Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Dabigatran Etexilate | Embolic Stroke of Undetermined Source | Italy
Previous Study | Return to List | Next Study

Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02239120
Recruitment Status : Completed
First Posted : September 12, 2014
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Stroke
Secondary Prevention
Interventions Drug: optional ASA as comedication
Drug: placebo to ASA
Drug: placebo to optional ASA as comedication
Drug: placebo to dabigatran etexilate
Drug: ASA 100 mg
Drug: dabigatran etexilate
Enrollment 5390
Recruitment Details This was randomised, active comparator, double-blind, 2 arms (1:1 ratio) event-driven Phase III trial in participants with embolic stroke of undetermined source (ESUS). Study was conducted at multiple centers in 42 countries between 3 Dec 2014 (first participant enrollment) and 14 August 2018 (last participant visit).
Pre-assignment Details All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensured that all participants met all inclusion/exclusion criteria. Participants were not to be randomized to trial treatment if any one of the specific entry criteria were not met.
Arm/Group Title Dabigatran Etexilate 110 or 150 Milligram (mg) Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Hide Arm/Group Description Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to <50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged <75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily. Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.
Period Title: Overall Study
Started [1] 2695 2695
Completed 2620 2623
Not Completed 75 72
Reason Not Completed
Death             56             58
Lost to Follow-up             19             14
[1]
Randomised
Arm/Group Title Dabigatran Etexilate 110 or 150 Milligram (mg) Acetylsalicylic Acid, Aspirin (ASA) 100 mg Total
Hide Arm/Group Description Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to <50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged <75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily. Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily. Total of all reporting groups
Overall Number of Baseline Participants 2695 2695 5390
Hide Baseline Analysis Population Description
Randomised set (RS): The RS consisted of all patients who were randomised, regardless of whether they took trial medication. The start date of the observation period for this population was the date of randomisation.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2695 participants 2695 participants 5390 participants
64.5  (11.44) 63.9  (11.39) 64.2  (11.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2695 participants 2695 participants 5390 participants
Female
1001
  37.1%
986
  36.6%
1987
  36.9%
Male
1694
  62.9%
1709
  63.4%
3403
  63.1%
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2695 participants 2695 participants 5390 participants
Hispanic or Latino
281
  10.4%
268
   9.9%
549
  10.2%
Not Hispanic or Latino
2354
  87.3%
2371
  88.0%
4725
  87.7%
Unknown or Not Reported
60
   2.2%
56
   2.1%
116
   2.2%
[1]
Measure Description: Information on race and ethnicity was not collected for all patients in France.
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2695 participants 2695 participants 5390 participants
American Indian or Alaska Native
11
   0.4%
20
   0.7%
31
   0.6%
Asian
631
  23.4%
597
  22.2%
1228
  22.8%
Native Hawaiian or Other Pacific Islander
2
   0.1%
4
   0.1%
6
   0.1%
Black or African American
54
   2.0%
40
   1.5%
94
   1.7%
White
1926
  71.5%
1966
  72.9%
3892
  72.2%
More than one race
10
   0.4%
12
   0.4%
22
   0.4%
Unknown or Not Reported
61
   2.3%
56
   2.1%
117
   2.2%
1.Primary Outcome
Title Adjudicated Recurrent Stroke
Hide Description Adjudicated recurrent stroke (ischemic, hemorrhagic, or unspecified) is presented. The annualised event rate represents the average number of events per patient during a 1-year period.
Time Frame From randomisation until full follow up period, approximately 43 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Randomised set (RS): RS consisted of all participants who were randomised, regardless of whether they took trial medication. The start date of the observation period for this population was the date of randomisation.
Arm/Group Title Dabigatran Etexilate 110 or 150 Milligram (mg) Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Hide Arm/Group Description:
Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to <50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged <75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.
Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.
Overall Number of Participants Analyzed 2695 2695
Measure Type: Number
Unit of Measure: Annualised event rate (%/ year)
4.09 4.80
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 110 or 150 Milligram (mg), Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1028
Comments [Not Specified]
Method Regression, Cox
Comments Covariates in model are age(<or>= 75years), creatinine clearance < or >= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.69 to 1.03
Estimation Comments [Not Specified]
2.Primary Outcome
Title First Major Bleed (Adjudicated)
Hide Description

First major bleed is primary safety endpoint. Major bleeds were defined according to the International Society of Thrombosis and Haemostasis (ISTH) definition as follows:

  • Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or,
  • Bleeding (which should be overt) associated with a reduction in haemoglobin of at least 2 grams/ decilitre (g/dL) (1.24 millimoles Per Litre (mmol/L)), or leading to transfusion of ≥2 units of blood or packed cells (equivalent to ≥4.5 units in Japan); the haemoglobin drop should be considered to be due to and temporally related to the bleeding event and/or,
  • Fatal bleed. The annualised event rate represents the average number of events per patient during a 1-year period.
Time Frame Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated set (TS): TS consisted of all patients who were treated with at least 1 dose of trial medication. The start date of the observation period for this population was the date of first intake of trial medication.
Arm/Group Title Dabigatran Etexilate 110 or 150 Milligram (mg) Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Hide Arm/Group Description:
Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to <50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged <75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.
Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.
Overall Number of Participants Analyzed 2676 2674
Measure Type: Number
Unit of Measure: Annualised event rate (%/ year)
1.84 1.33
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 110 or 150 Milligram (mg), Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1076
Comments [Not Specified]
Method Regression, Cox
Comments Covariates in model are age(<or>= 75years), creatinine clearance < or >= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
0.94 to 1.97
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Adjudicated Ischaemic Stroke
Hide Description Adjudicated ischaemic stroke is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period.
Time Frame From randomisation until full follow up period, up to 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
RS
Arm/Group Title Dabigatran Etexilate 110 or 150 Milligram (mg) Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Hide Arm/Group Description:
Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to <50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged <75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.
Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.
Overall Number of Participants Analyzed 2695 2695
Measure Type: Number
Unit of Measure: Annualised event rate (%/ year)
3.97 4.71
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 110 or 150 Milligram (mg), Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0892
Comments [Not Specified]
Method Regression, Cox
Comments Covariates in model are age(<or>= 75years), creatinine clearance < or >= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.68 to 1.03
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Adjudicated Composite of Non-fatal Stroke, Non-fatal Myocardial Infarction, or Cardiovascular Death
Hide Description Adjudicated composite of non-fatal stroke, non-fatal myocardial infarction (MI), or cardiovascular death is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period.
Time Frame From randomisation until full follow up period, up to 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
RS
Arm/Group Title Dabigatran Etexilate 110 or 150 Milligram (mg) Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Hide Arm/Group Description:
Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to <50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged <75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.
Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.
Overall Number of Participants Analyzed 2695 2695
Measure Type: Number
Unit of Measure: Annualised event rate (%/ year)
4.80 5.40
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 110 or 150 Milligram (mg), Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1911
Comments [Not Specified]
Method Regression, Cox
Comments Covariates in model are age(<or>= 75years), creatinine clearance < or >= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.73 to 1.06
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Disabling Stroke
Hide Description Disabling stroke (modified Rankin Scale greater than or equal to 4, as determined 3 months after recurrent stroke) is presented. The annualised event rate represents the average number of events per patient during a 1-year period.
Time Frame From randomisation until full follow up period, up to 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
RS
Arm/Group Title Dabigatran Etexilate 110 or 150 Milligram (mg) Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Hide Arm/Group Description:
Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to <50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged <75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.
Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.
Overall Number of Participants Analyzed 2695 2695
Measure Type: Number
Unit of Measure: Annualised event rate (%/ year)
0.55 0.93
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 110 or 150 Milligram (mg), Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0354
Comments [Not Specified]
Method Regression, Cox
Comments Covariates in model are age(<or>= 75years), creatinine clearance < or >= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.36 to 0.96
Estimation Comments [Not Specified]
6.Secondary Outcome
Title All-cause Death
Hide Description All-cause death is presented. The annualised event rate represents the average number of events per patient during a 1-year period.
Time Frame From randomisation until full follow up period, up to 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
RS
Arm/Group Title Dabigatran Etexilate 110 or 150 Milligram (mg) Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Hide Arm/Group Description:
Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to <50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged <75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.
Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.
Overall Number of Participants Analyzed 2695 2695
Measure Type: Number
Unit of Measure: Annualised event rate (%/ year)
1.24 1.28
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 110 or 150 Milligram (mg), Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8074
Comments [Not Specified]
Method Regression, Cox
Comments Covariates in model are age(<or>= 75years), creatinine clearance < or >= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.66 to 1.38
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Adjudicated Intracranial Hemorrhage
Hide Description

Adjudicated intracranial haemorrhage comprised the subtypes of intracerebral bleeds, intraventricular bleeds, subdural bleeds, epidural bleeds, and subarachnoid bleeds. Microbleeds did not qualify as intracranial haemorrhage, except when they were symptomatic.

The annualised event rate represents the average number of events per patient during a 1-year period.

Time Frame Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Dabigatran Etexilate 110 or 150 Milligram (mg) Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Hide Arm/Group Description:
Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to <50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged <75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.
Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.
Overall Number of Participants Analyzed 2676 2674
Measure Type: Number
Unit of Measure: Annualised event rate (%/ year)
0.67 0.63
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 110 or 150 Milligram (mg), Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9064
Comments [Not Specified]
Method Regression, Cox
Comments Covariates in model are age(<or>= 75years), creatinine clearance < or >= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.58 to 1.83
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Adjudicated Fatal Bleed
Hide Description Adjudicated fatal bleeding was defined as a bleeding event which the Independent Event Adjudication Committee (IAC) determined as the primary cause of death or contributed directly to death. The annualised event rate represents the average number of events per patient during a 1-year period. Because there were 0 events in one treatment group, the hazard ratio is unable to be calculated.
Time Frame Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Dabigatran Etexilate 110 or 150 Milligram (mg) Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Hide Arm/Group Description:
Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to <50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged <75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.
Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.
Overall Number of Participants Analyzed 2676 2674
Measure Type: Number
Unit of Measure: Annualised event rate (%/ year)
0.00 0.05
9.Secondary Outcome
Title Adjudicated Life-threatening Bleed
Hide Description

Major bleeds were to be classified as life-threatening if they met one or more of the following criteria: fatal bleed, symptomatic intracranial bleed, reduction in haemoglobin of at least 5 grams/ deciliter (g/dL), transfusion of at least 4 units of packed red blood cells (equivalent to 9 units in Japan), associated with hypotension requiring the use of intravenous inotropic agents, or necessitated surgical intervention.

The annualised event rate represents the average number of events per patient during a 1-year period.

Time Frame Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Dabigatran Etexilate 110 or 150 Milligram (mg) Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Hide Arm/Group Description:
Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to <50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged <75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.
Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.
Overall Number of Participants Analyzed 2676 2674
Measure Type: Number
Unit of Measure: Annualised event rate (%/ year)
0.76 0.91
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 110 or 150 Milligram (mg), Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4352
Comments [Not Specified]
Method Regression, Cox
Comments Covariates in model are age(<or>= 75years), creatinine clearance < or >= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.49 to 1.36
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Any Bleed (Investigator-reported)
Hide Description

This was the sum of all major and minor bleeds (Minor bleeds were clinical bleeds that did not fulfil the criteria for major bleeds), regardless of severity.

The annualised event rate represents the average number of events per patient during a 1-year period.

Time Frame Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Dabigatran Etexilate 110 or 150 Milligram (mg) Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Hide Arm/Group Description:
Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to <50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged <75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.
Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.
Overall Number of Participants Analyzed 2676 2674
Measure Type: Number
Unit of Measure: Annualised event rate (%/ year)
15.21 11.64
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 110 or 150 Milligram (mg), Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Regression, Cox
Comments Covariates in model are age(<or>= 75years), creatinine clearance < or >= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
1.12 to 1.47
Estimation Comments [Not Specified]
Time Frame Adverse Events (AE) and serious AE starting between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months. All-cause mortality reported from randomisation until full follow up period, approximately 43 months.
Adverse Event Reporting Description All-cause mortality numbers are based on randomized set whereas Serious Adverse Events (SAE) and non-SAE are based on treated set.
 
Arm/Group Title Dabigatran Etexilate 110 or 150 Milligram (mg) Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Hide Arm/Group Description Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to <50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged <75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily. Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.
All-Cause Mortality
Dabigatran Etexilate 110 or 150 Milligram (mg) Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   56/2695 (2.08%)   58/2695 (2.15%) 
Hide Serious Adverse Events
Dabigatran Etexilate 110 or 150 Milligram (mg) Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   724/2676 (27.06%)   740/2674 (27.67%) 
Blood and lymphatic system disorders     
Anaemia  1  7/2676 (0.26%)  3/2674 (0.11%) 
Pancytopenia  1  1/2676 (0.04%)  0/2674 (0.00%) 
Disseminated intravascular coagulation  1  0/2676 (0.00%)  1/2674 (0.04%) 
Febrile neutropenia  1  0/2676 (0.00%)  1/2674 (0.04%) 
Hypochromic anaemia  1  0/2676 (0.00%)  1/2674 (0.04%) 
Iron deficiency anaemia  1  2/2676 (0.07%)  0/2674 (0.00%) 
Cardiac disorders     
Acute myocardial infarction  1  11/2676 (0.41%)  8/2674 (0.30%) 
Angina pectoris  1  3/2676 (0.11%)  4/2674 (0.15%) 
Angina unstable  1  4/2676 (0.15%)  2/2674 (0.07%) 
Aortic valve incompetence  1  1/2676 (0.04%)  0/2674 (0.00%) 
Atrial fibrillation  1  24/2676 (0.90%)  20/2674 (0.75%) 
Atrial fibrillation or atrial flutter  1  34/2676 (1.27%)  29/2674 (1.08%) 
Atrial flutter  1  10/2676 (0.37%)  10/2674 (0.37%) 
Cardiac disorder  1  1/2676 (0.04%)  0/2674 (0.00%) 
Cardiac failure  1  5/2676 (0.19%)  10/2674 (0.37%) 
Cardiac failure acute  1  1/2676 (0.04%)  2/2674 (0.07%) 
Cardiac failure congestive  1  4/2676 (0.15%)  2/2674 (0.07%) 
Congestive cardiomyopathy  1  0/2676 (0.00%)  1/2674 (0.04%) 
Coronary artery disease  1  6/2676 (0.22%)  11/2674 (0.41%) 
Coronary artery stenosis  1  0/2676 (0.00%)  3/2674 (0.11%) 
Myocardial infarction  1  8/2676 (0.30%)  8/2674 (0.30%) 
Prinzmetal angina  1  2/2676 (0.07%)  1/2674 (0.04%) 
Sinus node dysfunction  1  1/2676 (0.04%)  1/2674 (0.04%) 
Ventricular extrasystoles  1  0/2676 (0.00%)  1/2674 (0.04%) 
Acute coronary syndrome  1  1/2676 (0.04%)  1/2674 (0.04%) 
Arrhythmia  1  1/2676 (0.04%)  2/2674 (0.07%) 
Atrial tachycardia  1  1/2676 (0.04%)  0/2674 (0.00%) 
Atrioventricular block second degree  1  2/2676 (0.07%)  1/2674 (0.04%) 
Bradycardia  1  2/2676 (0.07%)  0/2674 (0.00%) 
Cardiac arrest  1  3/2676 (0.11%)  5/2674 (0.19%) 
Cardiac failure chronic  1  1/2676 (0.04%)  0/2674 (0.00%) 
Cardiac ventricular thrombosis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Cardio-respiratory arrest  1  0/2676 (0.00%)  1/2674 (0.04%) 
Cardiomyopathy  1  0/2676 (0.00%)  1/2674 (0.04%) 
Myocardial ischaemia  1  1/2676 (0.04%)  0/2674 (0.00%) 
Myocarditis  1  2/2676 (0.07%)  0/2674 (0.00%) 
Palpitations  1  2/2676 (0.07%)  0/2674 (0.00%) 
Right ventricular failure  1  0/2676 (0.00%)  1/2674 (0.04%) 
Sinoatrial block  1  1/2676 (0.04%)  0/2674 (0.00%) 
Sinus arrest  1  0/2676 (0.00%)  1/2674 (0.04%) 
Sinus bradycardia  1  1/2676 (0.04%)  0/2674 (0.00%) 
Ventricular tachycardia  1  1/2676 (0.04%)  3/2674 (0.11%) 
Congenital, familial and genetic disorders     
Heart disease congenital  1  0/2676 (0.00%)  1/2674 (0.04%) 
Atrial septal defect  1  3/2676 (0.11%)  4/2674 (0.15%) 
Corneal dystrophy  1  0/2676 (0.00%)  1/2674 (0.04%) 
Cryopyrin associated periodic syndrome  1  1/2676 (0.04%)  0/2674 (0.00%) 
Factor V Leiden mutation  1  0/2676 (0.00%)  1/2674 (0.04%) 
Phimosis  1  4/2676 (0.15%)  1/2674 (0.04%) 
Ventricular septal defect  1  1/2676 (0.04%)  0/2674 (0.00%) 
Ear and labyrinth disorders     
Deafness  1  2/2676 (0.07%)  1/2674 (0.04%) 
Deafness neurosensory  1  2/2676 (0.07%)  0/2674 (0.00%) 
Sudden hearing loss  1  6/2676 (0.22%)  1/2674 (0.04%) 
Vertigo  1  7/2676 (0.26%)  8/2674 (0.30%) 
Vertigo positional  1  3/2676 (0.11%)  3/2674 (0.11%) 
Endocrine disorders     
Inappropriate antidiuretic hormone secretion  1  1/2676 (0.04%)  0/2674 (0.00%) 
Adrenal haematoma  1  1/2676 (0.04%)  0/2674 (0.00%) 
Adrenal mass  1  0/2676 (0.00%)  1/2674 (0.04%) 
Goitre  1  1/2676 (0.04%)  0/2674 (0.00%) 
Hyperthyroidism  1  0/2676 (0.00%)  1/2674 (0.04%) 
Hypothyroidism  1  1/2676 (0.04%)  0/2674 (0.00%) 
Toxic nodular goitre  1  1/2676 (0.04%)  0/2674 (0.00%) 
Eye disorders     
Cataract  1  4/2676 (0.15%)  7/2674 (0.26%) 
Diabetic retinopathy  1  1/2676 (0.04%)  0/2674 (0.00%) 
Eye haemorrhage  1  1/2676 (0.04%)  0/2674 (0.00%) 
Glaucoma  1  6/2676 (0.22%)  6/2674 (0.22%) 
Macular degeneration  1  3/2676 (0.11%)  2/2674 (0.07%) 
Macular fibrosis  1  1/2676 (0.04%)  2/2674 (0.07%) 
Pterygium  1  0/2676 (0.00%)  1/2674 (0.04%) 
Retinal drusen  1  0/2676 (0.00%)  1/2674 (0.04%) 
Vitreous haemorrhage  1  1/2676 (0.04%)  0/2674 (0.00%) 
Age-related macular degeneration  1  1/2676 (0.04%)  0/2674 (0.00%) 
Amaurosis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Amaurosis fugax  1  3/2676 (0.11%)  1/2674 (0.04%) 
Angle closure glaucoma  1  0/2676 (0.00%)  1/2674 (0.04%) 
Blepharitis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Cataract nuclear  1  1/2676 (0.04%)  0/2674 (0.00%) 
Dacryostenosis acquired  1  1/2676 (0.04%)  0/2674 (0.00%) 
Idiopathic orbital inflammation  1  1/2676 (0.04%)  0/2674 (0.00%) 
Macular hole  1  0/2676 (0.00%)  1/2674 (0.04%) 
Narrow anterior chamber angle  1  0/2676 (0.00%)  1/2674 (0.04%) 
Optic atrophy  1  0/2676 (0.00%)  1/2674 (0.04%) 
Optic ischaemic neuropathy  1  0/2676 (0.00%)  1/2674 (0.04%) 
Retinal artery occlusion  1  2/2676 (0.07%)  0/2674 (0.00%) 
Retinal detachment  1  0/2676 (0.00%)  1/2674 (0.04%) 
Retinal tear  1  1/2676 (0.04%)  0/2674 (0.00%) 
Vision blurred  1  1/2676 (0.04%)  0/2674 (0.00%) 
Visual impairment  1  2/2676 (0.07%)  1/2674 (0.04%) 
Gastrointestinal disorders     
Abdominal pain  1  3/2676 (0.11%)  1/2674 (0.04%) 
Colitis  1  0/2676 (0.00%)  2/2674 (0.07%) 
Duodenal ulcer haemorrhage  1  1/2676 (0.04%)  0/2674 (0.00%) 
Enterocolitis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Gastric ulcer  1  2/2676 (0.07%)  1/2674 (0.04%) 
Gastric ulcer haemorrhage  1  2/2676 (0.07%)  1/2674 (0.04%) 
Haematochezia  1  1/2676 (0.04%)  0/2674 (0.00%) 
Haemorrhoids  1  0/2676 (0.00%)  1/2674 (0.04%) 
Hiatus hernia  1  0/2676 (0.00%)  2/2674 (0.07%) 
Inguinal hernia  1  5/2676 (0.19%)  3/2674 (0.11%) 
Intra-abdominal haemorrhage  1  0/2676 (0.00%)  1/2674 (0.04%) 
Ischaemic enteritis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Large intestine polyp  1  2/2676 (0.07%)  1/2674 (0.04%) 
Melaena  1  0/2676 (0.00%)  1/2674 (0.04%) 
Rectal perforation  1  0/2676 (0.00%)  1/2674 (0.04%) 
Upper gastrointestinal haemorrhage  1  1/2676 (0.04%)  3/2674 (0.11%) 
Abdominal discomfort  1  0/2676 (0.00%)  1/2674 (0.04%) 
Abdominal hernia  1  1/2676 (0.04%)  0/2674 (0.00%) 
Abdominal pain upper  1  1/2676 (0.04%)  0/2674 (0.00%) 
Anal fissure  1  1/2676 (0.04%)  0/2674 (0.00%) 
Anal fistula  1  1/2676 (0.04%)  0/2674 (0.00%) 
Appendix disorder  1  0/2676 (0.00%)  1/2674 (0.04%) 
Colitis ischaemic  1  1/2676 (0.04%)  0/2674 (0.00%) 
Colitis ulcerative  1  1/2676 (0.04%)  0/2674 (0.00%) 
Constipation  1  2/2676 (0.07%)  2/2674 (0.07%) 
Diarrhoea  1  1/2676 (0.04%)  1/2674 (0.04%) 
Duodenal ulcer  1  0/2676 (0.00%)  1/2674 (0.04%) 
Erosive oesophagitis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Faecaloma  1  1/2676 (0.04%)  0/2674 (0.00%) 
Gastric haemorrhage  1  2/2676 (0.07%)  1/2674 (0.04%) 
Gastric polyps  1  1/2676 (0.04%)  0/2674 (0.00%) 
Gastritis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Gastrointestinal haemorrhage  1  7/2676 (0.26%)  5/2674 (0.19%) 
Gastrointestinal necrosis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Gastrointestinal ulcer haemorrhage  1  0/2676 (0.00%)  1/2674 (0.04%) 
Gastrooesophageal reflux disease  1  0/2676 (0.00%)  1/2674 (0.04%) 
Haemorrhoidal haemorrhage  1  0/2676 (0.00%)  1/2674 (0.04%) 
Ileal perforation  1  0/2676 (0.00%)  1/2674 (0.04%) 
Ileus  1  1/2676 (0.04%)  1/2674 (0.04%) 
Intestinal ischaemia  1  0/2676 (0.00%)  1/2674 (0.04%) 
Intestinal obstruction  1  0/2676 (0.00%)  3/2674 (0.11%) 
Intestinal perforation  1  1/2676 (0.04%)  0/2674 (0.00%) 
Intestinal polyp  1  1/2676 (0.04%)  0/2674 (0.00%) 
Irritable bowel syndrome  1  1/2676 (0.04%)  0/2674 (0.00%) 
Large intestine perforation  1  1/2676 (0.04%)  0/2674 (0.00%) 
Lower gastrointestinal haemorrhage  1  1/2676 (0.04%)  1/2674 (0.04%) 
Nausea  1  3/2676 (0.11%)  2/2674 (0.07%) 
Pancreatitis acute  1  1/2676 (0.04%)  0/2674 (0.00%) 
Pancreatitis chronic  1  1/2676 (0.04%)  1/2674 (0.04%) 
Peritoneal haemorrhage  1  1/2676 (0.04%)  0/2674 (0.00%) 
Rectal haemorrhage  1  2/2676 (0.07%)  1/2674 (0.04%) 
Retroperitoneal haemorrhage  1  0/2676 (0.00%)  1/2674 (0.04%) 
Small intestinal obstruction  1  0/2676 (0.00%)  2/2674 (0.07%) 
Subileus  1  0/2676 (0.00%)  1/2674 (0.04%) 
Vomiting  1  1/2676 (0.04%)  1/2674 (0.04%) 
General disorders     
Asthenia  1  2/2676 (0.07%)  1/2674 (0.04%) 
Chest pain  1  7/2676 (0.26%)  5/2674 (0.19%) 
Pyrexia  1  2/2676 (0.07%)  2/2674 (0.07%) 
Chest discomfort  1  1/2676 (0.04%)  0/2674 (0.00%) 
Death  1  3/2676 (0.11%)  6/2674 (0.22%) 
Fatigue  1  1/2676 (0.04%)  1/2674 (0.04%) 
Feeling cold  1  0/2676 (0.00%)  1/2674 (0.04%) 
Gait disturbance  1  0/2676 (0.00%)  2/2674 (0.07%) 
General physical health deterioration  1  1/2676 (0.04%)  0/2674 (0.00%) 
Ill-defined disorder  1  1/2676 (0.04%)  0/2674 (0.00%) 
Incarcerated hernia  1  1/2676 (0.04%)  0/2674 (0.00%) 
Inflammation  1  1/2676 (0.04%)  0/2674 (0.00%) 
Malaise  1  0/2676 (0.00%)  3/2674 (0.11%) 
Necrosis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Oedema peripheral  1  2/2676 (0.07%)  0/2674 (0.00%) 
Sudden cardiac death  1  0/2676 (0.00%)  1/2674 (0.04%) 
Sudden death  1  0/2676 (0.00%)  1/2674 (0.04%) 
Vascular stent stenosis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Hepatobiliary disorders     
Bile duct stone  1  0/2676 (0.00%)  3/2674 (0.11%) 
Cholecystitis  1  1/2676 (0.04%)  1/2674 (0.04%) 
Cholecystitis acute  1  3/2676 (0.11%)  1/2674 (0.04%) 
Cholelithiasis  1  4/2676 (0.15%)  3/2674 (0.11%) 
Hepatic function abnormal  1  0/2676 (0.00%)  1/2674 (0.04%) 
Hepatitis acute  1  1/2676 (0.04%)  0/2674 (0.00%) 
Hyperbilirubinaemia  1  1/2676 (0.04%)  0/2674 (0.00%) 
Acute hepatic failure  1  1/2676 (0.04%)  0/2674 (0.00%) 
Bile duct obstruction  1  0/2676 (0.00%)  1/2674 (0.04%) 
Cholecystitis chronic  1  1/2676 (0.04%)  0/2674 (0.00%) 
Hepatic failure  1  1/2676 (0.04%)  0/2674 (0.00%) 
Jaundice  1  0/2676 (0.00%)  1/2674 (0.04%) 
Jaundice cholestatic  1  0/2676 (0.00%)  1/2674 (0.04%) 
Immune system disorders     
Anaphylactic reaction  1  1/2676 (0.04%)  0/2674 (0.00%) 
Hypersensitivity  1  1/2676 (0.04%)  0/2674 (0.00%) 
Infections and infestations     
Appendicitis  1  2/2676 (0.07%)  2/2674 (0.07%) 
Bronchitis  1  2/2676 (0.07%)  1/2674 (0.04%) 
Bronchitis bacterial  1  0/2676 (0.00%)  1/2674 (0.04%) 
Cellulitis  1  3/2676 (0.11%)  1/2674 (0.04%) 
Erysipelas  1  2/2676 (0.07%)  0/2674 (0.00%) 
Escherichia sepsis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Infectious pleural effusion  1  0/2676 (0.00%)  1/2674 (0.04%) 
Influenza  1  5/2676 (0.19%)  4/2674 (0.15%) 
Periodontitis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Peritonitis  1  2/2676 (0.07%)  2/2674 (0.07%) 
Pneumonia  1  18/2676 (0.67%)  14/2674 (0.52%) 
Pneumonia bacterial  1  0/2676 (0.00%)  1/2674 (0.04%) 
Pyelonephritis acute  1  3/2676 (0.11%)  4/2674 (0.15%) 
Sepsis  1  5/2676 (0.19%)  6/2674 (0.22%) 
Tuberculous pleurisy  1  1/2676 (0.04%)  0/2674 (0.00%) 
Urinary tract infection  1  13/2676 (0.49%)  5/2674 (0.19%) 
Appendiceal abscess  1  1/2676 (0.04%)  0/2674 (0.00%) 
Arthritis bacterial  1  0/2676 (0.00%)  2/2674 (0.07%) 
Conjunctivitis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Cystitis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Dengue fever  1  1/2676 (0.04%)  0/2674 (0.00%) 
Device related infection  1  0/2676 (0.00%)  1/2674 (0.04%) 
Diverticulitis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Diverticulitis intestinal haemorrhagic  1  2/2676 (0.07%)  0/2674 (0.00%) 
Ear infection  1  1/2676 (0.04%)  0/2674 (0.00%) 
Endocarditis  1  0/2676 (0.00%)  2/2674 (0.07%) 
Epididymitis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Gangrene  1  0/2676 (0.00%)  2/2674 (0.07%) 
Gastroenteritis  1  3/2676 (0.11%)  2/2674 (0.07%) 
Gastroenteritis norovirus  1  1/2676 (0.04%)  1/2674 (0.04%) 
Haematoma infection  1  1/2676 (0.04%)  0/2674 (0.00%) 
Herpes zoster  1  1/2676 (0.04%)  0/2674 (0.00%) 
Infection  1  2/2676 (0.07%)  0/2674 (0.00%) 
Leptospirosis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Meningitis bacterial  1  1/2676 (0.04%)  0/2674 (0.00%) 
Mycotoxicosis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Neuroborreliosis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Neurosyphilis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Orchitis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Osteomyelitis  1  0/2676 (0.00%)  2/2674 (0.07%) 
Otitis media acute  1  1/2676 (0.04%)  0/2674 (0.00%) 
Parotitis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Perineal abscess  1  1/2676 (0.04%)  0/2674 (0.00%) 
Perirectal abscess  1  1/2676 (0.04%)  0/2674 (0.00%) 
Peritonitis bacterial  1  0/2676 (0.00%)  1/2674 (0.04%) 
Peritonsillar abscess  1  0/2676 (0.00%)  1/2674 (0.04%) 
Pneumonia viral  1  0/2676 (0.00%)  1/2674 (0.04%) 
Postoperative wound infection  1  1/2676 (0.04%)  0/2674 (0.00%) 
Pulmonary sepsis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Pulpitis dental  1  0/2676 (0.00%)  1/2674 (0.04%) 
Pyelonephritis  1  1/2676 (0.04%)  1/2674 (0.04%) 
Respiratory tract infection  1  2/2676 (0.07%)  3/2674 (0.11%) 
Septic embolus  1  0/2676 (0.00%)  1/2674 (0.04%) 
Septic shock  1  2/2676 (0.07%)  0/2674 (0.00%) 
Sialoadenitis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Thrombophlebitis septic  1  1/2676 (0.04%)  0/2674 (0.00%) 
Urosepsis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Vestibular neuronitis  1  1/2676 (0.04%)  1/2674 (0.04%) 
Injury, poisoning and procedural complications     
Airway burns  1  1/2676 (0.04%)  0/2674 (0.00%) 
Ankle fracture  1  4/2676 (0.15%)  2/2674 (0.07%) 
Arterial injury  1  1/2676 (0.04%)  0/2674 (0.00%) 
Clavicle fracture  1  0/2676 (0.00%)  1/2674 (0.04%) 
Contusion  1  2/2676 (0.07%)  1/2674 (0.04%) 
Fall  1  21/2676 (0.78%)  9/2674 (0.34%) 
Femoral neck fracture  1  3/2676 (0.11%)  1/2674 (0.04%) 
Femur fracture  1  3/2676 (0.11%)  2/2674 (0.07%) 
Joint injury  1  1/2676 (0.04%)  0/2674 (0.00%) 
Laceration  1  1/2676 (0.04%)  3/2674 (0.11%) 
Ligament sprain  1  1/2676 (0.04%)  2/2674 (0.07%) 
Meniscus injury  1  4/2676 (0.15%)  2/2674 (0.07%) 
Multiple fractures  1  1/2676 (0.04%)  1/2674 (0.04%) 
Near drowning  1  1/2676 (0.04%)  0/2674 (0.00%) 
Overdose  1  1/2676 (0.04%)  0/2674 (0.00%) 
Postoperative ileus  1  1/2676 (0.04%)  0/2674 (0.00%) 
Radius fracture  1  2/2676 (0.07%)  4/2674 (0.15%) 
Rib fracture  1  4/2676 (0.15%)  1/2674 (0.04%) 
Road traffic accident  1  2/2676 (0.07%)  2/2674 (0.07%) 
Spinal compression fracture  1  3/2676 (0.11%)  3/2674 (0.11%) 
Spinal cord injury  1  1/2676 (0.04%)  0/2674 (0.00%) 
Spinal cord injury cervical  1  0/2676 (0.00%)  1/2674 (0.04%) 
Spinal fracture  1  1/2676 (0.04%)  0/2674 (0.00%) 
Subarachnoid haemorrhage  1  2/2676 (0.07%)  4/2674 (0.15%) 
Subdural haematoma  1  7/2676 (0.26%)  3/2674 (0.11%) 
Subdural haemorrhage  1  3/2676 (0.11%)  1/2674 (0.04%) 
Thermal burn  1  1/2676 (0.04%)  0/2674 (0.00%) 
Tibia fracture  1  0/2676 (0.00%)  1/2674 (0.04%) 
Traumatic haemothorax  1  1/2676 (0.04%)  0/2674 (0.00%) 
Upper limb fracture  1  0/2676 (0.00%)  3/2674 (0.11%) 
Wound  1  1/2676 (0.04%)  0/2674 (0.00%) 
Wrist fracture  1  2/2676 (0.07%)  1/2674 (0.04%) 
Acetabulum fracture  1  1/2676 (0.04%)  0/2674 (0.00%) 
Alcohol poisoning  1  1/2676 (0.04%)  0/2674 (0.00%) 
Cervical vertebral fracture  1  0/2676 (0.00%)  2/2674 (0.07%) 
Chest injury  1  1/2676 (0.04%)  0/2674 (0.00%) 
Concussion  1  2/2676 (0.07%)  2/2674 (0.07%) 
Exposure during pregnancy  1  1/2676 (0.04%)  0/2674 (0.00%) 
Facial bones fracture  1  2/2676 (0.07%)  0/2674 (0.00%) 
Foot fracture  1  2/2676 (0.07%)  0/2674 (0.00%) 
Fracture  1  1/2676 (0.04%)  0/2674 (0.00%) 
Fracture displacement  1  0/2676 (0.00%)  1/2674 (0.04%) 
Hand fracture  1  0/2676 (0.00%)  2/2674 (0.07%) 
Head injury  1  1/2676 (0.04%)  0/2674 (0.00%) 
Hip fracture  1  2/2676 (0.07%)  1/2674 (0.04%) 
Humerus fracture  1  0/2676 (0.00%)  2/2674 (0.07%) 
Injury  1  2/2676 (0.07%)  0/2674 (0.00%) 
Intentional overdose  1  1/2676 (0.04%)  0/2674 (0.00%) 
Jaw fracture  1  0/2676 (0.00%)  1/2674 (0.04%) 
Joint dislocation  1  1/2676 (0.04%)  0/2674 (0.00%) 
Ligament rupture  1  1/2676 (0.04%)  0/2674 (0.00%) 
Limb injury  1  0/2676 (0.00%)  3/2674 (0.11%) 
Limb traumatic amputation  1  0/2676 (0.00%)  1/2674 (0.04%) 
Lower limb fracture  1  0/2676 (0.00%)  1/2674 (0.04%) 
Lumbar vertebral fracture  1  1/2676 (0.04%)  0/2674 (0.00%) 
Multiple injuries  1  0/2676 (0.00%)  1/2674 (0.04%) 
Muscle strain  1  0/2676 (0.00%)  1/2674 (0.04%) 
Pelvic fracture  1  0/2676 (0.00%)  1/2674 (0.04%) 
Poisoning deliberate  1  1/2676 (0.04%)  0/2674 (0.00%) 
Pubis fracture  1  1/2676 (0.04%)  0/2674 (0.00%) 
Pulmonary contusion  1  1/2676 (0.04%)  0/2674 (0.00%) 
Scapula fracture  1  1/2676 (0.04%)  0/2674 (0.00%) 
Skull fracture  1  1/2676 (0.04%)  0/2674 (0.00%) 
Tendon rupture  1  0/2676 (0.00%)  1/2674 (0.04%) 
Thoracic vertebral fracture  1  1/2676 (0.04%)  1/2674 (0.04%) 
Traumatic intracranial haemorrhage  1  2/2676 (0.07%)  1/2674 (0.04%) 
Ulna fracture  1  1/2676 (0.04%)  1/2674 (0.04%) 
Investigations     
Alanine aminotransferase increased  1  1/2676 (0.04%)  0/2674 (0.00%) 
Aspartate aminotransferase increased  1  1/2676 (0.04%)  0/2674 (0.00%) 
Creatinine renal clearance decreased  1  1/2676 (0.04%)  0/2674 (0.00%) 
Bile duct pressure increased  1  0/2676 (0.00%)  1/2674 (0.04%) 
Blood creatinine increased  1  0/2676 (0.00%)  1/2674 (0.04%) 
Blood glucose increased  1  1/2676 (0.04%)  0/2674 (0.00%) 
Blood pressure increased  1  0/2676 (0.00%)  1/2674 (0.04%) 
Computerised tomogram thorax abnormal  1  0/2676 (0.00%)  1/2674 (0.04%) 
Electrocardiogram Q waves  1  1/2676 (0.04%)  0/2674 (0.00%) 
Gamma-glutamyltransferase increased  1  0/2676 (0.00%)  1/2674 (0.04%) 
Haemoglobin decreased  1  0/2676 (0.00%)  1/2674 (0.04%) 
Influenza A virus test positive  1  0/2676 (0.00%)  1/2674 (0.04%) 
Prostatic specific antigen increased  1  0/2676 (0.00%)  1/2674 (0.04%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  3/2676 (0.11%)  0/2674 (0.00%) 
Diabetes mellitus inadequate control  1  1/2676 (0.04%)  2/2674 (0.07%) 
Hyperglycaemia  1  1/2676 (0.04%)  0/2674 (0.00%) 
Hypokalaemia  1  2/2676 (0.07%)  3/2674 (0.11%) 
Hyponatraemia  1  2/2676 (0.07%)  2/2674 (0.07%) 
Type 2 diabetes mellitus  1  1/2676 (0.04%)  2/2674 (0.07%) 
Dehydration  1  1/2676 (0.04%)  1/2674 (0.04%) 
Gout  1  0/2676 (0.00%)  1/2674 (0.04%) 
Hypoglycaemia  1  0/2676 (0.00%)  1/2674 (0.04%) 
Hypovolaemia  1  1/2676 (0.04%)  0/2674 (0.00%) 
Lactic acidosis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Metabolic acidosis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Obesity  1  0/2676 (0.00%)  1/2674 (0.04%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/2676 (0.11%)  2/2674 (0.07%) 
Back pain  1  3/2676 (0.11%)  2/2674 (0.07%) 
Diffuse idiopathic skeletal hyperostosis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Fracture nonunion  1  1/2676 (0.04%)  0/2674 (0.00%) 
Intervertebral disc degeneration  1  0/2676 (0.00%)  1/2674 (0.04%) 
Intervertebral disc protrusion  1  3/2676 (0.11%)  4/2674 (0.15%) 
Lumbar spinal stenosis  1  1/2676 (0.04%)  1/2674 (0.04%) 
Osteoarthritis  1  12/2676 (0.45%)  19/2674 (0.71%) 
Osteonecrosis  1  1/2676 (0.04%)  1/2674 (0.04%) 
Rotator cuff syndrome  1  3/2676 (0.11%)  0/2674 (0.00%) 
Systemic lupus erythematosus  1  0/2676 (0.00%)  1/2674 (0.04%) 
Arthritis  1  2/2676 (0.07%)  0/2674 (0.00%) 
Bursitis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Cervical spinal stenosis  1  0/2676 (0.00%)  2/2674 (0.07%) 
Foot deformity  1  1/2676 (0.04%)  1/2674 (0.04%) 
Groin pain  1  0/2676 (0.00%)  1/2674 (0.04%) 
Haemarthrosis  1  2/2676 (0.07%)  1/2674 (0.04%) 
Intervertebral disc disorder  1  0/2676 (0.00%)  1/2674 (0.04%) 
Jaw cyst  1  0/2676 (0.00%)  1/2674 (0.04%) 
Joint stiffness  1  1/2676 (0.04%)  0/2674 (0.00%) 
Limb discomfort  1  0/2676 (0.00%)  1/2674 (0.04%) 
Meniscal degeneration  1  1/2676 (0.04%)  0/2674 (0.00%) 
Mobility decreased  1  0/2676 (0.00%)  1/2674 (0.04%) 
Muscle haemorrhage  1  1/2676 (0.04%)  0/2674 (0.00%) 
Muscular weakness  1  0/2676 (0.00%)  1/2674 (0.04%) 
Musculoskeletal chest pain  1  2/2676 (0.07%)  2/2674 (0.07%) 
Musculoskeletal pain  1  2/2676 (0.07%)  1/2674 (0.04%) 
Necrotising myositis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Osteitis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Osteoporotic fracture  1  1/2676 (0.04%)  0/2674 (0.00%) 
Polymyalgia rheumatica  1  2/2676 (0.07%)  1/2674 (0.04%) 
Pseudarthrosis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Psoriatic arthropathy  1  1/2676 (0.04%)  0/2674 (0.00%) 
Rhabdomyolysis  1  1/2676 (0.04%)  1/2674 (0.04%) 
Spinal osteoarthritis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Synovial cyst  1  1/2676 (0.04%)  0/2674 (0.00%) 
Systemic scleroderma  1  1/2676 (0.04%)  0/2674 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenoma benign  1  0/2676 (0.00%)  1/2674 (0.04%) 
Basal cell carcinoma  1  9/2676 (0.34%)  12/2674 (0.45%) 
Bowen's disease  1  2/2676 (0.07%)  2/2674 (0.07%) 
Brain neoplasm  1  1/2676 (0.04%)  3/2674 (0.11%) 
Brain neoplasm malignant  1  0/2676 (0.00%)  1/2674 (0.04%) 
Breast cancer  1  1/2676 (0.04%)  1/2674 (0.04%) 
Carcinoid tumour  1  1/2676 (0.04%)  0/2674 (0.00%) 
Cerebellar haemangioma  1  0/2676 (0.00%)  1/2674 (0.04%) 
Cholangiocarcinoma  1  2/2676 (0.07%)  1/2674 (0.04%) 
Colon adenoma  1  0/2676 (0.00%)  2/2674 (0.07%) 
Colon cancer  1  8/2676 (0.30%)  2/2674 (0.07%) 
Colon cancer stage IV  1  0/2676 (0.00%)  1/2674 (0.04%) 
Colon neoplasm  1  1/2676 (0.04%)  0/2674 (0.00%) 
Endometrial cancer  1  1/2676 (0.04%)  0/2674 (0.00%) 
Gastric adenoma  1  1/2676 (0.04%)  0/2674 (0.00%) 
Gastric cancer  1  3/2676 (0.11%)  3/2674 (0.11%) 
Glioblastoma multiforme  1  2/2676 (0.07%)  1/2674 (0.04%) 
Hepatocellular carcinoma  1  0/2676 (0.00%)  1/2674 (0.04%) 
Hypopharyngeal cancer  1  1/2676 (0.04%)  0/2674 (0.00%) 
Laryngeal cancer stage 0  1  0/2676 (0.00%)  1/2674 (0.04%) 
Lip and/or oral cavity cancer  1  0/2676 (0.00%)  1/2674 (0.04%) 
Lung neoplasm malignant  1  2/2676 (0.07%)  1/2674 (0.04%) 
Malignant melanoma  1  2/2676 (0.07%)  2/2674 (0.07%) 
Myelodysplastic syndrome  1  1/2676 (0.04%)  1/2674 (0.04%) 
Papillary thyroid cancer  1  3/2676 (0.11%)  1/2674 (0.04%) 
Plasma cell myeloma  1  0/2676 (0.00%)  1/2674 (0.04%) 
Prostate cancer  1  7/2676 (0.26%)  6/2674 (0.22%) 
Uterine leiomyoma  1  1/2676 (0.04%)  0/2674 (0.00%) 
Adenocarcinoma of colon  1  1/2676 (0.04%)  3/2674 (0.11%) 
B-cell lymphoma  1  0/2676 (0.00%)  1/2674 (0.04%) 
Bladder cancer  1  1/2676 (0.04%)  2/2674 (0.07%) 
Bladder cancer recurrent  1  1/2676 (0.04%)  0/2674 (0.00%) 
Bladder neoplasm  1  1/2676 (0.04%)  1/2674 (0.04%) 
Bladder transitional cell carcinoma  1  1/2676 (0.04%)  0/2674 (0.00%) 
Breast cancer recurrent  1  0/2676 (0.00%)  1/2674 (0.04%) 
Clear cell renal cell carcinoma  1  0/2676 (0.00%)  1/2674 (0.04%) 
Colon cancer metastatic  1  1/2676 (0.04%)  0/2674 (0.00%) 
Colorectal cancer  1  0/2676 (0.00%)  1/2674 (0.04%) 
Duodenal neoplasm  1  0/2676 (0.00%)  1/2674 (0.04%) 
Endometrial adenocarcinoma  1  1/2676 (0.04%)  0/2674 (0.00%) 
Essential thrombocythaemia  1  0/2676 (0.00%)  1/2674 (0.04%) 
Invasive breast carcinoma  1  0/2676 (0.00%)  1/2674 (0.04%) 
Laryngeal cancer  1  0/2676 (0.00%)  2/2674 (0.07%) 
Lung adenocarcinoma  1  0/2676 (0.00%)  2/2674 (0.07%) 
Lung neoplasm  1  0/2676 (0.00%)  1/2674 (0.04%) 
Malignant melanoma in situ  1  1/2676 (0.04%)  0/2674 (0.00%) 
Metastases to liver  1  0/2676 (0.00%)  1/2674 (0.04%) 
Metastases to lung  1  0/2676 (0.00%)  2/2674 (0.07%) 
Metastases to lymph nodes  1  0/2676 (0.00%)  1/2674 (0.04%) 
Metastatic bronchial carcinoma  1  1/2676 (0.04%)  0/2674 (0.00%) 
Metastatic malignant melanoma  1  1/2676 (0.04%)  0/2674 (0.00%) 
Myelofibrosis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Myeloproliferative neoplasm  1  0/2676 (0.00%)  1/2674 (0.04%) 
Non-Hodgkin's lymphoma  1  1/2676 (0.04%)  0/2674 (0.00%) 
Oesophageal squamous cell carcinoma  1  0/2676 (0.00%)  1/2674 (0.04%) 
Ovarian adenoma  1  0/2676 (0.00%)  1/2674 (0.04%) 
Ovarian epithelial cancer metastatic  1  1/2676 (0.04%)  0/2674 (0.00%) 
Polycythaemia vera  1  0/2676 (0.00%)  1/2674 (0.04%) 
Prostate cancer recurrent  1  0/2676 (0.00%)  1/2674 (0.04%) 
Prostatic adenoma  1  1/2676 (0.04%)  0/2674 (0.00%) 
Rectal cancer  1  0/2676 (0.00%)  1/2674 (0.04%) 
Renal cancer  1  0/2676 (0.00%)  2/2674 (0.07%) 
Renal cell carcinoma recurrent  1  0/2676 (0.00%)  1/2674 (0.04%) 
Skin cancer  1  1/2676 (0.04%)  0/2674 (0.00%) 
Small intestine carcinoma  1  0/2676 (0.00%)  1/2674 (0.04%) 
Squamous cell carcinoma  1  3/2676 (0.11%)  1/2674 (0.04%) 
Squamous cell carcinoma of skin  1  0/2676 (0.00%)  2/2674 (0.07%) 
Squamous cell carcinoma of the vulva  1  1/2676 (0.04%)  0/2674 (0.00%) 
Thymoma  1  0/2676 (0.00%)  1/2674 (0.04%) 
Transitional cell carcinoma  1  1/2676 (0.04%)  0/2674 (0.00%) 
Tumour obstruction  1  0/2676 (0.00%)  1/2674 (0.04%) 
Nervous system disorders     
Brain stem infarction  1  1/2676 (0.04%)  0/2674 (0.00%) 
Cerebellar infarction  1  0/2676 (0.00%)  3/2674 (0.11%) 
Cerebral haemorrhage  1  1/2676 (0.04%)  0/2674 (0.00%) 
Cerebral infarction  1  25/2676 (0.93%)  42/2674 (1.57%) 
Cerebrovascular accident  1  95/2676 (3.55%)  97/2674 (3.63%) 
Diplegia  1  0/2676 (0.00%)  1/2674 (0.04%) 
Embolic cerebral infarction  1  0/2676 (0.00%)  1/2674 (0.04%) 
Embolic stroke  1  1/2676 (0.04%)  2/2674 (0.07%) 
Epilepsy  1  18/2676 (0.67%)  25/2674 (0.93%) 
Haemorrhagic cerebral infarction  1  1/2676 (0.04%)  1/2674 (0.04%) 
Headache  1  3/2676 (0.11%)  3/2674 (0.11%) 
Hemianaesthesia  1  2/2676 (0.07%)  2/2674 (0.07%) 
Hemiparesis  1  5/2676 (0.19%)  3/2674 (0.11%) 
Hypoaesthesia  1  1/2676 (0.04%)  4/2674 (0.15%) 
Intracranial aneurysm  1  1/2676 (0.04%)  0/2674 (0.00%) 
Ischaemic cerebral infarction  1  1/2676 (0.04%)  2/2674 (0.07%) 
Ischaemic stroke  1  47/2676 (1.76%)  45/2674 (1.68%) 
Lacunar infarction  1  0/2676 (0.00%)  1/2674 (0.04%) 
Multiple sclerosis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Muscle spasticity  1  0/2676 (0.00%)  1/2674 (0.04%) 
Post stroke seizure  1  3/2676 (0.11%)  0/2674 (0.00%) 
Seizure  1  17/2676 (0.64%)  16/2674 (0.60%) 
Temporal lobe epilepsy  1  0/2676 (0.00%)  1/2674 (0.04%) 
Thrombotic cerebral infarction  1  0/2676 (0.00%)  1/2674 (0.04%) 
Transient ischaemic attack  1  46/2676 (1.72%)  41/2674 (1.53%) 
Vertebrobasilar insufficiency  1  1/2676 (0.04%)  2/2674 (0.07%) 
Aphasia  1  2/2676 (0.07%)  2/2674 (0.07%) 
Ataxia  1  1/2676 (0.04%)  0/2674 (0.00%) 
Brain injury  1  1/2676 (0.04%)  0/2674 (0.00%) 
Brain stem stroke  1  1/2676 (0.04%)  0/2674 (0.00%) 
Carotid arteriosclerosis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Carotid artery aneurysm  1  1/2676 (0.04%)  0/2674 (0.00%) 
Carotid artery stenosis  1  3/2676 (0.11%)  3/2674 (0.11%) 
Carpal tunnel syndrome  1  0/2676 (0.00%)  1/2674 (0.04%) 
Central pain syndrome  1  1/2676 (0.04%)  0/2674 (0.00%) 
Cerebellar stroke  1  1/2676 (0.04%)  0/2674 (0.00%) 
Cerebral cyst  1  0/2676 (0.00%)  1/2674 (0.04%) 
Cerebral ischaemia  1  1/2676 (0.04%)  1/2674 (0.04%) 
Cerebral vasoconstriction  1  1/2676 (0.04%)  0/2674 (0.00%) 
Cervicobrachial syndrome  1  1/2676 (0.04%)  0/2674 (0.00%) 
Cervicogenic headache  1  0/2676 (0.00%)  1/2674 (0.04%) 
Cubital tunnel syndrome  1  0/2676 (0.00%)  1/2674 (0.04%) 
Dementia  1  1/2676 (0.04%)  2/2674 (0.07%) 
Diabetic neuropathy  1  1/2676 (0.04%)  0/2674 (0.00%) 
Dizziness  1  8/2676 (0.30%)  4/2674 (0.15%) 
Dizziness postural  1  1/2676 (0.04%)  0/2674 (0.00%) 
Encephalopathy  1  2/2676 (0.07%)  1/2674 (0.04%) 
Facial paralysis  1  0/2676 (0.00%)  3/2674 (0.11%) 
Facial paresis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Focal dyscognitive seizures  1  1/2676 (0.04%)  0/2674 (0.00%) 
Generalised tonic-clonic seizure  1  2/2676 (0.07%)  1/2674 (0.04%) 
Guillain-Barre syndrome  1  0/2676 (0.00%)  1/2674 (0.04%) 
Haemorrhage intracranial  1  1/2676 (0.04%)  1/2674 (0.04%) 
Haemorrhagic stroke  1  1/2676 (0.04%)  0/2674 (0.00%) 
Haemorrhagic transformation stroke  1  1/2676 (0.04%)  0/2674 (0.00%) 
Hypertensive encephalopathy  1  0/2676 (0.00%)  1/2674 (0.04%) 
Hypoglycaemic coma  1  1/2676 (0.04%)  0/2674 (0.00%) 
Hypoxic-ischaemic encephalopathy  1  0/2676 (0.00%)  1/2674 (0.04%) 
Loss of consciousness  1  1/2676 (0.04%)  0/2674 (0.00%) 
Memory impairment  1  0/2676 (0.00%)  1/2674 (0.04%) 
Metabolic encephalopathy  1  1/2676 (0.04%)  0/2674 (0.00%) 
Migraine  1  2/2676 (0.07%)  2/2674 (0.07%) 
Migraine with aura  1  1/2676 (0.04%)  1/2674 (0.04%) 
Monoparesis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Monoplegia  1  0/2676 (0.00%)  1/2674 (0.04%) 
Neuralgia  1  1/2676 (0.04%)  1/2674 (0.04%) 
Neuralgic amyotrophy  1  1/2676 (0.04%)  0/2674 (0.00%) 
Neurodegenerative disorder  1  0/2676 (0.00%)  1/2674 (0.04%) 
Neuroglycopenia  1  1/2676 (0.04%)  0/2674 (0.00%) 
Neurological symptom  1  0/2676 (0.00%)  2/2674 (0.07%) 
Neuropathy peripheral  1  1/2676 (0.04%)  1/2674 (0.04%) 
Paraesthesia  1  2/2676 (0.07%)  2/2674 (0.07%) 
Partial seizures  1  5/2676 (0.19%)  5/2674 (0.19%) 
Polyneuropathy  1  0/2676 (0.00%)  1/2674 (0.04%) 
Post stroke epilepsy  1  2/2676 (0.07%)  2/2674 (0.07%) 
Presyncope  1  1/2676 (0.04%)  0/2674 (0.00%) 
Pseudostroke  1  0/2676 (0.00%)  1/2674 (0.04%) 
Radial nerve compression  1  0/2676 (0.00%)  1/2674 (0.04%) 
Sciatica  1  2/2676 (0.07%)  2/2674 (0.07%) 
Sensory disturbance  1  0/2676 (0.00%)  1/2674 (0.04%) 
Sensory loss  1  1/2676 (0.04%)  0/2674 (0.00%) 
Status epilepticus  1  3/2676 (0.11%)  1/2674 (0.04%) 
Syncope  1  8/2676 (0.30%)  6/2674 (0.22%) 
Tonic convulsion  1  0/2676 (0.00%)  1/2674 (0.04%) 
Transient global amnesia  1  0/2676 (0.00%)  2/2674 (0.07%) 
Visual field defect  1  0/2676 (0.00%)  1/2674 (0.04%) 
Vocal cord paralysis  1  0/2676 (0.00%)  2/2674 (0.07%) 
Product Issues     
Device dislocation  1  0/2676 (0.00%)  1/2674 (0.04%) 
Psychiatric disorders     
Adjustment disorder  1  1/2676 (0.04%)  1/2674 (0.04%) 
Anxiety  1  1/2676 (0.04%)  2/2674 (0.07%) 
Bipolar disorder  1  0/2676 (0.00%)  1/2674 (0.04%) 
Completed suicide  1  1/2676 (0.04%)  1/2674 (0.04%) 
Delirium  1  5/2676 (0.19%)  2/2674 (0.07%) 
Depression  1  7/2676 (0.26%)  4/2674 (0.15%) 
Major depression  1  1/2676 (0.04%)  0/2674 (0.00%) 
Suicidal ideation  1  2/2676 (0.07%)  3/2674 (0.11%) 
Aggression  1  0/2676 (0.00%)  1/2674 (0.04%) 
Alcohol withdrawal syndrome  1  1/2676 (0.04%)  0/2674 (0.00%) 
Bipolar I disorder  1  0/2676 (0.00%)  1/2674 (0.04%) 
Confusional state  1  2/2676 (0.07%)  1/2674 (0.04%) 
Generalised anxiety disorder  1  1/2676 (0.04%)  0/2674 (0.00%) 
Hallucination  1  0/2676 (0.00%)  2/2674 (0.07%) 
Mental status changes  1  1/2676 (0.04%)  0/2674 (0.00%) 
Panic attack  1  1/2676 (0.04%)  1/2674 (0.04%) 
Post stroke depression  1  0/2676 (0.00%)  1/2674 (0.04%) 
Schizophrenia  1  0/2676 (0.00%)  1/2674 (0.04%) 
Somatic symptom disorder  1  0/2676 (0.00%)  1/2674 (0.04%) 
Renal and urinary disorders     
Acute kidney injury  1  8/2676 (0.30%)  10/2674 (0.37%) 
Diabetic nephropathy  1  1/2676 (0.04%)  0/2674 (0.00%) 
Hydronephrosis  1  2/2676 (0.07%)  0/2674 (0.00%) 
Nephrolithiasis  1  6/2676 (0.22%)  5/2674 (0.19%) 
Pollakiuria  1  0/2676 (0.00%)  1/2674 (0.04%) 
Postrenal failure  1  1/2676 (0.04%)  0/2674 (0.00%) 
Ureterolithiasis  1  0/2676 (0.00%)  4/2674 (0.15%) 
Anuria  1  0/2676 (0.00%)  1/2674 (0.04%) 
Calculus bladder  1  3/2676 (0.11%)  0/2674 (0.00%) 
Calculus urinary  1  3/2676 (0.11%)  0/2674 (0.00%) 
Chronic kidney disease  1  0/2676 (0.00%)  1/2674 (0.04%) 
Glomerulonephritis proliferative  1  0/2676 (0.00%)  1/2674 (0.04%) 
Haematuria  1  6/2676 (0.22%)  3/2674 (0.11%) 
Renal colic  1  1/2676 (0.04%)  3/2674 (0.11%) 
Renal failure  1  4/2676 (0.15%)  1/2674 (0.04%) 
Renal impairment  1  0/2676 (0.00%)  2/2674 (0.07%) 
Renal ischaemia  1  0/2676 (0.00%)  1/2674 (0.04%) 
Renal mass  1  0/2676 (0.00%)  1/2674 (0.04%) 
Renal tubular necrosis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Ureteric obstruction  1  0/2676 (0.00%)  1/2674 (0.04%) 
Urethral stenosis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Urinary retention  1  1/2676 (0.04%)  0/2674 (0.00%) 
Urinary tract obstruction  1  1/2676 (0.04%)  0/2674 (0.00%) 
Urogenital haemorrhage  1  1/2676 (0.04%)  0/2674 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  5/2676 (0.19%)  3/2674 (0.11%) 
Prostatitis  1  2/2676 (0.07%)  0/2674 (0.00%) 
Vaginal haemorrhage  1  2/2676 (0.07%)  1/2674 (0.04%) 
Acquired hydrocele  1  1/2676 (0.04%)  0/2674 (0.00%) 
Balanoposthitis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Breast mass  1  0/2676 (0.00%)  1/2674 (0.04%) 
Cervical dysplasia  1  0/2676 (0.00%)  1/2674 (0.04%) 
Cervical polyp  1  1/2676 (0.04%)  0/2674 (0.00%) 
Menorrhagia  1  3/2676 (0.11%)  0/2674 (0.00%) 
Spermatocele  1  1/2676 (0.04%)  0/2674 (0.00%) 
Uterine polyp  1  1/2676 (0.04%)  0/2674 (0.00%) 
Uterine prolapse  1  1/2676 (0.04%)  0/2674 (0.00%) 
Vaginal polyp  1  1/2676 (0.04%)  0/2674 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/2676 (0.04%)  1/2674 (0.04%) 
Bronchitis chronic  1  1/2676 (0.04%)  0/2674 (0.00%) 
Chronic obstructive pulmonary disease  1  6/2676 (0.22%)  6/2674 (0.22%) 
Dyspnoea exertional  1  1/2676 (0.04%)  1/2674 (0.04%) 
Emphysema  1  0/2676 (0.00%)  1/2674 (0.04%) 
Sleep apnoea syndrome  1  3/2676 (0.11%)  0/2674 (0.00%) 
Alveolitis allergic  1  0/2676 (0.00%)  1/2674 (0.04%) 
Atelectasis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Bronchopneumopathy  1  1/2676 (0.04%)  0/2674 (0.00%) 
Dyspnoea  1  8/2676 (0.30%)  1/2674 (0.04%) 
Hypoxia  1  0/2676 (0.00%)  1/2674 (0.04%) 
Interstitial lung disease  1  1/2676 (0.04%)  0/2674 (0.00%) 
Laryngeal oedema  1  1/2676 (0.04%)  0/2674 (0.00%) 
Nasal polyps  1  0/2676 (0.00%)  1/2674 (0.04%) 
Pleural effusion  1  1/2676 (0.04%)  2/2674 (0.07%) 
Pleurisy  1  0/2676 (0.00%)  1/2674 (0.04%) 
Pneumonia aspiration  1  0/2676 (0.00%)  1/2674 (0.04%) 
Pulmonary alveolar haemorrhage  1  1/2676 (0.04%)  0/2674 (0.00%) 
Pulmonary congestion  1  0/2676 (0.00%)  1/2674 (0.04%) 
Pulmonary embolism  1  0/2676 (0.00%)  7/2674 (0.26%) 
Pulmonary fibrosis  1  0/2676 (0.00%)  3/2674 (0.11%) 
Pulmonary oedema  1  1/2676 (0.04%)  0/2674 (0.00%) 
Respiratory failure  1  2/2676 (0.07%)  4/2674 (0.15%) 
Tachypnoea  1  0/2676 (0.00%)  1/2674 (0.04%) 
Skin and subcutaneous tissue disorders     
Eczema  1  1/2676 (0.04%)  0/2674 (0.00%) 
Haemorrhage subcutaneous  1  0/2676 (0.00%)  1/2674 (0.04%) 
Angioedema  1  1/2676 (0.04%)  0/2674 (0.00%) 
Dermatitis atopic  1  0/2676 (0.00%)  1/2674 (0.04%) 
Hypersensitivity vasculitis  1  2/2676 (0.07%)  0/2674 (0.00%) 
Nail disorder  1  0/2676 (0.00%)  1/2674 (0.04%) 
Psoriasis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Purpura  1  1/2676 (0.04%)  0/2674 (0.00%) 
Skin ulcer  1  2/2676 (0.07%)  0/2674 (0.00%) 
Social circumstances     
Tanning  1  1/2676 (0.04%)  0/2674 (0.00%) 
Surgical and medical procedures     
Cardiac pacemaker insertion  1  0/2676 (0.00%)  1/2674 (0.04%) 
Hysterectomy  1  0/2676 (0.00%)  1/2674 (0.04%) 
Myomectomy  1  1/2676 (0.04%)  0/2674 (0.00%) 
Tooth extraction  1  1/2676 (0.04%)  0/2674 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  4/2676 (0.15%)  9/2674 (0.34%) 
Ischaemia  1  0/2676 (0.00%)  3/2674 (0.11%) 
Peripheral artery occlusion  1  1/2676 (0.04%)  5/2674 (0.19%) 
Aortic aneurysm  1  0/2676 (0.00%)  2/2674 (0.07%) 
Aortic occlusion  1  0/2676 (0.00%)  1/2674 (0.04%) 
Aortic stenosis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Arteriosclerosis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Arteritis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Blue toe syndrome  1  1/2676 (0.04%)  0/2674 (0.00%) 
Circulatory collapse  1  2/2676 (0.07%)  1/2674 (0.04%) 
Embolism  1  1/2676 (0.04%)  0/2674 (0.00%) 
Extremity necrosis  1  1/2676 (0.04%)  0/2674 (0.00%) 
Hypertension  1  4/2676 (0.15%)  0/2674 (0.00%) 
Hypertensive crisis  1  11/2676 (0.41%)  4/2674 (0.15%) 
Hypotension  1  0/2676 (0.00%)  2/2674 (0.07%) 
Iliac artery occlusion  1  0/2676 (0.00%)  1/2674 (0.04%) 
Orthostatic hypotension  1  1/2676 (0.04%)  0/2674 (0.00%) 
Peripheral arterial occlusive disease  1  1/2676 (0.04%)  4/2674 (0.15%) 
Peripheral artery stenosis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Peripheral ischaemia  1  1/2676 (0.04%)  3/2674 (0.11%) 
Shock haemorrhagic  1  0/2676 (0.00%)  1/2674 (0.04%) 
Thrombophlebitis  1  0/2676 (0.00%)  1/2674 (0.04%) 
Varicose vein  1  0/2676 (0.00%)  1/2674 (0.04%) 
Vasospasm  1  1/2676 (0.04%)  0/2674 (0.00%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dabigatran Etexilate 110 or 150 Milligram (mg) Acetylsalicylic Acid, Aspirin (ASA) 100 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   306/2676 (11.43%)   295/2674 (11.03%) 
Cardiac disorders     
Atrial fibrillation  1  136/2676 (5.08%)  128/2674 (4.79%) 
Infections and infestations     
Nasopharyngitis  1  173/2676 (6.46%)  170/2674 (6.36%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
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.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Centre
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02239120    
Other Study ID Numbers: 1160.189
2013-003444-24 ( EudraCT Number )
First Submitted: September 10, 2014
First Posted: September 12, 2014
Results First Submitted: August 13, 2019
Results First Posted: September 6, 2019
Last Update Posted: September 6, 2019