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Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE) (RE-COVER II)

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ClinicalTrials.gov Identifier: NCT00680186
Recruitment Status : Completed
First Posted : May 20, 2008
Results First Posted : June 14, 2012
Last Update Posted : May 19, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Thromboembolism
Interventions Drug: Warfarin
Drug: Dabigatran etexilate
Enrollment 2589
Recruitment Details There were 2589 patients enrolled/randomised but only 2568 were treated.
Pre-assignment Details  
Arm/Group Title Dabigatran 150 mg Warfarin
Hide Arm/Group Description bid (twice daily) oral PRN (as needed) to maintain an INR (international normalised ratio) of 2.0-3.0
Period Title: Overall Study
Started 1280 [1] 1288 [1]
Completed 1155 [2] 1172 [2]
Not Completed 125 116
Reason Not Completed
Adverse Event             47             44
Protocol Violation             31             26
Lost to Follow-up             11             6
Withdrawal by Subject             32             39
Other             4             1
[1]
Started treatment.
[2]
Completed planned observation time.
Arm/Group Title Dabigatran 150 mg Warfarin Total
Hide Arm/Group Description bid oral PRN to maintain an INR of 2.0-3.0 Total of all reporting groups
Overall Number of Baseline Participants 1280 1288 2568
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1280 participants 1288 participants 2568 participants
54.7  (16.19) 55.1  (16.26) 54.9  (16.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1280 participants 1288 participants 2568 participants
Female
499
  39.0%
512
  39.8%
1011
  39.4%
Male
781
  61.0%
776
  60.2%
1557
  60.6%
Investigator assessed acute symptomatic deep vein thrombosis (DVT) of leg or pulmonary embolism (PE)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1280 participants 1288 participants 2568 participants
Symptomatic PE and symptomatic DVT 104 117 221
Symptomatic PE 298 297 595
Symptomatic DVT 877 873 1750
No PE and no DVT 1 1 2
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)
Hide 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 oral
PRN to maintain an INR of 2.0-3.0
Overall Number of Participants Analyzed 1279 1289
Measure Type: Number
Unit of Measure: participants
Participants with event (up to day 180) 30 28
Participants with event (up to end of ptp) 34 30
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments Hazard ratio (HR) vs. Warfarin (events occurring between randomisation and end of ptp). 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 0.0002
Comments Non-inferiority P-Value.Two co-primary analyses performed on primary endpoint. Both non inferiority for the risk difference (RD) (at day 180) and for the HR (up to end of ptp) analyses to be reached in order to conclude positively on primary endpoint
Method Regression, Cox
Comments Patients without events are censored at the end of ptp.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.13
Confidence Interval 95%
0.69 to 1.85
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments RD vs. Warfarin for Proportion of patients with VTE or death related to VTE at 6 months. Point estimate and 95% CI for the overall RD 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 RD based on KM estimates
Statistical Test of Hypothesis P-Value <0.0001
Comments Non-inferiority P-Value.Two co-primary analyses performed on primary endpoint. Both non inferiority for the RD (at day 180) and for the HR (events up to end of ptp) 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 0.2
Confidence Interval 95%
-1.0 to 1.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments HR vs. Warfarin (events occurring between randomisation and day 180). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE. This analysis was performed as sensitivity analysis for statistical analysis 1.
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 the earliest of last contact date or day 180.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.08
Confidence Interval 95%
0.64 to 1.8
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 ptp. 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.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Dabigatran 150 mg Warfarin
Hide Arm/Group Description:
bid oral
PRN to maintain an INR of 2.0-3.0
Overall Number of Participants Analyzed 1279 1289
Measure Type: Number
Unit of Measure: participants
Participants with event (up to day 180) 51 48
Participants with event (up to end of ptp) 57 51
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments RD vs. Warfarin for Proportion of patients with VTE or death at 6 months. Point estimate and 95% CI for the overall RD obtained based on the 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 0.6932
Comments [Not Specified]
Method Kaplan Meier weighted estimates
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (Percentage)
Estimated Value 0.3
Confidence Interval 95%
-1.1 to 1.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox 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 0.6383
Comments [Not Specified]
Method Regression, Cox
Comments Patients without events are censored at the end of ptp.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.09
Confidence Interval 95%
0.75 to 1.60
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 ptp. 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.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Dabigatran 150 mg Warfarin
Hide Arm/Group Description:
bid oral
PRN to maintain an INR of 2.0-3.0
Overall Number of Participants Analyzed 1279 1289
Measure Type: Number
Unit of Measure: participants
Participants with event (up to day 180) 25 17
Participants with event (up to end of ptp) 28 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments RD vs. Warfarin for Proportion of patients with symptomatic DVT at 6 months. Point estimate and 95% CI for the overall RD obtained based on the 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 0.1703
Comments [Not Specified]
Method Kaplan Meier weighted estimates
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (Percentage)
Estimated Value 0.6
Confidence Interval 95%
-0.3 to 1.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox 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 0.1054
Comments [Not Specified]
Method Regression, Cox
Comments Patients without events are censored at the end of ptp.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.65
Confidence Interval 95%
0.90 to 3.01
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 ptp. 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.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Dabigatran 150 mg Warfarin
Hide Arm/Group Description:
bid oral
PRN to maintain an INR of 2.0-3.0
Overall Number of Participants Analyzed 1279 1289
Measure Type: Number
Unit of Measure: participants
Participants with event (up to day 180) 7 13
Participants with event (up to end of ptp) 9 15
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments RD vs. Warfarin for Proportion of patients with symptomatic non-fatal PE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the 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 0.2283
Comments [Not Specified]
Method Kaplan Meier weighted estimates
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (Percentage)
Estimated Value -0.4
Confidence Interval 95%
-1.1 to 0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox 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 0.2101
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.59
Confidence Interval 95%
0.26 to 1.35
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 ptp. 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. Hazard ratios and 95% CI were not calculated because of insufficient number of events.
Time Frame From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Dabigatran 150 mg Warfarin
Hide Arm/Group Description:
bid oral
PRN to maintain an INR of 2.0-3.0
Overall Number of Participants Analyzed 1279 1289
Measure Type: Number
Unit of Measure: participants
Participants with event (up to day 180) 3 0
Participants with event (up to end of ptp) 3 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments RD at 6 months vs. Warfarin for Proportion of patients who died due to VTE . Point estimate and 95% CI for the overall RD obtained based on the 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 0.0830
Comments [Not Specified]
Method Kaplan Meier weighted estimates
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (Percentage)
Estimated Value 0.2
Confidence Interval 95%
0.0 to 0.5
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 ptp. 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.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Dabigatran 150 mg Warfarin
Hide Arm/Group Description:
bid oral
PRN to maintain an INR of 2.0-3.0
Overall Number of Participants Analyzed 1279 1289
Measure Type: Number
Unit of Measure: participants
Participants with event (up to day 180) 25 25
Participants with event (up to end of ptp) 29 26
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments RD at 6 months vs. Warfarin for Proportion of patients who died from any cause. Point estimate and 95% CI for the overall RD obtained based on the 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 0.7348
Comments [Not Specified]
Method Kaplan Meier weighted estimates
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (Percentage)
Estimated Value 0.1
Confidence Interval 95%
-0.7 to 1.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox 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 0.8939
Comments [Not Specified]
Method Regression, Cox
Comments Patients without events are censored at the end of ptp.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.04
Confidence Interval 95%
0.61 to 1.77
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE
Hide Description Symptomatic fatal and non-fatal PE which occured from randomisation to end of ptp. 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.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Dabigatran 150 mg Warfarin
Hide Arm/Group Description:
bid oral
PRN to maintain an INR of 2.0-3.0
Overall Number of Participants Analyzed 1279 1289
Measure Type: Number
Unit of Measure: participants
Participants with event (up to day 180) 8 13
Participants with event (up to end of ptp) 10 15
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments RD vs. Warfarin for Proportion of patients with symptomatic fatal and non-fatal PE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the 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 0.3210
Comments [Not Specified]
Method Kaplan Meier weighted estimates
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (Percentage)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-1.0 to 0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox 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 0.3021
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
0.29 to 1.46
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events
Hide Description

Major bleeding events (MBE) are 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) are defined as

  • spontaneous skin hematoma >=25 cm²
  • wound hematoma >=100 cm²
  • spontaneous nose bleed >5 min
  • macroscopic hematuria spontaneous or >24 hours if associated with an intervention
  • spontaneous rectal bleeding
  • 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
Hide 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 oral
PRN to maintain an INR of 2.0-3.0
Overall Number of Participants Analyzed 1280 1288
Measure Type: Number
Unit of Measure: participants
MBE 15 22
MBE and/or CRBE 64 102
Any bleeding event 200 285
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments HR vs. Warfarin (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of MBE was compared between treatment groups using the Cox 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 [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.69
Confidence Interval 95%
0.36 to 1.32
Estimation Comments This is the analysis of the time to the first MBE.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran 150 mg, Warfarin
Comments HR vs. Warfarin (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of any bleeding was compared between treatment groups using the Cox 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 <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.56 to 0.81
Estimation Comments This is the analysis of the time to the first occurrence of any bleeding event.
9.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). Patients having a centrally adjudicated definite ACS during intake of study drug and after stopping study drug, according to treatment group. ACS assessments pre-specified in the protocol without adjudication. Prior to database lock, the steering committee asked to have ACS events adjudicated by an independent committee. After database lock, the committee was provided with source documentation that was blinded to the patient's treatment assignment. ACS results presented are based on adjudication findings.
Time Frame From first intake of study drug to last contact date
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Dabigatran 150 mg Warfarin
Hide Arm/Group Description:
bid oral
PRN to maintain an INR of 2.0-3.0
Overall Number of Participants Analyzed 1280 1288
Measure Type: Number
Unit of Measure: participants
During intake of study drug 3 0
After stopping study drug 2 1
10.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
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Dabigatran 150 mg Warfarin
Hide Arm/Group Description:
bid oral
PRN to maintain an INR of 2.0-3.0
Overall Number of Participants Analyzed 1238 1248
Measure Type: Number
Unit of Measure: participants
AST increase 29 27
AST decrease 0 0
ALT increase 31 40
ALT decrease 0 0
Bilirubin increase 8 6
Bilirubin decrease 0 0
Time Frame From first intake of study drug to last intake of study drug + 6 days washout
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dabigatran 150 mg Warfarin
Hide Arm/Group Description bid 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   156/1280 (12.19%)   153/1288 (11.88%) 
Blood and lymphatic system disorders     
Anaemia  1  3/1280 (0.23%)  2/1288 (0.16%) 
Coagulopathy  1  0/1280 (0.00%)  1/1288 (0.08%) 
Febrile neutropenia  1  0/1280 (0.00%)  1/1288 (0.08%) 
Haemorrhagic anaemia  1  0/1280 (0.00%)  2/1288 (0.16%) 
Heparin-induced thrombocytopenia  1  1/1280 (0.08%)  0/1288 (0.00%) 
Polycythaemia  1  1/1280 (0.08%)  0/1288 (0.00%) 
Cardiac disorders     
Acute coronary syndrome  1  0/1280 (0.00%)  1/1288 (0.08%) 
Acute myocardial infarction  1  4/1280 (0.31%)  0/1288 (0.00%) 
Angina unstable  1  2/1280 (0.16%)  0/1288 (0.00%) 
Atrial fibrillation  1  2/1280 (0.16%)  1/1288 (0.08%) 
Atrial flutter  1  0/1280 (0.00%)  1/1288 (0.08%) 
Bradycardia  1  0/1280 (0.00%)  1/1288 (0.08%) 
Cardiac arrest  1  3/1280 (0.23%)  0/1288 (0.00%) 
Cardiac failure  1  1/1280 (0.08%)  3/1288 (0.23%) 
Cardiac failure congestive  1  2/1280 (0.16%)  1/1288 (0.08%) 
Myocardial infarction  1  0/1280 (0.00%)  1/1288 (0.08%) 
Myocardial ischaemia  1  0/1280 (0.00%)  1/1288 (0.08%) 
Pericardial effusion  1  0/1280 (0.00%)  1/1288 (0.08%) 
Right ventricular failure  1  0/1280 (0.00%)  1/1288 (0.08%) 
Ventricular fibrillation  1  0/1280 (0.00%)  1/1288 (0.08%) 
Ventricular tachycardia  1  0/1280 (0.00%)  1/1288 (0.08%) 
Ear and labyrinth disorders     
Vertigo  1  1/1280 (0.08%)  0/1288 (0.00%) 
Eye disorders     
Conjunctival haemorrhage  1  0/1280 (0.00%)  1/1288 (0.08%) 
Gastrointestinal disorders     
Abdominal distension  1  1/1280 (0.08%)  0/1288 (0.00%) 
Abdominal pain  1  0/1280 (0.00%)  4/1288 (0.31%) 
Abdominal pain lower  1  0/1280 (0.00%)  1/1288 (0.08%) 
Ascites  1  1/1280 (0.08%)  1/1288 (0.08%) 
Caecitis  1  0/1280 (0.00%)  1/1288 (0.08%) 
Colitis  1  1/1280 (0.08%)  0/1288 (0.00%) 
Constipation  1  0/1280 (0.00%)  1/1288 (0.08%) 
Diarrhoea  1  3/1280 (0.23%)  1/1288 (0.08%) 
Dysphagia  1  0/1280 (0.00%)  1/1288 (0.08%) 
Gastric ulcer haemorrhage  1  1/1280 (0.08%)  1/1288 (0.08%) 
Gastritis alcoholic  1  0/1280 (0.00%)  1/1288 (0.08%) 
Gastritis erosive  1  1/1280 (0.08%)  0/1288 (0.00%) 
Gastrointestinal haemorrhage  1  1/1280 (0.08%)  2/1288 (0.16%) 
Gastrooesophageal reflux disease  1  1/1280 (0.08%)  0/1288 (0.00%) 
Gingival bleeding  1  0/1280 (0.00%)  2/1288 (0.16%) 
Haematemesis  1  0/1280 (0.00%)  1/1288 (0.08%) 
Ileal fistula  1  0/1280 (0.00%)  1/1288 (0.08%) 
Intestinal obstruction  1  2/1280 (0.16%)  0/1288 (0.00%) 
Large intestinal obstruction  1  0/1280 (0.00%)  1/1288 (0.08%) 
Lower gastrointestinal haemorrhage  1  1/1280 (0.08%)  0/1288 (0.00%) 
Melaena  1  1/1280 (0.08%)  1/1288 (0.08%) 
Nausea  1  1/1280 (0.08%)  0/1288 (0.00%) 
Oesophageal varices haemorrhage  1  0/1280 (0.00%)  1/1288 (0.08%) 
Peritoneal haemorrhage  1  0/1280 (0.00%)  1/1288 (0.08%) 
Rectal haemorrhage  1  1/1280 (0.08%)  2/1288 (0.16%) 
Retroperitoneal haemorrhage  1  2/1280 (0.16%)  0/1288 (0.00%) 
Upper gastrointestinal haemorrhage  1  0/1280 (0.00%)  1/1288 (0.08%) 
Vomiting  1  2/1280 (0.16%)  0/1288 (0.00%) 
General disorders     
Asthenia  1  1/1280 (0.08%)  1/1288 (0.08%) 
Chest pain  1  7/1280 (0.55%)  5/1288 (0.39%) 
Death  1  1/1280 (0.08%)  1/1288 (0.08%) 
Fatigue  1  1/1280 (0.08%)  0/1288 (0.00%) 
Impaired healing  1  1/1280 (0.08%)  0/1288 (0.00%) 
Multi-organ failure  1  0/1280 (0.00%)  1/1288 (0.08%) 
Oedema peripheral  1  2/1280 (0.16%)  2/1288 (0.16%) 
Pain  1  2/1280 (0.16%)  0/1288 (0.00%) 
Pyrexia  1  2/1280 (0.16%)  2/1288 (0.16%) 
Hepatobiliary disorders     
Cholecystitis acute  1  0/1280 (0.00%)  1/1288 (0.08%) 
Jaundice  1  1/1280 (0.08%)  0/1288 (0.00%) 
Immune system disorders     
Behcet's syndrome  1  1/1280 (0.08%)  0/1288 (0.00%) 
Hypersensitivity  1  0/1280 (0.00%)  2/1288 (0.16%) 
Infections and infestations     
Abdominal abscess  1  0/1280 (0.00%)  1/1288 (0.08%) 
Abdominal wall abscess  1  1/1280 (0.08%)  0/1288 (0.00%) 
Abscess limb  1  1/1280 (0.08%)  0/1288 (0.00%) 
Anal abscess  1  0/1280 (0.00%)  1/1288 (0.08%) 
Bacterial sepsis  1  1/1280 (0.08%)  1/1288 (0.08%) 
Bone abscess  1  0/1280 (0.00%)  1/1288 (0.08%) 
Bronchitis  1  2/1280 (0.16%)  1/1288 (0.08%) 
Cellulitis  1  5/1280 (0.39%)  4/1288 (0.31%) 
Erysipelas  1  2/1280 (0.16%)  1/1288 (0.08%) 
Gastroenteritis  1  0/1280 (0.00%)  1/1288 (0.08%) 
Gastroenteritis salmonella  1  1/1280 (0.08%)  0/1288 (0.00%) 
Localised infection  1  0/1280 (0.00%)  1/1288 (0.08%) 
Lower respiratory tract infection  1  0/1280 (0.00%)  1/1288 (0.08%) 
Lung infection  1  1/1280 (0.08%)  0/1288 (0.00%) 
Meningitis  1  1/1280 (0.08%)  0/1288 (0.00%) 
Peritonitis bacterial  1  1/1280 (0.08%)  0/1288 (0.00%) 
Pneumonia  1  9/1280 (0.70%)  4/1288 (0.31%) 
Pulmonary tuberculoma  1  1/1280 (0.08%)  0/1288 (0.00%) 
Purulent pericarditis  1  1/1280 (0.08%)  0/1288 (0.00%) 
Pyelonephritis  1  2/1280 (0.16%)  1/1288 (0.08%) 
Respiratory tract infection  1  1/1280 (0.08%)  1/1288 (0.08%) 
Sepsis  1  3/1280 (0.23%)  4/1288 (0.31%) 
Subcutaneous abscess  1  0/1280 (0.00%)  1/1288 (0.08%) 
Syphilis  1  0/1280 (0.00%)  1/1288 (0.08%) 
Tracheobronchitis  1  0/1280 (0.00%)  1/1288 (0.08%) 
Urinary tract infection  1  3/1280 (0.23%)  4/1288 (0.31%) 
Urosepsis  1  1/1280 (0.08%)  0/1288 (0.00%) 
Wound infection  1  1/1280 (0.08%)  1/1288 (0.08%) 
Injury, poisoning and procedural complications     
Alcohol poisoning  1  1/1280 (0.08%)  1/1288 (0.08%) 
Concussion  1  0/1280 (0.00%)  1/1288 (0.08%) 
Fall  1  0/1280 (0.00%)  1/1288 (0.08%) 
Femoral neck fracture  1  0/1280 (0.00%)  1/1288 (0.08%) 
Gun shot wound  1  1/1280 (0.08%)  0/1288 (0.00%) 
Head injury  1  0/1280 (0.00%)  2/1288 (0.16%) 
Hip fracture  1  1/1280 (0.08%)  1/1288 (0.08%) 
Humerus fracture  1  1/1280 (0.08%)  0/1288 (0.00%) 
Incision site haematoma  1  0/1280 (0.00%)  1/1288 (0.08%) 
Multiple fractures  1  1/1280 (0.08%)  0/1288 (0.00%) 
Overdose  1  0/1280 (0.00%)  1/1288 (0.08%) 
Post procedural haematoma  1  1/1280 (0.08%)  0/1288 (0.00%) 
Radial nerve injury  1  1/1280 (0.08%)  0/1288 (0.00%) 
Snake bite  1  0/1280 (0.00%)  1/1288 (0.08%) 
Subdural haematoma  1  0/1280 (0.00%)  2/1288 (0.16%) 
Tendon rupture  1  0/1280 (0.00%)  1/1288 (0.08%) 
Toxicity to various agents  1  0/1280 (0.00%)  1/1288 (0.08%) 
Tracheal haemorrhage  1  0/1280 (0.00%)  1/1288 (0.08%) 
Upper limb fracture  1  0/1280 (0.00%)  1/1288 (0.08%) 
Investigations     
Activated partial thromboplastin time prolonged  1  0/1280 (0.00%)  1/1288 (0.08%) 
Alanine aminotransferase increased  1  0/1280 (0.00%)  2/1288 (0.16%) 
Aspartate aminotransferase increased  1  1/1280 (0.08%)  1/1288 (0.08%) 
Blood bilirubin increased  1  1/1280 (0.08%)  0/1288 (0.00%) 
Coagulation time prolonged  1  1/1280 (0.08%)  0/1288 (0.00%) 
Haemoglobin decreased  1  1/1280 (0.08%)  1/1288 (0.08%) 
Hepatic enzyme increased  1  1/1280 (0.08%)  1/1288 (0.08%) 
International normalised ratio fluctuation  1  0/1280 (0.00%)  1/1288 (0.08%) 
International normalised ratio increased  1  0/1280 (0.00%)  2/1288 (0.16%) 
Prothrombin time prolonged  1  0/1280 (0.00%)  1/1288 (0.08%) 
Metabolism and nutrition disorders     
Dehydration  1  2/1280 (0.16%)  0/1288 (0.00%) 
Diabetes mellitus  1  1/1280 (0.08%)  0/1288 (0.00%) 
Electrolyte imbalance  1  1/1280 (0.08%)  0/1288 (0.00%) 
Hypoglycaemia  1  1/1280 (0.08%)  0/1288 (0.00%) 
Hyponatraemia  1  1/1280 (0.08%)  0/1288 (0.00%) 
Hypophagia  1  1/1280 (0.08%)  0/1288 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthritis  1  0/1280 (0.00%)  1/1288 (0.08%) 
Back pain  1  1/1280 (0.08%)  1/1288 (0.08%) 
Compartment syndrome  1  1/1280 (0.08%)  0/1288 (0.00%) 
Costochondritis  1  1/1280 (0.08%)  0/1288 (0.00%) 
Groin pain  1  0/1280 (0.00%)  2/1288 (0.16%) 
Muscle haemorrhage  1  0/1280 (0.00%)  2/1288 (0.16%) 
Muscular weakness  1  1/1280 (0.08%)  0/1288 (0.00%) 
Osteoarthritis  1  1/1280 (0.08%)  1/1288 (0.08%) 
Osteodystrophy  1  1/1280 (0.08%)  0/1288 (0.00%) 
Pain in extremity  1  2/1280 (0.16%)  1/1288 (0.08%) 
Plantar fasciitis  1  1/1280 (0.08%)  0/1288 (0.00%) 
Rheumatoid arthritis  1  1/1280 (0.08%)  0/1288 (0.00%) 
Systemic lupus erythematosus  1  1/1280 (0.08%)  0/1288 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma  1  1/1280 (0.08%)  0/1288 (0.00%) 
Anal cancer  1  1/1280 (0.08%)  0/1288 (0.00%) 
B-cell lymphoma  1  0/1280 (0.00%)  1/1288 (0.08%) 
Basal cell carcinoma  1  1/1280 (0.08%)  0/1288 (0.00%) 
Benign neoplasm of bladder  1  0/1280 (0.00%)  1/1288 (0.08%) 
Bile duct cancer  1  1/1280 (0.08%)  2/1288 (0.16%) 
Bladder cancer  1  1/1280 (0.08%)  1/1288 (0.08%) 
Bladder cancer recurrent  1  1/1280 (0.08%)  0/1288 (0.00%) 
Brain cancer metastatic  1  1/1280 (0.08%)  0/1288 (0.00%) 
Brain neoplasm malignant  1  0/1280 (0.00%)  1/1288 (0.08%) 
Breast cancer  1  1/1280 (0.08%)  1/1288 (0.08%) 
Breast cancer recurrent  1  0/1280 (0.00%)  1/1288 (0.08%) 
Bronchial carcinoma  1  0/1280 (0.00%)  1/1288 (0.08%) 
Cancer pain  1  1/1280 (0.08%)  0/1288 (0.00%) 
Cervix carcinoma  1  1/1280 (0.08%)  0/1288 (0.00%) 
Colon cancer  1  2/1280 (0.16%)  1/1288 (0.08%) 
Diffuse large B-cell lymphoma  1  0/1280 (0.00%)  1/1288 (0.08%) 
Endometrial cancer  1  1/1280 (0.08%)  0/1288 (0.00%) 
Hepatic cancer metastatic  1  1/1280 (0.08%)  1/1288 (0.08%) 
Hepatic neoplasm malignant  1  2/1280 (0.16%)  1/1288 (0.08%) 
Lung neoplasm malignant  1  2/1280 (0.16%)  0/1288 (0.00%) 
Mantle cell lymphoma  1  1/1280 (0.08%)  0/1288 (0.00%) 
Meningioma  1  1/1280 (0.08%)  0/1288 (0.00%) 
Metastases to central nervous system  1  1/1280 (0.08%)  0/1288 (0.00%) 
Metastases to liver  1  1/1280 (0.08%)  2/1288 (0.16%) 
Metastases to lung  1  0/1280 (0.00%)  1/1288 (0.08%) 
Metastases to lymph nodes  1  1/1280 (0.08%)  1/1288 (0.08%) 
Metastatic neoplasm  1  0/1280 (0.00%)  1/1288 (0.08%) 
Myelodysplastic syndrome  1  0/1280 (0.00%)  1/1288 (0.08%) 
Nasopharyngeal cancer  1  0/1280 (0.00%)  1/1288 (0.08%) 
Neoplasm malignant  1  1/1280 (0.08%)  1/1288 (0.08%) 
Non-Hodgkin's lymphoma  1  0/1280 (0.00%)  2/1288 (0.16%) 
Ovarian cancer  1  2/1280 (0.16%)  1/1288 (0.08%) 
Ovarian cancer recurrent  1  1/1280 (0.08%)  0/1288 (0.00%) 
Pancreatic carcinoma  1  2/1280 (0.16%)  1/1288 (0.08%) 
Prostate cancer  1  1/1280 (0.08%)  2/1288 (0.16%) 
Prostate cancer metastatic  1  0/1280 (0.00%)  1/1288 (0.08%) 
Pseudomyxoma peritonei  1  0/1280 (0.00%)  1/1288 (0.08%) 
Renal cell carcinoma  1  2/1280 (0.16%)  0/1288 (0.00%) 
Squamous cell carcinoma  1  1/1280 (0.08%)  1/1288 (0.08%) 
Uterine cancer  1  0/1280 (0.00%)  1/1288 (0.08%) 
Uterine leiomyoma  1  2/1280 (0.16%)  0/1288 (0.00%) 
Nervous system disorders     
Cerebral haematoma  1  1/1280 (0.08%)  0/1288 (0.00%) 
Cerebral haemorrhage  1  1/1280 (0.08%)  1/1288 (0.08%) 
Cerebral infarction  1  1/1280 (0.08%)  0/1288 (0.00%) 
Cerebrovascular accident  1  0/1280 (0.00%)  2/1288 (0.16%) 
Dizziness  1  2/1280 (0.16%)  1/1288 (0.08%) 
Headache  1  1/1280 (0.08%)  0/1288 (0.00%) 
Ischaemic stroke  1  1/1280 (0.08%)  0/1288 (0.00%) 
Loss of consciousness  1  0/1280 (0.00%)  1/1288 (0.08%) 
Migraine  1  1/1280 (0.08%)  0/1288 (0.00%) 
Neuralgia  1  1/1280 (0.08%)  0/1288 (0.00%) 
Polyneuropathy  1  1/1280 (0.08%)  0/1288 (0.00%) 
Presyncope  1  1/1280 (0.08%)  0/1288 (0.00%) 
Syncope  1  2/1280 (0.16%)  0/1288 (0.00%) 
Transient ischaemic attack  1  1/1280 (0.08%)  0/1288 (0.00%) 
Psychiatric disorders     
Anxiety  1  0/1280 (0.00%)  1/1288 (0.08%) 
Completed suicide  1  1/1280 (0.08%)  0/1288 (0.00%) 
Confusional state  1  0/1280 (0.00%)  1/1288 (0.08%) 
Renal and urinary disorders     
Calculus bladder  1  0/1280 (0.00%)  1/1288 (0.08%) 
Calculus ureteric  1  0/1280 (0.00%)  2/1288 (0.16%) 
Haematuria  1  3/1280 (0.23%)  9/1288 (0.70%) 
Nephrolithiasis  1  1/1280 (0.08%)  0/1288 (0.00%) 
Renal colic  1  1/1280 (0.08%)  1/1288 (0.08%) 
Renal failure  1  1/1280 (0.08%)  0/1288 (0.00%) 
Renal failure acute  1  2/1280 (0.16%)  2/1288 (0.16%) 
Renal impairment  1  0/1280 (0.00%)  1/1288 (0.08%) 
Renal vein thrombosis  1  1/1280 (0.08%)  0/1288 (0.00%) 
Urethral haemorrhage  1  0/1280 (0.00%)  1/1288 (0.08%) 
Urethral stenosis  1  0/1280 (0.00%)  1/1288 (0.08%) 
Urinary retention  1  1/1280 (0.08%)  1/1288 (0.08%) 
Reproductive system and breast disorders     
Gynaecomastia  1  1/1280 (0.08%)  0/1288 (0.00%) 
Ovarian cyst  1  0/1280 (0.00%)  1/1288 (0.08%) 
Pelvic haematoma  1  0/1280 (0.00%)  1/1288 (0.08%) 
Vaginal haemorrhage  1  0/1280 (0.00%)  3/1288 (0.23%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/1280 (0.08%)  0/1288 (0.00%) 
Asthma  1  2/1280 (0.16%)  1/1288 (0.08%) 
Bronchial obstruction  1  0/1280 (0.00%)  1/1288 (0.08%) 
Chronic obstructive pulmonary disease  1  4/1280 (0.31%)  0/1288 (0.00%) 
Dyspnoea  1  3/1280 (0.23%)  8/1288 (0.62%) 
Epistaxis  1  1/1280 (0.08%)  0/1288 (0.00%) 
Haemoptysis  1  2/1280 (0.16%)  2/1288 (0.16%) 
Hyperventilation  1  0/1280 (0.00%)  1/1288 (0.08%) 
Pleural effusion  1  0/1280 (0.00%)  1/1288 (0.08%) 
Pleurisy  1  1/1280 (0.08%)  1/1288 (0.08%) 
Pleuritic pain  1  0/1280 (0.00%)  1/1288 (0.08%) 
Pneumonia aspiration  1  1/1280 (0.08%)  0/1288 (0.00%) 
Pneumothorax  1  0/1280 (0.00%)  1/1288 (0.08%) 
Pulmonary embolism  1  14/1280 (1.09%)  9/1288 (0.70%) 
Pulmonary mass  1  0/1280 (0.00%)  1/1288 (0.08%) 
Respiratory failure  1  2/1280 (0.16%)  0/1288 (0.00%) 
Social circumstances     
Social problem  1  1/1280 (0.08%)  0/1288 (0.00%) 
Surgical and medical procedures     
Intestinal operation  1  1/1280 (0.08%)  0/1288 (0.00%) 
Tenotomy  1  1/1280 (0.08%)  0/1288 (0.00%) 
Vascular disorders     
Aortic stenosis  1  0/1280 (0.00%)  1/1288 (0.08%) 
Circulatory collapse  1  1/1280 (0.08%)  0/1288 (0.00%) 
Deep vein thrombosis  1  13/1280 (1.02%)  8/1288 (0.62%) 
Embolism venous  1  0/1280 (0.00%)  1/1288 (0.08%) 
Haematoma  1  1/1280 (0.08%)  1/1288 (0.08%) 
Haemorrhage  1  2/1280 (0.16%)  1/1288 (0.08%) 
Hypertension  1  1/1280 (0.08%)  1/1288 (0.08%) 
Hypovolaemic shock  1  1/1280 (0.08%)  0/1288 (0.00%) 
Orthostatic hypotension  1  1/1280 (0.08%)  0/1288 (0.00%) 
Peripheral vascular disorder  1  1/1280 (0.08%)  0/1288 (0.00%) 
Subclavian vein thrombosis  1  0/1280 (0.00%)  1/1288 (0.08%) 
Thrombophlebitis  1  0/1280 (0.00%)  1/1288 (0.08%) 
Thrombosis  1  1/1280 (0.08%)  1/1288 (0.08%) 
Vascular compression  1  1/1280 (0.08%)  0/1288 (0.00%) 
Vena cava thrombosis  1  1/1280 (0.08%)  0/1288 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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   124/1280 (9.69%)   126/1288 (9.78%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  75/1280 (5.86%)  69/1288 (5.36%) 
Nervous system disorders     
Headache  1  57/1280 (4.45%)  70/1288 (5.43%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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 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
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00680186     History of Changes
Other Study ID Numbers: 1160.46
2007-002631-86 ( EudraCT Number: EudraCT )
First Submitted: May 16, 2008
First Posted: May 20, 2008
Results First Submitted: May 4, 2012
Results First Posted: June 14, 2012
Last Update Posted: May 19, 2014