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Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism) (EinsteinChoice)

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ClinicalTrials.gov Identifier: NCT02064439
Recruitment Status : Completed
First Posted : February 17, 2014
Results First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Pulmonary Embolism
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Interventions Drug: BAY 59-7939
Drug: ASA
Enrollment 3365
Recruitment Details In total 3439 participants were screened at 244 sites in 31 countries from 05-Mar-2014 (First Patient First Visit) to 15-Mar-2016 (Last Patient First Visit).
Pre-assignment Details Of the 3439 participants screened 43 did not complete screening. Thus, 3396 participants were randomly assigned to treatment, 31 of the randomized participants never received study medication because either withdrew consent or were withdrawn from the study based on protocol violations.
Arm/Group Title Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD Acetylsalicylic (ASA) 100 mg, OD
Hide Arm/Group Description Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
Period Title: Overall Study
Started 1127 [1] 1107 [2] 1131 [2]
Completed 984 969 949
Not Completed 143 138 182
Reason Not Completed
Adverse Event             51             47             46
Death             0             2             3
Withdrawal by Subject             29             18             26
Protocol Violation             3             5             3
Lost to Follow-up             1             3             4
Non-compliance with study medication             21             19             23
Physician Decision             0             1             1
Logistical difficulties             6             5             2
Efficacy outcome reached             18             16             57
Safety outcome reached             12             20             10
Other             2             2             7
[1]
Full Analysis Set (FAS), randomized and received study medication
[2]
FAS, randomized and received study medication
Arm/Group Title Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD Acetylsalicylic (ASA) 100 mg, OD Total
Hide Arm/Group Description Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. Total of all reporting groups
Overall Number of Baseline Participants 1127 1107 1131 3365
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1127 participants 1107 participants 1131 participants 3365 participants
58.8  (14.7) 57.9  (14.7) 58.8  (14.7) 58.5  (14.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1127 participants 1107 participants 1131 participants 3365 participants
Female
507
  45.0%
505
  45.6%
488
  43.1%
1500
  44.6%
Male
620
  55.0%
602
  54.4%
643
  56.9%
1865
  55.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1127 participants 1107 participants 1131 participants 3365 participants
Hispanic or Latino
31
   2.8%
31
   2.8%
30
   2.7%
92
   2.7%
Not Hispanic or Latino
892
  79.1%
899
  81.2%
889
  78.6%
2680
  79.6%
Unknown or Not Reported
204
  18.1%
177
  16.0%
212
  18.7%
593
  17.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1127 participants 1107 participants 1131 participants 3365 participants
American Indian or Alaska Native
2
   0.2%
0
   0.0%
2
   0.2%
4
   0.1%
Asian
161
  14.3%
159
  14.4%
159
  14.1%
479
  14.2%
Native Hawaiian or Other Pacific Islander
1
   0.1%
1
   0.1%
2
   0.2%
4
   0.1%
Black or African American
41
   3.6%
49
   4.4%
36
   3.2%
126
   3.7%
White
786
  69.7%
772
  69.7%
786
  69.5%
2344
  69.7%
More than one race
1
   0.1%
0
   0.0%
5
   0.4%
6
   0.2%
Unknown or Not Reported
135
  12.0%
126
  11.4%
141
  12.5%
402
  11.9%
1.Primary Outcome
Title Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism
Hide Description

The primary efficacy outcomes (i.e., recurrent venous thromboembolism [VTE] defined as composite of fatal or non-fatal symptomatic recurrent VTE, including unexplained death for which pulmonary embolism [PE] could not be ruled out) as confirmed by the central independent adjudication committee (CIAC) were considered up to the end of the individual intended duration of treatment.

Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.

Time Frame Up to 12 months, at least 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD Acetylsalicylic (ASA) 100 mg, OD
Hide Arm/Group Description:
Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
Overall Number of Participants Analyzed 1127 1107 1131
Measure Type: Number
Unit of Measure: participants
Composite 13 17 50
Symptomatic recurrent Deep vein thrombosis (DVT) 8 9 29
Symptomatic recurrent PE 5 6 19
Death (PE) 0 0 1
Death (unexplained and PE cannot be ruled out) 0 2 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD, Acetylsalicylic (ASA) 100 mg, OD
Comments Statistical analysis was performed on the first occurrence of the composite outcome.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).
Method Wald test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
0.20 to 0.59
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD, Acetylsalicylic (ASA) 100 mg, OD
Comments Statistical analysis was performed on the first occurrence of the composite outcome.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).
Method Wald test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.26
Confidence Interval (2-Sided) 98%
0.14 to 0.47
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD, Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD
Comments Statistical analysis was performed on the first occurrence of the composite outcome.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4328
Comments P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).
Method Wald test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.34
Confidence Interval (2-Sided) 95%
0.65 to 2.75
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With First Treatment-emergent Major Bleeding
Hide Description

The principal safety outcome was major bleeding which was defined according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH) as clinically overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra articular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death.

Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.

Time Frame Up to 12 months, at least 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD Acetylsalicylic (ASA) 100 mg, OD
Hide Arm/Group Description:
Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
Overall Number of Participants Analyzed 1127 1107 1131
Measure Type: Number
Unit of Measure: participants
Any major bleeding 5 6 3
Fatal bleeding 0 1 1
Non-fatal critical organ bleed 2 4 1
Non-fatal non-critical organ bleeding 3 1 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD, Acetylsalicylic (ASA) 100 mg, OD
Comments Statistical analysis was performed on the first occurrence of the composite outcome.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3235
Comments P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).
Method Wald test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.01
Confidence Interval (2-Sided) 95%
0.50 to 8.04
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD, Acetylsalicylic (ASA) 100 mg, OD
Comments Statistical analysis was performed on the first occurrence of the composite outcome.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5005
Comments P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).
Method Wald test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.64
Confidence Interval (2-Sided) 95%
0.39 to 6.84
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD, Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD
Comments Statistical analysis was performed on the first occurrence of the composite outcome.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7337
Comments P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).
Method Wald test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
0.37 to 4.03
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism
Hide Description The secondary efficacy outcome is the composite of the primary efficacy outcome, myocardial infarction (MI), ischemic stroke or non-central nervous system (CNS) systemic embolism. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
Time Frame Up to 12 months, at least 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD Acetylsalicylic (ASA) 100 mg, OD
Hide Arm/Group Description:
Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
Overall Number of Participants Analyzed 1127 1107 1131
Measure Type: Number
Unit of Measure: participants
Composite 18 19 56
Ischemic stroke 4 2 2
Non-CNS systemic embolism 1 0 1
Myocardial infarction 0 1 4
Symptomatic recurrent DVT 8 9 29
Symptomatic recurrent PE 5 6 18
Death (PE) 0 0 1
Death (unexplained and PE cannot be ruled out) 0 1 1
Death (cardiovascular: myocardial infarction) 0 0 0
Death (cardiovascular: ischemic stroke) 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD, Acetylsalicylic (ASA) 100 mg, OD
Comments Statistical analysis was performed on the first occurrence of the composite outcome.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).
Method Wald test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
0.20 to 0.57
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD, Acetylsalicylic (ASA) 100 mg, OD
Comments Statistical analysis was performed on the first occurrence of the composite outcome.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).
Method Wald test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.32
Confidence Interval (2-Sided) 95%
0.19 to 0.54
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD, Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD
Comments Statistical analysis was performed on the first occurrence of the composite outcome.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8172
Comments P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).
Method Wald test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.57 to 2.06
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days
Hide Description The secondary safety outcome was clinically relevant non-major (CRNM) bleeding, which was adjudicated by the CIAC using the ASA criteria: the bleeding was non-major and the bleeding was associated with a study medication interruption of more than 14 days.
Time Frame Up to 12 months, at least 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD Acetylsalicylic (ASA) 100 mg, OD
Hide Arm/Group Description:
Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
Overall Number of Participants Analyzed 1127 1107 1131
Measure Type: Number
Unit of Measure: participants
12 17 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD, Acetylsalicylic (ASA) 100 mg, OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3318
Comments P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).
Method Wald test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.44
Confidence Interval (2-Sided) 95%
0.69 to 3.02
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD, Acetylsalicylic (ASA) 100 mg, OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9726
Comments P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).
Method Wald test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.44 to 2.20
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD, Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3137
Comments P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).
Method Wald test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.46
Confidence Interval (2-Sided) 95%
0.70 to 3.06
Estimation Comments [Not Specified]
Time Frame From after start of study medication but not more than 2 days after stop of study medication.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD Acetylsalicylic (ASA) 100 mg, OD
Hide Arm/Group Description Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
All-Cause Mortality
Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD Acetylsalicylic (ASA) 100 mg, OD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD Acetylsalicylic (ASA) 100 mg, OD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   78/1127 (6.92%)      82/1107 (7.41%)      79/1131 (6.98%)    
Blood and lymphatic system disorders       
Anaemia * 1  0/1127 (0.00%)  0 2/1107 (0.18%)  2 0/1131 (0.00%)  0
Iron deficiency anaemia * 1  0/1127 (0.00%)  0 2/1107 (0.18%)  2 0/1131 (0.00%)  0
Thrombocytopenia * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Cardiac disorders       
Arteriosclerosis coronary artery * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Atrial fibrillation * 1  1/1127 (0.09%)  1 3/1107 (0.27%)  3 1/1131 (0.09%)  1
Atrial flutter * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Atrioventricular block second degree * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Bradycardia * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Cardiac failure * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Cardiac failure chronic * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Cardiac failure congestive * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Coronary artery disease * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 2/1131 (0.18%)  2
Mitral valve incompetence * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Myocardial ischaemia * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Pericarditis * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Pericarditis constrictive * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Tachycardia * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Ear and labyrinth disorders       
Vertigo * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 1/1131 (0.09%)  1
Vestibular disorder * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Sudden hearing loss * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Endocrine disorders       
Cushing's syndrome * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Eye disorders       
Corneal degeneration * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Gastrointestinal disorders       
Ascites * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Diverticulum * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Diverticulum intestinal * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Gastritis * 1  1/1127 (0.09%)  1 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Haemorrhoids * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Inguinal hernia * 1  1/1127 (0.09%)  1 2/1107 (0.18%)  2 0/1131 (0.00%)  0
Intestinal obstruction * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Pancreatitis acute * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Pancreatitis relapsing * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Umbilical hernia * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Subileus * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Hypertrophic anal papilla * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Abdominal hernia * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Eosinophilic oesophagitis * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Colon dysplasia * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
General disorders       
Chest pain * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Hepatobiliary disorders       
Bile duct stone * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Biliary colic * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Cholecystitis * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Cholecystitis acute * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 2/1131 (0.18%)  2
Cholelithiasis * 1  1/1127 (0.09%)  2 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Immune system disorders       
Overlap syndrome * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Infections and infestations       
Appendicitis * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Cellulitis * 1  1/1127 (0.09%)  1 2/1107 (0.18%)  2 1/1131 (0.09%)  1
Clostridium difficile colitis * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Diarrhoea infectious * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Diverticulitis * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Erysipelas * 1  2/1127 (0.18%)  2 0/1107 (0.00%)  0 2/1131 (0.18%)  2
Gastroenteritis * 1  2/1127 (0.18%)  2 1/1107 (0.09%)  1 1/1131 (0.09%)  1
Influenza * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Nasopharyngitis * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Orchitis * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Peritonitis * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Plasmodium falciparum infection * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Pneumonia * 1  2/1127 (0.18%)  2 5/1107 (0.45%)  6 3/1131 (0.27%)  3
Pseudomembranous colitis * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Pyelitis * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Pyelonephritis acute * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Sepsis * 1  1/1127 (0.09%)  1 3/1107 (0.27%)  3 2/1131 (0.18%)  2
Septic shock * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Urethral abscess * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Urinary tract infection * 1  2/1127 (0.18%)  2 4/1107 (0.36%)  6 0/1131 (0.00%)  0
Wound infection * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Urosepsis * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Abscess limb * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Arthritis bacterial * 1  0/1127 (0.00%)  0 2/1107 (0.18%)  3 0/1131 (0.00%)  0
Infective exacerbation of chronic obstructive airways disease * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Pseudomonal sepsis * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Pneumonia bacterial * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Lung infection * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Borrelia infection * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Post procedural infection * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Injury, poisoning and procedural complications       
Ankle fracture * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Clavicle fracture * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Fall * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 3/1131 (0.27%)  3
Femoral neck fracture * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Femur fracture * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 3/1131 (0.27%)  3
Fibula fracture * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Head injury * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Humerus fracture * 1  2/1127 (0.18%)  2 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Injury * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Joint dislocation * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Overdose * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Radius fracture * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Road traffic accident * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Spinal compression fracture * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Tendon rupture * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Tibia fracture * 1  1/1127 (0.09%)  1 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Cervical vertebral fracture * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Lumbar vertebral fracture * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Lower limb fracture * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Stomal hernia * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Pubis fracture * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Craniocerebral injury * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Investigations       
Cystoscopy * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Haemoglobin decreased * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
White blood cell count decreased * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
B-lymphocyte count increased * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Metabolism and nutrition disorders       
Diabetes mellitus inadequate control * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Obesity * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Type 2 diabetes mellitus * 1  2/1127 (0.18%)  2 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Joint ankylosis * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Osteitis * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  2
Osteoarthritis * 1  3/1127 (0.27%)  3 0/1107 (0.00%)  0 5/1131 (0.44%)  6
Pain in extremity * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Rheumatoid arthritis * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Spinal column stenosis * 1  0/1127 (0.00%)  0 2/1107 (0.18%)  2 1/1131 (0.09%)  1
Mobility decreased * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Intervertebral disc protrusion * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Musculoskeletal chest pain * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Meniscal degeneration * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Spinal pain * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  2 0/1131 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma of colon * 1  1/1127 (0.09%)  1 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Basal cell carcinoma * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 1/1131 (0.09%)  1
Benign gastric neoplasm * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Bladder cancer * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Bladder cancer recurrent * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Bladder transitional cell carcinoma * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Breast cancer * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Cervix carcinoma * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Cervix carcinoma recurrent * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Endometrial cancer * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Gastric cancer * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Leiomyosarcoma * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Lung carcinoma cell type unspecified stage IV * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Malignant melanoma stage I * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Malignant melanoma stage IV * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Meningioma * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Metastases to lung * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Metastases to lymph nodes * 1  1/1127 (0.09%)  1 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Oesophageal carcinoma * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Oesophageal carcinoma stage 0 * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Plasma cell myeloma * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Rectal cancer recurrent * 1  1/1127 (0.09%)  1 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Ureteric cancer * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Uterine cancer * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Uterine leiomyoma * 1  1/1127 (0.09%)  1 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Colon cancer metastatic * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Prostate cancer * 1  3/1127 (0.27%)  3 1/1107 (0.09%)  1 1/1131 (0.09%)  1
Cervix warts * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Malignant glioma * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Ovarian cancer stage IV * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Nervous system disorders       
Axonal neuropathy * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Dizziness * 1  1/1127 (0.09%)  2 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Dyskinesia * 1  2/1127 (0.18%)  2 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Headache * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Migraine * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Presyncope * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Sciatica * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Seizure * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Syncope * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 2/1131 (0.18%)  2
Facial paresis * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Psychiatric disorders       
Adjustment disorder with depressed mood * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Alcohol abuse * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 1/1131 (0.09%)  2
Alcoholism * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  2
Anxiety * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Depression * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 2/1131 (0.18%)  2
Paranoia * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Suicide attempt * 1  3/1127 (0.27%)  3 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Renal and urinary disorders       
Nephrolithiasis * 1  2/1127 (0.18%)  2 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Neurogenic bladder * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Renal colic * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 1/1131 (0.09%)  1
Renal failure * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Urinary retention * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 1/1131 (0.09%)  1
Tubulointerstitial nephritis * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Urethral stenosis * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Acute kidney injury * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 2/1131 (0.18%)  2
End stage renal disease * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Ureterolithiasis * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Reproductive system and breast disorders       
Prostatitis * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Acute pulmonary oedema * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Asthma * 1  1/1127 (0.09%)  1 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Chronic obstructive pulmonary disease * 1  1/1127 (0.09%)  1 3/1107 (0.27%)  4 3/1131 (0.27%)  3
Dyspnoea * 1  1/1127 (0.09%)  1 2/1107 (0.18%)  4 1/1131 (0.09%)  1
Interstitial lung disease * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Nasal polyps * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Pleural effusion * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  2 0/1131 (0.00%)  0
Pleurisy * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Pulmonary hypertension * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Respiratory failure * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Pulmonary mass * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Organising pneumonia * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Skin and subcutaneous tissue disorders       
Rash * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Seborrhoea * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Urticaria * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Pruritus generalised * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Cutaneous lupus erythematosus * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Surgical and medical procedures       
Hysterectomy * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Meningioma surgery * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
Vascular disorders       
Aortic aneurysm * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Aortic dissection * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Aortic stenosis * 1  0/1127 (0.00%)  0 1/1107 (0.09%)  1 0/1131 (0.00%)  0
Hypertension * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Hypertensive crisis * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Thrombophlebitis * 1  0/1127 (0.00%)  0 0/1107 (0.00%)  0 1/1131 (0.09%)  1
Peripheral arterial occlusive disease * 1  1/1127 (0.09%)  1 0/1107 (0.00%)  0 0/1131 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (19.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.3%
Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD Acetylsalicylic (ASA) 100 mg, OD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/1127 (3.55%)      35/1107 (3.16%)      38/1131 (3.36%)    
Cardiac disorders       
Atrial fibrillation * 1  6/1127 (0.53%)  6 2/1107 (0.18%)  2 3/1131 (0.27%)  3
Gastrointestinal disorders       
Abdominal pain upper * 1  2/1127 (0.18%)  3 2/1107 (0.18%)  2 5/1131 (0.44%)  5
Constipation * 1  2/1127 (0.18%)  2 0/1107 (0.00%)  0 7/1131 (0.62%)  8
Diarrhoea * 1  4/1127 (0.35%)  4 4/1107 (0.36%)  5 1/1131 (0.09%)  1
Dyspepsia * 1  1/1127 (0.09%)  1 3/1107 (0.27%)  3 4/1131 (0.35%)  4
Gastrooesophageal reflux disease * 1  1/1127 (0.09%)  1 5/1107 (0.45%)  5 6/1131 (0.53%)  6
Vomiting * 1  0/1127 (0.00%)  0 4/1107 (0.36%)  4 2/1131 (0.18%)  2
Infections and infestations       
Nasopharyngitis * 1  4/1127 (0.35%)  4 2/1107 (0.18%)  2 0/1131 (0.00%)  0
Upper respiratory tract infection * 1  1/1127 (0.09%)  1 4/1107 (0.36%)  6 3/1131 (0.27%)  4
Musculoskeletal and connective tissue disorders       
Back pain * 1  3/1127 (0.27%)  3 3/1107 (0.27%)  3 4/1131 (0.35%)  4
Myalgia * 1  2/1127 (0.18%)  2 2/1107 (0.18%)  2 4/1131 (0.35%)  4
Nervous system disorders       
Dizziness * 1  4/1127 (0.35%)  5 4/1107 (0.36%)  4 3/1131 (0.27%)  3
Skin and subcutaneous tissue disorders       
Pruritus * 1  8/1127 (0.71%)  8 3/1107 (0.27%)  3 3/1131 (0.27%)  3
Rash * 1  5/1127 (0.44%)  5 3/1107 (0.27%)  3 3/1131 (0.27%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (19.1)
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.
The steering committee will be responsible for the publication and presentation strategy. All publications will be based on data released or agreed by Bayer, verified by the steering committee.
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: Bayer AG
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02064439     History of Changes
Other Study ID Numbers: 16416
2013-000619-26 ( EudraCT Number )
First Submitted: February 14, 2014
First Posted: February 17, 2014
Results First Submitted: September 12, 2017
Results First Posted: December 19, 2017
Last Update Posted: December 19, 2017