%)
Oesophageal stenosis	1/2914 (0%)		0/2937 (0%)
Oesophageal ulcer	0/2914 (0%)		3/2937 (0.1%)
Oesophagitis	0/2914 (0%)		2/2937 (0.1%)
Pancreatic cyst	0/2914 (0%)		1/2937 (0%)
Pancreatitis	1/2914 (0%)		4/2937 (0.1%)
Pancreatitis acute	1/2914 (0%)		1/2937 (0%)
Peritoneal haemorrhage	1/2914 (0%)		0/2937 (0%)
Rectal haemorrhage	5/2914 (0.2%)		5/2937 (0.2%)
Rectal prolapse	1/2914 (0%)		1/2937 (0%)
Salivary hypersecretion	0/2914 (0%)		1/2937 (0%)
Small intestinal obstruction	5/2914 (0.2%)		6/2937 (0.2%)
Subileus	1/2914 (0%)		1/2937 (0%)
Upper gastrointestinal haemorrhage	4/2914 (0.1%)		5/2937 (0.2%)
Vomiting	6/2914 (0.2%)		6/2937 (0.2%)
General disorders
Adverse drug reaction	1/2914 (0%)		1/2937 (0%)
Asthenia	7/2914 (0.2%)		10/2937 (0.3%)
Chest discomfort	2/2914 (0.1%)		1/2937 (0%)
Chest pain	35/2914 (1.2%)		47/2937 (1.6%)
Death	1/2914 (0%)		1/2937 (0%)
Device breakage	1/2914 (0%)		0/2937 (0%)
Device dislocation	3/2914 (0.1%)		1/2937 (0%)
Device malfunction	1/2914 (0%)		1/2937 (0%)
Drug ineffective	1/2914 (0%)		0/2937 (0%)
Fatigue	1/2914 (0%)		0/2937 (0%)
Gait disturbance	2/2914 (0.1%)		0/2937 (0%)
General physical health deterioration	1/2914 (0%)		3/2937 (0.1%)
Generalised oedema	0/2914 (0%)		1/2937 (0%)
Hernia	6/2914 (0.2%)		4/2937 (0.1%)
Hernia obstructive	1/2914 (0%)		0/2937 (0%)
Impaired healing	2/2914 (0.1%)		1/2937 (0%)
Malaise	1/2914 (0%)		1/2937 (0%)
Medical device complication	0/2914 (0%)		1/2937 (0%)
Multi-organ disorder	1/2914 (0%)		0/2937 (0%)
Multi-organ failure	3/2914 (0.1%)		2/2937 (0.1%)
Necrosis	1/2914 (0%)		1/2937 (0%)
Non-cardiac chest pain	5/2914 (0.2%)		3/2937 (0.1%)
Oedema	0/2914 (0%)		2/2937 (0.1%)
Oedema peripheral	5/2914 (0.2%)		4/2937 (0.1%)
Pain	1/2914 (0%)		1/2937 (0%)
Pyrexia	3/2914 (0.1%)		4/2937 (0.1%)
Stent-graft endoleak	0/2914 (0%)		1/2937 (0%)
Sudden cardiac death	1/2914 (0%)		0/2937 (0%)
Sudden death	0/2914 (0%)		2/2937 (0.1%)
Hepatobiliary disorders
Bile duct obstruction	1/2914 (0%)		0/2937 (0%)
Bile duct stone	4/2914 (0.1%)		1/2937 (0%)
Biliary colic	1/2914 (0%)		0/2937 (0%)
Cholangitis	4/2914 (0.1%)		1/2937 (0%)
Cholangitis acute	1/2914 (0%)		0/2937 (0%)
Cholecystitis	10/2914 (0.3%)		7/2937 (0.2%)
Cholecystitis acute	4/2914 (0.1%)		0/2937 (0%)
Cholelithiasis	10/2914 (0.3%)		4/2937 (0.1%)
Hepatic cirrhosis	0/2914 (0%)		1/2937 (0%)
Hepatic failure	1/2914 (0%)		0/2937 (0%)
Hepatic function abnormal	2/2914 (0.1%)		1/2937 (0%)
Hepatitis toxic	1/2914 (0%)		0/2937 (0%)
Hepatomegaly	0/2914 (0%)		1/2937 (0%)
Hepatorenal syndrome	0/2914 (0%)		1/2937 (0%)
Jaundice cholestatic	1/2914 (0%)		1/2937 (0%)
Immune system disorders
Anaphylactic reaction	1/2914 (0%)		1/2937 (0%)
Anaphylactic shock	1/2914 (0%)		0/2937 (0%)
Infections and infestations
Abscess	1/2914 (0%)		0/2937 (0%)
Abscess limb	1/2914 (0%)		2/2937 (0.1%)
Abscess neck	0/2914 (0%)		1/2937 (0%)
Anal abscess	0/2914 (0%)		1/2937 (0%)
Appendicitis	3/2914 (0.1%)		3/2937 (0.1%)
Arthritis bacterial	2/2914 (0.1%)		1/2937 (0%)
Arthritis infective	0/2914 (0%)		2/2937 (0.1%)
Atypical pneumonia	1/2914 (0%)		0/2937 (0%)
Bacteraemia	4/2914 (0.1%)		1/2937 (0%)
Brain abscess	0/2914 (0%)		1/2937 (0%)
Bronchitis	11/2914 (0.4%)		8/2937 (0.3%)
Bronchitis viral	0/2914 (0%)		1/2937 (0%)
Bronchopneumonia	2/2914 (0.1%)		1/2937 (0%)
Cellulitis	25/2914 (0.9%)		25/2937 (0.9%)
Cellulitis staphylococcal	1/2914 (0%)		0/2937 (0%)
Cholecystitis infective	2/2914 (0.1%)		1/2937 (0%)
Chronic sinusitis	1/2914 (0%)		0/2937 (0%)
Clostridial infection	3/2914 (0.1%)		0/2937 (0%)
Clostridium difficile colitis	0/2914 (0%)		2/2937 (0.1%)
Corneal abscess	0/2914 (0%)		1/2937 (0%)
Cystitis	2/2914 (0.1%)		1/2937 (0%)
Dengue fever	1/2914 (0%)		0/2937 (0%)
Device related infection	0/2914 (0%)		3/2937 (0.1%)
Diabetic foot infection	1/2914 (0%)		0/2937 (0%)
Diverticulitis	1/2914 (0%)		6/2937 (0.2%)
Ear infection	1/2914 (0%)		1/2937 (0%)
Endocarditis	5/2914 (0.2%)		1/2937 (0%)
Endocarditis bacterial	0/2914 (0%)		1/2937 (0%)
Enterococcal sepsis	0/2914 (0%)		1/2937 (0%)
Erysipelas	7/2914 (0.2%)		6/2937 (0.2%)
Escherichia sepsis	1/2914 (0%)		1/2937 (0%)
Escherichia urinary tract infection	0/2914 (0%)		2/2937 (0.1%)
Eye infection	0/2914 (0%)		1/2937 (0%)
Fungal infection	0/2914 (0%)		1/2937 (0%)
Gangrene	2/2914 (0.1%)		2/2937 (0.1%)
Gastric ulcer helicobacter	0/2914 (0%)		1/2937 (0%)
Gastroenteritis	3/2914 (0.1%)		4/2937 (0.1%)
Gastroenteritis cryptosporidial	0/2914 (0%)		1/2937 (0%)
Gastroenteritis viral	0/2914 (0%)		2/2937 (0.1%)
Gastrointestinal infection	1/2914 (0%)		0/2937 (0%)
Groin abscess	1/2914 (0%)		0/2937 (0%)
Groin infection	0/2914 (0%)		1/2937 (0%)
Herpes ophthalmic	0/2914 (0%)		1/2937 (0%)
Herpes zoster	1/2914 (0%)		4/2937 (0.1%)
Herpes zoster ophthalmic	0/2914 (0%)		1/2937 (0%)
Herpes zoster oticus	0/2914 (0%)		1/2937 (0%)
Implant site infection	2/2914 (0.1%)		1/2937 (0%)
Infected bites	0/2914 (0%)		1/2937 (0%)
Infected cyst	1/2914 (0%)		0/2937 (0%)
Infected skin ulcer	1/2914 (0%)		0/2937 (0%)
Infection	5/2914 (0.2%)		5/2937 (0.2%)
Infective exacerbation of chronic obstructive airways disease	1/2914 (0%)		1/2937 (0%)
Influenza	1/2914 (0%)		2/2937 (0.1%)
Klebsiella sepsis	1/2914 (0%)		0/2937 (0%)
Labyrinthitis	1/2914 (0%)		0/2937 (0%)
Liver abscess	2/2914 (0.1%)		0/2937 (0%)
Lobar pneumonia	3/2914 (0.1%)		3/2937 (0.1%)
Localised infection	4/2914 (0.1%)		5/2937 (0.2%)
Lower respiratory tract infection	2/2914 (0.1%)		2/2937 (0.1%)
Lung infection	0/2914 (0%)		2/2937 (0.1%)
Nasopharyngitis	0/2914 (0%)		1/2937 (0%)
Neuroborreliosis	0/2914 (0%)		1/2937 (0%)
Oesophageal candidiasis	1/2914 (0%)		0/2937 (0%)
Oesophageal infection	1/2914 (0%)		0/2937 (0%)
Oral candidiasis	0/2914 (0%)		2/2937 (0.1%)
Osteomyelitis	2/2914 (0.1%)		4/2937 (0.1%)
Otitis externa	0/2914 (0%)		1/2937 (0%)
Pancreatic abscess	0/2914 (0%)		1/2937 (0%)
Parotitis	0/2914 (0%)		1/2937 (0%)
Peritonitis	1/2914 (0%)		1/2937 (0%)
Peritonitis bacterial	1/2914 (0%)		0/2937 (0%)
Peritonsillar abscess	0/2914 (0%)		1/2937 (0%)
Pharyngeal abscess	1/2914 (0%)		0/2937 (0%)
Pharyngolaryngeal abscess	0/2914 (0%)		1/2937 (0%)
Pneumonia	91/2914 (3.1%)		99/2937 (3.4%)
Pneumonia bacterial	1/2914 (0%)		0/2937 (0%)
Pneumonia legionella	0/2914 (0%)		1/2937 (0%)
Pneumonia pneumococcal	1/2914 (0%)		0/2937 (0%)
Post procedural infection	3/2914 (0.1%)		2/2937 (0.1%)
Postoperative wound infection	0/2914 (0%)		1/2937 (0%)
Pyelonephritis	1/2914 (0%)		3/2937 (0.1%)
Pyelonephritis acute	1/2914 (0%)		0/2937 (0%)
Respiratory tract infection	5/2914 (0.2%)		3/2937 (0.1%)
Sepsis	19/2914 (0.7%)		23/2937 (0.8%)
Septic shock	2/2914 (0.1%)		1/2937 (0%)
Sinusitis	1/2914 (0%)		1/2937 (0%)
Skin infection	2/2914 (0.1%)		1/2937 (0%)
Staphylococcal bacteraemia	1/2914 (0%)		0/2937 (0%)
Staphylococcal sepsis	1/2914 (0%)		0/2937 (0%)
Staphylococcal skin infection	0/2914 (0%)		1/2937 (0%)
Streptococcal bacteraemia	1/2914 (0%)		0/2937 (0%)
Tuberculosis	0/2914 (0%)		2/2937 (0.1%)
Upper respiratory tract infection	5/2914 (0.2%)		5/2937 (0.2%)
Urethritis chlamydial	0/2914 (0%)		1/2937 (0%)
Urinary tract infection	21/2914 (0.7%)		29/2937 (1%)
Urinary tract infection bacterial	0/2914 (0%)		1/2937 (0%)
Urinary tract infection pseudomonal	1/2914 (0%)		0/2937 (0%)
Urinary tract infection staphylococcal	1/2914 (0%)		0/2937 (0%)
Urosepsis	3/2914 (0.1%)		2/2937 (0.1%)
Viral infection	1/2914 (0%)		3/2937 (0.1%)
Vulvovaginal candidiasis	0/2914 (0%)		1/2937 (0%)
Wound infection	0/2914 (0%)		1/2937 (0%)
Injury, poisoning and procedural complications
Alcohol poisoning	0/2914 (0%)		1/2937 (0%)
Anaemia postoperative	0/2914 (0%)		2/2937 (0.1%)
Ankle fracture	3/2914 (0.1%)		8/2937 (0.3%)
Arterial injury	1/2914 (0%)		0/2937 (0%)
Arthropod sting	0/2914 (0%)		1/2937 (0%)
Carbon monoxide poisoning	1/2914 (0%)		0/2937 (0%)
Cartilage injury	1/2914 (0%)		0/2937 (0%)
Cervical vertebral fracture	0/2914 (0%)		1/2937 (0%)
Comminuted fracture	0/2914 (0%)		1/2937 (0%)
Concussion	1/2914 (0%)		1/2937 (0%)
Contusion	3/2914 (0.1%)		2/2937 (0.1%)
Craniocerebral injury	0/2914 (0%)		1/2937 (0%)
Deafness traumatic	1/2914 (0%)		0/2937 (0%)
Facial bones fracture	1/2914 (0%)		1/2937 (0%)
Fall	26/2914 (0.9%)		31/2937 (1.1%)
Fat embolism	1/2914 (0%)		0/2937 (0%)
Femoral neck fracture	4/2914 (0.1%)		9/2937 (0.3%)
Femur fracture	10/2914 (0.3%)		6/2937 (0.2%)
Fibula fracture	1/2914 (0%)		0/2937 (0%)
Fracture	3/2914 (0.1%)		1/2937 (0%)
Hand fracture	1/2914 (0%)		1/2937 (0%)
Head injury	1/2914 (0%)		2/2937 (0.1%)
Hip fracture	11/2914 (0.4%)		11/2937 (0.4%)
Humerus fracture	2/2914 (0.1%)		1/2937 (0%)
Iatrogenic injury	1/2914 (0%)		0/2937 (0%)
Incision site haemorrhage	1/2914 (0%)		0/2937 (0%)
Incisional hernia	1/2914 (0%)		0/2937 (0%)
Jaw fracture	0/2914 (0%)		1/2937 (0%)
Joint dislocation	1/2914 (0%)		2/2937 (0.1%)
Joint injury	0/2914 (0%)		1/2937 (0%)
Laceration	1/2914 (0%)		2/2937 (0.1%)
Limb injury	1/2914 (0%)		0/2937 (0%)
Lower limb fracture	0/2914 (0%)		2/2937 (0.1%)
Lumbar vertebral fracture	3/2914 (0.1%)		3/2937 (0.1%)
Meniscus lesion	1/2914 (0%)		0/2937 (0%)
Multiple fractures	0/2914 (0%)		1/2937 (0%)
Muscle rupture	1/2914 (0%)		0/2937 (0%)
Open wound	1/2914 (0%)		0/2937 (0%)
Overdose	0/2914 (0%)		1/2937 (0%)
Pelvic fracture	4/2914 (0.1%)		2/2937 (0.1%)
Post procedural haemorrhage	0/2914 (0%)		1/2937 (0%)
Procedural hypertension	0/2914 (0%)		1/2937 (0%)
Pubis fracture	1/2914 (0%)		3/2937 (0.1%)
Radius fracture	1/2914 (0%)		3/2937 (0.1%)
Rib fracture	3/2914 (0.1%)		3/2937 (0.1%)
Road traffic accident	2/2914 (0.1%)		4/2937 (0.1%)
Skin injury	0/2914 (0%)		1/2937 (0%)
Skull fracture	1/2914 (0%)		0/2937 (0%)
Snake bite	1/2914 (0%)		0/2937 (0%)
Soft tissue injury	2/2914 (0.1%)		0/2937 (0%)
Spinal compression fracture	5/2914 (0.2%)		5/2937 (0.2%)
Sternal fracture	1/2914 (0%)		0/2937 (0%)
Subdural haematoma	5/2914 (0.2%)		4/2937 (0.1%)
Subdural haemorrhage	2/2914 (0.1%)		2/2937 (0.1%)
Tendon injury	1/2914 (0%)		0/2937 (0%)
Tendon rupture	1/2914 (0%)		1/2937 (0%)
Tibia fracture	2/2914 (0.1%)		3/2937 (0.1%)
Toxicity to various agents	5/2914 (0.2%)		1/2937 (0%)
Traumatic arthritis	0/2914 (0%)		1/2937 (0%)
Traumatic fracture	1/2914 (0%)		0/2937 (0%)
Traumatic haematoma	0/2914 (0%)		1/2937 (0%)
Ulna fracture	0/2914 (0%)		3/2937 (0.1%)
Upper limb fracture	1/2914 (0%)		3/2937 (0.1%)
Vascular pseudoaneurysm	1/2914 (0%)		0/2937 (0%)
Wound dehiscence	0/2914 (0%)		1/2937 (0%)
Wound necrosis	3/2914 (0.1%)		0/2937 (0%)
Wrist fracture	2/2914 (0.1%)		2/2937 (0.1%)
Investigations
Blood glucagon abnormal	1/2914 (0%)		0/2937 (0%)
Blood glucose increased	0/2914 (0%)		1/2937 (0%)
Creatinine renal clearance decreased	2/2914 (0.1%)		2/2937 (0.1%)
Haemoglobin decreased	5/2914 (0.2%)		0/2937 (0%)
Heart rate decreased	2/2914 (0.1%)		0/2937 (0%)
Heart rate irregular	1/2914 (0%)		0/2937 (0%)
Hepatic enzyme increased	3/2914 (0.1%)		1/2937 (0%)
International normalised ratio increased	1/2914 (0%)		0/2937 (0%)
Liver function test abnormal	2/2914 (0.1%)		2/2937 (0.1%)
Platelet count decreased	0/2914 (0%)		1/2937 (0%)
Troponin I increased	1/2914 (0%)		0/2937 (0%)
Weight decreased	2/2914 (0.1%)		2/2937 (0.1%)
Metabolism and nutrition disorders
Dehydration	11/2914 (0.4%)		20/2937 (0.7%)
Diabetes mellitus	0/2914 (0%)		2/2937 (0.1%)
Diabetes mellitus inadequate control	3/2914 (0.1%)		2/2937 (0.1%)
Diabetic complication	0/2914 (0%)		2/2937 (0.1%)
Diabetic ketoacidosis	1/2914 (0%)		0/2937 (0%)
Electrolyte imbalance	0/2914 (0%)		1/2937 (0%)
Failure to thrive	0/2914 (0%)		2/2937 (0.1%)
Fluid overload	0/2914 (0%)		1/2937 (0%)
Gout	4/2914 (0.1%)		6/2937 (0.2%)
Haemochromatosis	0/2914 (0%)		1/2937 (0%)
Hyperglycaemia	2/2914 (0.1%)		2/2937 (0.1%)
Hyperkalaemia	4/2914 (0.1%)		1/2937 (0%)
Hypoglycaemia	4/2914 (0.1%)		3/2937 (0.1%)
Hypokalaemia	3/2914 (0.1%)		1/2937 (0%)
Hypomagnesaemia	1/2914 (0%)		0/2937 (0%)
Hyponatraemia	8/2914 (0.3%)		8/2937 (0.3%)
Lactic acidosis	1/2914 (0%)		0/2937 (0%)
Malnutrition	0/2914 (0%)		1/2937 (0%)
Metabolic acidosis	1/2914 (0%)		2/2937 (0.1%)
Type 1 diabetes mellitus	0/2914 (0%)		1/2937 (0%)
Type 2 diabetes mellitus	0/2914 (0%)		1/2937 (0%)
Vitamin B12 deficiency	1/2914 (0%)		0/2937 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	9/2914 (0.3%)		7/2937 (0.2%)
Arthritis	7/2914 (0.2%)		5/2937 (0.2%)
Arthropathy	0/2914 (0%)		1/2937 (0%)
Back pain	9/2914 (0.3%)		15/2937 (0.5%)
Bursitis	0/2914 (0%)		1/2937 (0%)
Cervical spinal stenosis	1/2914 (0%)		0/2937 (0%)
Chondrocalcinosis pyrophosphate	0/2914 (0%)		1/2937 (0%)
Crystal arthropathy	1/2914 (0%)		0/2937 (0%)
Dupuytren's contracture	1/2914 (0%)		0/2937 (0%)
Flank pain	0/2914 (0%)		1/2937 (0%)
Foot deformity	1/2914 (0%)		2/2937 (0.1%)
Intervertebral disc degeneration	1/2914 (0%)		1/2937 (0%)
Intervertebral disc protrusion	2/2914 (0.1%)		4/2937 (0.1%)
Jaw cyst	1/2914 (0%)		0/2937 (0%)
Joint swelling	0/2914 (0%)		3/2937 (0.1%)
Lumbar spinal stenosis	0/2914 (0%)		8/2937 (0.3%)
Muscular weakness	0/2914 (0%)		2/2937 (0.1%)
Musculoskeletal chest pain	0/2914 (0%)		1/2937 (0%)
Musculoskeletal pain	2/2914 (0.1%)		3/2937 (0.1%)
Neck pain	0/2914 (0%)		1/2937 (0%)
Osteoarthritis	28/2914 (1%)		36/2937 (1.2%)
Pain in extremity	4/2914 (0.1%)		2/2937 (0.1%)
Polyarthritis	1/2914 (0%)		1/2937 (0%)
Polymyalgia rheumatica	2/2914 (0.1%)		0/2937 (0%)
Pseudarthrosis	0/2914 (0%)		1/2937 (0%)
Rhabdomyolysis	1/2914 (0%)		3/2937 (0.1%)
Rheumatoid arthritis	0/2914 (0%)		1/2937 (0%)
Rotator cuff syndrome	2/2914 (0.1%)		2/2937 (0.1%)
Spinal column stenosis	1/2914 (0%)		1/2937 (0%)
Spinal osteoarthritis	1/2914 (0%)		2/2937 (0.1%)
Spondylolisthesis	0/2914 (0%)		1/2937 (0%)
Synovitis	1/2914 (0%)		0/2937 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia	1/2914 (0%)		1/2937 (0%)
Adenoma benign	1/2914 (0%)		0/2937 (0%)
Adrenal adenoma	1/2914 (0%)		0/2937 (0%)
Angiosarcoma	1/2914 (0%)		0/2937 (0%)
Basal cell carcinoma	3/2914 (0.1%)		2/2937 (0.1%)
Benign neoplasm of skin	1/2914 (0%)		0/2937 (0%)
Bile duct cancer	0/2914 (0%)		1/2937 (0%)
Bladder cancer	8/2914 (0.3%)		9/2937 (0.3%)
Bladder neoplasm	1/2914 (0%)		1/2937 (0%)
Bladder transitional cell carcinoma	1/2914 (0%)		0/2937 (0%)
Bone neoplasm malignant	1/2914 (0%)		0/2937 (0%)
Bone sarcoma	0/2914 (0%)		1/2937 (0%)
Brain neoplasm	1/2914 (0%)		1/2937 (0%)
Brain neoplasm malignant	0/2914 (0%)		1/2937 (0%)
Breast cancer	8/2914 (0.3%)		9/2937 (0.3%)
Breast cancer metastatic	0/2914 (0%)		1/2937 (0%)
Bronchial carcinoma	1/2914 (0%)		0/2937 (0%)
Carcinoid tumour	1/2914 (0%)		0/2937 (0%)
Cervix carcinoma	1/2914 (0%)		1/2937 (0%)
Choroid melanoma	1/2914 (0%)		0/2937 (0%)
Chronic lymphocytic leukaemia	1/2914 (0%)		0/2937 (0%)
Colon adenoma	1/2914 (0%)		0/2937 (0%)
Colon cancer	13/2914 (0.4%)		6/2937 (0.2%)
Colon cancer recurrent	0/2914 (0%)		1/2937 (0%)
Colon cancer stage 0	1/2914 (0%)		0/2937 (0%)
Endometrial cancer	1/2914 (0%)		1/2937 (0%)
Gallbladder cancer	0/2914 (0%)		1/2937 (0%)
Gastric cancer	4/2914 (0.1%)		3/2937 (0.1%)
Gastric neoplasm	1/2914 (0%)		0/2937 (0%)
Gastrointestinal carcinoma	1/2914 (0%)		0/2937 (0%)
Gastrointestinal tract adenoma	0/2914 (0%)		1/2937 (0%)
Gastrooesophageal cancer	0/2914 (0%)		1/2937 (0%)
Glioblastoma	0/2914 (0%)		2/2937 (0.1%)
Hepatic cancer metastatic	2/2914 (0.1%)		0/2937 (0%)
Hepatic neoplasm	1/2914 (0%)		0/2937 (0%)
Hepatic neoplasm malignant	2/2914 (0.1%)		2/2937 (0.1%)
Hodgkin's disease	0/2914 (0%)		1/2937 (0%)
Keratoacanthoma	0/2914 (0%)		1/2937 (0%)
Langerhans' cell histiocytosis	0/2914 (0%)		1/2937 (0%)
Large cell carcinoma of the respiratory tract stage unspecified	0/2914 (0%)		1/2937 (0%)
Laryngeal cancer recurrent	0/2914 (0%)		1/2937 (0%)
Lipoma	1/2914 (0%)		0/2937 (0%)
Liposarcoma	0/2914 (0%)		1/2937 (0%)
Lung adenocarcinoma	0/2914 (0%)		1/2937 (0%)
Lung cancer metastatic	3/2914 (0.1%)		0/2937 (0%)
Lung carcinoma cell type unspecified recurrent	1/2914 (0%)		0/2937 (0%)
Lung neoplasm	0/2914 (0%)		2/2937 (0.1%)
Lung neoplasm malignant	16/2914 (0.5%)		5/2937 (0.2%)
Lymphoma	0/2914 (0%)		4/2937 (0.1%)
Malignant melanoma	0/2914 (0%)		5/2937 (0.2%)
Malignant neoplasm of pleura	0/2914 (0%)		1/2937 (0%)
Meningioma	0/2914 (0%)		1/2937 (0%)
Metastases to bone	1/2914 (0%)		1/2937 (0%)
Metastases to central nervous system	1/2914 (0%)		2/2937 (0.1%)
Metastases to pelvis	1/2914 (0%)		0/2937 (0%)
Metastatic neoplasm	2/2914 (0.1%)		0/2937 (0%)
Multiple myeloma	1/2914 (0%)		0/2937 (0%)
Neoplasm malignant	6/2914 (0.2%)		5/2937 (0.2%)
Neoplasm prostate	0/2914 (0%)		1/2937 (0%)
Neuroendocrine carcinoma	1/2914 (0%)		0/2937 (0%)
Non-small cell lung cancer	2/2914 (0.1%)		1/2937 (0%)
Non-small cell lung cancer metastatic	0/2914 (0%)		1/2937 (0%)
Oesophageal adenocarcinoma	1/2914 (0%)		0/2937 (0%)
Oesophageal carcinoma	2/2914 (0.1%)		1/2937 (0%)
Ovarian cancer	1/2914 (0%)		0/2937 (0%)
Pancreatic carcinoma	1/2914 (0%)		4/2937 (0.1%)
Pancreatic carcinoma metastatic	2/2914 (0.1%)		2/2937 (0.1%)
Pancreatic neoplasm	3/2914 (0.1%)		0/2937 (0%)
Parathyroid tumour benign	1/2914 (0%)		0/2937 (0%)
Phaeochromocytoma	1/2914 (0%)		0/2937 (0%)
Prostate cancer	13/2914 (0.4%)		14/2937 (0.5%)
Prostate cancer metastatic	2/2914 (0.1%)		0/2937 (0%)
Prostate cancer recurrent	1/2914 (0%)		0/2937 (0%)
Rectal cancer	2/2914 (0.1%)		2/2937 (0.1%)
Rectal cancer recurrent	1/2914 (0%)		0/2937 (0%)
Rectal neoplasm	0/2914 (0%)		1/2937 (0%)
Renal cancer	2/2914 (0.1%)		3/2937 (0.1%)
Renal cell carcinoma	0/2914 (0%)		3/2937 (0.1%)
Small cell lung cancer stage unspecified	1/2914 (0%)		0/2937 (0%)
Squamous cell carcinoma	3/2914 (0.1%)		1/2937 (0%)
Squamous cell carcinoma of skin	4/2914 (0.1%)		2/2937 (0.1%)
Thymoma	1/2914 (0%)		0/2937 (0%)
Thyroid cancer	2/2914 (0.1%)		2/2937 (0.1%)
Thyroid cancer metastatic	0/2914 (0%)		1/2937 (0%)
Tongue neoplasm malignant stage unspecified	1/2914 (0%)		0/2937 (0%)
Transitional cell carcinoma	2/2914 (0.1%)		1/2937 (0%)
Ureteric cancer	0/2914 (0%)		1/2937 (0%)
Uterine cancer	1/2914 (0%)		1/2937 (0%)
Vulval cancer	0/2914 (0%)		1/2937 (0%)
Nervous system disorders
Amnesia	1/2914 (0%)		0/2937 (0%)
Aphasia	1/2914 (0%)		0/2937 (0%)
Brachial plexopathy	1/2914 (0%)		0/2937 (0%)
Brain stem stroke	1/2914 (0%)		0/2937 (0%)
Carotid artery insufficiency	1/2914 (0%)		0/2937 (0%)
Carotid artery occlusion	1/2914 (0%)		1/2937 (0%)
Carotid artery stenosis	4/2914 (0.1%)		5/2937 (0.2%)
Carotid sinus syndrome	0/2914 (0%)		1/2937 (0%)
Carpal tunnel syndrome	1/2914 (0%)		1/2937 (0%)
Cerebellar haemorrhage	2/2914 (0.1%)		0/2937 (0%)
Cerebral haemorrhage	0/2914 (0%)		1/2937 (0%)
Cerebral infarction	2/2914 (0.1%)		0/2937 (0%)
Cerebral ischaemia	0/2914 (0%)		1/2937 (0%)
Cerebrovascular accident	8/2914 (0.3%)		5/2937 (0.2%)
Cervical root pain	1/2914 (0%)		0/2937 (0%)
Chronic inflammatory demyelinating polyradiculoneuropathy	0/2914 (0%)		1/2937 (0%)
Cognitive disorder	2/2914 (0.1%)		1/2937 (0%)
Coma	1/2914 (0%)		0/2937 (0%)
Convulsion	5/2914 (0.2%)		2/2937 (0.1%)
Dementia	2/2914 (0.1%)		3/2937 (0.1%)
Dementia Alzheimer's type	1/2914 (0%)		2/2937 (0.1%)
Dizziness	4/2914 (0.1%)		7/2937 (0.2%)
Embolic stroke	1/2914 (0%)		0/2937 (0%)
Encephalopathy	4/2914 (0.1%)		2/2937 (0.1%)
Epilepsy	2/2914 (0.1%)		1/2937 (0%)
Grand mal convulsion	0/2914 (0%)		1/2937 (0%)
Haemorrhage intracranial	2/2914 (0.1%)		1/2937 (0%)
Haemorrhagic stroke	1/2914 (0%)		0/2937 (0%)
Headache	2/2914 (0.1%)		3/2937 (0.1%)
Hemiparesis	1/2914 (0%)		0/2937 (0%)
Hydrocephalus	1/2914 (0%)		1/2937 (0%)
Hypoaesthesia	1/2914 (0%)		2/2937 (0.1%)
IIIrd nerve paralysis	1/2914 (0%)		0/2937 (0%)
Intraventricular haemorrhage	0/2914 (0%)		1/2937 (0%)
Ischaemic stroke	5/2914 (0.2%)		2/2937 (0.1%)
Lumbar radiculopathy	1/2914 (0%)		0/2937 (0%)
Migraine	1/2914 (0%)		0/2937 (0%)
Myasthenia gravis	1/2914 (0%)		0/2937 (0%)
Myelopathy	0/2914 (0%)		1/2937 (0%)
Neuropathy peripheral	0/2914 (0%)		1/2937 (0%)
Normal pressure hydrocephalus	0/2914 (0%)		1/2937 (0%)
Paraesthesia	3/2914 (0.1%)		0/2937 (0%)
Paresis cranial nerve	1/2914 (0%)		0/2937 (0%)
Parkinson's disease	2/2914 (0.1%)		1/2937 (0%)
Parkinsonism	2/2914 (0.1%)		1/2937 (0%)
Partial seizures	1/2914 (0%)		0/2937 (0%)
Polyneuropathy	1/2914 (0%)		1/2937 (0%)
Presyncope	1/2914 (0%)		4/2937 (0.1%)
Sciatic nerve palsy	0/2914 (0%)		1/2937 (0%)
Sciatica	1/2914 (0%)		1/2937 (0%)
Subarachnoid haemorrhage	2/2914 (0.1%)		1/2937 (0%)
Syncope	24/2914 (0.8%)		24/2937 (0.8%)
Transient ischaemic attack	6/2914 (0.2%)		4/2937 (0.1%)
Tremor	0/2914 (0%)		1/2937 (0%)
Trigeminal neuralgia	1/2914 (0%)		0/2937 (0%)
VIIth nerve paralysis	2/2914 (0.1%)		0/2937 (0%)
Vertebrobasilar insufficiency	2/2914 (0.1%)		0/2937 (0%)
Vertigo CNS origin	0/2914 (0%)		1/2937 (0%)
Psychiatric disorders
Abnormal behaviour	1/2914 (0%)		0/2937 (0%)
Alcohol abuse	1/2914 (0%)		0/2937 (0%)
Alcohol withdrawal syndrome	0/2914 (0%)		1/2937 (0%)
Anxiety	1/2914 (0%)		0/2937 (0%)
Completed suicide	0/2914 (0%)		1/2937 (0%)
Confusional state	2/2914 (0.1%)		2/2937 (0.1%)
Delirium	3/2914 (0.1%)		2/2937 (0.1%)
Depression	1/2914 (0%)		5/2937 (0.2%)
Disorientation	0/2914 (0%)		1/2937 (0%)
Mental disorder	0/2914 (0%)		1/2937 (0%)
Mental status changes	5/2914 (0.2%)		1/2937 (0%)
Panic attack	1/2914 (0%)		0/2937 (0%)
Panic disorder	1/2914 (0%)		0/2937 (0%)
Suicide attempt	1/2914 (0%)		0/2937 (0%)
Renal and urinary disorders
Bladder obstruction	1/2914 (0%)		0/2937 (0%)
Bladder prolapse	1/2914 (0%)		0/2937 (0%)
Dysuria	1/2914 (0%)		0/2937 (0%)
Glomerulonephritis	0/2914 (0%)		1/2937 (0%)
Haematuria	2/2914 (0.1%)		7/2937 (0.2%)
Hydronephrosis	1/2914 (0%)		0/2937 (0%)
Nephrolithiasis	4/2914 (0.1%)		1/2937 (0%)
Nephrotic syndrome	1/2914 (0%)		1/2937 (0%)
Proteinuria	0/2914 (0%)		1/2937 (0%)
Renal colic	0/2914 (0%)		3/2937 (0.1%)
Renal cyst	1/2914 (0%)		0/2937 (0%)
Renal disorder	1/2914 (0%)		0/2937 (0%)
Renal embolism	0/2914 (0%)		1/2937 (0%)
Renal failure	19/2914 (0.7%)		9/2937 (0.3%)
Renal failure acute	23/2914 (0.8%)		23/2937 (0.8%)
Renal failure chronic	1/2914 (0%)		2/2937 (0.1%)
Renal impairment	1/2914 (0%)		2/2937 (0.1%)
Renal infarct	0/2914 (0%)		1/2937 (0%)
Urethral stenosis	1/2914 (0%)		0/2937 (0%)
Urinary retention	0/2914 (0%)		3/2937 (0.1%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	12/2914 (0.4%)		13/2937 (0.4%)
Ovarian cyst	0/2914 (0%)		1/2937 (0%)
Pelvic haematoma	1/2914 (0%)		0/2937 (0%)
Pelvic pain	1/2914 (0%)		0/2937 (0%)
Spermatocele	1/2914 (0%)		0/2937 (0%)
Uterine prolapse	0/2914 (0%)		1/2937 (0%)
Vaginal haemorrhage	0/2914 (0%)		1/2937 (0%)
Vaginal prolapse	1/2914 (0%)		0/2937 (0%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema	1/2914 (0%)		4/2937 (0.1%)
Acute respiratory failure	4/2914 (0.1%)		0/2937 (0%)
Alveolitis	0/2914 (0%)		1/2937 (0%)
Aspiration	1/2914 (0%)		0/2937 (0%)
Asthma	4/2914 (0.1%)		4/2937 (0.1%)
Bronchial secretion retention	0/2914 (0%)		1/2937 (0%)
Bronchitis chronic	2/2914 (0.1%)		2/2937 (0.1%)
Chronic obstructive pulmonary disease	27/2914 (0.9%)		30/2937 (1%)
Dysphonia	0/2914 (0%)		1/2937 (0%)
Dyspnoea	34/2914 (1.2%)		32/2937 (1.1%)
Dyspnoea exertional	1/2914 (0%)		0/2937 (0%)
Epistaxis	1/2914 (0%)		2/2937 (0.1%)
Haemoptysis	1/2914 (0%)		3/2937 (0.1%)
Haemothorax	2/2914 (0.1%)		3/2937 (0.1%)
Hypercapnia	1/2914 (0%)		0/2937 (0%)
Hypoxia	1/2914 (0%)		2/2937 (0.1%)
Idiopathic pulmonary fibrosis	1/2914 (0%)		0/2937 (0%)
Laryngeal oedema	1/2914 (0%)		0/2937 (0%)
Pleural effusion	11/2914 (0.4%)		7/2937 (0.2%)
Pleuritic pain	0/2914 (0%)		1/2937 (0%)
Pneumonia aspiration	0/2914 (0%)		1/2937 (0%)
Pneumothorax	0/2914 (0%)		2/2937 (0.1%)
Productive cough	2/2914 (0.1%)		0/2937 (0%)
Pulmonary congestion	0/2914 (0%)		1/2937 (0%)
Pulmonary embolism	1/2914 (0%)		2/2937 (0.1%)
Pulmonary fibrosis	1/2914 (0%)		1/2937 (0%)
Pulmonary haemorrhage	0/2914 (0%)		2/2937 (0.1%)
Pulmonary hypertension	3/2914 (0.1%)		3/2937 (0.1%)
Pulmonary mass	1/2914 (0%)		0/2937 (0%)
Pulmonary oedema	2/2914 (0.1%)		5/2937 (0.2%)
Respiratory distress	3/2914 (0.1%)		4/2937 (0.1%)
Respiratory failure	6/2914 (0.2%)		5/2937 (0.2%)
Sleep apnoea syndrome	2/2914 (0.1%)		1/2937 (0%)
Skin and subcutaneous tissue disorders
Decubitus ulcer	1/2914 (0%)		0/2937 (0%)
Diabetic foot	2/2914 (0.1%)		1/2937 (0%)
Eczema	0/2914 (0%)		1/2937 (0%)
Pemphigoid	1/2914 (0%)		0/2937 (0%)
Psoriasis	0/2914 (0%)		1/2937 (0%)
Purpura	0/2914 (0%)		1/2937 (0%)
Rash	2/2914 (0.1%)		1/2937 (0%)
Skin discolouration	0/2914 (0%)		1/2937 (0%)
Skin haemorrhage	1/2914 (0%)		0/2937 (0%)
Skin lesion	0/2914 (0%)		1/2937 (0%)
Skin ulcer	3/2914 (0.1%)		0/2937 (0%)
Stasis dermatitis	1/2914 (0%)		0/2937 (0%)
Urticaria	1/2914 (0%)		0/2937 (0%)
Social circumstances
Activities of daily living impaired	1/2914 (0%)		1/2937 (0%)
Surgical and medical procedures
Dental implantation	0/2914 (0%)		1/2937 (0%)
Lesion excision	1/2914 (0%)		0/2937 (0%)
Tooth extraction	0/2914 (0%)		1/2937 (0%)
Vascular disorders
Aneurysm	0/2914 (0%)		1/2937 (0%)
Aortic aneurysm	11/2914 (0.4%)		8/2937 (0.3%)
Aortic aneurysm rupture	2/2914 (0.1%)		0/2937 (0%)
Aortic dissection	5/2914 (0.2%)		1/2937 (0%)
Aortic intramural haematoma	1/2914 (0%)		0/2937 (0%)
Aortic stenosis	6/2914 (0.2%)		6/2937 (0.2%)
Arteriosclerosis	0/2914 (0%)		3/2937 (0.1%)
Arteritis	0/2914 (0%)		1/2937 (0%)
Blood pressure inadequately controlled	1/2914 (0%)		0/2937 (0%)
Circulatory collapse	2/2914 (0.1%)		0/2937 (0%)
Deep vein thrombosis	2/2914 (0.1%)		6/2937 (0.2%)
Femoral artery aneurysm	1/2914 (0%)		0/2937 (0%)
Femoral artery occlusion	1/2914 (0%)		0/2937 (0%)
Haematoma	2/2914 (0.1%)		3/2937 (0.1%)
Haemorrhage	4/2914 (0.1%)		5/2937 (0.2%)
Hypertension	11/2914 (0.4%)		10/2937 (0.3%)
Hypertensive crisis	1/2914 (0%)		1/2937 (0%)
Hypotension	8/2914 (0.3%)		9/2937 (0.3%)
Intermittent claudication	1/2914 (0%)		2/2937 (0.1%)
Ischaemia	0/2914 (0%)		1/2937 (0%)
Leriche syndrome	1/2914 (0%)		1/2937 (0%)
Malignant hypertension	1/2914 (0%)		0/2937 (0%)
Orthostatic hypotension	2/2914 (0.1%)		0/2937 (0%)
Peripheral arterial occlusive disease	4/2914 (0.1%)		2/2937 (0.1%)
Peripheral artery aneurysm	1/2914 (0%)		0/2937 (0%)
Peripheral artery stenosis	2/2914 (0.1%)		4/2937 (0.1%)
Peripheral artery thrombosis	1/2914 (0%)		0/2937 (0%)
Peripheral embolism	1/2914 (0%)		0/2937 (0%)
Peripheral ischaemia	2/2914 (0.1%)		1/2937 (0%)
Peripheral vascular disorder	2/2914 (0.1%)		4/2937 (0.1%)
Shock haemorrhagic	0/2914 (0%)		1/2937 (0%)
Temporal arteritis	1/2914 (0%)		0/2937 (0%)
Thrombosis	1/2914 (0%)		0/2937 (0%)
Venous occlusion	1/2914 (0%)		0/2937 (0%)
Other (Not Including Serious) Adverse Events
	Dabigatran 110 mg		Dabigatran 150 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

Non-serious adverse events were not collected on subjects in this study.

More Information

Certain Agreements

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

Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

Results Point of Contact

Name/Title	Boehringer Ingelheim Call Center
Organization	Boehringer Ingelheim Pharmaceuticals
Phone	1-800-243-0127
Email	clintriage.rdg@boehringer-ingelheim.com

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT00808067

Other Study ID Numbers:

1160.71
2008-005248-17

First Posted:

Dec 15, 2008

Last Update Posted:

Jun 9, 2014

Last Verified:

Mar 1, 2014

RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial

Study Details

Study Description

Brief Summary

The purposes of this study are:

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion criteria:

Exclusion criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact