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Trial record 49 of 115 for:    centurion

A Study Exploring Two Strategies of Rivaroxaban (JNJ39039039; BAY-59-7939) and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention (PIONEER AF-PCI)

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ClinicalTrials.gov Identifier: NCT01830543
Recruitment Status : Completed
First Posted : April 12, 2013
Results First Posted : July 31, 2017
Last Update Posted : September 19, 2017
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Atrial Fibrillation
Percutaneous Coronary Intervention
Interventions Drug: rivaroxaban 2.5 mg
Drug: rivaroxaban 15 mg
Drug: rivaroxaban 10 mg
Drug: aspirin (ASA)
Drug: vitamin K antagonist (VKA)
Drug: clopidogrel
Drug: prasugrel
Drug: ticagrelor
Enrollment 2124
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rivaroxaban 15 mg Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) Vitamin K Antagonist (VKA)
Hide Arm/Group Description Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months. Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12. Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Period Title: Overall Study
Started 709 709 706
Treated 696 706 697
Completed 550 557 492
Not Completed 159 152 214
Reason Not Completed
Subject Decision             19             21             57
Adverse Event             91             77             76
Death             20             22             22
Protocol Violation             3             7             7
Physician Decision             11             5             12
Withdrawal by consent             3             3             3
Other             12             17             37
Arm/Group Title Rivaroxaban 15 mg Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) Vitamin K Antagonist (VKA) Total
Hide Arm/Group Description Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months. Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12. Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12. Total of all reporting groups
Overall Number of Baseline Participants 709 709 706 2124
Hide Baseline Analysis Population Description
The intent-to-treat analysis set included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 709 participants 709 participants 706 participants 2124 participants
70.4  (9.12) 70  (9.11) 69.9  (8.67) 70.1  (8.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 709 participants 709 participants 706 participants 2124 participants
Female
181
  25.5%
174
  24.5%
188
  26.6%
543
  25.6%
Male
528
  74.5%
535
  75.5%
518
  73.4%
1581
  74.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 709 participants 709 participants 706 participants 2124 participants
Argentina 32 27 23 82
Australia 3 7 5 15
Belgium 14 18 20 52
Brazil 14 14 13 41
Bulgaria 67 80 74 221
Canada 23 24 19 66
Chile 5 7 6 18
Czech Republic 17 9 14 40
Denmark 2 2 8 12
France 33 26 25 84
Germany 96 98 101 295
Italy 26 26 20 72
Korea, Republic of 11 11 17 39
Malaysia 1 5 5 11
Mexico 7 3 3 13
Netherlands 24 17 27 68
Poland 71 78 69 218
Romania 15 16 19 50
Russian Federation 90 86 89 265
Sweden 15 14 18 47
Taiwan, Province of China 8 8 9 25
Turkey 11 14 18 43
Ukraine 19 24 17 60
United Kingdom 48 44 39 131
United States 56 49 46 151
South Africa 1 2 2 5
1.Primary Outcome
Title Percentage of Participants With Clinically Significant Bleeding
Hide Description Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA). TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of greater than or equal to (>=) 5 grams per deciliter (g/dL) (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent (%)). TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to less than (<) 5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent). A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.
Time Frame Up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Rivaroxaban 15 mg Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) Vitamin K Antagonist (VKA)
Hide Arm/Group Description:
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Overall Number of Participants Analyzed 696 706 697
Measure Type: Number
Unit of Measure: percentage of participants
15.7 16.6 24.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 15 mg, Vitamin K Antagonist (VKA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.47 to 0.76
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD), Vitamin K Antagonist (VKA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.63
Confidence Interval (2-Sided) 95%
0.5 to 0.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
Hide Description TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, Clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of >= 5 g/dL (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent).
Time Frame Up to Month 12 and end of DAPT-Month 1, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.
Arm/Group Title Rivaroxaban 15 mg Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) Vitamin K Antagonist (VKA)
Hide Arm/Group Description:
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Overall Number of Participants Analyzed 696 706 697
Measure Type: Number
Unit of Measure: percentage of participants
Up to Month 12 (n= 696, 706, 697) 2.0 1.7 2.9
End of DAPT-1 Month (n= 0, 108,113) NA [1]  0.9 4.4
End of DAPT-6 Month (n= 0, 248,243) NA [2]  2.8 3.7
End of DAPT-12 Month (n= 0, 350,341) NA [3]  1.1 1.8
[1]
Analysis at end of DAPT-1 month conducted only in participants who received DAPT as part of therapy.
[2]
Analysis at end of DAPT-6 month conducted only in participants who received DAPT as part of therapy.
[3]
Analysis at end of DAPT-12 month conducted only in participants who received DAPT as part of therapy.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 15 mg, Vitamin K Antagonist (VKA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.234
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
0.33 to 1.31
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD), Vitamin K Antagonist (VKA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.114
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
0.28 to 1.16
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding
Hide Description TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to <5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent).
Time Frame Up to Month 12 and end of DAPT-Month 1, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'n' signifies number of participants analyzed at specific time-point in this outcome measure.
Arm/Group Title Rivaroxaban 15 mg Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) Vitamin K Antagonist (VKA)
Hide Arm/Group Description:
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Overall Number of Participants Analyzed 696 706 697
Measure Type: Number
Unit of Measure: percentage of participants
Up to Month 12 (n= 696, 706, 697) 1.0 1.0 1.9
End of DAPT-1 Month (n= 0, 108, 113) NA [1]  0.9 1.8
End of DAPT-6 Month (n= 0, 248, 243) NA [2]  0.4 2.5
End of DAPT-12 Month (n= 0, 350, 341) NA [3]  1.4 1.5
[1]
Analysis at end of DAPT-1 month conducted only in participants who received DAPT as part of therapy.
[2]
Analysis at end of DAPT-6 month conducted only in participants who received DAPT as part of therapy.
[3]
Analysis at end of DAPT-12 month conducted only in participants who received DAPT as part of therapy.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 15 mg, Vitamin K Antagonist (VKA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.144
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.51
Confidence Interval (2-Sided) 95%
0.2 to 1.28
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD), Vitamin K Antagonist (VKA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.2 to 1.26
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)
Hide Description A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.
Time Frame Up to Month 12 and end of DAPT-Month 1, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'n' signifies number of participants analyzed at specific time-point in this outcome measure.
Arm/Group Title Rivaroxaban 15 mg Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) Vitamin K Antagonist (VKA)
Hide Arm/Group Description:
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Overall Number of Participants Analyzed 696 706 697
Measure Type: Number
Unit of Measure: percentage of participants
Up to Month 12 (n= 696, 706, 697) 13.4 14.4 19.9
End of DAPT-1 Month (n= 0, 108, 113) NA [1]  16.7 18.6
End of DAPT-6 Month (n= 0, 248, 243) NA [2]  12.9 23
End of DAPT-12 Month (n= 0, 350, 341) NA [3]  14.9 18.2
[1]
Analysis at end of DAPT-1 month conducted only in participants who received DAPT as part of therapy.
[2]
Analysis at end of DAPT-6 month conducted only in participants who received DAPT as part of therapy.
[3]
Analysis at end of DAPT-12 month conducted only in participants who received DAPT as part of therapy.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 15 mg, Vitamin K Antagonist (VKA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
0.47 to 0.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD), Vitamin K Antagonist (VKA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.52 to 0.86
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)
Hide Description Percentage of participants who experienced adverse cardiovascular events (cardiovascular death, myocardial Infarction (MI) and stroke) collectively, were assessed.
Time Frame Up to Month 12 and end of DAPT-Month 1, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.
Arm/Group Title Rivaroxaban 15 mg Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) Vitamin K Antagonist (VKA)
Hide Arm/Group Description:
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Overall Number of Participants Analyzed 694 704 695
Measure Type: Number
Unit of Measure: percentage of participants
Up to Month 12 (n= 694, 704, 695) 5.9 5.1 5.2
End of DAPT-1 Month (n= 0, 108, 112) NA [1]  5.6 4.5
End of DAPT-6 Month (n= 0, 248, 243) NA [2]  6.5 3.7
End of DAPT-12 Month (n= 0, 348, 340) NA [3]  4 6.5
[1]
Analysis at end of DAPT-1 month conducted only in participants who received DAPT as part of therapy.
[2]
Analysis at end of DAPT-6 month conducted only in participants who received DAPT as part of therapy.
[3]
Analysis at end of DAPT-12 month conducted only in participants who received DAPT as part of therapy.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 15 mg, Vitamin K Antagonist (VKA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.69 to 1.68
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD), Vitamin K Antagonist (VKA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.765
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.59 to 1.48
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Cardiovascular Death
Hide Description The percentage of participants with the first occurrence of cardiovascular death were evaluated.
Time Frame Up to Month 12 and end of DAPT-Month 1, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.
Arm/Group Title Rivaroxaban 15 mg Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) Vitamin K Antagonist (VKA)
Hide Arm/Group Description:
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Overall Number of Participants Analyzed 694 704 695
Measure Type: Number
Unit of Measure: percentage of participants
Up to Month 12 (n= 694, 704, 695) 2.2 2 1.6
End of DAPT-1 Month (n= 0, 108, 112) NA [1]  1.9 1.8
End of DAPT-6 Month (n= 0, 248, 243) NA [2]  2.4 1.6
End of DAPT-12 Month (n= 0, 348, 340) NA [3]  1.7 1.5
[1]
Analysis at end of DAPT-1 month conducted only in participants who received DAPT as part of therapy.
[2]
Analysis at end of DAPT-6 month conducted only in participants who received DAPT as part of therapy.
[3]
Analysis at end of DAPT-12 month conducted only in participants who received DAPT as part of therapy.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 15 mg, Vitamin K Antagonist (VKA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.523
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
0.59 to 2.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD), Vitamin K Antagonist (VKA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.664
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.54 to 2.62
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Myocardial Infarction
Hide Description The percentage of participants with the first occurrence of Myocardial Infarction were evaluated.
Time Frame Up to Month 12 and end of DAPT-Month 1, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.
Arm/Group Title Rivaroxaban 15 mg Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) Vitamin K Antagonist (VKA)
Hide Arm/Group Description:
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Overall Number of Participants Analyzed 694 704 695
Measure Type: Number
Unit of Measure: percentage of participants
Up to Month 12 (n= 694, 704, 695) 2.7 2.4 3
End of DAPT-1 Month (n= 0, 108, 112) NA [1]  2.8 0.9
End of DAPT-6 Month (n= 0, 248, 243) NA [2]  2.8 2.5
End of DAPT-12 Month (n= 0, 348, 340) NA [3]  2 4.1
[1]
Analysis at end of DAPT-1 month conducted only in participants who received DAPT as part of therapy.
[2]
Analysis at end of DAPT-6 month conducted only in participants who received DAPT as part of therapy.
[3]
Analysis at end of DAPT-12 month conducted only in participants who received DAPT as part of therapy.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 15 mg, Vitamin K Antagonist (VKA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.625
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.46 to 1.59
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD), Vitamin K Antagonist (VKA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.374
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.4 to 1.42
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Stroke
Hide Description The percentage of participants with the first occurrence of Stroke were evaluated.
Time Frame Up to Month 12 and end of DAPT-Month 1, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.
Arm/Group Title Rivaroxaban 15 mg Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) Vitamin K Antagonist (VKA)
Hide Arm/Group Description:
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Overall Number of Participants Analyzed 694 704 695
Measure Type: Number
Unit of Measure: percentage of participants
Up to Month 12 (n= 694, 704, 695) 1.2 1.4 1
End of DAPT-1 Month (n= 0, 108, 112) NA [1]  1.9 2.7
End of DAPT-6 Month (n= 0, 248, 243) NA [2]  2.4 0
End of DAPT-12 Month (n= 0, 348, 340) NA [3]  0.6 1.2
[1]
Analysis at end of DAPT-1 month conducted only in participants who received DAPT as part of therapy.
[2]
Analysis at end of DAPT-6 month conducted only in participants who received DAPT as part of therapy.
[3]
Analysis at end of DAPT-12 month conducted only in participants who received DAPT as part of therapy.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 15 mg, Vitamin K Antagonist (VKA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.891
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.39 to 2.96
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD), Vitamin K Antagonist (VKA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
0.52 to 3.58
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With Stent Thrombosis
Hide Description The percentage of participants with the first occurrence of stent thrombosis were evaluated.
Time Frame Up to Month 12 and end of DAPT-Month 1, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.
Arm/Group Title Rivaroxaban 15 mg Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) Vitamin K Antagonist (VKA)
Hide Arm/Group Description:
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Overall Number of Participants Analyzed 694 704 695
Measure Type: Number
Unit of Measure: percentage of participants
Up to Month 12 (n= 694, 704, 695) 0.7 0.9 0.6
End of DAPT-1 Month (n= 0, 108, 112) NA [1]  1.9 0.9
End of DAPT-6 Month (n= 0, 248, 243) NA [2]  1.6 0.4
End of DAPT-12 Month (n= 0, 348, 340) NA [3]  0 0.6
[1]
Analysis at end of DAPT-1 month conducted only in participants who received DAPT as part of therapy.
[2]
Analysis at end of DAPT-6 month conducted only in participants who received DAPT as part of therapy.
[3]
Analysis at end of DAPT-12 month conducted only in participants who received DAPT as part of therapy.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 15 mg, Vitamin K Antagonist (VKA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
0.32 to 4.45
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD), Vitamin K Antagonist (VKA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.574
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.44
Confidence Interval (2-Sided) 95%
0.4 to 5.09
Estimation Comments [Not Specified]
Time Frame Upto 12 months
Adverse Event Reporting Description The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
 
Arm/Group Title Rivaroxaban 15 mg Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) Vitamin K Antagonist (VKA)
Hide Arm/Group Description Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months. Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12. Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
All-Cause Mortality
Rivaroxaban 15 mg Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) Vitamin K Antagonist (VKA)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rivaroxaban 15 mg Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) Vitamin K Antagonist (VKA)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   237/696 (34.05%)   225/706 (31.87%)   271/697 (38.88%) 
Blood and lymphatic system disorders       
Anaemia * 1  5/696 (0.72%)  4/706 (0.57%)  4/697 (0.57%) 
Haemorrhagic Anaemia * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Hypergammaglobulinaemia * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Hypochromic Anaemia * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Microcytic Anaemia * 1  0/696 (0.00%)  1/706 (0.14%)  1/697 (0.14%) 
Cardiac disorders       
Acute Coronary Syndrome * 1  3/696 (0.43%)  1/706 (0.14%)  1/697 (0.14%) 
Acute Myocardial Infarction * 1  5/696 (0.72%)  5/706 (0.71%)  3/697 (0.43%) 
Angina Pectoris * 1  7/696 (1.01%)  13/706 (1.84%)  15/697 (2.15%) 
Angina Unstable * 1  16/696 (2.30%)  12/706 (1.70%)  23/697 (3.30%) 
Atrial Fibrillation * 1  13/696 (1.87%)  21/706 (2.97%)  23/697 (3.30%) 
Atrial Flutter * 1  0/696 (0.00%)  5/706 (0.71%)  4/697 (0.57%) 
Atrial Tachycardia * 1  0/696 (0.00%)  2/706 (0.28%)  1/697 (0.14%) 
Atrial Thrombosis * 1  4/696 (0.57%)  1/706 (0.14%)  0/697 (0.00%) 
Atrioventricular Block * 1  2/696 (0.29%)  0/706 (0.00%)  1/697 (0.14%) 
Atrioventricular Block Complete * 1  1/696 (0.14%)  1/706 (0.14%)  0/697 (0.00%) 
Bradyarrhythmia * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Bradycardia * 1  2/696 (0.29%)  1/706 (0.14%)  2/697 (0.29%) 
Cardiac Arrest * 1  0/696 (0.00%)  2/706 (0.28%)  2/697 (0.29%) 
Cardiac Disorder * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Cardiac Failure * 1  21/696 (3.02%)  16/706 (2.27%)  31/697 (4.45%) 
Cardiac Failure Acute * 1  3/696 (0.43%)  3/706 (0.42%)  4/697 (0.57%) 
Cardiac Failure Chronic * 1  3/696 (0.43%)  1/706 (0.14%)  3/697 (0.43%) 
Cardiac Failure Congestive * 1  7/696 (1.01%)  4/706 (0.57%)  11/697 (1.58%) 
Cardiac Pseudoaneurysm * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Cardiogenic Shock * 1  0/696 (0.00%)  1/706 (0.14%)  1/697 (0.14%) 
Cardiomyopathy * 1  1/696 (0.14%)  0/706 (0.00%)  1/697 (0.14%) 
Cardiovascular Disorder * 1  2/696 (0.29%)  0/706 (0.00%)  0/697 (0.00%) 
Coronary Artery Disease * 1  3/696 (0.43%)  5/706 (0.71%)  2/697 (0.29%) 
Coronary Artery Stenosis * 1  0/696 (0.00%)  1/706 (0.14%)  1/697 (0.14%) 
Coronary Artery Thrombosis * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Dressler's Syndrome * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Ischaemic Cardiomyopathy * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Left Ventricular Dysfunction * 1  1/696 (0.14%)  0/706 (0.00%)  1/697 (0.14%) 
Left Ventricular Failure * 1  1/696 (0.14%)  1/706 (0.14%)  0/697 (0.00%) 
Myocardial Infarction * 1  0/696 (0.00%)  1/706 (0.14%)  2/697 (0.29%) 
Myocardial Ischaemia * 1  0/696 (0.00%)  1/706 (0.14%)  2/697 (0.29%) 
Palpitations * 1  0/696 (0.00%)  1/706 (0.14%)  2/697 (0.29%) 
Pericardial Effusion * 1  0/696 (0.00%)  0/706 (0.00%)  2/697 (0.29%) 
Pericardial Haemorrhage * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Pericarditis * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Sinus Bradycardia * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Sinus Node Dysfunction * 1  4/696 (0.57%)  1/706 (0.14%)  2/697 (0.29%) 
Supraventricular Tachycardia * 1  0/696 (0.00%)  2/706 (0.28%)  1/697 (0.14%) 
Tachyarrhythmia * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Tachycardia Induced Cardiomyopathy * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Ventricular Arrhythmia * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Ventricular Extrasystoles * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Ventricular Fibrillation * 1  2/696 (0.29%)  1/706 (0.14%)  1/697 (0.14%) 
Ventricular Tachycardia * 1  3/696 (0.43%)  0/706 (0.00%)  1/697 (0.14%) 
Ear and labyrinth disorders       
Deafness Neurosensory * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Vertigo * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Endocrine disorders       
Hyperthyroidism * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Eye disorders       
Age-Related Macular Degeneration * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Cataract * 1  0/696 (0.00%)  0/706 (0.00%)  3/697 (0.43%) 
Eye Haemorrhage * 1  0/696 (0.00%)  1/706 (0.14%)  1/697 (0.14%) 
Vitreous Haemorrhage * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Gastrointestinal disorders       
Abdominal Pain * 1  3/696 (0.43%)  0/706 (0.00%)  0/697 (0.00%) 
Abdominal Pain Lower * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Acute Abdomen * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Anal Fistula * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Anal Haemorrhage * 1  0/696 (0.00%)  0/706 (0.00%)  2/697 (0.29%) 
Barrett's Oesophagus * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Change of Bowel Habit * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Colitis Microscopic * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Constipation * 1  0/696 (0.00%)  1/706 (0.14%)  1/697 (0.14%) 
Crohn's Disease * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Diarrhoea * 1  1/696 (0.14%)  0/706 (0.00%)  1/697 (0.14%) 
Duodenal Ulcer * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Dysphagia * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Enteritis * 1  0/696 (0.00%)  0/706 (0.00%)  2/697 (0.29%) 
Enterocolitis * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Faecaloma * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Gastric Haemorrhage * 1  0/696 (0.00%)  1/706 (0.14%)  1/697 (0.14%) 
Gastric Mucosa Erythema * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Gastric Ulcer * 1  1/696 (0.14%)  3/706 (0.42%)  3/697 (0.43%) 
Gastric Ulcer Haemorrhage * 1  0/696 (0.00%)  0/706 (0.00%)  2/697 (0.29%) 
Gastritis * 1  2/696 (0.29%)  1/706 (0.14%)  1/697 (0.14%) 
Gastritis Erosive * 1  0/696 (0.00%)  2/706 (0.28%)  2/697 (0.29%) 
Gastritis Haemorrhagic * 1  1/696 (0.14%)  1/706 (0.14%)  1/697 (0.14%) 
Gastroduodenitis Haemorrhagic * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Gastrointestinal Haemorrhage * 1  7/696 (1.01%)  7/706 (0.99%)  9/697 (1.29%) 
Gastrointestinal Ulcer * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Gastrooesophageal Reflux Disease * 1  1/696 (0.14%)  0/706 (0.00%)  1/697 (0.14%) 
Haematemesis * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Haematochezia * 1  1/696 (0.14%)  1/706 (0.14%)  0/697 (0.00%) 
Haemorrhoidal Haemorrhage * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Haemorrhoids * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Hiatus Hernia * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Impaired Gastric Emptying * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Inguinal Hernia * 1  3/696 (0.43%)  0/706 (0.00%)  1/697 (0.14%) 
Intestinal Haemorrhage * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Intestinal Ischaemia * 1  0/696 (0.00%)  1/706 (0.14%)  1/697 (0.14%) 
Intestinal Obstruction * 1  1/696 (0.14%)  1/706 (0.14%)  0/697 (0.00%) 
Intra-Abdominal Haematoma * 1  1/696 (0.14%)  0/706 (0.00%)  1/697 (0.14%) 
Lower Gastrointestinal Haemorrhage * 1  0/696 (0.00%)  1/706 (0.14%)  1/697 (0.14%) 
Mallory-Weiss Syndrome * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Melaena * 1  0/696 (0.00%)  1/706 (0.14%)  4/697 (0.57%) 
Mouth Haemorrhage * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Nausea * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Pancreatitis * 1  2/696 (0.29%)  0/706 (0.00%)  1/697 (0.14%) 
Pancreatitis Chronic * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Rectal Haemorrhage * 1  4/696 (0.57%)  2/706 (0.28%)  1/697 (0.14%) 
Small Intestinal Obstruction * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Stomatitis * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Tongue Haemorrhage * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Upper Gastrointestinal Haemorrhage * 1  2/696 (0.29%)  1/706 (0.14%)  2/697 (0.29%) 
General disorders       
Catheter Site Swelling * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Chest Discomfort * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Chest Pain * 1  8/696 (1.15%)  4/706 (0.57%)  9/697 (1.29%) 
Death * 1  2/696 (0.29%)  2/706 (0.28%)  0/697 (0.00%) 
Device Failure * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Drug Intolerance * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Drug Resistance * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Drug Withdrawal Syndrome * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Fatigue * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Gait Disturbance * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Malaise * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Medical Device Complication * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Multi-Organ Failure * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Non-Cardiac Chest Pain * 1  0/696 (0.00%)  1/706 (0.14%)  3/697 (0.43%) 
Oedema Peripheral * 1  2/696 (0.29%)  0/706 (0.00%)  0/697 (0.00%) 
Pyrexia * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Sudden Cardiac Death * 1  1/696 (0.14%)  1/706 (0.14%)  0/697 (0.00%) 
Sudden Death * 1  2/696 (0.29%)  1/706 (0.14%)  3/697 (0.43%) 
Ulcer Haemorrhage * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Vascular Stent Occlusion * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Vascular Stent Restenosis * 1  0/696 (0.00%)  1/706 (0.14%)  1/697 (0.14%) 
Vascular Stent Thrombosis * 1  1/696 (0.14%)  2/706 (0.28%)  0/697 (0.00%) 
Vessel Puncture Site Haematoma * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Hepatobiliary disorders       
Bile Duct Stone * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Cholangitis * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Cholecystitis * 1  0/696 (0.00%)  1/706 (0.14%)  2/697 (0.29%) 
Cholecystitis Acute * 1  1/696 (0.14%)  1/706 (0.14%)  1/697 (0.14%) 
Cholecystitis Chronic * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Cholelithiasis * 1  1/696 (0.14%)  0/706 (0.00%)  3/697 (0.43%) 
Hepatic Cyst * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Hepatitis Acute * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Hepatitis Toxic * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Hepatocellular Injury * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Jaundice * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Immune system disorders       
Anaphylactic Shock * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Infections and infestations       
Abdominal Wall Abscess * 1  2/696 (0.29%)  0/706 (0.00%)  0/697 (0.00%) 
Abscess Limb * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Appendicitis * 1  1/696 (0.14%)  0/706 (0.00%)  1/697 (0.14%) 
Arthritis Bacterial * 1  0/696 (0.00%)  2/706 (0.28%)  0/697 (0.00%) 
Bacterial Sepsis * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Bronchitis * 1  3/696 (0.43%)  1/706 (0.14%)  1/697 (0.14%) 
Bronchitis Bacterial * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Cellulitis * 1  1/696 (0.14%)  1/706 (0.14%)  2/697 (0.29%) 
Clostridium Difficile Colitis * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Cystitis * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Diverticulitis * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Encephalitis Viral * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Epididymitis * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Erysipelas * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Gangrene * 1  0/696 (0.00%)  2/706 (0.28%)  1/697 (0.14%) 
Gastroenteritis * 1  2/696 (0.29%)  0/706 (0.00%)  1/697 (0.14%) 
Gastrointestinal Infection * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Haematoma Infection * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Herpes Zoster * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Infected Skin Ulcer * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Infective Exacerbation of Chronic Obstructive Airways Disease * 1  0/696 (0.00%)  1/706 (0.14%)  1/697 (0.14%) 
Influenza * 1  1/696 (0.14%)  0/706 (0.00%)  1/697 (0.14%) 
Intervertebral Discitis * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Liver Abscess * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Localised Infection * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Lower Respiratory Tract Infection * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Nasopharyngitis * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Periodontitis * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Pneumonia * 1  12/696 (1.72%)  12/706 (1.70%)  14/697 (2.01%) 
Pyelonephritis * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Respiratory Tract Infection * 1  0/696 (0.00%)  0/706 (0.00%)  2/697 (0.29%) 
Scrotal Abscess * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Sepsis * 1  1/696 (0.14%)  1/706 (0.14%)  1/697 (0.14%) 
Septic Shock * 1  1/696 (0.14%)  0/706 (0.00%)  1/697 (0.14%) 
Tracheitis * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Tuberculosis * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Upper Respiratory Tract Infection * 1  0/696 (0.00%)  1/706 (0.14%)  1/697 (0.14%) 
Urinary Tract Infection * 1  2/696 (0.29%)  2/706 (0.28%)  3/697 (0.43%) 
Urosepsis * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Viral Upper Respiratory Tract Infection * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Injury, poisoning and procedural complications       
Compression Fracture * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Concussion * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Contusion * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Coronary Artery Restenosis * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Craniocerebral Injury * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Fall * 1  1/696 (0.14%)  2/706 (0.28%)  1/697 (0.14%) 
Femoral Neck Fracture * 1  2/696 (0.29%)  0/706 (0.00%)  0/697 (0.00%) 
Hip Fracture * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Humerus Fracture * 1  0/696 (0.00%)  0/706 (0.00%)  2/697 (0.29%) 
Incisional Hernia * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Lower Limb Fracture * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Muscle Rupture * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Overdose * 1  5/696 (0.72%)  6/706 (0.85%)  7/697 (1.00%) 
Pneumothorax Traumatic * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Post Procedural Complication * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Post Procedural Haematoma * 1  0/696 (0.00%)  0/706 (0.00%)  2/697 (0.29%) 
Post Procedural Haemorrhage * 1  1/696 (0.14%)  1/706 (0.14%)  0/697 (0.00%) 
Pubis Fracture * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Radius Fracture * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Rib Fracture * 1  1/696 (0.14%)  0/706 (0.00%)  1/697 (0.14%) 
Road Traffic Accident * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Subdural Haematoma * 1  1/696 (0.14%)  0/706 (0.00%)  2/697 (0.29%) 
Subdural Haemorrhage * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Toxicity to Various Agents * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Traumatic Fracture * 1  1/696 (0.14%)  0/706 (0.00%)  1/697 (0.14%) 
Traumatic Haematoma * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Upper Limb Fracture * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Vascular Pseudoaneurysm * 1  0/696 (0.00%)  1/706 (0.14%)  1/697 (0.14%) 
Wound Dehiscence * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Investigations       
Biopsy Prostate * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Cardiac Stress Test * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Ejection Fraction Decreased * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Electrocardiogram Ambulatory Abnormal * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Haemoglobin Decreased * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Hepatic Enzyme Increased * 1  0/696 (0.00%)  2/706 (0.28%)  0/697 (0.00%) 
International Normalised Ratio Increased * 1  0/696 (0.00%)  0/706 (0.00%)  4/697 (0.57%) 
Lipids Increased * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Metabolism and nutrition disorders       
Dehydration * 1  1/696 (0.14%)  1/706 (0.14%)  0/697 (0.00%) 
Diabetes Mellitus * 1  2/696 (0.29%)  0/706 (0.00%)  1/697 (0.14%) 
Diabetic Metabolic Decompensation * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Hyperglycaemia * 1  0/696 (0.00%)  0/706 (0.00%)  2/697 (0.29%) 
Hypokalaemia * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Hyponatraemia * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Metabolic Disorder * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Type 2 Diabetes Mellitus * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  0/696 (0.00%)  2/706 (0.28%)  1/697 (0.14%) 
Arthritis * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Back Pain * 1  1/696 (0.14%)  1/706 (0.14%)  0/697 (0.00%) 
Bursitis * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Exostosis * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Gouty Arthritis * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Haemarthrosis * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Intervertebral Disc Protrusion * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Joint Effusion * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Lumbar Spinal Stenosis * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Musculoskeletal Disorder * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Neck Pain * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Osteoarthritis * 1  1/696 (0.14%)  1/706 (0.14%)  3/697 (0.43%) 
Osteochondrosis * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Pain in Extremity * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Periarthritis * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Rhabdomyolysis * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Rheumatic Disorder * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Spinal Column Stenosis * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Spinal Disorder * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Spinal Osteoarthritis * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Spinal Pain * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adrenal Neoplasm * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Ameloblastoma * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Basal Cell Carcinoma * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Bladder Cancer * 1  1/696 (0.14%)  1/706 (0.14%)  0/697 (0.00%) 
Bladder Cancer Recurrent * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Bladder Neoplasm * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Bowen's Disease * 1  1/696 (0.14%)  1/706 (0.14%)  0/697 (0.00%) 
Brain Neoplasm Malignant * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Breast Cancer * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Breast Cancer Stage I * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Bronchial Carcinoma * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Cholangiocarcinoma * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Colon Cancer * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Colon Neoplasm * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Colorectal Adenocarcinoma * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Diffuse Large B-Cell Lymphoma * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Gallbladder Cancer Metastatic * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Gastrointestinal Stromal Tumour * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Hepatocellular Carcinoma * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Lung Neoplasm Malignant * 1  1/696 (0.14%)  2/706 (0.28%)  0/697 (0.00%) 
Meningioma * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Metastases to Liver * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Neoplasm * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Ovarian Cancer * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Pituitary Tumour Benign * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Prostate Cancer * 1  1/696 (0.14%)  0/706 (0.00%)  1/697 (0.14%) 
Rectal Cancer * 1  2/696 (0.29%)  0/706 (0.00%)  0/697 (0.00%) 
Rectal Neoplasm * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Renal Cell Carcinoma * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Renal Neoplasm * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Small Cell Lung Cancer Metastatic * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Squamous Cell Carcinoma * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Nervous system disorders       
Aphasia * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Carotid Artery Stenosis * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Cerebral Haemorrhage * 1  0/696 (0.00%)  2/706 (0.28%)  4/697 (0.57%) 
Cerebral Infarction * 1  1/696 (0.14%)  1/706 (0.14%)  0/697 (0.00%) 
Cerebral Ischaemia * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Cerebrovascular Accident * 1  2/696 (0.29%)  4/706 (0.57%)  0/697 (0.00%) 
Dizziness * 1  1/696 (0.14%)  1/706 (0.14%)  0/697 (0.00%) 
Dizziness Postural * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Encephalopathy * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Epilepsy * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Haemorrhagic Stroke * 1  1/696 (0.14%)  0/706 (0.00%)  1/697 (0.14%) 
Hemianopia * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Hemiparesis * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Hypoaesthesia * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Intercostal Neuralgia * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Intracranial Haematoma * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Ischaemic Stroke * 1  5/696 (0.72%)  2/706 (0.28%)  4/697 (0.57%) 
Lacunar Infarction * 1  1/696 (0.14%)  1/706 (0.14%)  0/697 (0.00%) 
Neuralgia * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Parkinson's Disease * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Presyncope * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Sciatica * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Syncope * 1  1/696 (0.14%)  4/706 (0.57%)  8/697 (1.15%) 
Tension Headache * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Transient Ischaemic Attack * 1  1/696 (0.14%)  1/706 (0.14%)  3/697 (0.43%) 
Viith Nerve Paralysis * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Psychiatric disorders       
Anxiety * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Anxiety Disorder * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Confusional State * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Delirium * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Depression * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Hallucination * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Renal and urinary disorders       
Acute Kidney Injury * 1  2/696 (0.29%)  2/706 (0.28%)  1/697 (0.14%) 
Bladder Tamponade * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Calculus Ureteric * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Calculus Urethral * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Calculus Urinary * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Haematuria * 1  5/696 (0.72%)  3/706 (0.42%)  4/697 (0.57%) 
Haemorrhage Urinary Tract * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Hydronephrosis * 1  1/696 (0.14%)  0/706 (0.00%)  1/697 (0.14%) 
Prerenal Failure * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Renal Artery Stenosis * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Renal Failure * 1  2/696 (0.29%)  1/706 (0.14%)  0/697 (0.00%) 
Renal Impairment * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Urethral Haemorrhage * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Urethral Stenosis * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Urinary Retention * 1  0/696 (0.00%)  2/706 (0.28%)  0/697 (0.00%) 
Reproductive system and breast disorders       
Cervical Polyp * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Acute Pulmonary Oedema * 1  2/696 (0.29%)  1/706 (0.14%)  1/697 (0.14%) 
Acute Respiratory Failure * 1  1/696 (0.14%)  1/706 (0.14%)  0/697 (0.00%) 
Bronchitis Chronic * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Bronchopneumopathy * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Chronic Obstructive Pulmonary Disease * 1  2/696 (0.29%)  2/706 (0.28%)  3/697 (0.43%) 
Dyspnoea * 1  6/696 (0.86%)  6/706 (0.85%)  10/697 (1.43%) 
Dyspnoea Exertional * 1  0/696 (0.00%)  1/706 (0.14%)  3/697 (0.43%) 
Dyspnoea at Rest * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Epistaxis * 1  5/696 (0.72%)  5/706 (0.71%)  5/697 (0.72%) 
Haemoptysis * 1  2/696 (0.29%)  2/706 (0.28%)  4/697 (0.57%) 
Haemothorax * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Interstitial Lung Disease * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Lung Disorder * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Pleural Effusion * 1  0/696 (0.00%)  1/706 (0.14%)  1/697 (0.14%) 
Pleurisy * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Pulmonary Congestion * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Pulmonary Hypertension * 1  0/696 (0.00%)  2/706 (0.28%)  0/697 (0.00%) 
Pulmonary Mass * 1  0/696 (0.00%)  1/706 (0.14%)  1/697 (0.14%) 
Pulmonary Oedema * 1  2/696 (0.29%)  1/706 (0.14%)  2/697 (0.29%) 
Respiratory Distress * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Respiratory Failure * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Sleep Apnoea Syndrome * 1  0/696 (0.00%)  2/706 (0.28%)  1/697 (0.14%) 
Skin and subcutaneous tissue disorders       
Diabetic Foot * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Neurodermatitis * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Skin Necrosis * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Skin Ulcer * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Urticaria * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Surgical and medical procedures       
Angioplasty * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Aortic Valve Replacement * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Cardiac Ablation * 1  2/696 (0.29%)  0/706 (0.00%)  0/697 (0.00%) 
Cardiac Pacemaker Insertion * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Cardiac Resynchronisation Therapy * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Cardioversion * 1  0/696 (0.00%)  2/706 (0.28%)  0/697 (0.00%) 
Cholecystectomy * 1  2/696 (0.29%)  0/706 (0.00%)  0/697 (0.00%) 
Coronary Arterial Stent Insertion * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Coronary Artery Bypass * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Hospitalisation * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Ileostomy Closure * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Implantable Defibrillator Insertion * 1  1/696 (0.14%)  2/706 (0.28%)  1/697 (0.14%) 
Knee Arthroplasty * 1  1/696 (0.14%)  2/706 (0.28%)  0/697 (0.00%) 
Mitral Valve Repair * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Percutaneous Coronary Intervention * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Renal Sympathetic Nerve Ablation * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Tooth Extraction * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Vascular disorders       
Aortic Aneurysm * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Aortic Stenosis * 1  1/696 (0.14%)  1/706 (0.14%)  0/697 (0.00%) 
Arterial Stenosis * 1  0/696 (0.00%)  2/706 (0.28%)  0/697 (0.00%) 
Arteriosclerosis * 1  0/696 (0.00%)  1/706 (0.14%)  1/697 (0.14%) 
Arteriovenous Fistula * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Circulatory Collapse * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Deep Vein Thrombosis * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Extremity Necrosis * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Femoral Artery Occlusion * 1  0/696 (0.00%)  0/706 (0.00%)  2/697 (0.29%) 
Haematoma * 1  2/696 (0.29%)  0/706 (0.00%)  3/697 (0.43%) 
Haemorrhage * 1  0/696 (0.00%)  1/706 (0.14%)  1/697 (0.14%) 
Hypertension * 1  3/696 (0.43%)  2/706 (0.28%)  2/697 (0.29%) 
Hypertensive Crisis * 1  1/696 (0.14%)  3/706 (0.42%)  2/697 (0.29%) 
Hypotension * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Intermittent Claudication * 1  1/696 (0.14%)  2/706 (0.28%)  0/697 (0.00%) 
Lymphocele * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Malignant Hypertension * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Peripheral Arterial Occlusive Disease * 1  4/696 (0.57%)  0/706 (0.00%)  2/697 (0.29%) 
Peripheral Artery Thrombosis * 1  2/696 (0.29%)  0/706 (0.00%)  0/697 (0.00%) 
Peripheral Embolism * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
Peripheral Ischaemia * 1  0/696 (0.00%)  2/706 (0.28%)  1/697 (0.14%) 
Peripheral Vascular Disorder * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Shock Haemorrhagic * 1  0/696 (0.00%)  0/706 (0.00%)  1/697 (0.14%) 
Venous Occlusion * 1  1/696 (0.14%)  0/706 (0.00%)  0/697 (0.00%) 
Venous Thrombosis * 1  0/696 (0.00%)  1/706 (0.14%)  0/697 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Rivaroxaban 15 mg Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) Vitamin K Antagonist (VKA)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   174/696 (25.00%)   210/706 (29.75%)   234/697 (33.57%) 
Cardiac disorders       
Angina Pectoris * 1  13/696 (1.87%)  18/706 (2.55%)  12/697 (1.72%) 
Gastrointestinal disorders       
Diarrhoea * 1  12/696 (1.72%)  18/706 (2.55%)  11/697 (1.58%) 
Gingival Bleeding * 1  17/696 (2.44%)  16/706 (2.27%)  18/697 (2.58%) 
General disorders       
Oedema Peripheral * 1  14/696 (2.01%)  12/706 (1.70%)  18/697 (2.58%) 
Injury, poisoning and procedural complications       
Contusion * 1  13/696 (1.87%)  35/706 (4.96%)  25/697 (3.59%) 
Subcutaneous Haematoma * 1  2/696 (0.29%)  10/706 (1.42%)  14/697 (2.01%) 
Nervous system disorders       
Dizziness * 1  8/696 (1.15%)  7/706 (0.99%)  15/697 (2.15%) 
Renal and urinary disorders       
Haematuria * 1  18/696 (2.59%)  14/706 (1.98%)  14/697 (2.01%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea * 1  27/696 (3.88%)  21/706 (2.97%)  18/697 (2.58%) 
Epistaxis * 1  67/696 (9.63%)  59/706 (8.36%)  82/697 (11.76%) 
Skin and subcutaneous tissue disorders       
Ecchymosis * 1  4/696 (0.57%)  16/706 (2.27%)  15/697 (2.15%) 
Vascular disorders       
Haematoma * 1  21/696 (3.02%)  31/706 (4.39%)  61/697 (8.75%) 
Hypertension * 1  17/696 (2.44%)  2/706 (0.28%)  7/697 (1.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 18.1
First the stratification to either 1, 6 or 12 months of DAPT was based upon clinician choice and was not randomized. Secondly there was not sufficient power to definitively assess efficacy due to the modest number of adverse CV events.
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.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Name/Title: Senior Director Clinical Development
Organization: Janssen Scientific Affairs, LLC
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT01830543     History of Changes
Other Study ID Numbers: CR100758
RIVAROXAFL3003 ( Other Identifier: Janssen Scientific Affairs, LLC )
2012-001491-11 ( EudraCT Number )
First Submitted: March 19, 2013
First Posted: April 12, 2013
Results First Submitted: June 30, 2017
Results First Posted: July 31, 2017
Last Update Posted: September 19, 2017