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GLORIA-AF Registry Program (Phase II/III - EU/EEA Member States)

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT01671007
Collaborator
(none)
10,471
Enrollment
523
Locations
87.7
Actual Duration (Months)
20
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    10471 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients With Atrial Fibrillation (Phase II/III - EU/EEA Member States)
    Actual Study Start Date :
    Aug 22, 2012
    Actual Primary Completion Date :
    Dec 13, 2019
    Actual Study Completion Date :
    Dec 13, 2019

    Outcome Measures

    Primary Outcome Measures

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Eligibility Criteria

    Criteria

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

    1. Age =>18 years at enrollment

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

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

    Other inclusion criteria apply.

    Exclusion criteria:

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

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

    3. AF with a generally reversible cause;

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Klinik Pirawarth, Therapie und Rehabilitation, Bad Pirawarth Bad Pirawarth Austria 2222
    2 KH der Barmherzigen Schwestern Linz Linz Austria 4010
    3 Kepler Univ. Klinikum Linz Linz Austria 4021
    4 Ordination Dr. Martin Koschutnik, Oberwart Oberwart Austria 7400
    5 KH d. Barmherzigen Brüder Wien, Neurologie Wien Austria 1020
    6 AKH - Medical University of Vienna Wien Austria 1090
    7 Namur - HOSP St-Luc de Bouge Bouge/Namur Belgium 5004
    8 AZ Sint-Lucas Brugge Belgium 8310
    9 Brussels - HOSP St-Jan Brussel Belgium 1000
    10 Brussels - HOSP Europe (Ste-Elisabeth) Brussel Belgium 1180
    11 ULB Hopital Erasme Bruxelles Belgium 1070
    12 Ziekenhuis Oost-Limburg - Campus Sint-Jan Genk Belgium 3600
    13 Liège - HOSP CHR de la Citadelle Liège Belgium 4000
    14 Ottignies - HOSP St-Pierre Ottignies Belgium 1340
    15 Tienen - PRAC De Wolf, Luc Tienen Belgium 3300
    16 MHAT "Deva Maria", Dept. of Cardiology, Burgas Burgas Bulgaria 5800
    17 MHAT "Dr.Stambolski", Cardiology&Intensiv Care Dept,Kazanlak Kazanlak Bulgaria 6100
    18 UMHAT Sv.Georgi EAD Plovdiv Bulgaria 4002
    19 MHAT, Fourth Dept. of Internal Medicine, Rousse Rousse Bulgaria 7002
    20 MHAT Akta Medika OOD, Sevlievo Sevlievo Bulgaria 5400
    21 Multiprofile Hospital for Active Treatment, Sliven Sliven Bulgaria 8800
    22 Diagnostic & Consultancy Center "Ascendent", Sofia Sofia Bulgaria 1202
    23 MHAT "National Cardiology Hosp." Cardiology Dept., Sofia Sofia Bulgaria 1309
    24 University Multiprofile Hospital 'Alexandrovska', Sofia Sofia Bulgaria 1431
    25 MHAT, "Vita" Surgery Department, Sofia Sofia Bulgaria 1505
    26 MHAT "Tsaritsa Yoanna-ISUL" Clinic of Cardiology, Sofia Sofia Bulgaria 1527
    27 UMHAT, Clinic of Cardiology, Stara Zagora Stara Zagora Bulgaria 6003
    28 Medical Military Academy MHAT Varna Varna Bulgaria 9010
    29 Specialized Hosp.f.Active Treatment, Cardiology Dept, Yambol Yambol Bulgaria 8600
    30 Magdalena-Special Hosp.f.Cardiovas.Surgery,Krapinske Toplice Krapinske Toplice Croatia 49217
    31 Thalassoterapia,Rehab.of heart&lung,Cardiology Clin, Opatija Opatija Croatia 51410
    32 Clinical Hospital Split Split Croatia 21000
    33 General Hosp. Zadar, Clinic of Internal Med, Cardiology Dept Zadar Croatia 23 000
    34 Clinical Hosp.Merkur,Clin.Internal Med,Cardiology Dep,Zagreb Zagreb Croatia 10 000
    35 Polyclinic St. Luke, Cardiology Dept., Zagreb Zagreb Croatia 10 000
    36 Univ. Hosp. Sisters of Mercy, Cardiology Dept., Zagreb Zagreb Croatia 10 000
    37 University hospital center Zagreb Zagreb Croatia 10 000
    38 Univ. Hosp. Sisters of Mercy, Neurology Clinic, Zagreb Zagreb Croatia 100 00
    39 University hospital center Zagreb Zagreb Croatia 10000
    40 Cardiology Private Practice, Brno Brno Czechia 61600
    41 University Hospital Brno Brno Czechia 625 00
    42 Cardiocentrum, Private Practice, Kladno Kladno Czechia 272 80
    43 Cardiology Private Practice Litovel Czechia 784 01
    44 Cardiology Private Practice, Praha Praha 5 Czechia 15005
    45 Cardiology Private Practice, Roznov pod Radhostem Roznov pod Radhostem Czechia 756 61
    46 Forskningens Hus Aalborg Denmark 9000
    47 Sydvestjysk Sygehus Esbjerg, Hjertemedicinsk afd. Esbjerg Denmark 6700
    48 Herlev and Gentofte Hospital Herlev Denmark 2730
    49 Nordsjællands Hospital - Hillerød Hillerød Denmark 3400
    50 Kolding Sygehus Kolding Denmark 6000
    51 Odense University Hospital Odense Denmark 5000
    52 North Estonia Med.Centre,Internal Med.Clin/Cardiology,Tallin Tallinn Estonia 134 19
    53 East Tallinn Central Hospital Tallin Estonia 10138
    54 HOP Général, Cardio, Abbeville Abbeville France 80142
    55 HOP d'Agen, Cardio, Agen Agen France 47923
    56 HOP d'Aix en Provence, cardio, Aix-en-Provence Aix en Provence France 13616
    57 HOP Général, Cardio, Abbeville Aix en Provence France 13616
    58 HOP Louis Pasteur, Cardio, Bagnols sur Ceze Bagnols sur Ceze France 30205
    59 HOP Bar le Duc, Pneumo, Bar le Duc Bar le Duc France 55012
    60 HOP de Bayonne Bayonne France 64109
    61 HOP Jean Minjoz Besancon France 25030
    62 CAB Berdagué P, Cardio, Beziers Beziers France 34500
    63 CAB Breton Dr Nicolas Beziers France 34500
    64 CLI Tivoli Bordeaux France 33000
    65 HOP Saint-André Bordeaux France 33075
    66 HOP Ambroise Paré Boulogne-Billancourt France 92104
    67 HOP Fleyriat, GERIA, Bourg-en-Bresse Bour-en-Bresse France 01012
    68 HOP de la Cavale Blanche Brest France 29609
    69 CLI les Cedres, Cardio, Brive La Gaillarde Brive La Gaillarde France 19100
    70 CAB Cadinot Dr D, Broglie Broglie France 27270
    71 CAB Frappé T, MG, BRUAY LA BUISSIERE Bruay la Buissière France 62700
    72 HOP de Béziers Béziers France 34525
    73 HOP Saint Martin, cardio, Caen Caen France 14000
    74 HOP Côte de Nacre Caen France 14033
    75 CAB Brunschwig, Cardio, Cannes Cannes France 06400
    76 HOP William Morey, Cardio, Chalon-Sur-Saône Chalon-Sur-Saône France 71100
    77 CAB Loiselet P Cherbourg France 50100
    78 HOP Gabriel-Montpied Clermont Ferrand France 63000
    79 CAB Brunehaut M, Cardio, Clermont Ferrand Clermont Ferrand France 63100
    80 HOP Sud Francilien Corbeil Essonnes France 91106
    81 HOP Sud Francilien, Cardio, Corbeil-Essonnes Corbeil-Essonnes France 91106
    82 HOP Henri Mondor Creteil France 94000
    83 HOP Bocage Dijon France 21079
    84 HOP Louis Pasteur, Cardio, Dole Dole France 39108
    85 CTRE Evecquemont, Cardio, Evecquemont Evecquemont France 78740
    86 HOP du Val d'Ariège, Cardio, Foix Foix France 09107
    87 HOP Michallon La Tronche France 38700
    88 CAB Benhalima B, Cardio, Le bourget Le Bourget France 93350
    89 HOP André Mignot Le Chesnay France 78150
    90 HOP Louis Pasteur, Cardio, Le Coudray Le Coudray France 28630
    91 HOP Le Mans Le Mans France 72037
    92 CAB Phan Cao Phai, Cardio, Levallois Perret Levallois Perret France 92300
    93 CLI Libournais, Cardio, Libourne Libourne France 33500
    94 HOP Robert Boulin, cardio, Libourne Libourne France 33500
    95 CLI de la Louviere Lille France 59000
    96 CLI le Colombier, Cardio, Limoges Limoges France 87100
    97 HOP St Joseph-St Luc, Cardio, Lyon Lyon cedex 7 France 69365
    98 CAB Gartenlaub O, Cardio, Maison Alfort Maisons Alfort France 94700
    99 HOP Timone Marseille cedex 5 France 13385
    100 CAB, Salem A, Cardio, Marseille Marseille France 13001
    101 HOP Européen Marseille France 13003
    102 CAB Scala P-J Marseille France 13008
    103 CAB Scemama J Marseille France 13008
    104 CAB vial, Cardio, Marseille Marseille France 13009
    105 HOP des Rayettes Martigues France 13698
    106 HOP de la région d'Annecy, Cardio, Metz-Tessy Metz-Tessy France 74370
    107 CAB Dillinger J, MG, Mondelange Mondelange France 57300
    108 CLI de Montargis, Cardio, Montargis Montargis France 45200
    109 CLI du Pont de Chaume Montauban France 82000
    110 HOP Raincy Montfermeil, Cardio, Montfermeil Montfermeil France 93370
    111 HOP Arnaud de Villeneuve Montpellier France 34295
    112 CAB Prunier L, Cardio, Montreuil Montreuil France 93100
    113 HOP Central, Neuro, Nancy Nancy France 54035
    114 HOP de Courbevoie, Spécialités Med, Neuilly sur Seine Neuilly sur Seine France 92200
    115 CAB Jamon Y, Cardio, Nîmes Nimes France 30000
    116 HOP Carémeau Nîmes France 3000
    117 CLI Les Franciscaines, cardio, Nïmes Nïmes France 30032
    118 HOP Orléans, Cardio, Orléans Orléans France 45100
    119 CAB Audouin P, Cardio, Paris Paris France 75007
    120 CLI Turin, Cardio, Paris Paris France 75008
    121 CAB Cohen S, Paris Paris France 75012
    122 CAB Poulain F, Paris Paris France 75014
    123 HOP Européen G. Pompidou Paris France 75015
    124 HOP Pontchaillou Rennes Cedex France 35033
    125 CAB Duvilla N, Cardio, Rouen Rouen France 76000
    126 CAB Dascotte O, Cardio, St André lez Lille Saint André lez Lille France 59350
    127 CAB Lequeux B, Cardio, Saint Benoit Saint Benoit France 86280
    128 HOP Privé de la Loire, Cardio, Saint Etienne Saint Etienne France 42000
    129 CAB Dary P, Cardio, St-Yrieix-la-Perche Saint-Yrieix-la-Perche France 87500
    130 CAB Tessier P, Cardio, St Raphael St Raphael France 83700
    131 CAB Muller J-J, Cardio, Strasbourg Strasbourg France 67000
    132 CLI de l'Ormeau, Cardio, Tarbes Tarbes France 65000
    133 CAB Houppe Nousse MP, Cardio, Thionville Thionville France 57100
    134 HOP du Léman Thonon-les-bains France 74203
    135 HOP Sainte Musse Toulon France 83100
    136 HOP Rangueil Toulouse France 31059
    137 HOP Cardio, Tourcoing Tourcoing France 59200
    138 CAB Leprince P, MG, Tours Tours France 37000
    139 HOP Trousseau Tours France 37044
    140 CLI Village de Santé, Cardio, Trélaze Trelaze France 49804
    141 HOP Valence, Cardio, Valence Valence France 26000
    142 HOP Bretagne Atlantique, Cardio, Vannes Vannes France 56017
    143 CAB Lejay D, MG, Vieux Condé Vieux Condé France 59690
    144 CAB Schaupp T, MG, Vihiers Vihiers France 49310
    145 Bezirkskrankenhaus, Ansbach Ansbach Germany 91522
    146 Kerckhoff-Klinik, Bad Nauheim Bad Nauheim Germany 61231
    147 Neurologische Klinik GmbH, Bad Neustadt Bad Neustadt/Saale Germany 97616
    148 Sozialstiftung Bamberg Bamberg Germany 96046
    149 Evangelisches Elisabeth-Krankenhaus, Berlin Mitte Berlin Germany 10785
    150 Praxis Dr. Rieker, Berlin Berlin Germany 10789
    151 Vivantes Netzwerk für Gesundheit GmbH Berlin Germany 10967
    152 Charité - Universitätsmedizin Berlin Berlin Germany 12203
    153 Vivantes Netzwerk für Gesundheit GmbH Berlin Germany 12351
    154 Praxis Dr. Altmann, Berlin Berlin Germany 12489
    155 Praxisgemeinschaft Dres. Weinrich Berlin Germany 12555
    156 Praxis Dr. Claus, 10969 Berlin Berlin Germany 12559
    157 Kardiologische Praxis Dr. Jochen Bott Berlin Germany 13405
    158 Vivantes Netzwerk für Gesundheit GmbH Berlin Germany 13505
    159 Vivantes Netzwerk für Gesundheit GmbH Berlin Germany 13509
    160 Vivantes Netzwerk für Gesundheit GmbH Berlin Germany 13585
    161 Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH Bochum Germany 44791
    162 Gesundheit Nord gGmbH | Klinikverbund Bremen Bremen Germany 28177
    163 Klinikum Bremerhaven Bremerhaven Germany 27574
    164 Herz- und Gefaesszentrum am Neumarkt Celle Germany 29221
    165 Gemeinschaftspraxis Dr. med. J. Sek, Chemnitz Chemnitz Germany 09116
    166 Klinikum Coburg gGmbH Coburg Germany 96450
    167 HELIOS Amper Kliniken, Dachau Dachau Germany 85221
    168 Kardiologische Praxisgemeinschaft,Darmstadt Darmstadt Germany 64287
    169 Praxis Dr. Rybak, Dessau Dessau-Roßlau Germany 06847
    170 Klinikum Lippe-Detmold GmbH Detmold Germany 32756
    171 Kardiologischen Gemeinschaftspraxis Dinslaken Dinslaken Germany 46535
    172 Praxis Dr. med. Bernhard-Paul Lodde Dortmund Germany 44147
    173 Praxisklinik Herz und Gefäße Dresden Germany 01099
    174 Universitätsklinikum Carl Gustav Carus Dresden Dresden Germany 01307
    175 Evangelisches Krankenhaus Düsseldorf Düsseldorf Germany 40217
    176 Universitätsklinikum Erlangen Erlangen Germany 91054
    177 Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH Essen Germany 45122
    178 Klinikum Esslingen GmbH Esslingen Germany 73730
    179 Praxis für Herz-Kreislauf-Erkrankungen Zeulenroda-Greiz Greiz Germany 07973
    180 Asklepios Klinik St. Geort Hamburg Germany 20099
    181 Universitätsklinikum Hamburg-Eppendorf Hamburg Germany 20246
    182 Asklepios Klinik Harburg Hamburg Germany 21075
    183 Asklepios Klinik Barmbek Hamburg Germany 22291
    184 Praxis Herz im Zentrum Laske Hannover Germany 30159
    185 Universitätsklinikum Heidelberg Heidelberg Germany 69120
    186 Klinikum Ingolstadt GmbH Ingolstadt Germany 85049
    187 Praxis Dr. Mibach, Itzehoe Itzehoe Germany 25524
    188 Universitätsklinikum Jena Jena Germany 07740
    189 Kardiologische Gemeinschaftspraxis Kassel Kassel Germany 34117
    190 Praxis Dr. med. Frickel Siegfried Kempen Germany 47906
    191 Praxis Dr. med. Matthias Gabelmann Kirchzarten Germany 79199
    192 St. Antonius-Hospital, Kleve Kleve Germany 47533
    193 Praxis für Kardiologie, Köln Köln Germany 51105
    194 Universitätsklinikum Leipzig Leipzig Germany 04103
    195 Herzzentrum Leipzig GmbH Leipzig Germany 04289
    196 Klinikum Leverkusen gGmbH, Leverkusen Leverkusen Germany 51375
    197 Cardio Centrum Ludwigsburg Ludwigsburg Germany 71634
    198 Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen Germany 67063
    199 Universitätsklinikum Magdeburg A. ö. R. Magdeburg Germany 39120
    200 Gemeinsachftspraxis Regner/Schmitt/Kros, Mainz Mainz Germany 55116
    201 Praxis Dr.med. Jens Taggeselle, Markkleeberg Markkleeberg Germany 04416
    202 Klinikum Memmingen Memmingen Germany 87700
    203 Johannes Wesling Klinikum Minden Germany 32429
    204 Kliniken Maria Hilf GmbH Moenchengladbach Germany 41063
    205 Praxis Dr. med. Norbert Schön, Mühldorf Mühldorf Germany 84453
    206 Herzzentrum ALTER HOF München München Germany 80331
    207 Klinikum rechts der Isar der Technischen Universität München München Germany 81675
    208 Universitätsklinikum Münster Münster Germany 45129
    209 Praxis Dr. med. Joachim Gmehling Nürnberg Germany 90402
    210 Klinikum Osnabrück GmbH Osnabrueck Germany 49076
    211 St. Vincenz-Krankenhaus GmbH Paderborn Germany 33098
    212 Kardiologische Praxis Papenburg Papenburg Germany 26871
    213 Kardiologisches Zentrum Peine Peine Germany 31224
    214 Städt. Krankenhaus, Pforzheim Pforzheim Germany 75175
    215 Kardiologische Gemeinschaftspraxis Potsdam Potsdam Germany 14471
    216 Kardiologische Gemeinschaftspraxis Rostock Rostock Germany 18057
    217 Kreisklinikum Siegen GmbH Siegen Germany 57076
    218 Berufsausübungsgemeinschaft Klein /Kratochvil Stuttgart Germany 70178
    219 Herzklinik Ulm Gemeinschaftspraxis Ulm Germany 89077
    220 Schwarzwald-Baar Klinikum Villingen-Schwenningen Germany 78011
    221 Kardiologische Praxis, Wermsdorf Wermsdorf Germany 04779
    222 MedKonsil, Wiesbaden Wiesbaden Germany 65189
    223 Kardiologische Gemeinschaftspraxis Wittenberg Wittenberg Germany 06886
    224 Universitätsklinikum Würzburg Würzburg Germany 97080
    225 University Hospital of Alexandroupolis Alexandroupoli Greece 68100
    226 Euroclinic of Athens Athens Greece 11521
    227 "Korgialeneio-Benakeio" Hellenic Red Cross Hospital Athens Greece 11526
    228 Sotiria Hosp.,Hypertension Unit,3rd Clinic of Internal Med. Athens Greece 11527
    229 Asclepion Voulas Hospital, Cardiological Clinic Athens Greece 16673
    230 General Hospital of Chalkida Chalkida Greece 34100
    231 General Hospital of Chania Chania Greece 73100
    232 General Hospital of Edessa, Cardiology Clinic Edessa Greece 58200
    233 Gen. Hosp. of Elefsina "Thriassio" Elefsina Greece 19600
    234 University General Hospital of Heraklion Herakleion, Crete Greece 71110
    235 Univ. Gen. Hosp. of Ioannina Ioannina Greece 45500
    236 General Hospital Komotinis Komotini Greece 69100
    237 General University Hospital of Larissa Larissa Greece 41110
    238 University of Patras Medical School Patras Greece 26504
    239 General Hospital of Rhodes Rhodes Greece 85100
    240 Gen. Hosp. of Thessaloniki "Hippokation", Cardiology Clinic Thessaloniki Greece 54642
    241 "Papageorgiou" General Hospital of Thessaloniki, B' Cardiolo Thessaloniki Greece 56429
    242 General Panarkadiko Hospital of Tripolis, Cardiology Clinic Tripoli Greece 22100
    243 Portiuncula Hospital Ballinasloe Ireland H53 T971
    244 St James's Hospital Dublin 8 Ireland Dublin 8
    245 Adelaide & Meath Hospital Dublin Ireland 24
    246 University Hospital Galway Galway Ireland GALWAY
    247 The Redhouse Family Practice Mallow Ireland
    248 Ospedale Riuniti Albano Genzano Albano Laziale Italy 00041
    249 Az. Osp. S.M. di Misericordia Albenga Italy 17031
    250 Az. Ospedaliere Umberto I di Ancona Ancona Italy 60020
    251 Ospedale Reg Umberto Parini Aosta Italy 11100
    252 Ospedale C. G. Mazzoni Ascoli Piceno Italy 63100
    253 AZ. Osp. Assisi U.O. Assisi Italy 06081
    254 Osp. SS Filippo Nicola Avezzano Italy 67051
    255 Policlinico di Bari Bari Italy 70124
    256 Policlinico Universitario di Bari Bari Italy 70124
    257 Policlinico S. Orsola Malpighi Bologna Italy 40138
    258 A. O. G. Brotzu Cagliari Italy 09134
    259 Presidio Ospedaliero di Castrovillari Castrovillari (CS) Italy 87012
    260 P. O. "Garibaldi" - Nesima Catania Italy 95122
    261 A.O. Univ. Vittorio Ferrarotto S. Bambino Catania Italy 95124
    262 Policlinico Universitario Mater Domini, Universita di Catanzaro Catanzaro Italy 88100
    263 Osp. Clin. SS. Anunziata Chieti Italy 66013
    264 Azienda Ospedaliera Universitaria Arcispedale Sant'Anna Cona (FE) Italy 44124
    265 Osp.S.Salvatore Coppitto (AQ) Italy 67100
    266 AZ. Osped. Ospedale Maggiore di Crema Crema (CR) Italy 26013
    267 A. Istituti Osp. di Cremona Cremona Italy 26100
    268 Ospedale S. Biagio Domodossola (VB) Italy 28845
    269 P. O. S. Maria Nuova Firenze Italy 50122
    270 Azienda Ospedaliera Careggi Firenze Italy 50134
    271 Azienda Ospedaliera Careggi Firenze Italy 50139
    272 Az.Osp. Universitaria "Ospedali Riuniti" Foggia Italy 71100
    273 Ospedale S. Cuore di Gesù Gallipoli Italy 73014
    274 Policlinico San Martino Genova Italy 16132
    275 Ospedale della Misericordia Grosseto Italy 58100
    276 Ospedale F. Veneziale Isernia Italy 86170
    277 Azienda Ospedaliera C. Poma Mantova Italy 46100
    278 Osp. Pediatrico Aprano Pasquinucci Massa Italy 54100
    279 Az Osp. Amico " Gaetano Fucito" Mercato San Severino (SA) Italy 84085
    280 Centro Cardiologico Monzino-IRCCS Milano Italy 20138
    281 Nuovo Ospedale Civile S. Agostino-Estense Modena Italy 46100
    282 Osp.Riun.Valdichiana Senese Montepulciano Senese (SI) Italy 53045
    283 A.O. San Gerardo di Monza Monza (MB) Italy 20900
    284 Ospedale Nuovo Pellegrini Napoli Italy 80134
    285 Ospedale Cardarelli Napoli Italy 80135
    286 Osp.Sacro Cuore-Don Calabria Negrar (VR) Italy 37024
    287 Az. Osp. San Giacomo Novi Ligure Italy 15067
    288 Az. Osp. San Francesco Nuoro Italy 08100
    289 Azienda Sanitaria Ospedale S. Luigi Gonzaga Orbassano (TO) Italy 10043
    290 Azienda Ospedaliera Universitaria di Padova Padova Italy 35128
    291 A.O. Univ. Policlinico Giaccone Palermo Italy 90129
    292 Fondazione IRCCS Policlinico S. Matteo Pavia Italy 27100
    293 Ospedale S.Maria della Misericordia, AO di Perugia Perugia Italy 06156
    294 Ospedale San Salvatore Pesaro Italy 6121
    295 Osp. Guglielmo da Saliceto AUSL di Piacenza Piacenza Italy 29121
    296 Ospedale Santa Corona Azienda Sanitaria Locale n.2 Savonese Pietra Ligure Italy 17027
    297 Ospedale di Cisanello Pisa Italy 56124
    298 Ospedale S.Tommaso dei Battuti Portogruaro (VE) Italy 30026
    299 P.O.S. Maria Grazie Pozzuoli Italy 80078
    300 Azienda Unità Sanitaria Locale di Reggio Emilia Reggio Emilia Italy 12100
    301 Ospedale "Giambattista Grassi Roma Italy 00122
    302 Pol. Universitario Tor Vergata Roma Italy 00133
    303 Azienda Complessa Ospedaliera Ospedale San Fiippo Neri Roma Italy 00135
    304 Ospedale "S. Eugenio" Roma Italy 00144
    305 A.O. San Camillo Forlanini Roma Italy 00151
    306 Umberto I Pol. di Roma-Università di Roma La Sapienza Roma Italy 00161
    307 Policlinico Gemelli Roma Italy 00168
    308 Policlinico Casilino U.O. Cardiologia Roma Italy 00169
    309 Az. Osp.Madre Giuseppina Vannini- Roma Italy 00177
    310 Az. Osp. S.Giovanni-Addolorata Roma Italy 00184
    311 Ospedale S. Spirito Roma Italy 00193
    312 Nuovo Ospedale Civile di Sassuolo Sassuolo Italy 41049
    313 IRCCS Gruppo Multimedica Sesto S.Giovanni (MI) Italy 20090
    314 A.O.U. Senese Policlinico Santa Maria alle Scotte Siena Italy 53100
    315 AO Città della Salute e della Torino Italy 10126
    316 Ospedale Mauriziano di Torino Torino Italy 10128
    317 Ospedale S. Maria di Ca' Foncello Azienda ULSS9 TREVISO Treviso Italy 31100
    318 A. O. S. Maria della Misericordia Udine Italy 33100
    319 A. O. Ospedale Circolo Fond. Macchi Varese Italy 21100
    320 Ospedale San Bortolo Vicenza Italy 36100
    321 Liepaja Regional Hospital, Therapy Department Liepaja Latvia 3414
    322 P.Stradins Clin.Univ.Hosp,Cardio.Diagnos&Outpatient Dep,Riga Riga Latvia 1002
    323 Riga East University Hospital Riga Latvia 1038
    324 Jeroen Bosch Ziekenhuis-Hertogenbosch 's HERTOGENBOSCH Netherlands 5223 GZ
    325 Amsterdam UMC, Locatie AMC Amsterdam Netherlands 1105 AZ
    326 Rijnstate Hospital Arnhem Netherlands 6815 AD
    327 IJsselland Ziekenhuis Capelle Aan Den Ijssel Netherlands 2906 ZC
    328 Reinier de Graaf Groep Delft Netherlands 2625 AD
    329 Noordwest Ziekenhuisgroep Den Helder Netherlands 1782 GZ
    330 Deventer Ziekenhuis Deventer Netherlands 7416 SE
    331 Van Weel-Bethesda Ziekenhuis Dirksland Netherlands 3247 BW
    332 Catharina Ziekenhuis Eindhoven Netherlands 5623 EJ
    333 Medisch Spectrum Twente Enschede Netherlands 7512KZ
    334 Zuyderland Medisch Centrum Heerlen Netherlands 6419 PC
    335 TREANT zorggroep Hoogeveen Netherlands 7909 AA
    336 Westfries Gasthuis Hoorn Netherlands 1624 NP
    337 METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht Maastricht Netherlands 6229 HX
    338 St. Antonius ziekenhuis, locatie Nieuwegein Nieuwegein Netherlands 3435 CM
    339 Havenziekenhuis Rotterdam Netherlands 3011 TD
    340 Zuyderland Medisch Centrum Sittard - Geleen Netherlands 6162 BG
    341 Antonius Ziekenhuis Sneek Netherlands 8601 ZK
    342 Ziekenhuis Rivierenland Tiel Netherlands 4002 WP
    343 VieCuri Medisch Centrum, locatie Venray Venray Netherlands 5801 CE
    344 Isala Zwolle Zwolle Netherlands 8011 JW
    345 Legegruppen Arendal Arendal Norway N-4836
    346 Vestre Viken HF, Bærum sykehus Drammen Norway N-3004
    347 Medisinsk Senter Fornebu DA Fornebu Norway N-1364
    348 Vestre Viken, Ringerike Sykehus HF Hønefoss Norway N-3511
    349 Sykehuset Innlandet HF, Kongsvinger Kongsvinger Norway N-2212
    350 Sykehuset Innlandet HF, Avd. Lillehammer Lillehammer Norway N-2629
    351 Volvat Medisinske senter, Oslo Oslo Norway N-0370
    352 Universitetssykehuset Nord-Norge, Tromsø Tromsø Norway N-9038
    353 Univ. Clinic Hosp, Bialystok Bialystok Poland 15276
    354 Private Practice Jacek Kowalczyk, Bytom Bytom Poland 41902
    355 Specialist Out-patient Clinics 'Na Gornej',Cieszyn Cieszyn Poland 43400
    356 Specialistic Cardiology&Hypertension Out-patient Clin,Kielce Kielce Poland 25525
    357 Private Practice of Heart Diseases Malgorzata Lelonek,Lodz Lodz Poland 90727
    358 Allmedica Sp. z.o.o, prac. Nowy Targ Nowy Targ Poland 34400
    359 Private Specialistic Practices, Nysa Nysa Poland 48300
    360 Reg.Hosp, Intern.Med.Ward w/ Intensive Cardiol.Care, Opoczno Opoczno Poland 26300
    361 Szpital Specjalistyczny w Pulawach Pulawy Poland 24-100
    362 Cardiology Out-patient Clinic "Cardio-Plus", Radlin Radlin Poland 44144
    363 Internal Medicine,Cardiol.practiceWanda&Jerzy Sudnik,Sokolka Sokolka Poland 16100
    364 Individual Specialist.Private Practice Dr.W.Krysiak,Szczecin Szczecin Poland
    365 Individual Specialistic Private Practice,Dr.A.Tomasik,Zabrze Zabrze Poland 41800
    366 Slaskie Center Heart Disease SUM,Cardiol.&Electr.Clin.Zabrze Zabrze Poland 41800
    367 Hospital Garcia de Orta, EPE Almada Portugal 2805-267
    368 CHLO, EPE - Hospital de Santa Cruz Carnaxide Portugal 2799-523
    369 Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã Covilhã Portugal 6200-251
    370 Centro Hospitalar Algarve, EPE Faro Portugal 8000-386
    371 CHULN, EPE - Hospital de Santa Maria Lisboa Portugal 1064-035
    372 CHLO, EPE - Hospital S. Francisco Xavier Lisboa Portugal 1449-005
    373 Hospital da Luz Lisboa Portugal 1500-650
    374 CHULN, EPE - Hospital de Santa Maria Lisboa Portugal 1649-035
    375 Centro Hospitalar Universitário São João,EPE Porto Portugal 4202-451
    376 Hospital de Santiago Setúbal Portugal 2900-722
    377 Hospital do Espírito Santo, EPE Évora Portugal 7000-811
    378 CMI Dr. Bogdan Minescu, Braila Braila Romania 810262
    379 Emergency University Hospital, Bucharest Bucharest Romania 050098
    380 ILRO Medical SRL, Bucharest Bucharest Romania 10628
    381 Med.Centre Diagnosis,Treatm&Prev Med.Cardiol.Dept, Bucharest Bucharest Romania 11792
    382 SC Titan Medical SRL, Bucharest Bucharest Romania 21323
    383 Humanitas Medical Center, Bucharest Bucharest Romania 62272
    384 SC Cardiomed SRL, Cluj Napoca Cluj Napoca Romania 400015
    385 SC Cardiomed SRL, Constanta Constanta Romania 900704
    386 S.C Cardiomed S.R.L Craiova Romania 200147
    387 SC Cardiomed SRL, Iasi Iasi Romania 700034
    388 Galenus Medical Center, Targu Mures Targu Mures Romania 540099
    389 Medicorclinics, Timisoara Timisoara Romania 300014
    390 General Hospital Celje Celje Slovenia 3000
    391 Univ. Medical Centre Ljubljana, Dept. of Vascular Diseases Ljubljana Slovenia 1000
    392 Hospital A Coruña A Coruña Spain 15006
    393 Hospital del Mar Barcelona Spain 08003
    394 Hospital Vall d'Hebron Barcelona Spain 08035
    395 Hospital Clínic de Barcelona Barcelona Spain 08036
    396 CAP Passeig de Maragall Barcelona Spain 08041
    397 Hospital Santa Lucía Cartagena (Murcia) Spain 30202
    398 Consultorio Cañaveral Cañaveral (Cáceres) Spain 10820
    399 Hospital La Princesa Cáceres Spain 10820
    400 Hospital Universitario Reina Sofía Córdoba Spain 14004
    401 Hospital Universitario Virgen de la Arrixaca El Palmar - Murcia Spain 30120
    402 Hospital Universitario San Cecilio Granada Spain 18012
    403 Hospital Jerez de la Frontera Jerez De La Frontera - Cádiz Spain 11407
    404 Hospital de Gran Canaria Dr. Negrín Las Palmas de Gran Canaria Spain 35010
    405 Hospital Severo Ochoa Leganes - Madrid Spain 28911
    406 Hospital de León Leon Spain 24071
    407 Hospital de León León Spain 24071
    408 Hospital Universitario Lucus Augusti Lugo Spain 27004
    409 Hospital Ramón y Cajal Madrid Spain 28031
    410 Centro de Salud Jazmin Madrid Spain 28033
    411 Centro de Salud Isla de Oza Madrid Spain 28035
    412 Fundación Jiménez Díaz Madrid Spain 28040
    413 Hospital Regional Universitario de Málaga Madrid Spain 28040
    414 Hospital Universitario 12 de Octubre Madrid Spain 28041
    415 Hospital La Paz Madrid Spain 28046
    416 Hospital Virgen de la Victoria Malaga Spain 29010
    417 Hospital Costa del Sol Marbella . Málaga Spain 29603
    418 Hospital de Son Llàtzer Palma de Mallorca Spain 07198
    419 Complejo Hospitalario de Navarra Pamplona Spain 31009
    420 Hospital General Universitario de Alicante San Juan de Alicante Spain 03550
    421 Hospital Moises Broggi Sant Joan Despi Spain 08970
    422 Hospital Universitario Marqués de Valdecilla Santander Spain 39008
    423 Hospital Clínico de Santiago Santiago de Compostela Spain 15706
    424 Hospital San Juan de Dios Sevilla Spain 41005
    425 Hospital Virgen del Rocío Sevilla Spain 41012
    426 ABP Salud Sevilla Sevilla Spain 41013
    427 Hospital Nuestra Señora de Valme Sevilla Spain 41014
    428 CS Ingeniero Joaquin Benlloch Valencia Spain 46006
    429 Hospital Univ La Fe Valencia Spain 46009
    430 Hospital General Universitario de Valencia Valencia Spain 46014
    431 Hospital Arnau de Vilanova Valencia Spain 46015
    432 Hospital Dr. Peset Valencia Spain 46017
    433 Hospital Meixoeiro Vigo Spain 36200
    434 Hospital Povisa Vigo Spain 36211
    435 Hospital Comarcal Axarquía Vélez-Málaga Spain 29700
    436 Falu lasarett Falun Sweden 791 82
    437 Sahlgrenska Universitetssjukhuset, Östra Göteborg Sweden 416 85
    438 Skånes universitetssjukhus, Malmö Malmö Sweden 205 02
    439 Stockholm Heart Center AB Stockholm Sweden 111 35
    440 Danderyds Sjukhus Stockholm Sweden 182 88
    441 Norrlands Universitetssjukhus Umeå Sweden 901 85
    442 Centrallasarettet, Västerås Västerås Sweden 721 89
    443 Gale Farm Surgery Acomb United Kingdom YO24 3BU
    444 William Harvey Hospital Ashford United Kingdom TN24 0LZ
    445 Axbridge and Wedmore Medical Practice Axbridge United Kingdom BS26 2BJ
    446 Basildon University Hospital Basildon United Kingdom SS16 5NL
    447 North Hampshire Hospital Basingstoke United Kingdom RG24 9NA
    448 Royal United Hospital Bath United Kingdom BA1 3NG
    449 Beehive Surgery Bath United Kingdom BA2 1NH
    450 Birmingham City Hospital Birmingham United Kingdom B18 7QH
    451 Royal Bournemouth and Christchurch Hospital Bournemouth United Kingdom BH7 7DW
    452 Bradford on Avon Health Centre Bradford on Avon United Kingdom BA15 1DQ
    453 Southmead Hospital Bristol United Kingdom BS10 5NB
    454 Bradgate Surgery Bristol United Kingdom BS10 6SP
    455 Bristol Royal Infirmary Bristol United Kingdom BS2 8HW
    456 Clevedon Riverside Group Bristol United Kingdom BS21 6DG
    457 Burbage Surgery Burbage, Hinkley United Kingdom LE10 2SE
    458 West Suffolk Hospital Bury St Edmunds United Kingdom IP33 2QZ
    459 Cumberland Infirmary Carlisle United Kingdom CA2 7HY
    460 Countess of Chester Hospital Chester United Kingdom CH2 1UL
    461 Castle Hill Hopsital Cottingham United Kingdom HU16 5JQ
    462 Pound Hill Medical Group Crawley United Kingdom RH10 7DX
    463 Dorset County Hospital Dorchester United Kingdom DT1 2JY
    464 Russells Hall Hospital Dudley United Kingdom DY1 2HQ
    465 Ninewells Hospital & Medical School Dundee United Kingdom DD1 9SY
    466 University Hospital of North Durham Durham United Kingdom DH1 5TW
    467 Royal Devon and Exeter Hospital Exeter United Kingdom EX2 5DW
    468 Gloucestershire Royal Hospital Gloucester United Kingdom GL1 3NN
    469 The County Hospital Hereford United Kingdom HR1 2ER
    470 Wycombe General Hospital High Wycombe United Kingdom HP11 2TT
    471 Honiton Surgery Group - Seamark Honiton United Kingdom EX14 2NY
    472 Hedon Group Practice Hull United Kingdom HU12 8JD
    473 Airedale General Hospital Keighley United Kingdom BD20 6TD
    474 Westmorland General Hospital Kendal United Kingdom LA9 7RG
    475 Sherbourne Medical Centre Leamington Spa United Kingdom CV32 4RA
    476 Leeds General Infirmary Leeds United Kingdom LS1 3EX
    477 Research Unit, Liverpool Heart and Chest Hospital Liverpool United Kingdom L14 3PE
    478 Aintree University Hospital Liverpool United Kingdom L9 7AL
    479 Altnagelvin Area Hospital Londonderry United Kingdom BT47 6SB
    480 University Hospital Lewisham London United Kingdom SE13 6LH
    481 St George's Hospital London United Kingdom SW17 0RE
    482 Luton and Dunstable University Hospital Luton United Kingdom LU4 0DZ
    483 St Chad's Surgery Midsomer Norton United Kingdom BA3 2UH
    484 Northampton General Hospital Northampton United Kingdom NN1 5BD
    485 Norfolk and Norwich University Hospital Norwich United Kingdom NR4 7UY
    486 George Eliot Hospital Nuneaton United Kingdom CV10 7DJ
    487 Royal Oldham Hospital Oldham United Kingdom OL1 2JH
    488 Perth Royal Infirmary Perth United Kingdom PH1 1NX
    489 Peterborough City Hospital Peterborough United Kingdom PE3 9GZ
    490 Derriford Hospital Plymouth United Kingdom PL6 8DH
    491 Poole Hospital Poole United Kingdom BH15 2JB
    492 Craigavon Area Hospital Portadown, County Atrim United Kingdom BT63 5QQ
    493 Royal Preston Hospital Preston United Kingdom PR2 9HT
    494 Royal Berkshire Hospital Reading United Kingdom RG1 5AN
    495 Alexandra Hospital Redditch United Kingdom B98 7UB
    496 Cape Cornwall Surgery Saint Just, Penzance United Kingdom TR19 7HX
    497 Salisbury District Hospital Salisbury United Kingdom SP2 8BJ
    498 Royal Shrewsbury Hospital Shrewsbury United Kingdom SY3 8XQ
    499 Wexham Park Hospital Slough United Kingdom SL2 4HL
    500 The Conquest Hospital St Leonards on Sea United Kingdom TN37 7RD
    501 County Hospital Stafford United Kingdom ST16 3SA
    502 Branch End Surgery Stocksfield United Kingdom NE43 7LL
    503 Royal Stoke University Hospital Stoke-on-Trent United Kingdom ST4 6QG
    504 Sunderland Royal Hospital Sunderland United Kingdom SR4 7TP
    505 King's Mill Hospital Sutton in Ashfield United Kingdom NG17 4JL
    506 Singleton Hospital Swansea United Kingdom SA2 8QA
    507 Musgrove Park Hospital Taunton United Kingdom TA1 5DA
    508 Torbay Hospital Torquay United Kingdom TQ2 7AA
    509 South Tyneside District Hospital Tyne-and-Wear United Kingdom NE34 0PL
    510 Hillingdon Hospital Uxbridge United Kingdom UB8 3NN
    511 Wansford Surgery Wansford, Peterborough United Kingdom PE8 6PL
    512 The Avenue Surgery Warminster United Kingdom BA12 9AA
    513 Warwick Hospital Warwick United Kingdom CV34 5BJ
    514 Queen Elizabeth II Hospital Welwyn Garden City United Kingdom AL7 4HQ
    515 Westbury Group Practice Westbury United Kingdom BA13 3FQ
    516 Southend General Hospital Westcliffe-on-Sea United Kingdom SS0 0RY
    517 Whitby Group Practice Whitby United Kingdom YO21 1SD
    518 Arrowe Park Hospital Wirral United Kingdom CH49 5PE
    519 New Cross Hospital Wolverhampton United Kingdom WV10 0QP
    520 Jorvik Medical Practice York United Kingdom YO1 7NP
    521 York Medical Group York United Kingdom YO24 4HD
    522 The York Hospital York United Kingdom YO31 8HE
    523 MyHealth, Strensall Health Care Centre York United Kingdom YO32 5UA

    Sponsors and Collaborators

    • Boehringer Ingelheim

    Investigators

    • Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Boehringer Ingelheim
    ClinicalTrials.gov Identifier:
    NCT01671007
    Other Study ID Numbers:
    • 1160.136
    First Posted:
    Aug 23, 2012
    Last Update Posted:
    Dec 31, 2020
    Last Verified:
    Dec 1, 2020
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    Participant Flow

    Recruitment Details This study investigated characteristics of patients with non-valvular atrial fibrillation influencing the choice of antithrombotic treatment for the prevention of stroke, and the safety and effectiveness of dabigatran versus Vitamin K Antagonist for up to 3-year follow-up period.
    Pre-assignment Detail All subjects were screened for eligibility prior to participation in the study. Subjects attended a participating site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
    Arm/Group Title Dabigatran Etexilate - Baseline Vitamin K Antagonist (VKA) - Baseline Rivaroxaban - Baseline Apixaban - Baseline Edoxaban - Baseline Acetylsalicylic Acid (ASA) - Baseline Antiplts Other Than ASA - Baseline No Treatment - Baseline Combinations With Oral Anticoagulants - Baseline
    Arm/Group Description Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Rivaroxaban at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Apixaban at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Edoxaban at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Acetylsalicylic acid (ASA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Antiplts other than Acetylsalicylic acid (ASA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed no treatment at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed the treatments with combinations with oral anticoagulants at baseline were included in this group. This group of patients were not included in the safety analysis as no specific treatment can be defined. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
    Period Title: Overall Study
    STARTED 2089 2834 2033 2214 180 513 80 526 2
    All Eligible 2066 2758 2008 2197 180 507 79 507 2
    COMPLETED 1768 2183 1667 1846 155 401 59 394 2
    NOT COMPLETED 321 651 366 368 25 112 21 132 0

    Baseline Characteristics

    Arm/Group Title Dabigatran Etexilate - Baseline Vitamin K Antagonist (VKA) - Baseline Rivaroxaban - Baseline Apixaban - Baseline Edoxaban - Baseline Acetylsalicylic Acid (ASA) - Baseline Antiplts Other Than ASA - Baseline No Treatment - Baseline Combinations With Oral Anticoagulants - Baseline Total
    Arm/Group Description Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Rivaroxaban at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Apixaban at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Edoxaban at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Acetylsalicylic acid (ASA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Antiplts other than Acetylsalicylic acid (ASA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed no treatment at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed the treatments with combinations with oral anticoagulants at baseline were included in this group. This group of patients were not included in the safety analysis as no specific treatment can be defined. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Total of all reporting groups
    Overall Participants 2066 2758 2008 2197 180 507 79 507 2 10304
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    71.3
    (9.4)
    72.8
    (9.5)
    71.1
    (10.1)
    73.3
    (9.8)
    73.3
    (9.2)
    70.5
    (12.4)
    74.2
    (11.1)
    68.7
    (12.5)
    71.5
    (0.7)
    72.0
    (10.1)
    Sex: Female, Male (Count of Participants)
    Female
    942
    45.6%
    1252
    45.4%
    894
    44.5%
    990
    45.1%
    86
    47.8%
    234
    46.2%
    25
    31.6%
    246
    48.5%
    1
    50%
    4670
    45.3%
    Male
    1124
    54.4%
    1506
    54.6%
    1114
    55.5%
    1207
    54.9%
    94
    52.2%
    273
    53.8%
    54
    68.4%
    261
    51.5%
    1
    50%
    5634
    54.7%
    Race/Ethnicity, Customized (Count of Participants)
    American Indian or Alaska Native
    5
    0.2%
    14
    0.5%
    0
    0%
    1
    0%
    0
    0%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    21
    0.2%
    Asian
    4
    0.2%
    4
    0.1%
    7
    0.3%
    7
    0.3%
    0
    0%
    2
    0.4%
    0
    0%
    1
    0.2%
    0
    0%
    25
    0.2%
    Black/African American
    4
    0.2%
    6
    0.2%
    9
    0.4%
    9
    0.4%
    1
    0.6%
    1
    0.2%
    1
    1.3%
    0
    0%
    0
    0%
    31
    0.3%
    Native Hawaiian/Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    White
    1792
    86.7%
    2526
    91.6%
    1735
    86.4%
    1835
    83.5%
    178
    98.9%
    430
    84.8%
    75
    94.9%
    482
    95.1%
    2
    100%
    9055
    87.9%
    Other
    7
    0.3%
    9
    0.3%
    4
    0.2%
    6
    0.3%
    1
    0.6%
    2
    0.4%
    0
    0%
    2
    0.4%
    0
    0%
    31
    0.3%
    Missing
    254
    12.3%
    199
    7.2%
    253
    12.6%
    339
    15.4%
    0
    0%
    71
    14%
    3
    3.8%
    22
    4.3%
    0
    0%
    1141
    11.1%

    Outcome Measures

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

    Outcome Measure Data

    Analysis Population Description
    Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
    Arm/Group Title Dabigatran Etexilate - Baseline Vitamin K Antagonist (VKA) - Baseline
    Arm/Group Description Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
    Measure Participants 1946 2509
    Number (95% Confidence Interval) [Events per 100 person-years]
    2.30
    3.02
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate - Baseline, Vitamin K Antagonist (VKA) - Baseline
    Comments A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.83
    Confidence Interval (2-Sided) 95%
    0.64 to 1.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).
    2. Primary Outcome
    Title Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death)
    Description Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
    Time Frame From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

    Outcome Measure Data

    Analysis Population Description
    Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
    Arm/Group Title Dabigatran Etexilate - Baseline Vitamin K Antagonist (VKA) - Baseline
    Arm/Group Description Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
    Measure Participants 1946 2509
    Number (95% Confidence Interval) [Events per 100 person-years]
    1.91
    2.36
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate - Baseline, Vitamin K Antagonist (VKA) - Baseline
    Comments A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.94
    Confidence Interval (2-Sided) 95%
    0.70 to 1.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).
    3. Primary Outcome
    Title Incidence Rate of Stroke or Systemic Embolism
    Description Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
    Time Frame From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

    Outcome Measure Data

    Analysis Population Description
    Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
    Arm/Group Title Dabigatran Etexilate - Baseline Vitamin K Antagonist (VKA) - Baseline
    Arm/Group Description Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
    Measure Participants 1946 2509
    Number (95% Confidence Interval) [Events per 100 person-years]
    0.69
    1.01
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate - Baseline, Vitamin K Antagonist (VKA) - Baseline
    Comments A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.67
    Confidence Interval (2-Sided) 95%
    0.43 to 1.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).
    4. Primary Outcome
    Title Incidence Rate of Stroke
    Description Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.
    Time Frame From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

    Outcome Measure Data

    Analysis Population Description
    Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
    Arm/Group Title Dabigatran Etexilate - Baseline Vitamin K Antagonist (VKA) - Baseline
    Arm/Group Description Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
    Measure Participants 1946 2509
    Number (95% Confidence Interval) [Events per 100 person-years]
    0.64
    0.96
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate - Baseline, Vitamin K Antagonist (VKA) - Baseline
    Comments A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.68
    Confidence Interval (2-Sided) 95%
    0.43 to 1.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).
    5. Primary Outcome
    Title Incidence Rate of Transient Ischaemic Attack (TIA)
    Description Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
    Time Frame From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

    Outcome Measure Data

    Analysis Population Description
    Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
    Arm/Group Title Dabigatran Etexilate - Baseline Vitamin K Antagonist (VKA) - Baseline
    Arm/Group Description Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
    Measure Participants 1946 2509
    Number (95% Confidence Interval) [Events per 100 person-years]
    0.30
    0.26
    6. Primary Outcome
    Title Incidence Rate of Systemic Embolism (SEE)
    Description Incidence rate of systemic embolism (SEE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
    Time Frame From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

    Outcome Measure Data

    Analysis Population Description
    Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
    Arm/Group Title Dabigatran Etexilate - Baseline Vitamin K Antagonist (VKA) - Baseline
    Arm/Group Description Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
    Measure Participants 1946 2509
    Number (95% Confidence Interval) [Events per 100 person-years]
    0.07
    0.06
    7. Primary Outcome
    Title Incidence Rate of Pulmonary Embolism (PE)
    Description Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
    Time Frame From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

    Outcome Measure Data

    Analysis Population Description
    Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
    Arm/Group Title Dabigatran Etexilate - Baseline Vitamin K Antagonist (VKA) - Baseline
    Arm/Group Description Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
    Measure Participants 1946 2509
    Number (95% Confidence Interval) [Events per 100 person-years]
    0.09
    0.06
    8. Primary Outcome
    Title Incidence Rate of Major Bleeding Events
    Description Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.
    Time Frame From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

    Outcome Measure Data

    Analysis Population Description
    Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
    Arm/Group Title Dabigatran Etexilate - Baseline Vitamin K Antagonist (VKA) - Baseline
    Arm/Group Description Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
    Measure Participants 1946 2509
    Number (95% Confidence Interval) [Events per 100 person-years]
    0.73
    1.42
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate - Baseline, Vitamin K Antagonist (VKA) - Baseline
    Comments A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, abnormal kidney function, concomitant antiplatelets use and concomitant use of drugs related to bleeding.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.58
    Confidence Interval (2-Sided) 95%
    0.38 to 0.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).
    9. Primary Outcome
    Title Incidence Rate of Life-threatening Bleeding Events
    Description Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.
    Time Frame From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

    Outcome Measure Data

    Analysis Population Description
    Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
    Arm/Group Title Dabigatran Etexilate - Baseline Vitamin K Antagonist (VKA) - Baseline
    Arm/Group Description Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
    Measure Participants 1946 2509
    Number (95% Confidence Interval) [Events per 100 person-years]
    0.50
    1.04
    10. Primary Outcome
    Title Incidence Rate of Vascular Death
    Description Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
    Time Frame From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

    Outcome Measure Data

    Analysis Population Description
    Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
    Arm/Group Title Dabigatran Etexilate - Baseline Vitamin K Antagonist (VKA) - Baseline
    Arm/Group Description Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
    Measure Participants 1946 2509
    Number (95% Confidence Interval) [Events per 100 person-years]
    0.76
    1.00
    11. Primary Outcome
    Title Incidence Rate of Myocardial Infarction
    Description Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
    Time Frame From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

    Outcome Measure Data

    Analysis Population Description
    Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
    Arm/Group Title Dabigatran Etexilate - Baseline Vitamin K Antagonist (VKA) - Baseline
    Arm/Group Description Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
    Measure Participants 1946 2509
    Number (95% Confidence Interval) [Events per 100 person-years]
    0.34
    0.45
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate - Baseline, Vitamin K Antagonist (VKA) - Baseline
    Comments A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, concomitant antiplatelets use, concomitant use of drugs related to bleeding, hypertension, and diabetes.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.95
    Confidence Interval (2-Sided) 95%
    0.49 to 1.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).
    12. Primary Outcome
    Title Incidence Rate of All-cause Death
    Description Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
    Time Frame From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

    Outcome Measure Data

    Analysis Population Description
    Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
    Arm/Group Title Dabigatran Etexilate - Baseline Vitamin K Antagonist (VKA) - Baseline
    Arm/Group Description Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study. Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
    Measure Participants 1946 2509
    Number (95% Confidence Interval) [Events per 100 person-years]
    2.08
    3.27
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate - Baseline, Vitamin K Antagonist (VKA) - Baseline
    Comments A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.78
    Confidence Interval (2-Sided) 95%
    0.60 to 1.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).

    Adverse Events

    Time Frame From baseline visit until study completion or discontinuation, up to 3 years of follow-up.
    Adverse Event Reporting Description Enrolled and treated: All patients entered in the electronic data capture system who signed the informed consent and treated with at least once with the study treatments. Patients who were prescribed the combinations of oral anticoagulants at enrollment were excluded as no specific treatment can be defined for this group. For patients from the 'No treatment-initial' group, only their adverse events that happened when receiving certain treatment were reported in the respective treatment group.
    Arm/Group Title Dabigatran Etexilate - at Least Once During the Study Vitamin K Antagonist (VKA) - at Least Once During the Study Rivaroxaban - at Least Once During the Study Apixaban - at Least Once During the Study Edoxaban - at Least Once During the Study Acetylsalicylic Acid (ASA) - at Least Once During the Study Antiplts Other Than ASA - at Least Once During the Study
    Arm/Group Description All patients received at least once dabigatran etexilate during the study were included in the group. Adverse events which happened when the patients received dabigatran etexilate were reported in this group. Patients can take any Antithrombotic treatments during the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive. All patients received at least once Vitamin K Antagonist (VKA) during the study were included in the group. Adverse events which happened when the patients received Vitamin K Antagonist (VKA) were reported in this group. Patients can take any Antithrombotic treatments during the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive. All patients received at least once Rivaroxaban during the study were included in the group. Adverse events which happened when the patients received Rivaroxaban were reported in this group. Patients can take any Antithrombotic treatments during the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive. All patients received at least once Apixaban during the study were included in the group. Adverse events which happened when the patients received Apixaban were reported in this group. Patients can take any Antithrombotic treatments during the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive. All patients received at least once Edoxaban during the study were included in the group. Adverse events which happened when the patients received Edoxaban were reported in this group. Patients can take any Antithrombotic treatments during the study. Adverse events were reported in the treatment group a patient actually received when the adverse event happened. Hence, the treatment groups in the adverse events section are not mutually exclusive. All patients received at least once Acetylsalicylic acid (ASA) during the study were included in the group. Adverse events which happened when the patients received Acetylsalicylic acid (ASA) were reported in this group. Patients can take any Antithrombotic treatments during the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive. All patients received at least once Antiplts other than Acetylsalicylic acid (ASA) during the study were included in the group. Adverse events which happened when the patients received Antiplts other than ASA were reported in this group. Patients can take any Antithrombotic treatments during the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.
    All Cause Mortality
    Dabigatran Etexilate - at Least Once During the Study Vitamin K Antagonist (VKA) - at Least Once During the Study Rivaroxaban - at Least Once During the Study Apixaban - at Least Once During the Study Edoxaban - at Least Once During the Study Acetylsalicylic Acid (ASA) - at Least Once During the Study Antiplts Other Than ASA - at Least Once During the Study
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 116/2385 (4.9%) 264/3258 (8.1%) 166/2576 (6.4%) 207/2934 (7.1%) 17/368 (4.6%) 141/1940 (7.3%) 33/427 (7.7%)
    Serious Adverse Events
    Dabigatran Etexilate - at Least Once During the Study Vitamin K Antagonist (VKA) - at Least Once During the Study Rivaroxaban - at Least Once During the Study Apixaban - at Least Once During the Study Edoxaban - at Least Once During the Study Acetylsalicylic Acid (ASA) - at Least Once During the Study Antiplts Other Than ASA - at Least Once During the Study
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 79/2385 (3.3%) 157/3258 (4.8%) 92/2576 (3.6%) 99/2934 (3.4%) 10/368 (2.7%) 70/1940 (3.6%) 14/427 (3.3%)
    Blood and lymphatic system disorders
    Anaemia 4/2385 (0.2%) 7/3258 (0.2%) 7/2576 (0.3%) 11/2934 (0.4%) 1/368 (0.3%) 6/1940 (0.3%) 0/427 (0%)
    Blood loss anaemia 2/2385 (0.1%) 3/3258 (0.1%) 2/2576 (0.1%) 0/2934 (0%) 0/368 (0%) 2/1940 (0.1%) 0/427 (0%)
    Eosinophilia 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Hypochromic anaemia 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Iron deficiency anaemia 0/2385 (0%) 1/3258 (0%) 1/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Microcytic anaemia 0/2385 (0%) 0/3258 (0%) 1/2576 (0%) 1/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Splenic haematoma 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Thrombocytopenia 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Cardiac disorders
    Atrial fibrillation 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Atrial thrombosis 0/2385 (0%) 1/3258 (0%) 1/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Bradycardia 0/2385 (0%) 2/3258 (0.1%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Cardiac arrest 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Cardiac failure 2/2385 (0.1%) 4/3258 (0.1%) 0/2576 (0%) 2/2934 (0.1%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Cardiac failure congestive 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Cardiac tamponade 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Cardiac ventricular thrombosis 0/2385 (0%) 0/3258 (0%) 1/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Hypertensive cardiomyopathy 0/2385 (0%) 0/3258 (0%) 1/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Mitral valve incompetence 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Myocardial infarction 2/2385 (0.1%) 2/3258 (0.1%) 1/2576 (0%) 0/2934 (0%) 0/368 (0%) 2/1940 (0.1%) 0/427 (0%)
    Ear and labyrinth disorders
    Vertigo 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Eye disorders
    Eye haemorrhage 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 2/2934 (0.1%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Retinal artery embolism 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Gastrointestinal disorders
    Abdominal pain 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Acute abdomen 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Anal haemorrhage 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 2/2934 (0.1%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Barrett's oesophagus 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Colitis 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Colitis ischaemic 0/2385 (0%) 0/3258 (0%) 1/2576 (0%) 1/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Diarrhoea 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Diarrhoea haemorrhagic 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Discoloured vomit 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Diverticulum intestinal 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 1/2934 (0%) 1/368 (0.3%) 0/1940 (0%) 0/427 (0%)
    Duodenal ulcer haemorrhage 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Dyspepsia 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Gastric haemorrhage 2/2385 (0.1%) 1/3258 (0%) 1/2576 (0%) 2/2934 (0.1%) 0/368 (0%) 2/1940 (0.1%) 0/427 (0%)
    Gastric ulcer 1/2385 (0%) 0/3258 (0%) 2/2576 (0.1%) 0/2934 (0%) 0/368 (0%) 2/1940 (0.1%) 0/427 (0%)
    Gastric ulcer haemorrhage 1/2385 (0%) 0/3258 (0%) 1/2576 (0%) 0/2934 (0%) 1/368 (0.3%) 0/1940 (0%) 0/427 (0%)
    Gastritis 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Gastroduodenal ulcer 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Gastrointestinal disorder 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Gastrointestinal haemorrhage 8/2385 (0.3%) 10/3258 (0.3%) 14/2576 (0.5%) 6/2934 (0.2%) 2/368 (0.5%) 12/1940 (0.6%) 1/427 (0.2%)
    Gastrooesophageal reflux disease 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Haematemesis 0/2385 (0%) 2/3258 (0.1%) 2/2576 (0.1%) 1/2934 (0%) 0/368 (0%) 2/1940 (0.1%) 0/427 (0%)
    Haematochezia 2/2385 (0.1%) 0/3258 (0%) 1/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Haemorrhoidal haemorrhage 1/2385 (0%) 0/3258 (0%) 1/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Hiatus hernia 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Intestinal ischaemia 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Intra-abdominal haemorrhage 1/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Large intestine perforation 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Lower gastrointestinal haemorrhage 8/2385 (0.3%) 6/3258 (0.2%) 4/2576 (0.2%) 1/2934 (0%) 1/368 (0.3%) 3/1940 (0.2%) 3/427 (0.7%)
    Mallory-Weiss syndrome 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Melaena 0/2385 (0%) 0/3258 (0%) 3/2576 (0.1%) 1/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Mesenteric haemorrhage 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Nausea 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Oesophageal ulcer haemorrhage 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Peptic ulcer 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Peritoneal haemorrhage 1/2385 (0%) 0/3258 (0%) 1/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Rectal haemorrhage 5/2385 (0.2%) 2/3258 (0.1%) 4/2576 (0.2%) 1/2934 (0%) 1/368 (0.3%) 1/1940 (0.1%) 0/427 (0%)
    Retroperitoneal haemorrhage 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Small intestinal haemorrhage 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Upper gastrointestinal haemorrhage 4/2385 (0.2%) 12/3258 (0.4%) 7/2576 (0.3%) 5/2934 (0.2%) 0/368 (0%) 2/1940 (0.1%) 3/427 (0.7%)
    Vomiting 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Vomiting projectile 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    General disorders
    Asthenia 0/2385 (0%) 0/3258 (0%) 1/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Death 0/2385 (0%) 0/3258 (0%) 2/2576 (0.1%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 2/427 (0.5%)
    Medical device site haematoma 0/2385 (0%) 0/3258 (0%) 1/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Multiple organ dysfunction syndrome 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Non-cardiac chest pain 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Puncture site haemorrhage 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Sudden death 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Suprapubic pain 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Vessel puncture site haematoma 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Hepatobiliary disorders
    Cholecystitis 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Hepatic failure 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Infections and infestations
    Bronchitis 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Cystitis 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Diverticulitis intestinal haemorrhagic 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Empyema 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Gastroenteritis 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Pneumonia 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Urinary tract infection 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Urosepsis 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Injury, poisoning and procedural complications
    Anaemia postoperative 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Contusion 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Extradural haematoma 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Fall 1/2385 (0%) 4/3258 (0.1%) 0/2576 (0%) 2/2934 (0.1%) 0/368 (0%) 2/1940 (0.1%) 0/427 (0%)
    Head injury 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Hip fracture 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Overdose 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Post procedural haematoma 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Post procedural haematuria 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 1/427 (0.2%)
    Post procedural haemorrhage 1/2385 (0%) 2/3258 (0.1%) 2/2576 (0.1%) 0/2934 (0%) 0/368 (0%) 2/1940 (0.1%) 1/427 (0.2%)
    Procedural haemorrhage 0/2385 (0%) 2/3258 (0.1%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Skin laceration 0/2385 (0%) 0/3258 (0%) 2/2576 (0.1%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Splenic injury 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Subcutaneous haematoma 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Subdural haematoma 3/2385 (0.1%) 5/3258 (0.2%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 2/1940 (0.1%) 0/427 (0%)
    Subdural haemorrhage 1/2385 (0%) 3/3258 (0.1%) 1/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Toxicity to various agents 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Traumatic haematoma 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Traumatic haemothorax 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Traumatic renal injury 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Investigations
    Bleeding time prolonged 0/2385 (0%) 0/3258 (0%) 1/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    International normalised ratio increased 0/2385 (0%) 5/3258 (0.2%) 1/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Liver function test increased 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Occult blood 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Transaminases increased 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Musculoskeletal and connective tissue disorders
    Groin pain 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Haemarthrosis 1/2385 (0%) 1/3258 (0%) 2/2576 (0.1%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Haematoma muscle 0/2385 (0%) 2/3258 (0.1%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Muscle haemorrhage 0/2385 (0%) 2/3258 (0.1%) 1/2576 (0%) 2/2934 (0.1%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Osteoarthritis 0/2385 (0%) 0/3258 (0%) 1/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastrointestinal carcinoma 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Lung neoplasm malignant 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Myelodysplastic syndrome 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Rectal cancer 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Bladder cancer 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 1/427 (0.2%)
    Nervous system disorders
    Ataxia 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Basal ganglia haemorrhage 0/2385 (0%) 1/3258 (0%) 1/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Brain injury 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Cerebellar haemorrhage 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Cerebellar infarction 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Cerebellar stroke 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Cerebral haematoma 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Cerebral haemorrhage 0/2385 (0%) 8/3258 (0.2%) 2/2576 (0.1%) 3/2934 (0.1%) 1/368 (0.3%) 2/1940 (0.1%) 0/427 (0%)
    Cerebral infarction 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Cerebrovascular accident 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Embolic stroke 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 1/368 (0.3%) 0/1940 (0%) 0/427 (0%)
    Haemorrhage intracranial 1/2385 (0%) 4/3258 (0.1%) 2/2576 (0.1%) 1/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Haemorrhagic stroke 1/2385 (0%) 3/3258 (0.1%) 4/2576 (0.2%) 3/2934 (0.1%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Haemorrhagic transformation stroke 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Headache 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Intracranial haematoma 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Ischaemic cerebral infarction 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 1/427 (0.2%)
    Ischaemic stroke 7/2385 (0.3%) 5/3258 (0.2%) 3/2576 (0.1%) 4/2934 (0.1%) 0/368 (0%) 3/1940 (0.2%) 2/427 (0.5%)
    Subarachnoid haemorrhage 0/2385 (0%) 2/3258 (0.1%) 2/2576 (0.1%) 2/2934 (0.1%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Syncope 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Transient ischaemic attack 4/2385 (0.2%) 6/3258 (0.2%) 3/2576 (0.1%) 4/2934 (0.1%) 0/368 (0%) 3/1940 (0.2%) 0/427 (0%)
    Vascular dementia 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Psychiatric disorders
    Anxiety 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Renal and urinary disorders
    Acute kidney injury 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Haematuria 3/2385 (0.1%) 8/3258 (0.2%) 6/2576 (0.2%) 5/2934 (0.2%) 0/368 (0%) 2/1940 (0.1%) 0/427 (0%)
    Haemorrhage urinary tract 0/2385 (0%) 0/3258 (0%) 1/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Hypertensive nephropathy 0/2385 (0%) 0/3258 (0%) 1/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Nephrotic syndrome 0/2385 (0%) 0/3258 (0%) 1/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Renal haematoma 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Renal infarct 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Renal injury 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Ureterolithiasis 0/2385 (0%) 0/3258 (0%) 1/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Urinary retention 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Urogenital haemorrhage 1/2385 (0%) 4/3258 (0.1%) 1/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Reproductive system and breast disorders
    Breast haematoma 0/2385 (0%) 0/3258 (0%) 1/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Uterine haemorrhage 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 1/368 (0.3%) 0/1940 (0%) 0/427 (0%)
    Vaginal haemorrhage 1/2385 (0%) 0/3258 (0%) 1/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Epistaxis 3/2385 (0.1%) 16/3258 (0.5%) 6/2576 (0.2%) 7/2934 (0.2%) 1/368 (0.3%) 4/1940 (0.2%) 0/427 (0%)
    Haemoptysis 1/2385 (0%) 2/3258 (0.1%) 1/2576 (0%) 2/2934 (0.1%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Haemothorax 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Pleural effusion 0/2385 (0%) 1/3258 (0%) 1/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Pulmonary embolism 1/2385 (0%) 2/3258 (0.1%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Respiratory tract haemorrhage 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Skin and subcutaneous tissue disorders
    Erythema 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Haemorrhage subcutaneous 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Skin ulcer 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 1/427 (0.2%)
    Vascular disorders
    Aortic aneurysm rupture 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Arterial haemorrhage 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Embolism arterial 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Haematoma 1/2385 (0%) 8/3258 (0.2%) 1/2576 (0%) 4/2934 (0.1%) 0/368 (0%) 1/1940 (0.1%) 1/427 (0.2%)
    Haemorrhage 1/2385 (0%) 4/3258 (0.1%) 1/2576 (0%) 3/2934 (0.1%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Ischaemia 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 1/1940 (0.1%) 0/427 (0%)
    Peripheral embolism 1/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Peripheral ischaemia 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Shock haemorrhagic 1/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Subgaleal haematoma 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Venous haemorrhage 0/2385 (0%) 1/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Deep vein thrombosis 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 1/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)
    Other (Not Including Serious) Adverse Events
    Dabigatran Etexilate - at Least Once During the Study Vitamin K Antagonist (VKA) - at Least Once During the Study Rivaroxaban - at Least Once During the Study Apixaban - at Least Once During the Study Edoxaban - at Least Once During the Study Acetylsalicylic Acid (ASA) - at Least Once During the Study Antiplts Other Than ASA - at Least Once During the Study
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/2385 (0%) 0/3258 (0%) 0/2576 (0%) 0/2934 (0%) 0/368 (0%) 0/1940 (0%) 0/427 (0%)

    Limitations/Caveats

    The data used in this analysis included only patients participating in Phase III of this study. Patients participating in Phase II were reported and analyzed in the 1160.129 phase II report, and were not planned to be reported separately for 1160.136.

    More Information

    Certain Agreements

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

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

    Results Point of Contact

    Name/Title Boehringer Ingelheim Call Center
    Organization Boehringer Ingelheim
    Phone 1-800-243-0127
    Email clintriage.rdg@boehringer-ingelheim.com
    Responsible Party:
    Boehringer Ingelheim
    ClinicalTrials.gov Identifier:
    NCT01671007
    Other Study ID Numbers:
    • 1160.136
    First Posted:
    Aug 23, 2012
    Last Update Posted:
    Dec 31, 2020
    Last Verified:
    Dec 1, 2020