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Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (RE-COVER I)

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ClinicalTrials.gov Identifier: NCT00291330
Recruitment Status : Completed
First Posted : February 14, 2006
Results First Posted : February 11, 2011
Last Update Posted : June 6, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Thromboembolism
Interventions Drug: dabigatran etexilate 150 mg
Drug: warfarin (INR 2-3)
Enrollment 2564
Recruitment Details There were 2564 patients enrolled/randomised in this trial but only 2539 started treatment
Pre-assignment Details  
Arm/Group Title Dabigatran 150 mg Warfarin
Hide Arm/Group Description bid (twice daily) oral PRN to maintain an INR of 2.0-3.0
Period Title: Overall Study
Started 1273 [1] 1266 [1]
Completed 1172 [2] 1169 [2]
Not Completed 101 97
Reason Not Completed
Adverse Event             47             40
Protocol Violation             13             20
Lost to Follow-up             16             11
Withdrawal by Subject             22             25
Other             3             1
[1]
Started Treatment
[2]
Completed planned observation time
Arm/Group Title Dabigatran 150 mg Warfarin Total
Hide Arm/Group Description bid (twice daily) oral PRN to maintain an INR of 2.0-3.0 Total of all reporting groups
Overall Number of Baseline Participants 1273 1266 2539
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 1273 participants 1266 participants 2539 participants
55.0  (15.8) 54.4  (16.2) 54.7  (16.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1273 participants 1266 participants 2539 participants
Female
535
  42.0%
520
  41.1%
1055
  41.6%
Male
738
  58.0%
746
  58.9%
1484
  58.4%
Acute symptomatic DVT of the leg and/or PE as assessed by investigator   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1273 participants 1266 participants 2539 participants
Symptomatic PE and symptomatic DVT 121 124 245
Symptomatic PE 270 271 541
Symptomatic DVT 880 869 1749
No PE and no DVT 2 2 4
[1]
Measure Description: Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)
1.Primary Outcome
Title Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE
Hide Description All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Time Frame For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.
Arm/Group Title Dabigatran 150 mg Warfarin
Hide Arm/Group Description:
bid (twice daily) oral
PRN to maintain an INR of 2.0-3.0
Overall Number of Participants Analyzed 1274 1265
Measure Type: Number
Unit of Measure: Participants
Participants with event (up to day 180) 30 27
Participants with event (up to end of ptp) 34 32
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non inferiority margin was set up to 2.75 for the HR analysis
Statistical Test of Hypothesis P-Value <0.0001
Comments Non-inferiority P-Value. Two Statistical analyses performed on primary endpoint. Both non inferiority for the risk difference and for the hazard ratio analyses to be reached in order to conclude positively on the primary endpoint.
Method Regression, Cox
Comments Patients without events are censored at the end of post treatment period (day 224)
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.05
Confidence Interval 95%
0.65 to 1.70
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments Risk difference vs. Warfarin for Proportion of patients with VTE or death related to VTE at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non inferiority margin was set up to 3.6% for the risk difference based on KM estimates
Statistical Test of Hypothesis P-Value <0.0001
Comments Non-inferiority P-Value. Two Statistical analyses performed on primary endpoint. Both non inferiority for the risk difference and for the hazard ratio analyses to be reached in order to conclude positively on the primary endpoint.
Method Kaplan Meier weighted estimates
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (Percentage)
Estimated Value 0.40
Confidence Interval 95%
-0.80 to 1.50
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments Hazard ratio vs. Warfarin (events occurring between randomisation and the day 180). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Cox
Comments Patients without events are censored at day 180
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.10
Confidence Interval 95%
0.65 to 1.84
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Recurrent Symptomatic VTE and All Deaths
Hide Description

VTE or any death which occured from randomisation to end of post treatment period.

All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.

Time Frame For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.
Arm/Group Title Dabigatran 150 mg Warfarin
Hide Arm/Group Description:
bid (twice daily) oral
PRN to maintain an INR of 2.0-3.0
Overall Number of Participants Analyzed 1274 1265
Measure Type: Number
Unit of Measure: Participants
Participants with event (up to day 180) 48 44
Participants with event (up to end of ptp) 55 53
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments Risk difference vs. Warfarin for Proportion of patients with VTE or death at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6220
Comments [Not Specified]
Method Kaplan Meier weighted estimates
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (Percentage)
Estimated Value 0.30
Confidence Interval 95%
-1.00 to 1.70
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9844
Comments [Not Specified]
Method Regression, Cox
Comments Patients without events are censored at the end of post treatment period (day 224)
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.00
Confidence Interval 95%
0.69 to 1.46
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Recurrent Symptomatic DVT
Hide Description

Symptomatic DVT which occured from randomisation to end of post treatment period.

All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.

Time Frame For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.
Arm/Group Title Dabigatran 150 mg Warfarin
Hide Arm/Group Description:
bid (twice daily) oral
PRN to maintain an INR of 2.0-3.0
Overall Number of Participants Analyzed 1274 1265
Measure Type: Number
Unit of Measure: participants
Participants with event (up to day 180) 16 18
Participants with event (up to end of ptp) 17 22
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments Risk difference vs. Warfarin for Proportion of patients with symptomatic DVT at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6466
Comments [Not Specified]
Method Kaplan Meier weighted estimates
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (Percentage)
Estimated Value -0.20
Confidence Interval 95%
-1.10 to 0.70
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3850
Comments [Not Specified]
Method Regression, Cox
Comments Patients without events are censored at the end of post treatment period (day 224)
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.76
Confidence Interval 95%
0.40 to 1.42
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Recurrent Symptomatic Non-fatal PE
Hide Description

Symptomatic non-fatal PE which occured from randomisation to end of post treatment period.

All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.

Time Frame For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.
Arm/Group Title Dabigatran 150 mg Warfarin
Hide Arm/Group Description:
bid (twice daily) oral
PRN to maintain an INR of 2.0-3.0
Overall Number of Participants Analyzed 1274 1265
Measure Type: Number
Unit of Measure: participants
Participants with event (up to day 180) 13 7
Participants with event (up to end of ptp) 16 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments Risk difference vs. Warfarin for Proportion of patients with symptomatic non-fatal PE at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2981
Comments [Not Specified]
Method Kaplan Meier weighted estimates
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (Percentage)
Estimated Value 0.30
Confidence Interval 95%
-0.30 to 1.00
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1092
Comments [Not Specified]
Method Regression, Cox
Comments Patients without events are censored at the end of post treatment period (day 224)
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.00
Confidence Interval 95%
0.86 to 4.68
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants Who Died Due to VTE
Hide Description

VTE - related deaths which occured from randomisation to end of post treatment period.

All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.

Time Frame For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.
Arm/Group Title Dabigatran 150 mg Warfarin
Hide Arm/Group Description:
bid (twice daily) oral
PRN to maintain an INR of 2.0-3.0
Overall Number of Participants Analyzed 1274 1265
Measure Type: Number
Unit of Measure: participants
Participants with event (up to day 180) 1 3
Participants with event (up to end of ptp) 1 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments Risk difference at 6 months vs. Warfarin for Proportion of patients who died due to VTE . Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5327
Comments [Not Specified]
Method Kaplan Meier weighted estimates
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (Percentage)
Estimated Value -0.30
Confidence Interval 95%
-1.20 to 0.60
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3332
Comments [Not Specified]
Method Regression, Cox
Comments Patients without events are censored at the end of post treatment period (day 224)
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.33
Confidence Interval 95%
0.03 to 3.15
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants Who Died (Any Cause)
Hide Description Any deaths which occured from randomisation to end of post treatment period. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Time Frame For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.
Arm/Group Title Dabigatran 150 mg Warfarin
Hide Arm/Group Description:
bid (twice daily) oral
PRN to maintain an INR of 2.0-3.0
Overall Number of Participants Analyzed 1274 1265
Measure Type: Number
Unit of Measure: participants
Participants with event (up to day 180) 21 21
Participants with event (up to end of ptp) 25 25
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments Risk difference at 6 months vs. Warfarin for Proportion of patients who died from any cause. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8018
Comments [Not Specified]
Method Kaplan Meier weighted estimates
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (Percentage)
Estimated Value -0.10
Confidence Interval 95%
-1.00 to 0.80
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8203
Comments [Not Specified]
Method Regression, Cox
Comments Patients without events are censored at the end of post treatment period (day 224)
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval 95%
0.54 to 1.63
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With Bleeding Events
Hide Description

Major bleeding events (MBE) were defined as

  • 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

Clinically-relevant bleeding events (CRBE) was defined as

  • spontaneous skin hematoma >=25 cm²
  • spontaneous nose bleed >5 min
  • macroscopic hematuria spontaneous or >24 hours if associated with an intervention
  • spontaneous rectal bleeding (more than spotting on toilet paper)
  • gingival bleeding >5 min
  • leading to hospitalisation and / or requiring surgical treatment
  • leading to a transfusion of <2 units of whole blood or red cells
  • any other bleeding event considered clinically relevant by the investigator

Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.

Time Frame From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti−coagulant therapy on and after last intake of active study drug)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set (TS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as treated.
Arm/Group Title Dabigatran 150 mg Warfarin
Hide Arm/Group Description:
bid (twice daily) oral
PRN to maintain an INR of 2.0-3.0
Overall Number of Participants Analyzed 1273 1266
Measure Type: Number
Unit of Measure: participants
Major bleeding events 20 24
MBE and/or CRBE 71 111
Any bleeding events 207 280
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments Hazard ratio vs. Warfarin for the category major bleeding events (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5063
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.82
Confidence Interval 95%
0.45 to 1.48
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments Hazard ratio vs. Warfarin for the category of any bleeding events (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.59 to 0.85
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants With Acute Coronary Syndrome (ACS)
Hide Description

Any ACS occurring during the conduct of the study (centrally adjudicated as definite).

Counts of patients having a centrally adjudicated definite ACS during intake of active study drug, after stopping active study drug and before or without intake of active study drug, according to treatment group.

All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.

Time Frame From first intake of study drug to end of study conduct
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set (TS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as treated.
Arm/Group Title Dabigatran 150 mg Warfarin
Hide Arm/Group Description:
bid (twice daily) oral
PRN to maintain an INR of 2.0-3.0
Overall Number of Participants Analyzed 1273 1266
Measure Type: Number
Unit of Measure: participants
During intake of active study drug 5 3
After stopping active study drug 4 2
Before/without intake of active study drug 2 0
9.Secondary Outcome
Title Laboratory Analyses
Hide Description Frequency of patients with possible clinically significant abnormalities.
Time Frame From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti−coagulant therapy on and after last intake of active study drug)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set (TS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as treated.
Arm/Group Title Dabigatran 150 mg Warfarin
Hide Arm/Group Description:
bid (twice daily) oral
PRN to maintain an INR of 2.0-3.0
Overall Number of Participants Analyzed 1204 1198
Measure Type: Number
Unit of Measure: participants
AST increase 21 22
AST decrease 0 0
ALT increase 26 38
ALT decrease 0 0
Bilirubin increase 7 13
Bilirubin decrease 0 0
Time Frame From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti−coagulant therapy on and after last intake of active study drug)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dabigatran 150 mg Warfarin
Hide Arm/Group Description bid (twice daily) oral PRN to maintain an INR of 2.0-3.0
All-Cause Mortality
Dabigatran 150 mg Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran 150 mg Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   165/1273 (12.96%)   150/1266 (11.85%) 
Blood and lymphatic system disorders     
Anaemia  1  5/1273 (0.39%)  2/1266 (0.16%) 
Febrile neutropenia  1  1/1273 (0.08%)  0/1266 (0.00%) 
Iron deficiency anaemia  1  2/1273 (0.16%)  0/1266 (0.00%) 
Cardiac disorders     
Acute coronary syndrome  1  0/1273 (0.00%)  2/1266 (0.16%) 
Acute myocardial infarction  1  1/1273 (0.08%)  0/1266 (0.00%) 
Angina pectoris  1  2/1273 (0.16%)  0/1266 (0.00%) 
Angina unstable  1  0/1273 (0.00%)  1/1266 (0.08%) 
Arrhythmia  1  0/1273 (0.00%)  2/1266 (0.16%) 
Atrial fibrillation  1  2/1273 (0.16%)  2/1266 (0.16%) 
Atrioventricular block  1  0/1273 (0.00%)  1/1266 (0.08%) 
Bradyarrhythmia  1  0/1273 (0.00%)  1/1266 (0.08%) 
Cardiac arrest  1  0/1273 (0.00%)  1/1266 (0.08%) 
Cardiac failure  1  0/1273 (0.00%)  1/1266 (0.08%) 
Cardiopulmonary failure  1  0/1273 (0.00%)  1/1266 (0.08%) 
Coronary artery disease  1  1/1273 (0.08%)  0/1266 (0.00%) 
Coronary artery occlusion  1  1/1273 (0.08%)  0/1266 (0.00%) 
Left ventricular failure  1  1/1273 (0.08%)  0/1266 (0.00%) 
Myocardial infarction  1  2/1273 (0.16%)  0/1266 (0.00%) 
Myocardial ischaemia  1  1/1273 (0.08%)  0/1266 (0.00%) 
Pericardial effusion  1  1/1273 (0.08%)  0/1266 (0.00%) 
Ear and labyrinth disorders     
Ear haemorrhage  1  0/1273 (0.00%)  1/1266 (0.08%) 
Middle ear inflammation  1  0/1273 (0.00%)  1/1266 (0.08%) 
Vertigo  1  1/1273 (0.08%)  0/1266 (0.00%) 
Endocrine disorders     
Goitre  1  0/1273 (0.00%)  1/1266 (0.08%) 
Eye disorders     
Optic ischaemic neuropathy  1  1/1273 (0.08%)  0/1266 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  0/1273 (0.00%)  1/1266 (0.08%) 
Abdominal symptom  1  0/1273 (0.00%)  1/1266 (0.08%) 
Colonic polyp  1  2/1273 (0.16%)  1/1266 (0.08%) 
Crohn's disease  1  1/1273 (0.08%)  0/1266 (0.00%) 
Diarrhoea  1  0/1273 (0.00%)  2/1266 (0.16%) 
Duodenal ulcer  1  1/1273 (0.08%)  0/1266 (0.00%) 
Duodenal ulcer haemorrhage  1  1/1273 (0.08%)  0/1266 (0.00%) 
Faeces discoloured  1  0/1273 (0.00%)  1/1266 (0.08%) 
Gastric ulcer  1  0/1273 (0.00%)  1/1266 (0.08%) 
Gastritis  1  0/1273 (0.00%)  1/1266 (0.08%) 
Gastrointestinal disorder  1  0/1273 (0.00%)  1/1266 (0.08%) 
Gastrointestinal haemorrhage  1  1/1273 (0.08%)  3/1266 (0.24%) 
Gastrooesophageal reflux disease  1  1/1273 (0.08%)  0/1266 (0.00%) 
Gingival bleeding  1  0/1273 (0.00%)  1/1266 (0.08%) 
Haematemesis  1  1/1273 (0.08%)  0/1266 (0.00%) 
Inguinal hernia  1  0/1273 (0.00%)  1/1266 (0.08%) 
Intestinal obstruction  1  1/1273 (0.08%)  0/1266 (0.00%) 
Nausea  1  1/1273 (0.08%)  0/1266 (0.00%) 
Oesophageal haemorrhage  1  1/1273 (0.08%)  0/1266 (0.00%) 
Oesophageal ulcer  1  1/1273 (0.08%)  0/1266 (0.00%) 
Pancreatic mass  1  0/1273 (0.00%)  1/1266 (0.08%) 
Pneumoperitoneum  1  1/1273 (0.08%)  0/1266 (0.00%) 
Rectal haemorrhage  1  6/1273 (0.47%)  1/1266 (0.08%) 
Small intestinal haemorrhage  1  1/1273 (0.08%)  0/1266 (0.00%) 
Small intestinal obstruction  1  1/1273 (0.08%)  0/1266 (0.00%) 
Vomiting  1  1/1273 (0.08%)  1/1266 (0.08%) 
General disorders     
Asthenia  1  1/1273 (0.08%)  0/1266 (0.00%) 
Chest discomfort  1  1/1273 (0.08%)  1/1266 (0.08%) 
Chest pain  1  4/1273 (0.31%)  6/1266 (0.47%) 
Death  1  1/1273 (0.08%)  1/1266 (0.08%) 
Drug ineffective  1  1/1273 (0.08%)  0/1266 (0.00%) 
General physical health deterioration  1  0/1273 (0.00%)  1/1266 (0.08%) 
Haemorrhagic cyst  1  0/1273 (0.00%)  1/1266 (0.08%) 
Multi-organ failure  1  1/1273 (0.08%)  1/1266 (0.08%) 
Non-cardiac chest pain  1  4/1273 (0.31%)  0/1266 (0.00%) 
Oedema  1  0/1273 (0.00%)  1/1266 (0.08%) 
Oedema peripheral  1  1/1273 (0.08%)  4/1266 (0.32%) 
Polyp  1  1/1273 (0.08%)  0/1266 (0.00%) 
Pseudocyst  1  0/1273 (0.00%)  1/1266 (0.08%) 
Pyrexia  1  1/1273 (0.08%)  0/1266 (0.00%) 
Hepatobiliary disorders     
Bile duct obstruction  1  0/1273 (0.00%)  1/1266 (0.08%) 
Bile duct stone  1  1/1273 (0.08%)  1/1266 (0.08%) 
Cholangitis  1  1/1273 (0.08%)  0/1266 (0.00%) 
Cholecystitis  1  2/1273 (0.16%)  0/1266 (0.00%) 
Cholecystitis acute  1  0/1273 (0.00%)  1/1266 (0.08%) 
Cholecystitis chronic  1  1/1273 (0.08%)  0/1266 (0.00%) 
Cholelithiasis  1  1/1273 (0.08%)  1/1266 (0.08%) 
Hepatic cirrhosis  1  1/1273 (0.08%)  0/1266 (0.00%) 
Hepatic necrosis  1  1/1273 (0.08%)  0/1266 (0.00%) 
Hepatitis fulminant  1  0/1273 (0.00%)  1/1266 (0.08%) 
Hydrocholecystis  1  1/1273 (0.08%)  0/1266 (0.00%) 
Immune system disorders     
Sarcoidosis  1  0/1273 (0.00%)  1/1266 (0.08%) 
Infections and infestations     
Abscess  1  1/1273 (0.08%)  0/1266 (0.00%) 
Anal abscess  1  0/1273 (0.00%)  1/1266 (0.08%) 
Bronchitis  1  2/1273 (0.16%)  1/1266 (0.08%) 
Bronchopneumonia  1  3/1273 (0.24%)  0/1266 (0.00%) 
Cellulitis  1  2/1273 (0.16%)  3/1266 (0.24%) 
Empyema  1  1/1273 (0.08%)  0/1266 (0.00%) 
Erysipelas  1  1/1273 (0.08%)  1/1266 (0.08%) 
Gastroenteritis  1  5/1273 (0.39%)  0/1266 (0.00%) 
Labyrinthitis  1  1/1273 (0.08%)  0/1266 (0.00%) 
Lobar pneumonia  1  2/1273 (0.16%)  0/1266 (0.00%) 
Lower respiratory tract infection  1  1/1273 (0.08%)  1/1266 (0.08%) 
Lung abscess  1  0/1273 (0.00%)  1/1266 (0.08%) 
Peritoneal infection  1  0/1273 (0.00%)  1/1266 (0.08%) 
Pneumonia  1  5/1273 (0.39%)  8/1266 (0.63%) 
Pyelonephritis  1  0/1273 (0.00%)  1/1266 (0.08%) 
Respiratory tract infection  1  1/1273 (0.08%)  0/1266 (0.00%) 
Sepsis  1  2/1273 (0.16%)  0/1266 (0.00%) 
Sinusitis  1  0/1273 (0.00%)  1/1266 (0.08%) 
Subcutaneous abscess  1  0/1273 (0.00%)  1/1266 (0.08%) 
Tonsillitis  1  0/1273 (0.00%)  1/1266 (0.08%) 
Urinary tract infection  1  2/1273 (0.16%)  2/1266 (0.16%) 
Vestibular neuronitis  1  0/1273 (0.00%)  1/1266 (0.08%) 
Wound sepsis  1  0/1273 (0.00%)  1/1266 (0.08%) 
Injury, poisoning and procedural complications     
Abdominal injury  1  0/1273 (0.00%)  1/1266 (0.08%) 
Fall  1  0/1273 (0.00%)  2/1266 (0.16%) 
Femur fracture  1  0/1273 (0.00%)  1/1266 (0.08%) 
Graft thrombosis  1  0/1273 (0.00%)  1/1266 (0.08%) 
Hip fracture  1  1/1273 (0.08%)  0/1266 (0.00%) 
Joint dislocation  1  1/1273 (0.08%)  1/1266 (0.08%) 
Joint injury  1  0/1273 (0.00%)  1/1266 (0.08%) 
Limb injury  1  1/1273 (0.08%)  0/1266 (0.00%) 
Lower limb fracture  1  0/1273 (0.00%)  1/1266 (0.08%) 
Multiple injuries  1  1/1273 (0.08%)  0/1266 (0.00%) 
Post procedural haematuria  1  0/1273 (0.00%)  1/1266 (0.08%) 
Radius fracture  1  0/1273 (0.00%)  1/1266 (0.08%) 
Rib fracture  1  0/1273 (0.00%)  1/1266 (0.08%) 
Road traffic accident  1  2/1273 (0.16%)  1/1266 (0.08%) 
Synovial rupture  1  0/1273 (0.00%)  1/1266 (0.08%) 
Tibia fracture  1  1/1273 (0.08%)  0/1266 (0.00%) 
Traumatic haematoma  1  0/1273 (0.00%)  1/1266 (0.08%) 
Vascular pseudoaneurysm  1  0/1273 (0.00%)  1/1266 (0.08%) 
Vascular pseudoaneurysm ruptured  1  1/1273 (0.08%)  0/1266 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  1/1273 (0.08%)  0/1266 (0.00%) 
Aspartate aminotransferase increased  1  1/1273 (0.08%)  0/1266 (0.00%) 
Biopsy bladder  1  0/1273 (0.00%)  1/1266 (0.08%) 
Cardiac imaging procedure abnormal  1  1/1273 (0.08%)  0/1266 (0.00%) 
Haemoglobin decreased  1  2/1273 (0.16%)  0/1266 (0.00%) 
Hepatic enzyme increased  1  1/1273 (0.08%)  0/1266 (0.00%) 
International normalised ratio increased  1  0/1273 (0.00%)  1/1266 (0.08%) 
Investigation  1  1/1273 (0.08%)  0/1266 (0.00%) 
Liver function test abnormal  1  1/1273 (0.08%)  1/1266 (0.08%) 
Troponin I increased  1  1/1273 (0.08%)  0/1266 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  0/1273 (0.00%)  1/1266 (0.08%) 
Dehydration  1  1/1273 (0.08%)  0/1266 (0.00%) 
Diabetes mellitus  1  1/1273 (0.08%)  0/1266 (0.00%) 
Diabetes mellitus inadequate control  1  0/1273 (0.00%)  1/1266 (0.08%) 
Hypoalbuminaemia  1  1/1273 (0.08%)  0/1266 (0.00%) 
Hypoglycaemia  1  1/1273 (0.08%)  0/1266 (0.00%) 
Hypokalaemia  1  1/1273 (0.08%)  0/1266 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  2/1273 (0.16%)  1/1266 (0.08%) 
Bone pain  1  0/1273 (0.00%)  1/1266 (0.08%) 
Chondrocalcinosis  1  0/1273 (0.00%)  1/1266 (0.08%) 
Fibromyalgia  1  0/1273 (0.00%)  1/1266 (0.08%) 
Flank pain  1  1/1273 (0.08%)  0/1266 (0.00%) 
Fracture nonunion  1  0/1273 (0.00%)  2/1266 (0.16%) 
Haemarthrosis  1  0/1273 (0.00%)  3/1266 (0.24%) 
Jaw cyst  1  1/1273 (0.08%)  0/1266 (0.00%) 
Muscle haemorrhage  1  0/1273 (0.00%)  1/1266 (0.08%) 
Musculoskeletal pain  1  0/1273 (0.00%)  1/1266 (0.08%) 
Myalgia  1  1/1273 (0.08%)  0/1266 (0.00%) 
Osteoarthritis  1  1/1273 (0.08%)  0/1266 (0.00%) 
Osteochondrosis  1  0/1273 (0.00%)  1/1266 (0.08%) 
Pain in extremity  1  1/1273 (0.08%)  2/1266 (0.16%) 
Spinal osteoarthritis  1  0/1273 (0.00%)  1/1266 (0.08%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia  1  1/1273 (0.08%)  0/1266 (0.00%) 
B-cell lymphoma recurrent  1  1/1273 (0.08%)  0/1266 (0.00%) 
Bladder cancer  1  0/1273 (0.00%)  2/1266 (0.16%) 
Breast cancer  1  1/1273 (0.08%)  0/1266 (0.00%) 
Cervix carcinoma recurrent  1  1/1273 (0.08%)  1/1266 (0.08%) 
Colon cancer  1  2/1273 (0.16%)  2/1266 (0.16%) 
Fibroadenoma of breast  1  1/1273 (0.08%)  0/1266 (0.00%) 
Gallbladder cancer  1  2/1273 (0.16%)  0/1266 (0.00%) 
Gastrointestinal carcinoma  1  1/1273 (0.08%)  0/1266 (0.00%) 
Hepatic neoplasm malignant  1  1/1273 (0.08%)  0/1266 (0.00%) 
Lung adenocarcinoma  1  1/1273 (0.08%)  0/1266 (0.00%) 
Lung neoplasm malignant  1  0/1273 (0.00%)  2/1266 (0.16%) 
Malignant melanoma  1  0/1273 (0.00%)  1/1266 (0.08%) 
Malignant neoplasm progression  1  0/1273 (0.00%)  1/1266 (0.08%) 
Malignant pleural effusion  1  0/1273 (0.00%)  1/1266 (0.08%) 
Metastases to adrenals  1  1/1273 (0.08%)  0/1266 (0.00%) 
Metastases to liver  1  5/1273 (0.39%)  2/1266 (0.16%) 
Metastases to lung  1  0/1273 (0.00%)  1/1266 (0.08%) 
Metastases to lymph nodes  1  1/1273 (0.08%)  0/1266 (0.00%) 
Metastases to spleen  1  0/1273 (0.00%)  1/1266 (0.08%) 
Metastases to the mediastinum  1  1/1273 (0.08%)  1/1266 (0.08%) 
Metastatic malignant melanoma  1  0/1273 (0.00%)  1/1266 (0.08%) 
Metastatic neoplasm  1  1/1273 (0.08%)  1/1266 (0.08%) 
Oesophageal carcinoma  1  1/1273 (0.08%)  0/1266 (0.00%) 
Ovarian cancer metastatic  1  0/1273 (0.00%)  1/1266 (0.08%) 
Ovarian epithelial cancer  1  1/1273 (0.08%)  0/1266 (0.00%) 
Pancreatic carcinoma  1  1/1273 (0.08%)  1/1266 (0.08%) 
Prostate cancer  1  1/1273 (0.08%)  2/1266 (0.16%) 
Prostatic adenoma  1  1/1273 (0.08%)  0/1266 (0.00%) 
Renal cancer  1  1/1273 (0.08%)  0/1266 (0.00%) 
Renal cell carcinoma  1  1/1273 (0.08%)  0/1266 (0.00%) 
Renal neoplasm  1  2/1273 (0.16%)  1/1266 (0.08%) 
Sarcoma  1  0/1273 (0.00%)  1/1266 (0.08%) 
Uterine cancer  1  0/1273 (0.00%)  1/1266 (0.08%) 
Nervous system disorders     
Acute polyneuropathy  1  0/1273 (0.00%)  1/1266 (0.08%) 
Cerebellar haemorrhage  1  0/1273 (0.00%)  1/1266 (0.08%) 
Cerebral ischaemia  1  1/1273 (0.08%)  0/1266 (0.00%) 
Convulsion  1  0/1273 (0.00%)  1/1266 (0.08%) 
Dizziness  1  0/1273 (0.00%)  1/1266 (0.08%) 
Dizziness postural  1  0/1273 (0.00%)  1/1266 (0.08%) 
Epilepsy  1  0/1273 (0.00%)  1/1266 (0.08%) 
Haemorrhage intracranial  1  0/1273 (0.00%)  2/1266 (0.16%) 
Headache  1  1/1273 (0.08%)  1/1266 (0.08%) 
Hemiparesis  1  0/1273 (0.00%)  1/1266 (0.08%) 
Ischaemic stroke  1  3/1273 (0.24%)  0/1266 (0.00%) 
Migraine  1  0/1273 (0.00%)  1/1266 (0.08%) 
Polyneuropathy  1  1/1273 (0.08%)  0/1266 (0.00%) 
Presyncope  1  1/1273 (0.08%)  1/1266 (0.08%) 
Somnolence  1  0/1273 (0.00%)  1/1266 (0.08%) 
Speech disorder  1  0/1273 (0.00%)  1/1266 (0.08%) 
Subdural hygroma  1  1/1273 (0.08%)  0/1266 (0.00%) 
Syncope  1  1/1273 (0.08%)  1/1266 (0.08%) 
Transient ischaemic attack  1  2/1273 (0.16%)  1/1266 (0.08%) 
Pregnancy, puerperium and perinatal conditions     
Abortion incomplete  1  0/1273 (0.00%)  1/1266 (0.08%) 
Psychiatric disorders     
Anxiety  1  2/1273 (0.16%)  0/1266 (0.00%) 
Depression  1  2/1273 (0.16%)  0/1266 (0.00%) 
Renal and urinary disorders     
Calculus ureteric  1  0/1273 (0.00%)  1/1266 (0.08%) 
Calculus urinary  1  0/1273 (0.00%)  1/1266 (0.08%) 
Haematuria  1  4/1273 (0.31%)  9/1266 (0.71%) 
Renal colic  1  1/1273 (0.08%)  1/1266 (0.08%) 
Renal failure  1  2/1273 (0.16%)  1/1266 (0.08%) 
Renal failure acute  1  1/1273 (0.08%)  0/1266 (0.00%) 
Renal vein thrombosis  1  1/1273 (0.08%)  0/1266 (0.00%) 
Urethral stenosis  1  1/1273 (0.08%)  0/1266 (0.00%) 
Urinary retention  1  1/1273 (0.08%)  0/1266 (0.00%) 
Reproductive system and breast disorders     
Bartholinitis  1  1/1273 (0.08%)  0/1266 (0.00%) 
Breast haemorrhage  1  0/1273 (0.00%)  1/1266 (0.08%) 
Endometriosis  1  1/1273 (0.08%)  0/1266 (0.00%) 
Metrorrhagia  1  2/1273 (0.16%)  0/1266 (0.00%) 
Prostatitis  1  1/1273 (0.08%)  1/1266 (0.08%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  1/1273 (0.08%)  0/1266 (0.00%) 
Asthma  1  1/1273 (0.08%)  0/1266 (0.00%) 
Chronic obstructive pulmonary disease  1  1/1273 (0.08%)  1/1266 (0.08%) 
Cough  1  1/1273 (0.08%)  0/1266 (0.00%) 
Dyspnoea  1  5/1273 (0.39%)  10/1266 (0.79%) 
Epistaxis  1  1/1273 (0.08%)  2/1266 (0.16%) 
Haemoptysis  1  1/1273 (0.08%)  1/1266 (0.08%) 
Haemothorax  1  1/1273 (0.08%)  2/1266 (0.16%) 
Hydropneumothorax  1  0/1273 (0.00%)  2/1266 (0.16%) 
Hyperventilation  1  1/1273 (0.08%)  0/1266 (0.00%) 
Lung disorder  1  1/1273 (0.08%)  0/1266 (0.00%) 
Lung infiltration  1  0/1273 (0.00%)  1/1266 (0.08%) 
Pleural effusion  1  3/1273 (0.24%)  2/1266 (0.16%) 
Pleural fibrosis  1  1/1273 (0.08%)  0/1266 (0.00%) 
Pleurisy  1  1/1273 (0.08%)  2/1266 (0.16%) 
Pneumonia aspiration  1  0/1273 (0.00%)  1/1266 (0.08%) 
Pneumothorax  1  1/1273 (0.08%)  0/1266 (0.00%) 
Pulmonary embolism  1  14/1273 (1.10%)  7/1266 (0.55%) 
Pulmonary infarction  1  1/1273 (0.08%)  1/1266 (0.08%) 
Pulmonary oedema  1  1/1273 (0.08%)  0/1266 (0.00%) 
Respiratory failure  1  2/1273 (0.16%)  0/1266 (0.00%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  1/1273 (0.08%)  0/1266 (0.00%) 
Erythema  1  0/1273 (0.00%)  1/1266 (0.08%) 
Erythema nodosum  1  1/1273 (0.08%)  0/1266 (0.00%) 
Leukocytoclastic vasculitis  1  0/1273 (0.00%)  1/1266 (0.08%) 
Surgical and medical procedures     
Abortion induced  1  0/1273 (0.00%)  1/1266 (0.08%) 
Vascular disorders     
Accelerated hypertension  1  0/1273 (0.00%)  1/1266 (0.08%) 
Arterial thrombosis limb  1  1/1273 (0.08%)  0/1266 (0.00%) 
Deep vein thrombosis  1  10/1273 (0.79%)  9/1266 (0.71%) 
Haematoma  1  1/1273 (0.08%)  1/1266 (0.08%) 
Haemorrhage  1  1/1273 (0.08%)  0/1266 (0.00%) 
Hypotension  1  0/1273 (0.00%)  1/1266 (0.08%) 
Iliac artery thrombosis  1  1/1273 (0.08%)  0/1266 (0.00%) 
Lymphoedema  1  1/1273 (0.08%)  0/1266 (0.00%) 
Peripheral artery aneurysm  1  1/1273 (0.08%)  0/1266 (0.00%) 
Peripheral ischaemia  1  1/1273 (0.08%)  0/1266 (0.00%) 
Post thrombotic syndrome  1  1/1273 (0.08%)  1/1266 (0.08%) 
Shock haemorrhagic  1  1/1273 (0.08%)  0/1266 (0.00%) 
Thrombosis  1  0/1273 (0.00%)  1/1266 (0.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dabigatran 150 mg Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   163/1273 (12.80%)   209/1266 (16.51%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  63/1273 (4.95%)  69/1266 (5.45%) 
Nervous system disorders     
Headache  1  78/1273 (6.13%)  87/1266 (6.87%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  35/1273 (2.75%)  78/1266 (6.16%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any publication of the results 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
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00291330     History of Changes
Other Study ID Numbers: 1160.53
2005-001999-12 ( EudraCT Number: EudraCT )
First Submitted: February 13, 2006
First Posted: February 14, 2006
Results First Submitted: November 18, 2010
Results First Posted: February 11, 2011
Last Update Posted: June 6, 2014