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Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Patients With Atherosclerosis (TRA 2°P - TIMI 50) (P04737)

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ClinicalTrials.gov Identifier: NCT00526474
Recruitment Status : Completed
First Posted : September 10, 2007
Results First Posted : June 18, 2014
Last Update Posted : September 21, 2018
Sponsor:
Collaborator:
The Thrombolysis in Myocardial Infarction Study (TIMI) Group
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Atherosclerosis
Ischemia
Myocardial Infarction
Cerebrovascular Accident
Peripheral Arterial Disease
Interventions Drug: Vorapaxar
Drug: Placebo
Enrollment 26449
Recruitment Details Prior to planned study completion, the Data Safety Monitoring Board (DSMB) recommended discontinuation of study drug in all participants with a pre- or post-randomization history of stroke. A total of 4510 participants had study medication stopped, however these participants were included in the overall population for efficacy and safety analyses.
Pre-assignment Details The Intent to Treat (ITT) Population, defined as all enrolled participants who were randomly assigned to a treatment group.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description 1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care. one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Period Title: Overall Study
Started 13224 13225
Received Study Drug 13166 13186
Completed 12932 12953
Not Completed 292 272
Arm/Group Title Placebo Vorapaxar Total
Hide Arm/Group Description 1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care. one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care. Total of all reporting groups
Overall Number of Baseline Participants 13224 13225 26449
Hide Baseline Analysis Population Description
The Intent to Treat (ITT) Population, defined as all enrolled participants who were randomly assigned to a treatment group.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13224 participants 13225 participants 26449 participants
<65 years 8273 8188 16461
65-<75 years 3445 3523 6968
>=75 years 1506 1514 3020
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13224 participants 13225 participants 26449 participants
Female
3172
  24.0%
3154
  23.8%
6326
  23.9%
Male
10052
  76.0%
10071
  76.2%
20123
  76.1%
1.Primary Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, or Urgent Coronary Revascularization (UCR) Within 3 Years From Randomization
Hide Description The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, or UCR. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, or UCR within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 13224 13225
Measure Type: Number
Unit of Measure: Percentage of Participants
12.4 11.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.82 to 0.95
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
2.Secondary Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, or Stroke Within 3 Years From Randomization
Hide Description The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, or stroke. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, or stroke within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 13224 13225
Measure Type: Number
Unit of Measure: Percentage of Participants
10.5 9.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.80 to 0.94
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
3.Secondary Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Met Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) Moderate or Severe Bleeding Criteria Within 3 Years From Randomization
Hide Description Adverse events were categorized as “bleeding events” if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the GUSTO cooperative group criteria as follows: Mild , Moderate or Severe and the grading was adjudicated by the CEC. The Kaplan-Meier estimate reports the percentage of participants who experienced GUSTO moderate or severe bleeding within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
As Treated Population, which included all participants who received at least 1 dose of study medication.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 13166 13186
Measure Type: Number
Unit of Measure: Percentage of Participants
2.9 4.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.51
Confidence Interval (2-Sided) 95%
1.31 to 1.74
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
4.Secondary Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 3 Years From Randomization
Hide Description Adverse events were categorized as “bleeding events” if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria as major, minor or other. “Clinically Significant Bleeding” was defined as the composite of TIMI Major bleeding, TIMI Minor bleeding, or bleeding that required unplanned medical or surgical treatment or unplanned laboratory evaluation even if it did not meet the criteria for TIMI major or minor bleeding. The Kaplan-Meier estimate reports the percentage of participants who experienced clinically significant bleeding within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
As Treated Population, which included all participants who received at least 1 dose of study medication.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 13166 13186
Measure Type: Number
Unit of Measure: Percentage of Participants
11.3 15.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.41
Confidence Interval (2-Sided) 95%
1.31 to 1.51
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
5.Secondary Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Death From Any Cause, MI, Stroke, or UCR Within 3 Years From Randomization
Hide Description The time (in days) from study start to the occurrence of any of the following clinical outcomes was recorded: death from any cause, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced death from any cause, MI, stroke, or UCR within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 13224 13225
Measure Type: Number
Unit of Measure: Perentage of Participants
14.2 13.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.85 to 0.98
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
6.Secondary Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or an MI Within 3 Years From Randomization
Hide Description The time (in days) from study start to the occurrence of CV death or MI. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death or MI within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 13224 13225
Measure Type: Number
Unit of Measure: Percentage of Participants
8.2 7.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.78 to 0.94
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
7.Secondary Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, UCR, or Urgent Hospitalization for Vascular Cause of Ischemic Nature (UH-VCIN) Within 3 Years From Randomization
Hide Description The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, UCR or UH-VCIN. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, UCR, or UH-VCIN within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 13224 13225
Measure Type: Number
Unit of Measure: Percentage of Participants
14.7 13.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.81 to 0.93
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
8.Secondary Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause, or Experienced an MI, Stroke, or Any Revascularization Within 3 Years From Randomization
Hide Description The time (in days) from study start to death from any cause or the first occurrence of any of the following clinical outcomes was recorded: MI, stroke, or any revascularization procedure . A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause, or experienced an MI, stroke, or any revascularization within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 13224 13225
Measure Type: Number
Unit of Measure: Percentage of Participants
22.6 20.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.86 to 0.96
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
9.Secondary Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, Any Revascularization, or UH-VCIN Within 3 Years From Randomization
Hide Description The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, any revascularization, or UH-VCIN. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, any revascularization procedure, or UH-VCIN within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 13224 13225
Measure Type: Number
Unit of Measure: Percentage of Participants
22.1 19.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.85 to 0.95
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
10.Secondary Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 3 Years From Randomization
Hide Description The time (in days) from study start to CV death (if reported) was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 13224 13225
Measure Type: Number
Unit of Measure: Percentage of Participants
3.0 2.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.151
Comments [Not Specified]
Method Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.76 to 1.04
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
11.Secondary Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 3 Years From Randomization
Hide Description The time (in days) from study start to the first occurrence of an MI was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced an MI within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 13224 13225
Measure Type: Number
Unit of Measure: Percentage of Participants
6.1 5.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.74 to 0.93
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
12.Secondary Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 3 Years From Randomization
Hide Description The time (in days) from study start to the first occurrence of UCR was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced UCR within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 13224 13225
Measure Type: Number
Unit of Measure: Percentage of Participants
2.6 2.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.108
Comments [Not Specified]
Method Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.75 to 1.03
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
13.Secondary Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 3 Years From Randomization
Hide Description The time (in days) from study start to first experience of a stroke was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced a stroke within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 13224 13225
Measure Type: Number
Unit of Measure: Percentage of Participants
2.8 2.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.733
Comments [Not Specified]
Method Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.83 to 1.14
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
14.Secondary Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 3 Years From Randomization
Hide Description The time (in days) from study start to death from any cause was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 13224 13225
Measure Type: Number
Unit of Measure: Percentage of Participants
5.3 5.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.411
Comments [Not Specified]
Method Cox Proportional Hazards Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.85 to 1.07
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
15.Secondary Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Had a UH-VCIN Within 3 Years From Randomization
Hide Description The time (in days) from study start to the first occurrence of an UH-VCIN was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had a UH-VCIN within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 13224 13225
Measure Type: Number
Unit of Measure: Percentage of Participants
5.5 4.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.74 to 0.93
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
16.Secondary Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Had Any Revascularization Performed Within 3 Years From Randomization
Hide Description The time (in days) from study start to the first occurrence of a revascularization was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had any revascularization performed within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 13224 13225
Measure Type: Number
Unit of Measure: Percentage of Participants
15.5 13.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.83 to 0.95
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
17.Post-Hoc Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, or UCR Within 3 Years From Randomization
Hide Description The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, or UCR within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intended Label Population: all enrolled participants with coronary arterial disease (CAD) or peripheral arterial disease (PAD) and no history of a stroke or transient ischemic attack (TIA)
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 10090 10080
Measure Type: Number
Unit of Measure: Percentage of Participants
11.8 10.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.76 to 0.90
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
18.Post-Hoc Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, or Stroke Within 3 Years From Randomization
Hide Description The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, or stroke. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, or stroke within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 10090 10080
Measure Type: Number
Unit of Measure: Percentage of Participants
9.5 7.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.73 to 0.89
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
19.Post-Hoc Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Met GUSTO Moderate or Severe Bleeding Criteria Within 3 Years From Randomization
Hide Description Adverse events were categorized as “bleeding events” if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the GUSTO cooperative group criteria as follows: Mild , Moderate or Severe and the grading was adjudicated by the CEC. The Kaplan-Meier estimate reports the percentage of participants who experienced GUSTO moderate or severe bleeding within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intended Label Safety Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA who received at least 1 dose of study drug
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 10049 10059
Measure Type: Number
Unit of Measure: Percentage of Participants
2.7 3.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.45
Confidence Interval (2-Sided) 95%
1.23 to 1.71
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
20.Post-Hoc Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 3 Years From Randomization
Hide Description Adverse events were categorized as “bleeding events” if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the TIMI Study Group criteria as major, minor or other. “Clinically Significant Bleeding” was defined as the composite of TIMI Major bleeding, TIMI Minor bleeding, or bleeding that required unplanned medical or surgical treatment or unplanned laboratory evaluation even if it did not meet the criteria for TIMI major or minor bleeding. The Kaplan-Meier estimate reports the percentage of participants who experienced clinically significant bleeding within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intended Label Safety Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA who received at least 1 dose of study drug
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 10049 10059
Measure Type: Number
Unit of Measure: Percentage of Participants
11.1 15.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.42
Confidence Interval (2-Sided) 95%
1.31 to 1.54
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
21.Post-Hoc Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Death From Any Cause, MI, Stroke, or UCR Within 3 Years From Randomization
Hide Description The time (in days) from study start to the occurrence of any of the following clinical outcomes was recorded: death from any cause, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced death from any cause, MI, stroke, or UCR within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 10090 10080
Measure Type: Number
Unit of Measure: Percentage of Participants
13.5 11.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.79 to 0.93
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
22.Post-Hoc Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or an MI Within 3 Years From Randomization
Hide Description The time (in days) from study start to the occurrence of CV death or first occurrence of an MI. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death or MI within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 10090 10080
Measure Type: Number
Unit of Measure: Percentage of Partcipants
8.3 7.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.75 to 0.93
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
23.Post-Hoc Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, UCR, or UH-VCIN Within 3 Years From Randomization
Hide Description The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, UCR, or UH-VCIN . A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, UCR, or UH-VCIN within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 10090 10080
Measure Type: Number
Unit of Measure: Percentage of Participants
13.9 11.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.77 to 0.90
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
24.Post-Hoc Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause, or Experienced an MI, Stroke, or Any Revascularization Within 3 Years From Randomization
Hide Description The time (in days) from study start to death from any cause or the first occurrence of any of the following clinical outcomes was recorded: MI, stroke, or any revascularization procedure . A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause, or experienced an MI, stroke, or any revascularization within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 10090 10080
Measure Type: Number
Unit of Measure: Percentage of Participants
22.5 20.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.83 to 0.95
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
25.Post-Hoc Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, Any Revascularization, or UH-VCIN Within 3 Years From Randomization
Hide Description The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, any revascularization, or UH-VCIN. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, any revascularization procedure, or UH-VCIN within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 10090 10080
Measure Type: Number
Unit of Measure: Percentage of Participants
21.8 19.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.83 to 0.94
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
26.Post-Hoc Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 3 Years From Randomization
Hide Description The time (in days) from study start to the CV death (if reported) was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 10090 10080
Measure Type: Number
Unit of Measure: Percentage of Participants
2.8 2.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.108
Comments [Not Specified]
Method Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.71 to 1.03
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
27.Post-Hoc Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 3 Years From Randomization
Hide Description The time (in days) from study start to the first occurrence of an MI was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced an MI within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 10090 10080
Measure Type: Number
Unit of Measure: Percentage of Participants
6.4 5.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.73 to 0.93
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
28.Post-Hoc Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 3 Years From Randomization
Hide Description The time (in days) from study start to the first occurrence of UCR was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced UCR within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 10090 10080
Measure Type: Number
Unit of Measure: Percentage of Participants
3.0 2.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.127
Comments [Not Specified]
Method Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.74 to 1.04
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
29.Post-Hoc Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 3 Years From Randomization
Hide Description The time (in days) from study start to first experience of a stroke was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced a stroke within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 10090 10080
Measure Type: Number
Unit of Measure: Percentage of Participants
1.6 1.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
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 Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.52 to 0.87
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
30.Post-Hoc Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 3 Years From Randomization
Hide Description The time (in days) from study start to death from any cause was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 10090 10080
Measure Type: Number
Unit of Measure: Percentage of Participants
4.8 4.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.249
Comments [Not Specified]
Method Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.80 to 1.06
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
31.Post-Hoc Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Had a UH-VCIN Within 3 Years From Randomization
Hide Description The time (in days) from study start to the first occurrence of a UH-VCIN was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had a UH-VCIN within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 10090 10080
Measure Type: Number
Unit of Measure: Percentage of Participants
5.6 4.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.76 to 0.98
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
32.Post-Hoc Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Had Any Revascularization Performed Within 3 Years From Randomization
Hide Description The time (in days) from study start to the first occurrence of any revascularization was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had any revascularization performed within 3 years from randomization.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Overall Number of Participants Analyzed 10090 10080
Measure Type: Number
Unit of Measure: Percentage of Participants
16.6 14.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vorapaxar
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Cox Proportional Hazards Regression
Comments Hazard Ratio calculated with covariates for treatment and stratification factors
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.83 to 0.96
Estimation Comments Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.
Time Frame up to 3 years
Adverse Event Reporting Description Adverse events are reported using the As Treated Population, which included all participants who received at least 1 dose of study medication and are reported according to treatment received
 
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description 1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care. one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
All-Cause Mortality
Placebo Vorapaxar
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Vorapaxar
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3419/13166 (25.97%)      3514/13186 (26.65%)    
Blood and lymphatic system disorders     
ANAEMIA  1  12/13166 (0.09%)  13 45/13186 (0.34%)  47
ANAEMIA HAEMOLYTIC AUTOIMMUNE  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
ANAEMIA OF CHRONIC DISEASE  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
APLASIA PURE RED CELL  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
AUTOIMMUNE THROMBOCYTOPENIA  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
COAGULOPATHY  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
FEBRILE NEUTROPENIA  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
HAEMORRHAGIC ANAEMIA  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
HAEMORRHAGIC DIATHESIS  1  4/13166 (0.03%)  4 7/13186 (0.05%)  7
HEPARIN-INDUCED THROMBOCYTOPENIA  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
IDIOPATHIC THROMBOCYTOPENIC PURPURA  1  0/13166 (0.00%)  0 3/13186 (0.02%)  3
IRON DEFICIENCY ANAEMIA  1  4/13166 (0.03%)  4 16/13186 (0.12%)  16
LEUKOCYTOSIS  1  1/13166 (0.01%)  1 2/13186 (0.02%)  2
LEUKOPENIA  1  1/13166 (0.01%)  1 2/13186 (0.02%)  2
LYMPHADENOPATHY  1  1/13166 (0.01%)  1 2/13186 (0.02%)  2
MICROCYTIC ANAEMIA  1  0/13166 (0.00%)  0 3/13186 (0.02%)  3
NEPHROGENIC ANAEMIA  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
NEUTROPENIA  1  1/13166 (0.01%)  1 2/13186 (0.02%)  2
NORMOCHROMIC NORMOCYTIC ANAEMIA  1  0/13166 (0.00%)  0 2/13186 (0.02%)  2
PANCYTOPENIA  1  2/13166 (0.02%)  2 3/13186 (0.02%)  3
PERNICIOUS ANAEMIA  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
RETROPERITONEAL LYMPHADENOPATHY  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
SPLENIC HAEMORRHAGE  1  2/13166 (0.02%)  2 0/13186 (0.00%)  0
THROMBOCYTOPENIA  1  23/13166 (0.17%)  23 19/13186 (0.14%)  20
THROMBOCYTOSIS  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
THROMBOTIC THROMBOCYTOPENIC PURPURA  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
Cardiac disorders     
ACUTE CORONARY SYNDROME  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
ADAMS-STOKES SYNDROME  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
ANGINA PECTORIS  1  7/13166 (0.05%)  8 2/13186 (0.02%)  2
AORTIC VALVE INCOMPETENCE  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
AORTIC VALVE STENOSIS  1  4/13166 (0.03%)  4 5/13186 (0.04%)  5
ARRHYTHMIA  1  2/13166 (0.02%)  2 3/13186 (0.02%)  3
ARRHYTHMIA SUPRAVENTRICULAR  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
ATRIAL FIBRILLATION  1  106/13166 (0.81%)  118 137/13186 (1.04%)  156
ATRIAL FLUTTER  1  18/13166 (0.14%)  19 28/13186 (0.21%)  28
ATRIAL TACHYCARDIA  1  3/13166 (0.02%)  3 0/13186 (0.00%)  0
ATRIAL THROMBOSIS  1  1/13166 (0.01%)  1 2/13186 (0.02%)  2
ATRIOVENTRICULAR BLOCK  1  3/13166 (0.02%)  3 3/13186 (0.02%)  3
ATRIOVENTRICULAR BLOCK COMPLETE  1  13/13166 (0.10%)  13 19/13186 (0.14%)  19
ATRIOVENTRICULAR BLOCK FIRST DEGREE  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
ATRIOVENTRICULAR BLOCK SECOND DEGREE  1  8/13166 (0.06%)  9 4/13186 (0.03%)  4
BIFASCICULAR BLOCK  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
BRADYCARDIA  1  27/13166 (0.21%)  27 20/13186 (0.15%)  20
BUNDLE BRANCH BLOCK LEFT  1  2/13166 (0.02%)  3 0/13186 (0.00%)  0
BUNDLE BRANCH BLOCK RIGHT  1  2/13166 (0.02%)  2 0/13186 (0.00%)  0
CARDIAC ANEURYSM  1  0/13166 (0.00%)  0 2/13186 (0.02%)  2
CARDIAC ARREST  1  13/13166 (0.10%)  13 2/13186 (0.02%)  2
CARDIAC ASTHMA  1  0/13166 (0.00%)  0 2/13186 (0.02%)  2
CARDIAC FAILURE  1  174/13166 (1.32%)  222 183/13186 (1.39%)  245
CARDIAC FAILURE ACUTE  1  5/13166 (0.04%)  5 4/13186 (0.03%)  5
CARDIAC FAILURE CHRONIC  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
CARDIAC FAILURE CONGESTIVE  1  82/13166 (0.62%)  99 95/13186 (0.72%)  121
CARDIAC TAMPONADE  1  5/13166 (0.04%)  5 4/13186 (0.03%)  5
CARDIO-RESPIRATORY ARREST  1  4/13166 (0.03%)  4 3/13186 (0.02%)  3
CARDIOGENIC SHOCK  1  10/13166 (0.08%)  10 8/13186 (0.06%)  8
CARDIOMYOPATHY  1  5/13166 (0.04%)  5 3/13186 (0.02%)  3
CARDIOPULMONARY FAILURE  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
CHRONOTROPIC INCOMPETENCE  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
CONDUCTION DISORDER  1  2/13166 (0.02%)  2 0/13186 (0.00%)  0
CONGESTIVE CARDIOMYOPATHY  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
CORONARY ARTERY DISEASE  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
DRESSLER'S SYNDROME  1  1/13166 (0.01%)  1 2/13186 (0.02%)  3
EXTRASYSTOLES  1  2/13166 (0.02%)  2 0/13186 (0.00%)  0
HEART VALVE INCOMPETENCE  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
HYPERTENSIVE HEART DISEASE  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
INTRACARDIAC THROMBUS  1  3/13166 (0.02%)  3 1/13186 (0.01%)  1
ISCHAEMIC CARDIOMYOPATHY  1  8/13166 (0.06%)  8 11/13186 (0.08%)  11
LEFT VENTRICULAR DYSFUNCTION  1  2/13166 (0.02%)  2 10/13186 (0.08%)  10
LEFT VENTRICULAR FAILURE  1  0/13166 (0.00%)  0 2/13186 (0.02%)  2
MITRAL VALVE INCOMPETENCE  1  4/13166 (0.03%)  4 4/13186 (0.03%)  4
MITRAL VALVE PROLAPSE  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
MITRAL VALVE STENOSIS  1  1/13166 (0.01%)  1 3/13186 (0.02%)  3
MYOCARDIAL RUPTURE  1  2/13166 (0.02%)  2 0/13186 (0.00%)  0
MYOPERICARDITIS  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
NODAL ARRHYTHMIA  1  1/13166 (0.01%)  1 2/13186 (0.02%)  2
PALPITATIONS  1  3/13166 (0.02%)  3 7/13186 (0.05%)  7
PERICARDIAL EFFUSION  1  4/13166 (0.03%)  4 3/13186 (0.02%)  3
PERICARDIAL HAEMORRHAGE  1  2/13166 (0.02%)  2 8/13186 (0.06%)  8
PERICARDITIS  1  9/13166 (0.07%)  9 3/13186 (0.02%)  3
PULSELESS ELECTRICAL ACTIVITY  1  1/13166 (0.01%)  1 3/13186 (0.02%)  3
SICK SINUS SYNDROME  1  20/13166 (0.15%)  20 20/13186 (0.15%)  22
SINUS ARREST  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
SINUS ARRHYTHMIA  1  4/13166 (0.03%)  4 4/13186 (0.03%)  4
SINUS BRADYCARDIA  1  4/13166 (0.03%)  4 3/13186 (0.02%)  3
SINUS TACHYCARDIA  1  4/13166 (0.03%)  4 4/13186 (0.03%)  4
STRESS CARDIOMYOPATHY  1  0/13166 (0.00%)  0 1/13186 (0.01%)  2
SUPRAVENTRICULAR EXTRASYSTOLES  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
SUPRAVENTRICULAR TACHYCARDIA  1  16/13166 (0.12%)  20 13/13186 (0.10%)  14
TACHYARRHYTHMIA  1  2/13166 (0.02%)  2 1/13186 (0.01%)  1
TACHYCARDIA  1  1/13166 (0.01%)  1 2/13186 (0.02%)  2
TORSADE DE POINTES  1  0/13166 (0.00%)  0 2/13186 (0.02%)  2
VENTRICULAR ARRHYTHMIA  1  2/13166 (0.02%)  2 3/13186 (0.02%)  3
VENTRICULAR ASYSTOLE  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
VENTRICULAR DYSFUNCTION  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
VENTRICULAR DYSSYNCHRONY  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
VENTRICULAR EXTRASYSTOLES  1  4/13166 (0.03%)  5 4/13186 (0.03%)  4
VENTRICULAR FIBRILLATION  1  15/13166 (0.11%)  16 16/13186 (0.12%)  16
VENTRICULAR TACHYCARDIA  1  37/13166 (0.28%)  49 37/13186 (0.28%)  42
Congenital, familial and genetic disorders     
ARTERIOVENOUS MALFORMATION  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
ATRIAL SEPTAL DEFECT  1  0/13166 (0.00%)  0 2/13186 (0.02%)  2
EPIDERMOLYSIS  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
GASTROINTESTINAL ANGIODYSPLASIA  1  0/13166 (0.00%)  0 2/13186 (0.02%)  2
GASTROINTESTINAL ANGIODYSPLASIA HAEMORRHAGIC  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
GASTROINTESTINAL ARTERIOVENOUS MALFORMATION  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
HAEMORRHAGIC ARTERIOVENOUS MALFORMATION  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
HIP DYSPLASIA  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
HYDROCELE  1  2/13166 (0.02%)  2 0/13186 (0.00%)  0
PHIMOSIS  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
PORPHYRIA  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
PYLORIC STENOSIS  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
VENTRICULAR SEPTAL DEFECT  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
Ear and labyrinth disorders     
ACUTE VESTIBULAR SYNDROME  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
DEAFNESS  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
HYPOACUSIS  1  0/13166 (0.00%)  0 2/13186 (0.02%)  2
MENIERE'S DISEASE  1  3/13166 (0.02%)  3 0/13186 (0.00%)  0
SUDDEN HEARING LOSS  1  2/13166 (0.02%)  2 1/13186 (0.01%)  1
VERTIGO  1  16/13166 (0.12%)  17 23/13186 (0.17%)  24
VERTIGO POSITIONAL  1  5/13166 (0.04%)  5 3/13186 (0.02%)  3
VESTIBULAR DISORDER  1  0/13166 (0.00%)  0 2/13186 (0.02%)  2
Endocrine disorders     
ADDISON'S DISEASE  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
ADRENAL MASS  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
AUTOIMMUNE THYROIDITIS  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
BASEDOW'S DISEASE  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
GOITRE  1  5/13166 (0.04%)  5 1/13186 (0.01%)  1
HYPERCALCAEMIA OF MALIGNANCY  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
HYPERPARATHYROIDISM  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
HYPERTHYROIDISM  1  3/13166 (0.02%)  3 4/13186 (0.03%)  4
HYPOTHYROIDISM  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION  1  2/13166 (0.02%)  2 0/13186 (0.00%)  0
Eye disorders     
AMAUROSIS  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
BLINDNESS UNILATERAL  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
CATARACT  1  15/13166 (0.11%)  15 10/13186 (0.08%)  12
CONJUNCTIVAL HAEMORRHAGE  1  0/13166 (0.00%)  0 2/13186 (0.02%)  2
CORNEAL OEDEMA  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
DIABETIC RETINOPATHY  1  2/13166 (0.02%)  2 2/13186 (0.02%)  3
ENDOCRINE OPHTHALMOPATHY  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
EYE HAEMORRHAGE  1  5/13166 (0.04%)  6 3/13186 (0.02%)  3
GLAUCOMA  1  3/13166 (0.02%)  3 1/13186 (0.01%)  1
HYPHAEMA  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
LACRIMATION INCREASED  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
MACULAR DEGENERATION  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
MACULAR FIBROSIS  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
MACULAR HOLE  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
OCULAR HYPERTENSION  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
OPTIC ISCHAEMIC NEUROPATHY  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
OPTIC NEUROPATHY  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
POSTERIOR CAPSULE OPACIFICATION  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
RETINAL ARTERY THROMBOSIS  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
RETINAL DETACHMENT  1  6/13166 (0.05%)  6 4/13186 (0.03%)  4
RETINAL VEIN OCCLUSION  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
RETINAL VEIN THROMBOSIS  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
ULCERATIVE KERATITIS  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
VISION BLURRED  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
VISUAL IMPAIRMENT  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
VITREOUS HAEMORRHAGE  1  2/13166 (0.02%)  2 0/13186 (0.00%)  0
Gastrointestinal disorders     
ABDOMINAL ADHESIONS  1  1/13166 (0.01%)  1 2/13186 (0.02%)  2
ABDOMINAL COMPARTMENT SYNDROME  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
ABDOMINAL DISCOMFORT  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
ABDOMINAL HERNIA  1  6/13166 (0.05%)  6 4/13186 (0.03%)  4
ABDOMINAL HERNIA OBSTRUCTIVE  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
ABDOMINAL MASS  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
ABDOMINAL PAIN  1  17/13166 (0.13%)  18 9/13186 (0.07%)  9
ABDOMINAL PAIN LOWER  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
ABDOMINAL PAIN UPPER  1  9/13166 (0.07%)  9 10/13186 (0.08%)  10
ABDOMINAL WALL HAEMORRHAGE  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
ACUTE ABDOMEN  1  2/13166 (0.02%)  2 0/13186 (0.00%)  0
ANAL FISTULA  1  2/13166 (0.02%)  2 2/13186 (0.02%)  2
ANAL HAEMORRHAGE  1  1/13166 (0.01%)  2 2/13186 (0.02%)  2
ASCITES  1  2/13166 (0.02%)  2 1/13186 (0.01%)  1
BARRETT'S OESOPHAGUS  1  2/13166 (0.02%)  2 1/13186 (0.01%)  1
BUCCAL POLYP  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
COLITIS  1  7/13166 (0.05%)  7 9/13186 (0.07%)  9
COLITIS EROSIVE  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
COLITIS ISCHAEMIC  1  8/13166 (0.06%)  8 8/13186 (0.06%)  9
COLITIS ULCERATIVE  1  1/13166 (0.01%)  1 2/13186 (0.02%)  2
COLONIC POLYP  1  6/13166 (0.05%)  6 14/13186 (0.11%)  14
COLONIC PSEUDO-OBSTRUCTION  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
CONSTIPATION  1  10/13166 (0.08%)  10 11/13186 (0.08%)  11
CROHN'S DISEASE  1  3/13166 (0.02%)  3 3/13186 (0.02%)  3
DENTAL CARIES  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
DENTAL NECROSIS  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
DIABETIC GASTROPARESIS  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
DIARRHOEA  1  4/13166 (0.03%)  4 7/13186 (0.05%)  8
DIARRHOEA HAEMORRHAGIC  1  2/13166 (0.02%)  2 2/13186 (0.02%)  2
DIVERTICULAR PERFORATION  1  2/13166 (0.02%)  2 0/13186 (0.00%)  0
DIVERTICULITIS INTESTINAL HAEMORRHAGIC  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
DIVERTICULUM  1  3/13166 (0.02%)  3 4/13186 (0.03%)  4
DIVERTICULUM INTESTINAL  1  0/13166 (0.00%)  0 2/13186 (0.02%)  2
DIVERTICULUM INTESTINAL HAEMORRHAGIC  1  0/13166 (0.00%)  0 3/13186 (0.02%)  5
DIVERTICULUM OESOPHAGEAL  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
DUODENAL PERFORATION  1  2/13166 (0.02%)  2 0/13186 (0.00%)  0
DUODENAL ULCER  1  5/13166 (0.04%)  5 8/13186 (0.06%)  9
DUODENAL ULCER HAEMORRHAGE  1  3/13166 (0.02%)  3 3/13186 (0.02%)  3
DUODENITIS  1  2/13166 (0.02%)  2 1/13186 (0.01%)  1
DYSPEPSIA  1  5/13166 (0.04%)  5 10/13186 (0.08%)  10
DYSPHAGIA  1  5/13166 (0.04%)  5 4/13186 (0.03%)  4
ENTERITIS  1  4/13166 (0.03%)  4 2/13186 (0.02%)  2
ENTEROCELE  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
ENTEROCOLITIS  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
ENTEROCOLITIS HAEMORRHAGIC  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
ENTEROVESICAL FISTULA  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
EPIGASTRIC DISCOMFORT  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
EPIPLOIC APPENDAGITIS  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
EROSIVE DUODENITIS  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
EROSIVE OESOPHAGITIS  1  3/13166 (0.02%)  3 4/13186 (0.03%)  4
FAECALOMA  1  4/13166 (0.03%)  4 2/13186 (0.02%)  2
FAECES DISCOLOURED  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
FEMORAL HERNIA, OBSTRUCTIVE  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
FOOD POISONING  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
FUNCTIONAL GASTROINTESTINAL DISORDER  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
GASTRIC DISORDER  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
GASTRIC HAEMORRHAGE  1  1/13166 (0.01%)  2 3/13186 (0.02%)  3
GASTRIC PERFORATION  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
GASTRIC ULCER  1  6/13166 (0.05%)  6 11/13186 (0.08%)  11
GASTRIC ULCER HAEMORRHAGE  1  5/13166 (0.04%)  5 6/13186 (0.05%)  6
GASTRIC ULCER PERFORATION  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
GASTRIC VOLVULUS  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
GASTRITIS  1  29/13166 (0.22%)  29 26/13186 (0.20%)  26
GASTRITIS ALCOHOLIC  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
GASTRITIS ATROPHIC  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
GASTRITIS EROSIVE  1  3/13166 (0.02%)  3 6/13186 (0.05%)  7
GASTRODUODENAL ULCER  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
GASTROINTESTINAL DISORDER  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
GASTROINTESTINAL HAEMORRHAGE  1  38/13166 (0.29%)  42 62/13186 (0.47%)  70
GASTROINTESTINAL INFLAMMATION  1  2/13166 (0.02%)  2 0/13186 (0.00%)  0
GASTROINTESTINAL NECROSIS  1  0/13166 (0.00%)  0 3/13186 (0.02%)  3
GASTROINTESTINAL OBSTRUCTION  1  2/13166 (0.02%)  2 1/13186 (0.01%)  1
GASTROINTESTINAL TELANGIECTASIA  1  0/13166 (0.00%)  0 2/13186 (0.02%)  2
GASTROINTESTINAL ULCER HAEMORRHAGE  1  2/13166 (0.02%)  2 0/13186 (0.00%)  0
GASTROOESOPHAGEAL REFLUX DISEASE  1  31/13166 (0.24%)  33 23/13186 (0.17%)  24
GINGIVAL BLEEDING  1  0/13166 (0.00%)  0 2/13186 (0.02%)  2
HAEMATEMESIS  1  19/13166 (0.14%)  19 28/13186 (0.21%)  28
HAEMATOCHEZIA  1  21/13166 (0.16%)  24 16/13186 (0.12%)  18
HAEMORRHOIDAL HAEMORRHAGE  1  5/13166 (0.04%)  6 7/13186 (0.05%)  7
HAEMORRHOIDS  1  1/13166 (0.01%)  1 4/13186 (0.03%)  4
HERNIAL EVENTRATION  1  1/13166 (0.01%)  2 0/13186 (0.00%)  0
HIATUS HERNIA  1  5/13166 (0.04%)  5 4/13186 (0.03%)  4
ILEAL STENOSIS  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
ILEUS  1  5/13166 (0.04%)  5 8/13186 (0.06%)  10
IMPAIRED GASTRIC EMPTYING  1  2/13166 (0.02%)  2 2/13186 (0.02%)  2
INFLAMMATORY BOWEL DISEASE  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
INGUINAL HERNIA  1  35/13166 (0.27%)  35 42/13186 (0.32%)  44
INGUINAL HERNIA STRANGULATED  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
INGUINAL HERNIA, OBSTRUCTIVE  1  2/13166 (0.02%)  2 4/13186 (0.03%)  4
INTESTINAL ISCHAEMIA  1  8/13166 (0.06%)  8 3/13186 (0.02%)  3
INTESTINAL MASS  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
INTESTINAL OBSTRUCTION  1  9/13166 (0.07%)  9 13/13186 (0.10%)  14
INTESTINAL PERFORATION  1  1/13166 (0.01%)  1 7/13186 (0.05%)  7
INTESTINAL POLYP  1  1/13166 (0.01%)  1 2/13186 (0.02%)  2
INTESTINAL STRANGULATION  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
JEJUNAL PERFORATION  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
LARGE INTESTINAL HAEMORRHAGE  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
LARGE INTESTINAL OBSTRUCTION  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
LARGE INTESTINAL ULCER  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
LARGE INTESTINAL ULCER HAEMORRHAGE  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
LARGE INTESTINE PERFORATION  1  2/13166 (0.02%)  2 4/13186 (0.03%)  4
LOWER GASTROINTESTINAL HAEMORRHAGE  1  8/13166 (0.06%)  8 5/13186 (0.04%)  5
LUMBAR HERNIA  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
MALABSORPTION  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
MALLORY-WEISS SYNDROME  1  2/13166 (0.02%)  2 2/13186 (0.02%)  2
MECHANICAL ILEUS  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
MELAENA  1  44/13166 (0.33%)  49 69/13186 (0.52%)  76
MESENTERIC ARTERY STENOSIS  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
MESENTERIC ARTERY THROMBOSIS  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
MESENTERIC VASCULAR INSUFFICIENCY  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
MOUTH CYST  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
NAUSEA  1  5/13166 (0.04%)  5 8/13186 (0.06%)  8
OESOPHAGEAL ACHALASIA  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
OESOPHAGEAL HAEMORRHAGE  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
OESOPHAGEAL OBSTRUCTION  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
OESOPHAGEAL RUPTURE  1  0/13166 (0.00%)  0 2/13186 (0.02%)  2
OESOPHAGEAL SPASM  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
OESOPHAGEAL STENOSIS  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
OESOPHAGEAL ULCER  1  0/13166 (0.00%)  0 2/13186 (0.02%)  2
OESOPHAGEAL ULCER HAEMORRHAGE  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
OESOPHAGITIS  1  4/13166 (0.03%)  4 10/13186 (0.08%)  11
PANCREATIC CYST  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
PANCREATIC DISORDER  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
PANCREATITIS  1  17/13166 (0.13%)  21 17/13186 (0.13%)  18
PANCREATITIS ACUTE  1  11/13166 (0.08%)  13 9/13186 (0.07%)  11
PANCREATITIS RELAPSING  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
PAPILLA OF VATER STENOSIS  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
PAROTID GLAND ENLARGEMENT  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
PEPTIC ULCER  1  2/13166 (0.02%)  2 5/13186 (0.04%)  5
PEPTIC ULCER HAEMORRHAGE  1  0/13166 (0.00%)  0 2/13186 (0.02%)  2
PERITONEAL HAEMORRHAGE  1  0/13166 (0.00%)  0 2/13186 (0.02%)  2
PHARYNGOESOPHAGEAL DIVERTICULUM  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
POLYP COLORECTAL  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
PROCTITIS  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
PROCTITIS HAEMORRHAGIC  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
PROCTITIS ULCERATIVE  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
RECTAL HAEMORRHAGE  1  37/13166 (0.28%)  41 53/13186 (0.40%)  59
RECTAL PROLAPSE  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
RECTAL ULCER  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
RETROPERITONEAL HAEMATOMA  1  0/13166 (0.00%)  0 2/13186 (0.02%)  2
RETROPERITONEAL HAEMORRHAGE  1  3/13166 (0.02%)  3 8/13186 (0.06%)  8
SALIVARY GLAND CALCULUS  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
SMALL INTESTINAL HAEMORRHAGE  1  2/13166 (0.02%)  2 2/13186 (0.02%)  2
SMALL INTESTINAL OBSTRUCTION  1  14/13166 (0.11%)  18 12/13186 (0.09%)  12
SMALL INTESTINAL PERFORATION  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
SPIGELIAN HERNIA  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
SPLENIC ARTERY ANEURYSM  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
SUBILEUS  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
THROMBOSIS MESENTERIC VESSEL  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
TONGUE HAEMATOMA  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
TONGUE OEDEMA  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
UMBILICAL HERNIA  1  10/13166 (0.08%)  10 6/13186 (0.05%)  6
UMBILICAL HERNIA, OBSTRUCTIVE  1  2/13166 (0.02%)  2 2/13186 (0.02%)  2
UPPER GASTROINTESTINAL HAEMORRHAGE  1  17/13166 (0.13%)  20 15/13186 (0.11%)  16
VARICES OESOPHAGEAL  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
VOMITING  1  4/13166 (0.03%)  4 1/13186 (0.01%)  1
General disorders     
ADVERSE DRUG REACTION  1  12/13166 (0.09%)  12 16/13186 (0.12%)  16
APPLICATION SITE BLEEDING  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
ASTHENIA  1  5/13166 (0.04%)  5 1/13186 (0.01%)  1
CATHETER SITE HAEMATOMA  1  4/13166 (0.03%)  4 8/13186 (0.06%)  8
CATHETER SITE HAEMORRHAGE  1  5/13166 (0.04%)  5 5/13186 (0.04%)  5
CHEST DISCOMFORT  1  10/13166 (0.08%)  11 6/13186 (0.05%)  6
CHEST PAIN  1  14/13166 (0.11%)  16 15/13186 (0.11%)  15
CYST  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
CYST RUPTURE  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
DEVICE BREAKAGE  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
DEVICE DISLOCATION  1  2/13166 (0.02%)  3 3/13186 (0.02%)  4
DEVICE FAILURE  1  0/13166 (0.00%)  0 2/13186 (0.02%)  2
DEVICE LEAD DAMAGE  1  1/13166 (0.01%)  1 2/13186 (0.02%)  2
DEVICE MALFUNCTION  1  3/13166 (0.02%)  3 7/13186 (0.05%)  7
DEVICE OCCLUSION  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
DISCOMFORT  1  2/13166 (0.02%)  2 0/13186 (0.00%)  0
DRUG INTERACTION  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
EXERCISE TOLERANCE DECREASED  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
FATIGUE  1  1/13166 (0.01%)  1 2/13186 (0.02%)  2
GAIT DISTURBANCE  1  2/13166 (0.02%)  2 2/13186 (0.02%)  2
GENERAL PHYSICAL HEALTH DETERIORATION  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
GRAVITATIONAL OEDEMA  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
HERNIA  1  2/13166 (0.02%)  2 2/13186 (0.02%)  3
HERNIA OBSTRUCTIVE  1  0/13166 (0.00%)  0 2/13186 (0.02%)  2
HYPERPLASIA  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
HYPERTROPHY  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
HYPOTHERMIA  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
ILL-DEFINED DISORDER  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
IMPAIRED HEALING  1  5/13166 (0.04%)  5 6/13186 (0.05%)  6
IMPLANT SITE EROSION  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
IMPLANT SITE PAIN  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
INFLAMMATION  1  2/13166 (0.02%)  2 0/13186 (0.00%)  0
MALAISE  1  4/13166 (0.03%)  4 0/13186 (0.00%)  0
MEDICAL DEVICE COMPLICATION  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
MUCOSAL INFLAMMATION  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
MULTI-ORGAN DISORDER  1  0/13166 (0.00%)  0 2/13186 (0.02%)  2
MULTI-ORGAN FAILURE  1  4/13166 (0.03%)  4 6/13186 (0.05%)  6
NECROSIS  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
NODULE  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
NON-CARDIAC CHEST PAIN  1  458/13166 (3.48%)  548 443/13186 (3.36%)  519
OEDEMA  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
OEDEMA PERIPHERAL  1  4/13166 (0.03%)  4 4/13186 (0.03%)  4
PAIN  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
PERFORATED ULCER  1  1/13166 (0.01%)  2 0/13186 (0.00%)  0
POLYP  1  1/13166 (0.01%)  1 3/13186 (0.02%)  3
POLYSEROSITIS  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
PYREXIA  1  11/13166 (0.08%)  12 9/13186 (0.07%)  9
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME  1  2/13166 (0.02%)  2 0/13186 (0.00%)  0
THROMBOSIS IN DEVICE  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
ULCER  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
ULCER HAEMORRHAGE  1  2/13166 (0.02%)  2 1/13186 (0.01%)  1
Hepatobiliary disorders     
BILE DUCT OBSTRUCTION  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
BILE DUCT STONE  1  6/13166 (0.05%)  6 4/13186 (0.03%)  4
BILIARY COLIC  1  2/13166 (0.02%)  2 3/13186 (0.02%)  3
BILIARY DILATATION  1  0/13166 (0.00%)  0 1/13186 (0.01%)  1
BILIARY DYSKINESIA  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
CHOLANGITIS  1  1/13166 (0.01%)  1 3/13186 (0.02%)  3
CHOLANGITIS ACUTE  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
CHOLECYSTITIS  1  26/13166 (0.20%)  26 31/13186 (0.24%)  32
CHOLECYSTITIS ACUTE  1  18/13166 (0.14%)  19 18/13186 (0.14%)  18
CHOLECYSTITIS CHRONIC  1  1/13166 (0.01%)  1 3/13186 (0.02%)  3
CHOLELITHIASIS  1  42/13166 (0.32%)  42 42/13186 (0.32%)  43
CHOLESTASIS  1  2/13166 (0.02%)  2 0/13186 (0.00%)  0
GALLBLADDER DISORDER  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
GALLBLADDER POLYP  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
HEPATIC CIRRHOSIS  1  5/13166 (0.04%)  5 1/13186 (0.01%)  1
HEPATIC FAILURE  1  1/13166 (0.01%)  1 3/13186 (0.02%)  3
HEPATIC MASS  1  1/13166 (0.01%)  1 0/13186 (0.00%)  0
HEPATIC STEATOSIS  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
HEPATITIS  1  1/13166 (0.01%)  1 1/13186 (0.01%)  1
HEPATITIS ACUTE  1  1/13166 (0.01%)  1 1/13