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RE-MEDY: Secondary Prevention of Venous Thrombo Embolism (VTE).

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00329238
Collaborator
(none)
2,867
Enrollment
275
Locations
2
Arms
10.4
Patients Per Site

Study Details

Study Description

Brief Summary

The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
2867 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Phase III, Randomised, Multicenter, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for the Secondary Prevention of Venous Thromboembolism.
Study Start Date :
May 1, 2006
Actual Primary Completion Date :
Oct 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dabigatran

Patient to receive 1 capsule containing dabigatran 150 mg twice daily plus placebo tablets for warfarin as decided by sham INR measurements

Drug: Dabigatran
Dabigatran 150 mg BID (twice daily)
Active Comparator: Warfarin (INR of 2.0-3.0)

Patient to receive warfarin tablets to target INR 2.0-3.0 plus placebo capsules for dabigatran twice daily

Drug: Warfarin
Warfarin dosed individually to maintain INR 2.0-3.0

Outcome Measures

Primary Outcome Measures

  1. Composite of Recurrent VTE or VTE Death at 36 Months [36 months]

    Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.

  2. Composite of Recurrent VTE or VTE Death at 18 Months [18 months]

    Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.

Secondary Outcome Measures

  1. Composite of Recurrent VTE or All Cause Death at 36 Months [36 months]

    Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.

  2. Composite of Recurrent VTE or All Cause Death at 18 Months [18 months]

    Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.

  3. Deep Vein Thrombosis (DVT) at 36 Months [36 months]

    Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.

  4. DVT at 18 Months [18 months]

    Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.

  5. Symptomatic Pulmonary Embolism (PE) at 36 Months [36 months]

    Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.

  6. Symptomatic Pulmonary Embolism (PE) at 18 Months [18 months]

    Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.

  7. Deaths Related to VTE at 36 Months [36 months]

    Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.

  8. Deaths Related to VTE at 18 Months [18 months]

    Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.

  9. Deaths of All Causes at 36 Months [36 months]

    Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.

  10. Deaths of All Causes at 18 Months [18 months]

    Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.

  11. Number of Participants With Bleeding Events [first intake of study drug until 6 days following last intake of study drug]

    MBE (major bleeding event) if it fulfilled at least one of the following criteria Fatal bleeding Symptomatic bleeding in a critical area or organ. Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells. Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria Spontaneous skin haematoma ≥25 cm2 Spontaneous nose bleed >5 min duration Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting >24 h Spontaneous rectal bleeding Gingival bleeding >5 min Bleeding leading to hospitalisation or requiring surgical treatment Bleeding leading to a transfusion of <2 units of whole blood or red cells Any other bleeding event considered clinically relevant by the investigator

  12. Laboratory Analysis [18 months + 30 days follow up]

    Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: ≥3 x ULN (AST, ALT), ≥2 x ULN (AP), and ≥2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality).

  13. Number of Participants With Definite Acute Coronary Syndrome (ACS) [day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination]

    All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner.

Eligibility Criteria

Criteria

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

Inclusion_Criteria

  • Acute symptomatic deep vein thrombosis (DVT)

  • Pulmonary embolism (PE) 3-12 months prior to screening, which has been documented by objective testing

Exclusion criteria:

Exclusion_Criteria

  • Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more weeks during the 3-12 months of treatment for the prior VTE.

  • Patients who in the investigators judgement are perceived as having an excessive risk of bleeding Elevated Aspartate aminotransferase (AST) or Alanine tranminase (ALT) > 2x ULN

  • Severe renal impairment (estimated creatinine clearance <= 30 ml/min)

Contacts and Locations

Locations

Site City State Country Postal Code
1 1160.47.01035 Boehringer Ingelheim Investigational Site Mobile Alabama United States
2 1160.47.01056 Boehringer Ingelheim Investigational Site Hartford Connecticut United States
3 1160.47.01044 Boehringer Ingelheim Investigational Site Clearwater Florida United States
4 1160.47.01019 Boehringer Ingelheim Investigational Site Augusta Georgia United States
5 1160.47.01008 Boehringer Ingelheim Investigational Site Decatur Georgia United States
6 1160.47.01014 Boehringer Ingelheim Investigational Site Baltimore Maryland United States
7 1160.47.01018 Boehringer Ingelheim Investigational Site Roxbury Crossing Massachusetts United States
8 1160.47.01023 Boehringer Ingelheim Investigational Site Detroit Michigan United States
9 1160.47.01009 Boehringer Ingelheim Investigational Site St. Louis Park Minnesota United States
10 1160.47.01031 Boehringer Ingelheim Investigational Site Lebanon New Hampshire United States
11 1160.47.01036 Boehringer Ingelheim Investigational Site Albuquerque New Mexico United States
12 1160.47.01027 Boehringer Ingelheim Investigational Site Chapel Hill North Carolina United States
13 1160.47.01039 Boehringer Ingelheim Investigational Site Winston-Salem North Carolina United States
14 1160.47.01030 Boehringer Ingelheim Investigational Site Grand Forks North Dakota United States
15 1160.47.01013 Boehringer Ingelheim Investigational Site Toledo Ohio United States
16 1160.47.01052 Boehringer Ingelheim Investigational Site Altoona Pennsylvania United States
17 1160.47.01055 Boehringer Ingelheim Investigational Site Summerville South Carolina United States
18 1160.47.01017 Boehringer Ingelheim Investigational Site Richmond Virginia United States
19 1160.47.54017 Boehringer Ingelheim Investigational Site Adrogué Argentina
20 1160.47.54015 Boehringer Ingelheim Investigational Site Bahía Blanca Argentina
21 1160.47.54001 Boehringer Ingelheim Investigational Site Capital Federal Argentina
22 1160.47.54003 Boehringer Ingelheim Investigational Site Capital Federal Argentina
23 1160.47.54005 Boehringer Ingelheim Investigational Site Capital Federal Argentina
24 1160.47.54006 Boehringer Ingelheim Investigational Site Capital Federal Argentina
25 1160.47.54007 Boehringer Ingelheim Investigational Site Capital Federal Argentina
26 1160.47.54010 Boehringer Ingelheim Investigational Site Capital Federal Argentina
27 1160.47.54016 Boehringer Ingelheim Investigational Site La Plata Argentina
28 1160.47.54014 Boehringer Ingelheim Investigational Site Mar del Plata Argentina
29 1160.47.54013 Boehringer Ingelheim Investigational Site Quilmes Argentina
30 1160.47.54011 Boehringer Ingelheim Investigational Site Rosario Argentina
31 1160.47.54018 Boehringer Ingelheim Investigational Site Salta Argentina
32 1160.47.54012 Boehringer Ingelheim Investigational Site Santa Fe Argentina
33 1160.47.61002 Princess Alexandra Hospital Wooloongabba Queensland Australia
34 1160.47.61004 Boehringer Ingelheim Investigational Site Bedford Park South Australia Australia
35 1160.47.61003 Boehringer Ingelheim Investigational Site Box Hill Victoria Australia
36 1160.47.61001 Boehringer Ingelheim Investigational Site Clayton Victoria Australia
37 1160.47.61006 Boehringer Ingelheim Investigational Site Windsor Victoria Australia
38 1160.47.61005 Boehringer Ingelheim Investigational Site Perth Western Australia Australia
39 1160.47.43001 Boehringer Ingelheim Investigational Site Graz Austria
40 1160.47.43003 Boehringer Ingelheim Investigational Site Innsbruck Austria
41 1160.47.43002 Boehringer Ingelheim Investigational Site Wien Austria
42 1160.47.43004 Boehringer Ingelheim Investigational Site Wien Austria
43 1160.47.32001 Boehringer Ingelheim Investigational Site Bruxelles Belgium
44 1160.47.32002 Boehringer Ingelheim Investigational Site Bruxelles Belgium
45 1160.47.32005 Boehringer Ingelheim Investigational Site Leuven Belgium
46 1160.47.32004 Boehringer Ingelheim Investigational Site Liège Belgium
47 1160.47.55010 Boehringer Ingelheim Investigational Site Brasília Brazil
48 1160.47.55007 Boehringer Ingelheim Investigational Site Campinas - SP Brazil
49 1160.47.55014 Boehringer Ingelheim Investigational Site Curitiba Brazil
50 1160.47.55017 Boehringer Ingelheim Investigational Site Juvene - Paraná - Brazil
51 1160.47.55012 Boehringer Ingelheim Investigational Site pTO aLEGRE Brazil
52 1160.47.55016 Boehringer Ingelheim Investigational Site Rio de Janeiro - RJ Brazil
53 1160.47.55018 Boehringer Ingelheim Investigational Site São Bernardo do Campo Brazil
54 1160.47.55005 Boehringer Ingelheim Investigational Site São José do Rio Preto Brazil
55 1160.47.35910 Boehringer Ingelheim Investigational Site Plovdiv Bulgaria
56 1160.47.35908 Boehringer Ingelheim Investigational Site Rousse Bulgaria
57 1160.47.35901 Boehringer Ingelheim Investigational Site Sofia Bulgaria
58 1160.47.35903 Boehringer Ingelheim Investigational Site Sofia Bulgaria
59 1160.47.35904 Boehringer Ingelheim Investigational Site Sofia Bulgaria
60 1160.47.35906 Boehringer Ingelheim Investigational Site Sofia Bulgaria
61 1160.47.35907 Boehringer Ingelheim Investigational Site Sofia Bulgaria
62 1160.47.35905 Boehringer Ingelheim Investigational Site Varna Bulgaria
63 1160.47.02006 Boehringer Ingelheim Investigational Site Edmonton Alberta Canada
64 1160.47.02013 Boehringer Ingelheim Investigational Site Edmonton Alberta Canada
65 1160.47.02021 Boehringer Ingelheim Investigational Site Victoria British Columbia Canada
66 1160.47.02004 Boehringer Ingelheim Investigational Site Saint Johns New Brunswick Canada
67 1160.47.02001 Boehringer Ingelheim Investigational Site Halifax Nova Scotia Canada
68 1160.47.02002 Boehringer Ingelheim Investigational Site Hamilton Ontario Canada
69 1160.47.02005 Boehringer Ingelheim Investigational Site Hamilton Ontario Canada
70 1160.47.02010 Boehringer Ingelheim Investigational Site Hamilton Ontario Canada
71 1160.47.02022 Boehringer Ingelheim Investigational Site Hamilton Ontario Canada
72 1160.47.02015 Boehringer Ingelheim Investigational Site Ottawa Ontario Canada
73 1160.47.02019 Boehringer Ingelheim Investigational Site Toronto Ontario Canada
74 1160.47.02008 Boehringer Ingelheim Investigational Site Montreal Quebec Canada
75 1160.47.02009 Boehringer Ingelheim Investigational Site Montreal Quebec Canada
76 1160.47.02014 Boehringer Ingelheim Investigational Site Montreal Quebec Canada
77 1160.47.02017 Boehringer Ingelheim Investigational Site Montreal Quebec Canada
78 1160.47.86001 Boehringer Ingelheim Investigational Site Beijing China
79 1160.47.86015 Boehringer Ingelheim Investigational Site Beijing China
80 1160.47.86014 Boehringer Ingelheim Investigational Site Chengdu China
81 1160.47.86012 Boehringer Ingelheim Investigational Site Guangzhou China
82 1160.47.86009 Boehringer Ingelheim Investigational Site Hangzhou China
83 1160.47.86010 Boehringer Ingelheim Investigational Site Hangzhou China
84 1160.47.86013 Boehringer Ingelheim Investigational Site Nanjing China
85 1160.47.86002 Boehringer Ingelheim Investigational Site Shanghai China
86 1160.47.86003 Boehringer Ingelheim Investigational Site Shanghai China
87 1160.47.86004 Boehringer Ingelheim Investigational Site Shanghai China
88 1160.47.86005 Boehringer Ingelheim Investigational Site Shanghai China
89 1160.47.86006 Boehringer Ingelheim Investigational Site Shanghai China
90 1160.47.86007 Boehringer Ingelheim Investigational Site Shanghai China
91 1160.47.86016 Boehringer Ingelheim Investigational Site Shanghai China
92 1160.47.86011 Boehringer Ingelheim Investigational Site Shijiazhuang China
93 1160.47.42001 Boehringer Ingelheim Investigational Site Brno Czech Republic
94 1160.47.42002 Boehringer Ingelheim Investigational Site Hradec Kralove Czech Republic
95 1160.47.42011 Boehringer Ingelheim Investigational Site Hranice Czech Republic
96 1160.47.42012 Boehringer Ingelheim Investigational Site Liberec Czech Republic
97 1160.47.42015 Boehringer Ingelheim Investigational Site Novy Jicin Czech Republic
98 1160.47.42005 Boehringer Ingelheim Investigational Site Ostrava-Vitkovice Czech Republic
99 1160.47.42004 Boehringer Ingelheim Investigational Site Praha 2 Czech Republic
100 1160.47.42014 Boehringer Ingelheim Investigational Site Tabor Czech Republic
101 1160.47.42010 Boehringer Ingelheim Investigational Site Usti nad Labem Czech Republic
102 1160.47.42007 Boehringer Ingelheim Investigational Site Zlin Czech Republic
103 1160.47.45008 Boehringer Ingelheim Investigational Site Esbjerg Denmark
104 1160.47.45009 Boehringer Ingelheim Investigational Site Holbæk Denmark
105 1160.47.45002 Boehringer Ingelheim Investigational Site Kolding Denmark
106 1160.47.45004 Boehringer Ingelheim Investigational Site København NV Denmark
107 1160.47.45007 Boehringer Ingelheim Investigational Site København S Denmark
108 1160.47.45006 Boehringer Ingelheim Investigational Site Slagelse Denmark
109 1160.47.35804 Boehringer Ingelheim Investigational Site Espoo Finland
110 1160.47.35801 Boehringer Ingelheim Investigational Site Helsinki Finland
111 1160.47.35802 Boehringer Ingelheim Investigational Site Jyväskylä Finland
112 1160.47.35805 Boehringer Ingelheim Investigational Site Kuopio Finland
113 1160.47.35803 Boehringer Ingelheim Investigational Site Tampere Finland
114 1160.47.3301A Boehringer Ingelheim Investigational Site Brest Cedex France
115 1160.47.3301B Boehringer Ingelheim Investigational Site Brest Cedex France
116 1160.47.3301C Boehringer Ingelheim Investigational Site Brest Cedex France
117 1160.47.3301D Boehringer Ingelheim Investigational Site Brest Cedex France
118 1160.47.3301E Boehringer Ingelheim Investigational Site Brest Cedex France
119 1160.47.3301F Boehringer Ingelheim Investigational Site Brest Cedex France
120 1160.47.3301H Boehringer Ingelheim Investigational Site Brest Cedex France
121 1160.47.3301I Boehringer Ingelheim Investigational Site Brest Cedex France
122 1160.47.3302A Boehringer Ingelheim Investigational Site Lorient France
123 1160.47.3303A Boehringer Ingelheim Investigational Site St Etienne Cedex 2 France
124 1160.47.3303B Boehringer Ingelheim Investigational Site St Etienne Cedex 2 France
125 1160.47.3303C Boehringer Ingelheim Investigational Site St Etienne Cedex 2 France
126 1160.47.3303D Boehringer Ingelheim Investigational Site St Etienne Cedex 2 France
127 1160.47.3308A Boehringer Ingelheim Investigational Site Vandoeuvre les Nancy France
128 1160.47.49017 Boehringer Ingelheim Investigational Site Dresden Germany
129 1160.47.49018 Boehringer Ingelheim Investigational Site Dresden Germany
130 1160.47.49003 Boehringer Ingelheim Investigational Site Köln Germany
131 1160.47.49005 Boehringer Ingelheim Investigational Site Mannheim Germany
132 1160.47.49006 Boehringer Ingelheim Investigational Site Mannheim Germany
133 1160.47.49007 Boehringer Ingelheim Investigational Site München Germany
134 1160.47.49008 Boehringer Ingelheim Investigational Site München Germany
135 1160.47.49009 Boehringer Ingelheim Investigational Site Püttlingen Germany
136 1160.47.30001 Boehringer Ingelheim Investigational Site Athens Greece
137 1160.47.30006 Boehringer Ingelheim Investigational Site Athens Greece
138 1160.47.30007 Boehringer Ingelheim Investigational Site Athens Greece
139 1160.47.30009 Boehringer Ingelheim Investigational Site Athens Greece
140 1160.47.36001 Boehringer Ingelheim Investigational Site Budapest Hungary
141 1160.47.36006 Boehringer Ingelheim Investigational Site Budapest Hungary
142 1160.47.36007 Boehringer Ingelheim Investigational Site Budapest Hungary
143 1160.47.36002 Boehringer Ingelheim Investigational Site Debrecen Hungary
144 1160.47.36012 Boehringer Ingelheim Investigational Site Gyula Hungary
145 1160.47.36004 Boehringer Ingelheim Investigational Site Miskolc Hungary
146 1160.47.36003 Boehringer Ingelheim Investigational Site Pecs Hungary
147 1160.47.36011 Boehringer Ingelheim Investigational Site Szombathely Hungary
148 1160.47.36010 Boehringer Ingelheim Investigational Site Székesfehérvár Hungary
149 1160.47.91002 Boehringer Ingelheim Investigational Site Ahmedabad India
150 1160.47.91011 Boehringer Ingelheim Investigational Site Bangalore India
151 1160.47.91015 Boehringer Ingelheim Investigational Site Bangalore India
152 1160.47.91012 Boehringer Ingelheim Investigational Site Chennai India
153 1160.47.91017 Boehringer Ingelheim Investigational Site Chennai India
154 1160.47.91009 Boehringer Ingelheim Investigational Site Madurai India
155 1160.47.91007 Boehringer Ingelheim Investigational Site Mysore India
156 1160.47.91003 Boehringer Ingelheim Investigational Site New Delhi India
157 1160.47.91006 Boehringer Ingelheim Investigational Site new Delhi India
158 1160.47.91010 Boehringer Ingelheim Investigational Site New Delhi India
159 1160.47.91001 Boehringer Ingelheim Investigational Site Pune India
160 1160.47.91005 Boehringer Ingelheim Investigational Site Pune India
161 1160.47.91008 Boehringer Ingelheim Investigational Site Pune India
162 1160.47.91014 Boehringer Ingelheim Investigational Site Trivandrum India
163 1160.47.91004 Boehringer Ingelheim Investigational Site Vadodara India
164 1160.47.97202 Boehringer Ingelheim Investigational Site Afula Israel
165 1160.47.97207 Boehringer Ingelheim Investigational Site Ashkelon Israel
166 1160.47.97211 Boehringer Ingelheim Investigational Site Haifa Israel
167 1160.47.97203 Boehringer Ingelheim Investigational Site Holon Israel
168 1160.47.97205 Boehringer Ingelheim Investigational Site Kfar Saba Israel
169 1160.47.97206 Boehringer Ingelheim Investigational Site Petach Tikva Israel
170 1160.47.97208 Boehringer Ingelheim Investigational Site Rehovot Israel
171 1160.47.97210 Boehringer Ingelheim Investigational Site Tel Aviv Israel
172 1160.47.97204 Boehringer Ingelheim Investigational Site Tel Hashomer Israel
173 1160.47.97201 Boehringer Ingelheim Investigational Site Zerifin Israel
174 1160.47.39003 Boehringer Ingelheim Investigational Site Bologna Italy
175 1160.47.39004 Boehringer Ingelheim Investigational Site Cremona Italy
176 1160.47.39006 Boehringer Ingelheim Investigational Site Genova Italy
177 1160.47.39008 Boehringer Ingelheim Investigational Site Milano Italy
178 1160.47.39007 Boehringer Ingelheim Investigational Site Reggio Emilia Italy
179 1160.47.39009 Boehringer Ingelheim Investigational Site Udine Italy
180 1160.47.39005 Boehringer Ingelheim Investigational Site Vittorio Veneto Italy
181 1160.47.52036 Boehringer Ingelheim Investigational Site Chihuahua Mexico
182 1160.47.52039 Boehringer Ingelheim Investigational Site Culiacan Mexico
183 1160.47.52030 Boehringer Ingelheim Investigational Site Guadalajara, Jal. Mexico
184 1160.47.52027 Boehringer Ingelheim Investigational Site Monterrey Mexico
185 1160.47.52034 Boehringer Ingelheim Investigational Site San Luis Potosí Mexico
186 1160.47.31001 Boehringer Ingelheim Investigational Site Amersfoort Netherlands
187 1160.47.31006 Boehringer Ingelheim Investigational Site Amsterdam Netherlands
188 1160.47.31007 Boehringer Ingelheim Investigational Site Amsterdam Netherlands
189 1160.47.31010 Boehringer Ingelheim Investigational Site Den Bosch Netherlands
190 1160.47.31014 Boehringer Ingelheim Investigational Site Heerlen Netherlands
191 1160.47.31005 Boehringer Ingelheim Investigational Site Maastricht Netherlands
192 1160.47.31004 Boehringer Ingelheim Investigational Site Rotterdam Netherlands
193 1160.47.31009 Boehringer Ingelheim Investigational Site Rotterdam Netherlands
194 1160.47.64004 Boehringer Ingelheim Investigational Site Christchurch New Zealand
195 1160.47.64003 Boehringer Ingelheim Investigational Site Grafton New Zealand
196 1160.47.64002 Boehringer Ingelheim Investigational Site Otahuhu New Zealand
197 1160.47.64001 Boehringer Ingelheim Investigational Site Takapuna Auckland 9 New Zealand
198 1160.47.47001 Boehringer Ingelheim Investigational Site Oslo Norway
199 1160.47.47004 Boehringer Ingelheim Investigational Site Oslo Norway
200 1160.47.47003 Boehringer Ingelheim Investigational Site Rud Norway
201 1160.47.47005 Boehringer Ingelheim Investigational Site Trondheim Norway
202 1160.47.48004 Boehringer Ingelheim Investigational Site Kielce Poland
203 1160.47.48005 Boehringer Ingelheim Investigational Site Krakow Poland
204 1160.47.48007 Boehringer Ingelheim Investigational Site Krakow Poland
205 1160.47.48003 Boehringer Ingelheim Investigational Site Poznan Poland
206 1160.47.48006 Boehringer Ingelheim Investigational Site Warsaw Poland
207 1160.47.35104 Boehringer Ingelheim Investigational Site Almada Portugal
208 1160.47.35109 Boehringer Ingelheim Investigational Site Coimbra Portugal
209 1160.47.35107 Boehringer Ingelheim Investigational Site Covilhã Portugal
210 1160.47.35101 Boehringer Ingelheim Investigational Site Lisboa Portugal
211 1160.47.35102 Boehringer Ingelheim Investigational Site Lisboa Portugal
212 1160.47.35105 Boehringer Ingelheim Investigational Site Lisboa Portugal
213 1160.47.07022 Boehringer Ingelheim Investigational Site Belgorod Russian Federation
214 1160.47.07011 Boehringer Ingelheim Investigational Site Chelyabinsk Russian Federation
215 1160.47.07021 Boehringer Ingelheim Investigational Site Chelyabinsk Russian Federation
216 1160.47.07007 Boehringer Ingelheim Investigational Site Ekaterinburg Russian Federation
217 1160.47.07016 Boehringer Ingelheim Investigational Site Krasnodar Russian Federation
218 1160.47.07004 Boehringer Ingelheim Investigational Site Kursk Russian Federation
219 1160.47.07010 Boehringer Ingelheim Investigational Site Novosibirsk Russian Federation
220 1160.47.07020 Boehringer Ingelheim Investigational Site Omsk Russian Federation
221 1160.47.07018 Boehringer Ingelheim Investigational Site Pskov Russian Federation
222 1160.47.07009 Boehringer Ingelheim Investigational Site Rostov-na-Donu Russian Federation
223 1160.47.07023 Boehringer Ingelheim Investigational Site Rostov-na-Donu Russian Federation
224 1160.47.07024 Boehringer Ingelheim Investigational Site Rostov-na-Donu Russian Federation
225 1160.47.07025 Boehringer Ingelheim Investigational Site Rostov-na-Donu Russian Federation
226 1160.47.07001 Boehringer Ingelheim Investigational Site St. Petersburg Russian Federation
227 1160.47.07002 Boehringer Ingelheim Investigational Site St. Petersburg Russian Federation
228 1160.47.07017 Boehringer Ingelheim Investigational Site St. Petersburg Russian Federation
229 1160.47.07019 Boehringer Ingelheim Investigational Site Tyumen Russian Federation
230 1160.47.07014 Boehringer Ingelheim Investigational Site Ufa Russian Federation
231 1160.47.07005 Boehringer Ingelheim Investigational Site Yaroslavl Russian Federation
232 1160.47.07006 Boehringer Ingelheim Investigational Site Yaroslavl Russian Federation
233 1160.47.42107 Boehringer Ingelheim Investigational Site Banska Bystrica Slovakia
234 1160.47.42106 Boehringer Ingelheim Investigational Site Lucenec Slovakia
235 1160.47.42102 Boehringer Ingelheim Investigational Site Nitra Slovakia
236 1160.47.42103 Boehringer Ingelheim Investigational Site Nove Zamky Slovakia
237 1160.47.42104 Boehringer Ingelheim Investigational Site Zilina Slovakia
238 1160.47.27001 Boehringer Ingelheim Investigational Site Johannesburg South Africa
239 1160.47.27002 Boehringer Ingelheim Investigational Site Johannesburg South Africa
240 1160.47.27006 Boehringer Ingelheim Investigational Site Johannesburg South Africa
241 1160.47.27007 Pretoria South Africa
242 1160.47.27003 Boehringer Ingelheim Investigational Site Randburg South Africa
243 1160.47.27005 Boehringer Ingelheim Investigational Site Roodepoort South Africa
244 1160.47.34006 Boehringer Ingelheim Investigational Site Alicante Spain
245 1160.47.34012 Boehringer Ingelheim Investigational Site Badalona (Barcelona) Spain
246 1160.47.34001 Boehringer Ingelheim Investigational Site Barcelona Spain
247 1160.47.34002 Boehringer Ingelheim Investigational Site Barcelona Spain
248 1160.47.34007 Boehringer Ingelheim Investigational Site Cartagena. Murcia Spain
249 1160.47.34003 Boehringer Ingelheim Investigational Site Cuenca Spain
250 1160.47.34009 Boehringer Ingelheim Investigational Site Madrid Spain
251 1160.47.34004 Boehringer Ingelheim Investigational Site Santander Spain
252 1160.47.34011 Boehringer Ingelheim Investigational Site Valencia Spain
253 1160.47.46002 Boehringer Ingelheim Investigational Site Göteborg Sweden
254 1160.47.46006 Boehringer Ingelheim Investigational Site Jönköping Sweden
255 1160.47.46001 Boehringer Ingelheim Investigational Site Stockholm Sweden
256 1160.47.46007 Boehringer Ingelheim Investigational Site Stockholm Sweden
257 1160.47.46008 Boehringer Ingelheim Investigational Site Stockholm Sweden
258 1160.47.46005 Boehringer Ingelheim Investigational Site Sundsvall Sweden
259 1160.47.46003 Boehringer Ingelheim Investigational Site Uppsala Sweden
260 1160.47.90003 Boehringer Ingelheim Investigational Site Ankara Turkey
261 1160.47.90004 Boehringer Ingelheim Investigational Site Ankara Turkey
262 1160.47.90005 Boehringer Ingelheim Investigational Site Ankara Turkey
263 1160.47.90001 Boehringer Ingelheim Investigational Site Istanbul Turkey
264 1160.47.90002 Boehringer Ingelheim Investigational Site Istanbul Turkey
265 1160.47.90007 Boehringer Ingelheim Investigational Site Istanbul Turkey
266 1160.47.90006 Boehringer Ingelheim Investigational Site Izmir Turkey
267 1160.47.38002 Boehringer Ingelheim Investigational Site Kharkov Ukraine
268 1160.47.38006 Boehringer Ingelheim Investigational Site Kiev Ukraine
269 1160.47.38005 Boehringer Ingelheim Investigational Site Vinnitsa Ukraine
270 1160.47.38003 Boehringer Ingelheim Investigational Site Zaporozhye Ukraine
271 1160.47.44005 Boehringer Ingelheim Investigational Site Headington, Oxford United Kingdom
272 1160.47.44009 Boehringer Ingelheim Investigational Site London United Kingdom
273 1160.47.44011 Boehringer Ingelheim Investigational Site London United Kingdom
274 1160.47.44006 Boehringer Ingelheim Investigational Site Newcastle upon Tyne United Kingdom
275 1160.47.44012 Boehringer Ingelheim Investigational Site Sheffield United Kingdom

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00329238
Other Study ID Numbers:
  • 1160.47
  • 2005-002536-94
First Posted:
May 24, 2006
Last Update Posted:
May 19, 2014
Last Verified:
Dec 1, 2013
Additional relevant MeSH terms:
Thromboembolism
Warfarin
Dabigatran

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Dabigatran Warfarin
Arm/Group Description 150 mg twice daily, total daily dose 300 mg Target International Normalized Ratio (INR) of 2.0 to 3.0
Period Title: Overall Study
STARTED 1430 1426
COMPLETED 1154 1145
NOT COMPLETED 276 281

Baseline Characteristics

Arm/Group Title Dabigatran Warfarin Total
Arm/Group Description 150 mg twice daily, total daily dose 300 mg Target International Normalized Ratio (INR) of 2.0 to 3.0 Total of all reporting groups
Overall Participants 1430 1426 2856
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
55.38
(14.99)
53.90
(15.34)
54.64
(15.18)
Age, Customized (participants) [Number]
>=18 to <40 years
237
16.6%
269
18.9%
506
17.7%
>=40 to <50 years
250
17.5%
291
20.4%
541
18.9%
>=50 to <65 years
500
35%
459
32.2%
959
33.6%
>=65 to <75 years
303
21.2%
288
20.2%
591
20.7%
>= 75 years
140
9.8%
119
8.3%
259
9.1%
Sex: Female, Male (Count of Participants)
Female
559
39.1%
555
38.9%
1114
39%
Male
871
60.9%
871
61.1%
1742
61%
Race/Ethnicity, Customized (Number) [Number]
Not Hispanic/Latino
1325
92.7%
1317
92.4%
2642
92.5%
Hispanic/Latino
105
7.3%
109
7.6%
214
7.5%
Race/Ethnicity, Customized (Number) [Number]
White
1288
90.1%
1284
90%
2572
90.1%
Black
29
2%
28
2%
57
2%
Asian
113
7.9%
114
8%
227
7.9%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]
171.55
(9.73)
171.95
(10.08)
171.75
(9.90)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]
86.09
(19.26)
85.95
(18.87)
86.02
(19.06)
Weight category (Number) [Number]
< 50 kg
10
0.7%
5
0.4%
15
0.5%
>= 50 to < 100 kg
1120
78.3%
1117
78.3%
2237
78.3%
>= 100 kg
299
20.9%
300
21%
599
21%
Missing
1
0.1%
4
0.3%
5
0.2%
Body Mass Index (BMI) (kg/square meter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/square meter]
29.15
(5.65)
29.01
(5.75)
29.08
(5.70)
Body Mass Index (BMI) category (Number) [Number]
<25 kg/square meter
315
22%
334
23.4%
649
22.7%
>=25 to <30 kg/square meter
571
39.9%
584
41%
1155
40.4%
>=30 to <35 kg/square meter
356
24.9%
330
23.1%
686
24%
>= 35 kg/square meter
186
13%
174
12.2%
360
12.6%
Missing
2
0.1%
4
0.3%
6
0.2%
Smoking history (Number) [Number]
Non-smoker
814
56.9%
829
58.1%
1643
57.5%
Ex-smoker
393
27.5%
366
25.7%
759
26.6%
Current smoker
223
15.6%
231
16.2%
454
15.9%
Serum creatinine clearance (mL/min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mL/min]
104.2
(38.6)
106.6
(37.9)
105.4
(38.3)
Serum creatinine clearance category (Number) [Number]
>=0 to <30 mL/min
0
0%
4
0.3%
4
0.1%
>=30 to <50 mL/min
59
4.1%
45
3.2%
104
3.6%
>=50 to <80 mL/min
328
22.9%
289
20.3%
617
21.6%
>= 80 mL/min
1031
72.1%
1072
75.2%
2103
73.6%
Missing
12
0.8%
16
1.1%
28
1%

Outcome Measures

1. Primary Outcome
Title Composite of Recurrent VTE or VTE Death at 36 Months
Description Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.
Time Frame 36 months

Outcome Measure Data

Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Arm/Group Description 150 mg twice daily, total daily dose 300 mg Target International Normalized Ratio (INR) of 2.0 to 3.0
Measure Participants 1430 1426
Number of participants with event
26
1.8%
18
1.3%
Number of participants with no event
1404
98.2%
1408
98.7%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments
Type of Statistical Test Non-Inferiority or Equivalence
Comments Comparisons between treatment groups were performed using a Cox regression analysis with treatment and baseline stratification factor in the model.
Statistical Test of Hypothesis p-Value 0.0137
Comments p-value for non-inferiority. The non-inferiority margin for the hazard ratio was chosen to be 2.85.
Method Regression, Cox
Comments HR within cohort estimated by Cox regr. with treatment and baseline stratific. factor. Overall HR calc. by pooling with inverse variance weighting.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.44
Confidence Interval () 95%
0.78 to 2.64
Parameter Dispersion Type:
Value:
Estimation Comments HR for time to first recurrent VTE or VTE death.
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.2424
Comments p-value for superiority. If non-inferiority could be established for HR and for the risk difference, the upper bound of the 95% CI for the hazard ratio was then compared with 1 to evaluate the superiority claim of dabigatran over warfarin.
Method Regression, Cox
Comments
2. Primary Outcome
Title Composite of Recurrent VTE or VTE Death at 18 Months
Description Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.
Time Frame 18 months

Outcome Measure Data

Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Arm/Group Description 150 mg twice daily, total daily dose 300 mg Target International Normalized Ratio (INR) of 2.0 to 3.0
Measure Participants 1430 1426
Number of participants with event
22
1.5%
17
1.2%
Number of participants with no event
1408
98.5%
1409
98.8%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments
Type of Statistical Test Non-Inferiority or Equivalence
Comments Comparisons between treatment groups were performed using a Cox regression analysis with treatment and baseline stratification factor in the model.
Statistical Test of Hypothesis p-Value <0.0001
Comments p-value for non-inferiority. The non-inferiority margin for the risk difference was chosen to be 2.80.
Method Regression, Cox
Comments Risk difference for time to first recurrent VTE/VTE death is calculated based on weighted KM estimates across the cohorts via meta-analysis approach.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.38
Confidence Interval () 95%
-0.50 to 1.25
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.4013
Comments p-value for superiority. If non-inferiority could be established for HR and for the risk difference, the upper bound of the 95% CI for the risk difference was then compared with 0 to evaluate the superiority claim of dabigatran over warfarin.
Method Kaplan-Meier
Comments
3. Secondary Outcome
Title Composite of Recurrent VTE or All Cause Death at 36 Months
Description Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.
Time Frame 36 months

Outcome Measure Data

Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Arm/Group Description 150 mg twice daily, total daily dose 300 mg Target International Normalized Ratio (INR) of 2.0 to 3.0
Measure Participants 1430 1426
Number of participants with event
42
2.9%
36
2.5%
Number of participants with no event
1388
97.1%
1390
97.5%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.4732
Comments
Method Regression, Cox
Comments Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.18
Confidence Interval () 95%
0.75 to 1.84
Parameter Dispersion Type:
Value:
Estimation Comments HR for time to first centrally adjudicated recurrent VTE or all cause death.
4. Secondary Outcome
Title Composite of Recurrent VTE or All Cause Death at 18 Months
Description Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.
Time Frame 18 months

Outcome Measure Data

Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Arm/Group Description 150 mg twice daily, total daily dose 300 mg Target International Normalized Ratio (INR) of 2.0 to 3.0
Measure Participants 1430 1426
Number of participants with event
36
2.5%
32
2.2%
Number of participants with no event
1394
97.5%
1394
97.8%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Dabigatran versus Warfarin
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.8876
Comments
Method Kaplan-Meier
Comments Risk difference for the time to first centrally adjudicated recurrent VTE or all cause death at month 18.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.09
Confidence Interval () 95%
-1.11 to 1.28
Parameter Dispersion Type:
Value:
Estimation Comments
5. Secondary Outcome
Title Deep Vein Thrombosis (DVT) at 36 Months
Description Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.
Time Frame 36 months

Outcome Measure Data

Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Arm/Group Description 150 mg twice daily, total daily dose 300 mg Target International Normalized Ratio (INR) of 2.0 to 3.0
Measure Participants 1430 1426
Number of participants with event
17
1.2%
13
0.9%
Number of participants with no event
1413
98.8%
1413
99.1%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Dabigatran versus Warfarin
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.4548
Comments
Method Regression, Cox
Comments Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.32
Confidence Interval () 95%
0.64 to 2.71
Parameter Dispersion Type:
Value:
Estimation Comments HR for time to first centrally adjudicated recurrent symptomatic DVT
6. Secondary Outcome
Title DVT at 18 Months
Description Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.
Time Frame 18 months

Outcome Measure Data

Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Arm/Group Description 150 mg twice daily, total daily dose 300 mg Target International Normalized Ratio (INR) of 2.0 to 3.0
Measure Participants 1430 1426
Number of participants with event
15
1%
12
0.8%
Number of participants with no event
1415
99%
1414
99.2%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Dabigatran versus Warfarin
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.6563
Comments
Method Kaplan-Meier
Comments Risk difference for the time to first centrally adjudicated recurrent symptomatic DVT at Month 18.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.19
Confidence Interval () 95%
-0.63 to 1.00
Parameter Dispersion Type:
Value:
Estimation Comments
7. Secondary Outcome
Title Symptomatic Pulmonary Embolism (PE) at 36 Months
Description Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.
Time Frame 36 months

Outcome Measure Data

Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Arm/Group Description 150 mg twice daily, total daily dose 300 mg Target International Normalized Ratio (INR) of 2.0 to 3.0
Measure Participants 1430 1426
Number of participants with event
10
0.7%
5
0.4%
Number of participants with no event
1420
99.3%
1421
99.6%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Dabigatran versus Warfarin
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.1925
Comments
Method Regression, Cox
Comments Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.04
Confidence Interval () 95%
0.70 to 5.98
Parameter Dispersion Type:
Value:
Estimation Comments Hazard ratio for time to first centrally adjudicated recurrent symptomatic PE.
8. Secondary Outcome
Title Symptomatic Pulmonary Embolism (PE) at 18 Months
Description Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.
Time Frame 18 months

Outcome Measure Data

Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Arm/Group Description 150 mg twice daily, total daily dose 300 mg Target International Normalized Ratio (INR) of 2.0 to 3.0
Measure Participants 1430 1426
Number of participants with event
8
0.6%
5
0.4%
Number of participants with no event
1422
99.4%
1421
99.6%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Dabigatran versus Warfarin
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.3723
Comments
Method Kaplan-Meier
Comments
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.26
Confidence Interval () 95%
-0.32 to 0.84
Parameter Dispersion Type:
Value:
Estimation Comments Risk difference for the time to first centrally adjudicated recurrent symptomatic PE at Month 18
9. Secondary Outcome
Title Deaths Related to VTE at 36 Months
Description Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.
Time Frame 36 months

Outcome Measure Data

Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Arm/Group Description 150 mg twice daily, total daily dose 300 mg Target International Normalized Ratio (INR) of 2.0 to 3.0
Measure Participants 1430 1426
Number of participants with event
1
0.1%
1
0.1%
Number of participants with no event
1429
99.9%
1425
99.9%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Dabigatran versus Warfarin
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.9921
Comments
Method Regression, Cox
Comments Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval () 95%
0.06 to 16.22
Parameter Dispersion Type:
Value:
Estimation Comments Hazard ratio for time to deaths related to VTE.
10. Secondary Outcome
Title Deaths Related to VTE at 18 Months
Description Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.
Time Frame 18 months

Outcome Measure Data

Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Arm/Group Description 150 mg twice daily, total daily dose 300 mg Target International Normalized Ratio (INR) of 2.0 to 3.0
Measure Participants 1430 1426
Number of participants with event
1
0.1%
1
0.1%
Number of participants with no event
1429
99.9%
1425
99.9%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Dabigatran versus Warfarin
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.9204
Comments
Method Kaplan-Meier
Comments Risk difference for the time to deaths related to VTE at Month 18.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.01
Confidence Interval () 95%
-0.20 to 0.23
Parameter Dispersion Type:
Value:
Estimation Comments
11. Secondary Outcome
Title Deaths of All Causes at 36 Months
Description Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.
Time Frame 36 months

Outcome Measure Data

Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Arm/Group Description 150 mg twice daily, total daily dose 300 mg Target International Normalized Ratio (INR) of 2.0 to 3.0
Measure Participants 1430 1426
Number of participants with event
17
1.2%
19
1.3%
Number of participants with no event
1413
98.8%
1407
98.7%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Dabigatran versus Warfarin
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.7405
Comments
Method Regression, Cox
Comments Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Confidence Interval () 95%
0.47 to 1.72
Parameter Dispersion Type:
Value:
Estimation Comments Hazard ratio for time to all deaths
12. Secondary Outcome
Title Deaths of All Causes at 18 Months
Description Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.
Time Frame 18 months

Outcome Measure Data

Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Arm/Group Description 150 mg twice daily, total daily dose 300 mg Target International Normalized Ratio (INR) of 2.0 to 3.0
Measure Participants 1430 1426
Number of participants with event
15
1%
16
1.1%
Number of participants with no event
1415
99%
1410
98.9%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Dabigatran versus Warfarin
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.9622
Comments
Method Kaplan-Meier
Comments Risk difference for the time to all deaths at Month 18.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.02
Confidence Interval () 95%
-0.89 to 0.84
Parameter Dispersion Type:
Value:
Estimation Comments
13. Secondary Outcome
Title Number of Participants With Bleeding Events
Description MBE (major bleeding event) if it fulfilled at least one of the following criteria Fatal bleeding Symptomatic bleeding in a critical area or organ. Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells. Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria Spontaneous skin haematoma ≥25 cm2 Spontaneous nose bleed >5 min duration Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting >24 h Spontaneous rectal bleeding Gingival bleeding >5 min Bleeding leading to hospitalisation or requiring surgical treatment Bleeding leading to a transfusion of <2 units of whole blood or red cells Any other bleeding event considered clinically relevant by the investigator
Time Frame first intake of study drug until 6 days following last intake of study drug

Outcome Measure Data

Analysis Population Description
FAS as treated
Arm/Group Title Dabigatran Warfarin
Arm/Group Description 150 mg twice daily, total daily dose 300 mg Target International Normalized Ratio (INR) of 2.0 to 3.0
Measure Participants 1430 1426
patients with MBE
13
0.9%
25
1.8%
patients with MBE and /or CRBE
80
5.6%
145
10.2%
patients with any bleeding event
277
19.4%
373
26.2%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors (including active cancer at baseline and symptomatic PE as qualifying event) and their interaction.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0577
Comments
Method Regression, Cox
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.52
Confidence Interval () 95%
0.27 to 1.02
Parameter Dispersion Type:
Value:
Estimation Comments This is the analysis of the time to the first MBE.
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors (including active cancer at baseline and symptomatic PE as qualifying event) and their interaction.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments
Method Regression, Cox
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.61 to 0.83
Parameter Dispersion Type:
Value:
Estimation Comments This is the analysis of the time to the first occurrence of any bleeding event.
14. Secondary Outcome
Title Laboratory Analysis
Description Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: ≥3 x ULN (AST, ALT), ≥2 x ULN (AP), and ≥2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality).
Time Frame 18 months + 30 days follow up

Outcome Measure Data

Analysis Population Description
FAS as treated
Arm/Group Title Dabigatran Warfarin
Arm/Group Description 150 mg twice daily, total daily dose 300 mg Target International Normalized Ratio (INR) of 2.0 to 3.0
Measure Participants 1411 1402
ALT increase
26
1.8%
30
2.1%
AST increase
23
1.6%
23
1.6%
Alkaline phosphatase
9
0.6%
14
1%
Total bilirubin
9
0.6%
8
0.6%
15. Secondary Outcome
Title Number of Participants With Definite Acute Coronary Syndrome (ACS)
Description All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner.
Time Frame day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination

Outcome Measure Data

Analysis Population Description
FAS as treated
Arm/Group Title Dabigatran Warfarin
Arm/Group Description 150 mg twice daily, total daily dose 300 mg Target International Normalized Ratio (INR) of 2.0 to 3.0
Measure Participants 1430 1415
During intake of study drug, N=1430 , N=1415
12
0.8%
2
0.1%
After stopping study drug, N=1426, N=1400
1
0.1%
5
0.4%

Adverse Events

Time Frame 18-month treatment period
Adverse Event Reporting Description 30-day follow-up period subsequent to the completion of treatment
Arm/Group Title Dabigatran Warfarin Post Dabigatran Post Warfarin
Arm/Group Description 150 mg twice daily, total daily dose 300 mg Target International Normalized Ratio (INR) of 2.0 to 3.0
All Cause Mortality
Dabigatran Warfarin Post Dabigatran Post Warfarin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Dabigatran Warfarin Post Dabigatran Post Warfarin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 227/1430 (15.9%) 224/1426 (15.7%) 33/1395 (2.4%) 41/1384 (3%)
Blood and lymphatic system disorders
Anaemia 3/1430 (0.2%) 3/1426 (0.2%) 0/1395 (0%) 0/1384 (0%)
Anaemia megaloblastic 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Haemorrhagic anaemia 0/1430 (0%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Iron deficiency anaemia 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Neutropenia 0/1430 (0%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Splenic infarction 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Cardiac disorders
Acute coronary syndrome 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 1/1384 (0.1%)
Acute left ventricular failure 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Acute myocardial infarction 4/1430 (0.3%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Angina pectoris 2/1430 (0.1%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Angina unstable 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Atrial fibrillation 4/1430 (0.3%) 4/1426 (0.3%) 0/1395 (0%) 0/1384 (0%)
Atrial flutter 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Atrial tachycardia 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Cardiac arrest 2/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Cardiac asthma 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Cardiac failure 1/1430 (0.1%) 0/1426 (0%) 2/1395 (0.1%) 0/1384 (0%)
Cardiac failure chronic 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Cardiac failure congestive 1/1430 (0.1%) 3/1426 (0.2%) 0/1395 (0%) 1/1384 (0.1%)
Cardio-respiratory arrest 1/1430 (0.1%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Cardiogenic shock 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Cardiomegaly 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Cardiomyopathy 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Cardiopulmonary failure 0/1430 (0%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Congestive cardiomyopathy 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Cor pulmonale 0/1430 (0%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Coronary artery disease 2/1430 (0.1%) 1/1426 (0.1%) 1/1395 (0.1%) 0/1384 (0%)
Coronary artery occlusion 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Coronary artery stenosis 3/1430 (0.2%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Left ventricular failure 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Myocardial infarction 6/1430 (0.4%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Myocardial ischaemia 0/1430 (0%) 2/1426 (0.1%) 0/1395 (0%) 1/1384 (0.1%)
Palpitations 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Supraventricular tachycardia 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Tachycardia 0/1430 (0%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Ventricular tachycardia 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Congenital, familial and genetic disorders
Metabolic myopathy 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Vitello-intestinal duct remnant 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Ear and labyrinth disorders
Hypoacusis 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Vertigo 2/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Endocrine disorders
Goitre 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Eye disorders
Cataract 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Diabetic retinopathy 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Diplopia 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Retinal detachment 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Retinal vascular thrombosis 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Trichiasis 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Vitreous haemorrhage 0/1430 (0%) 2/1426 (0.1%) 0/1395 (0%) 1/1384 (0.1%)
Gastrointestinal disorders
Abdominal hernia 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Abdominal hernia obstructive 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Abdominal pain 4/1430 (0.3%) 8/1426 (0.6%) 1/1395 (0.1%) 0/1384 (0%)
Abdominal pain lower 2/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Abdominal pain upper 1/1430 (0.1%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Acute abdomen 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Colitis ischaemic 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Colonic polyp 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Constipation 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Diarrhoea 2/1430 (0.1%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Diverticular perforation 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Diverticulum intestinal haemorrhagic 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Duodenal ulcer 0/1430 (0%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Duodenitis 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Faecal incontinence 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Faecal vomiting 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Gastric polyps 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Gastric ulcer 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Gastritis 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 1/1384 (0.1%)
Gastritis erosive 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Gastrointestinal haemorrhage 1/1430 (0.1%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Gastrointestinal hypomotility 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Gastrointestinal pain 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Gastrooesophageal reflux disease 2/1430 (0.1%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Gingival bleeding 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Hernial eventration 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Hiatus hernia 2/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Ileus 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Inguinal hernia 4/1430 (0.3%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Intestinal obstruction 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Intestinal polyp 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Intestinal strangulation 0/1430 (0%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Large intestine perforation 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Lower gastrointestinal haemorrhage 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Mallory-Weiss syndrome 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Melaena 0/1430 (0%) 3/1426 (0.2%) 0/1395 (0%) 0/1384 (0%)
Mouth ulceration 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Nausea 0/1430 (0%) 0/1426 (0%) 1/1395 (0.1%) 1/1384 (0.1%)
Pancreatitis acute 0/1430 (0%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Pancreatitis chronic 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Pancreatitis relapsing 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Peptic ulcer haemorrhage 0/1430 (0%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Peritoneal haematoma 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Peritoneal haemorrhage 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Peritonitis 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Pneumoperitoneum 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Rectal haemorrhage 4/1430 (0.3%) 2/1426 (0.1%) 0/1395 (0%) 1/1384 (0.1%)
Reflux oesophagitis 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Retroperitoneal haemorrhage 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Small intestinal haemorrhage 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Subileus 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Umbilical hernia 0/1430 (0%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Umbilical hernia, obstructive 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Upper gastrointestinal haemorrhage 1/1430 (0.1%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Vomiting 2/1430 (0.1%) 4/1426 (0.3%) 1/1395 (0.1%) 0/1384 (0%)
General disorders
Adverse drug reaction 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Asthenia 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Chest discomfort 4/1430 (0.3%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Chest pain 4/1430 (0.3%) 9/1426 (0.6%) 0/1395 (0%) 2/1384 (0.1%)
Death 0/1430 (0%) 1/1426 (0.1%) 1/1395 (0.1%) 0/1384 (0%)
Device breakage 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Device occlusion 0/1430 (0%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Diapedesis 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Facial pain 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Fatigue 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
General physical health deterioration 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Hernia 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Hypothermia 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Inflammation 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Mass 0/1430 (0%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Non-cardiac chest pain 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Oedema 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Oedema peripheral 1/1430 (0.1%) 4/1426 (0.3%) 0/1395 (0%) 0/1384 (0%)
Pain 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Pyrexia 1/1430 (0.1%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Sudden death 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Hepatobiliary disorders
Bile duct stone 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Cholangitis 0/1430 (0%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Cholecystitis 1/1430 (0.1%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Cholecystitis acute 3/1430 (0.2%) 1/1426 (0.1%) 0/1395 (0%) 1/1384 (0.1%)
Cholecystitis chronic 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Cholelithiasis 1/1430 (0.1%) 3/1426 (0.2%) 1/1395 (0.1%) 1/1384 (0.1%)
Chronic hepatitis 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Hepatic steatosis 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Jaundice cholestatic 1/1430 (0.1%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Immune system disorders
Hypersensitivity 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Infections and infestations
Abdominal abscess 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Appendicitis 0/1430 (0%) 3/1426 (0.2%) 0/1395 (0%) 0/1384 (0%)
Bacteraemia 0/1430 (0%) 1/1426 (0.1%) 1/1395 (0.1%) 0/1384 (0%)
Bronchiolitis 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 1/1384 (0.1%)
Bronchitis 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Bronchopneumonia 1/1430 (0.1%) 1/1426 (0.1%) 1/1395 (0.1%) 0/1384 (0%)
Cellulitis 3/1430 (0.2%) 5/1426 (0.4%) 1/1395 (0.1%) 0/1384 (0%)
Diverticulitis 2/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 1/1384 (0.1%)
Endometritis 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Erysipelas 3/1430 (0.2%) 3/1426 (0.2%) 0/1395 (0%) 0/1384 (0%)
Gangrene 0/1430 (0%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Gingival abscess 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Gnathostomiasis 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Infected skin ulcer 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Infection 0/1430 (0%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Liver abscess 0/1430 (0%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Lobar pneumonia 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Lower respiratory tract infection 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 1/1384 (0.1%)
Lung infection 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Lymphangitis 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Meningococcal sepsis 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Necrotising fasciitis 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Oral herpes 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Otitis externa 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Pneumonia 6/1430 (0.4%) 5/1426 (0.4%) 0/1395 (0%) 1/1384 (0.1%)
Pneumonia staphylococcal 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Pneumonia viral 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Postoperative wound infection 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Pulpitis dental 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Purulence 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Purulent discharge 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Pyelonephritis 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Rectal abscess 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Respiratory tract infection 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Scrotal abscess 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Sepsis 3/1430 (0.2%) 1/1426 (0.1%) 0/1395 (0%) 3/1384 (0.2%)
Septic shock 0/1430 (0%) 0/1426 (0%) 2/1395 (0.1%) 0/1384 (0%)
Sinusitis 2/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Tooth infection 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Urinary tract infection 2/1430 (0.1%) 3/1426 (0.2%) 1/1395 (0.1%) 0/1384 (0%)
Urosepsis 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Viral infection 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Wound infection 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Injury, poisoning and procedural complications
Accidental drug intake by child 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Acetabulum fracture 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Ankle fracture 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Chemical peritonitis 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Chest injury 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Concussion 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Contusion 0/1430 (0%) 2/1426 (0.1%) 1/1395 (0.1%) 0/1384 (0%)
Drug exposure during pregnancy 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Eye injury 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Face injury 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Fall 4/1430 (0.3%) 4/1426 (0.3%) 1/1395 (0.1%) 2/1384 (0.1%)
Femoral neck fracture 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Femur fracture 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 1/1384 (0.1%)
Fibula fracture 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Foot fracture 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Hand fracture 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Hip fracture 2/1430 (0.1%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Humerus fracture 0/1430 (0%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Incisional hernia 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Injury 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Joint injury 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Limb traumatic amputation 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Lower limb fracture 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Meniscus lesion 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Overdose 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Periorbital haematoma 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Perirenal haematoma 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Post procedural haemorrhage 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Radius fracture 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Renal haematoma 0/1430 (0%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Road traffic accident 2/1430 (0.1%) 4/1426 (0.3%) 0/1395 (0%) 0/1384 (0%)
Skin laceration 0/1430 (0%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Spinal cord injury 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Splenic rupture 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Stab wound 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Subdural haematoma 0/1430 (0%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Subdural haemorrhage 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Tibia fracture 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Upper limb fracture 0/1430 (0%) 3/1426 (0.2%) 0/1395 (0%) 0/1384 (0%)
Vascular graft occlusion 1/1430 (0.1%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Wound 0/1430 (0%) 3/1426 (0.2%) 0/1395 (0%) 0/1384 (0%)
Wound dehiscence 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Wound haemorrhage 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Wound secretion 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Investigations
Alanine aminotransferase increased 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Arteriogram coronary normal 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Aspartate aminotransferase increased 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Blood creatinine increased 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Body temperature increased 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Coagulation time prolonged 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Gamma-glutamyltransferase increased 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Hepatic enzyme increased 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
International normalised ratio increased 1/1430 (0.1%) 4/1426 (0.3%) 0/1395 (0%) 0/1384 (0%)
Weight decreased 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Metabolism and nutrition disorders
Dehydration 2/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Diabetes mellitus 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Diabetes mellitus inadequate control 2/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Hyperglycaemia 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Hyperlipidaemia 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Hypoproteinaemia 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Musculoskeletal and connective tissue disorders
Amyotrophy 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Arthralgia 2/1430 (0.1%) 4/1426 (0.3%) 0/1395 (0%) 0/1384 (0%)
Arthritis 1/1430 (0.1%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Back pain 2/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Bone pain 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Costochondritis 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Foot deformity 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Haemarthrosis 0/1430 (0%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Intervertebral disc protrusion 2/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Muscle haemorrhage 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Muscular weakness 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Musculoskeletal chest pain 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Myalgia 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Neck pain 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Osteoarthritis 2/1430 (0.1%) 4/1426 (0.3%) 1/1395 (0.1%) 0/1384 (0%)
Pain in extremity 2/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Pain in jaw 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Periostitis 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Pseudarthrosis 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 1/1384 (0.1%)
Rheumatoid arthritis 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Rotator cuff syndrome 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Sacroiliitis 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Sensation of heaviness 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Spinal column stenosis 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Spinal disorder 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Spinal osteoarthritis 2/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Spondylitis 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Adenocarcinoma pancreas 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
B-cell lymphoma 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Basal cell carcinoma 3/1430 (0.2%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Bile duct cancer 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Bladder cancer 2/1430 (0.1%) 2/1426 (0.1%) 2/1395 (0.1%) 0/1384 (0%)
Bone cancer metastatic 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Brain neoplasm 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Breast cancer 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 2/1384 (0.1%)
Cervix carcinoma 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Chondrosarcoma 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Colon cancer 2/1430 (0.1%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Colon neoplasm 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Endometrial cancer 0/1430 (0%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Gastric cancer 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Gastric neoplasm 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Gastrointestinal cancer metastatic 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Hepatic neoplasm 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Hepatic neoplasm malignant 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Large intestine carcinoma 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Laryngeal cancer 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Liposarcoma 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Lung cancer metastatic 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Lung neoplasm malignant 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Lung squamous cell carcinoma stage unspecified 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Malignant ascites 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Malignant melanoma 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Malignant neoplasm progression 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Metastases to bladder 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Metastases to bone 2/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Metastases to central nervous system 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Metastases to liver 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Metastases to lung 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Metastases to lymph nodes 0/1430 (0%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Metastases to meninges 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Metastases to peritoneum 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Metastases to retroperitoneum 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Metastasis 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Morton's neuroma 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Myelodysplastic syndrome 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Neoplasm 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Neoplasm malignant 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Non-Hodgkin's lymphoma 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Oesophageal carcinoma 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Omentum neoplasm 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Ovarian cancer 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Ovarian cancer recurrent 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Pancreatic carcinoma 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Pancreatic carcinoma metastatic 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Pancreatic neoplasm 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Penis carcinoma 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Prostate cancer 5/1430 (0.3%) 7/1426 (0.5%) 1/1395 (0.1%) 0/1384 (0%)
Prostate cancer metastatic 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Prostatic adenoma 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Rectal cancer 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Renal cancer 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Sarcoma 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Skin cancer 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Squamous cell carcinoma 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Thyroid cancer 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Transitional cell carcinoma 0/1430 (0%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Tumour invasion 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Uterine leiomyoma 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Nervous system disorders
Brain stem stroke 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Carotid artery dissection 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Carpal tunnel syndrome 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Cerebral haematoma 0/1430 (0%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Cerebral haemorrhage 2/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Cerebral infarction 0/1430 (0%) 1/1426 (0.1%) 1/1395 (0.1%) 0/1384 (0%)
Cerebral thrombosis 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Cerebrovascular accident 2/1430 (0.1%) 2/1426 (0.1%) 0/1395 (0%) 1/1384 (0.1%)
Cognitive disorder 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Coma 0/1430 (0%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Convulsion 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Diabetic encephalopathy 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Diabetic neuropathy 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Dizziness 2/1430 (0.1%) 3/1426 (0.2%) 0/1395 (0%) 0/1384 (0%)
Epilepsy 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Facial neuralgia 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Guillain-Barre syndrome 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Headache 2/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Hemiparesis 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Hypoxic-ischaemic encephalopathy 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Intercostal neuralgia 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Ischaemic stroke 3/1430 (0.2%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Lacunar infarction 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Loss of consciousness 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Motor dysfunction 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Multiple sclerosis 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Parkinson's disease 1/1430 (0.1%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Presyncope 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Sciatica 2/1430 (0.1%) 0/1426 (0%) 3/1395 (0.2%) 0/1384 (0%)
Sensory disturbance 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Sensory loss 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Syncope 4/1430 (0.3%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Transient ischaemic attack 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
VIIth nerve paralysis 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Vascular encephalopathy 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Eclampsia 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Ectopic pregnancy 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Psychiatric disorders
Bipolar disorder 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 1/1384 (0.1%)
Completed suicide 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Depression 3/1430 (0.2%) 2/1426 (0.1%) 1/1395 (0.1%) 0/1384 (0%)
Mental disorder 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Suicide attempt 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Renal and urinary disorders
Calculus ureteric 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Dysuria 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Haematuria 2/1430 (0.1%) 6/1426 (0.4%) 2/1395 (0.1%) 0/1384 (0%)
Hydronephrosis 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Nephrolithiasis 2/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Nephropathy 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Nephrotic syndrome 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Pollakiuria 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Renal artery stenosis 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Renal colic 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Renal failure 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Renal failure acute 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Renal haemorrhage 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Renal infarct 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Urinary bladder haemorrhage 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Urinary bladder polyp 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Urinary incontinence 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Urinary retention 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Reproductive system and breast disorders
Benign prostatic hyperplasia 2/1430 (0.1%) 4/1426 (0.3%) 0/1395 (0%) 0/1384 (0%)
Cervical dysplasia 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Endometriosis 0/1430 (0%) 1/1426 (0.1%) 1/1395 (0.1%) 0/1384 (0%)
Epididymal enlargement 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Menometrorrhagia 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Menorrhagia 0/1430 (0%) 3/1426 (0.2%) 0/1395 (0%) 0/1384 (0%)
Metrorrhagia 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Ovarian cyst 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Prostatitis 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Uterine polyp 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Vaginal discharge 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Vaginal haemorrhage 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Respiratory, thoracic and mediastinal disorders
Alveolitis 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Asthma 3/1430 (0.2%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Chronic obstructive pulmonary disease 2/1430 (0.1%) 3/1426 (0.2%) 0/1395 (0%) 0/1384 (0%)
Cough 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Dyspnoea 5/1430 (0.3%) 3/1426 (0.2%) 0/1395 (0%) 1/1384 (0.1%)
Eosinophilic pneumonia 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Epistaxis 0/1430 (0%) 3/1426 (0.2%) 0/1395 (0%) 0/1384 (0%)
Haemoptysis 0/1430 (0%) 2/1426 (0.1%) 0/1395 (0%) 1/1384 (0.1%)
Lung disorder 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Pleural effusion 0/1430 (0%) 1/1426 (0.1%) 1/1395 (0.1%) 0/1384 (0%)
Pneumonitis 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Pulmonary embolism 9/1430 (0.6%) 3/1426 (0.2%) 3/1395 (0.2%) 2/1384 (0.1%)
Pulmonary fibrosis 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Pulmonary hypertension 3/1430 (0.2%) 1/1426 (0.1%) 1/1395 (0.1%) 0/1384 (0%)
Pulmonary oedema 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Respiratory arrest 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Respiratory disorder 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Respiratory failure 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 1/1384 (0.1%)
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Hyperhidrosis 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Neurodermatitis 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Panniculitis 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Pruritus 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Rash 0/1430 (0%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Skin ulcer 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Urticaria 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Vascular purpura 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Surgical and medical procedures
Abortion induced 1/1430 (0.1%) 2/1426 (0.1%) 2/1395 (0.1%) 1/1384 (0.1%)
Colostomy closure 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Femoral hernia repair 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Finger amputation 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Hip arthroplasty 2/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Incisional hernia repair 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Joint arthroplasty 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Knee arthroplasty 0/1430 (0%) 2/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Rotator cuff repair 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Tooth extraction 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Vascular disorders
Aneurysm ruptured 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Aortic aneurysm 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Aortic dissection 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Arterial insufficiency 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Arterial thrombosis limb 1/1430 (0.1%) 0/1426 (0%) 1/1395 (0.1%) 1/1384 (0.1%)
Arteriosclerosis 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Circulatory collapse 2/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Deep vein thrombosis 10/1430 (0.7%) 6/1426 (0.4%) 1/1395 (0.1%) 2/1384 (0.1%)
Haematoma 0/1430 (0%) 3/1426 (0.2%) 0/1395 (0%) 1/1384 (0.1%)
Haemorrhage 1/1430 (0.1%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Hypertension 2/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Hypotension 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Hypovolaemic shock 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Lymphoedema 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Peripheral arterial occlusive disease 0/1430 (0%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Peripheral artery aneurysm 0/1430 (0%) 1/1426 (0.1%) 0/1395 (0%) 0/1384 (0%)
Peripheral embolism 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Peripheral ischaemia 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Phlebitis 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Post thrombotic syndrome 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Shock 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Thrombophlebitis superficial 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Thrombosis 2/1430 (0.1%) 0/1426 (0%) 1/1395 (0.1%) 0/1384 (0%)
Varicose ulceration 0/1430 (0%) 0/1426 (0%) 0/1395 (0%) 1/1384 (0.1%)
Varicose vein 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Venous insufficiency 1/1430 (0.1%) 0/1426 (0%) 0/1395 (0%) 0/1384 (0%)
Other (Not Including Serious) Adverse Events
Dabigatran Warfarin Post Dabigatran Post Warfarin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 409/1430 (28.6%) 415/1426 (29.1%) 34/1395 (2.4%) 32/1384 (2.3%)
Gastrointestinal disorders
Diarrhoea 73/1430 (5.1%) 51/1426 (3.6%) 4/1395 (0.3%) 3/1384 (0.2%)
General disorders
Oedema peripheral 76/1430 (5.3%) 68/1426 (4.8%) 8/1395 (0.6%) 3/1384 (0.2%)
Infections and infestations
Influenza 75/1430 (5.2%) 67/1426 (4.7%) 2/1395 (0.1%) 11/1384 (0.8%)
Nasopharyngitis 112/1430 (7.8%) 127/1426 (8.9%) 5/1395 (0.4%) 8/1384 (0.6%)
Musculoskeletal and connective tissue disorders
Pain in extremity 109/1430 (7.6%) 110/1426 (7.7%) 9/1395 (0.6%) 6/1384 (0.4%)
Nervous system disorders
Headache 84/1430 (5.9%) 100/1426 (7%) 4/1395 (0.3%) 8/1384 (0.6%)
Respiratory, thoracic and mediastinal disorders
Epistaxis 46/1430 (3.2%) 92/1426 (6.5%) 7/1395 (0.5%) 3/1384 (0.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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

Results Point of Contact

Name/Title Boehringer Ingelheim Call Center
Organization Boehringer Ingelheim Pharmaceuticals
Phone 1-800-243-0127
Email clintriage.rdg@boehringer-ingelheim.com
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00329238
Other Study ID Numbers:
  • 1160.47
  • 2005-002536-94
First Posted:
May 24, 2006
Last Update Posted:
May 19, 2014
Last Verified:
Dec 1, 2013