Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Particpants With Acute Coronary Syndrome (TRA•CER) (Study P04736)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00527943
Recruitment Status : Terminated (The trial was terminated at the request of the Data and Safety Monitoring Board.)
First Posted : September 11, 2007
Results First Posted : June 9, 2014
Last Update Posted : September 21, 2018
Sponsor:
Collaborator:
Duke Clinical Research Institute
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
Myocardial Ischemia
Myocardial Infarction
Interventions Drug: Vorapaxar
Drug: Placebo
Enrollment 12944
Recruitment Details Prior to the planned study completion, the Data Safety Monitoring Board recommended that all participants stop treatment and that the study be closed-out. The protocol-defined target number of primary efficacy endpoints had been reached by this time. However, follow-up in the study was terminated earlier than planned.
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 Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care. Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Period Title: Overall Study
Started 6471 6473
Received Treatment 6441 6446
Completed 6311 6327
Not Completed 160 146
Arm/Group Title Placebo Vorapaxar Total
Hide Arm/Group Description Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care. Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care. Total of all reporting groups
Overall Number of Baseline Participants 6471 6473 12944
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6471 participants 6473 participants 12944 participants
<65 years 3369 3390 6759
65 to <75 years 2006 1973 3979
>= 75 years 1096 1110 2206
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6471 participants 6473 participants 12944 participants
Female
1822
  28.2%
1810
  28.0%
3632
  28.1%
Male
4649
  71.8%
4663
  72.0%
9312
  71.9%
1.Primary Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular Death, Myocardial Infarction, Stroke, Recurrent Ischemia With Re-hospitalization, and/or Urgent Coronary Revascularization Within 2 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: cardiovascular (CV) death, myocardial infarction (MI), stroke, recurrent ischemia with re-hospitalization (RIR), and/or urgent coronary revascularization (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 at least 1 of the components of the primary composite efficacy endpoint within 2 years from randomization.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Overall Number of Participants Analyzed 6471 6473
Measure Type: Number
Unit of Measure: Percentage of Participants
19.9 18.5
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 0.072
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%
0.85 to 1.01
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 Cardiovascular Death, Myocardial Infarction, and/or Stroke Within 2 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: cardiovascular (CV) death, myocardial infarction (MI), and/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 at least 1 of the components of the secondary composite efficacy endpoint within 2 years from randomization.
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Overall Number of Participants Analyzed 6471 6473
Measure Type: Number
Unit of Measure: Percentage of Participants
16.4 14.7
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 0.018
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%
0.81 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.
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 2 Years From Randomization
Hide Description Adverse events were categorized as "bleeding events" if the intensity 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 2 years from randomization.
Time Frame Up to 2 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:
Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Overall Number of Participants Analyzed 6441 6446
Measure Type: Number
Unit of Measure: Percentage of Participants
5.8 7.6
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 1.36
Confidence Interval (2-Sided) 95%
1.18 to 1.57
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 2 Years From Randomization
Hide Description Adverse events were categorized as "bleeding events" if the intensity 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 2 years from randomization.
Time Frame Up to 2 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:
Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Overall Number of Participants Analyzed 6441 6446
Measure Type: Number
Unit of Measure: Percentage of Participants
14.6 19.5
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%
1.29 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.
5.Secondary Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, or UCR Within 2 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 2 years from randomization.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Overall Number of Participants Analyzed 6471 6473
Measure Type: Number
Unit of Measure: Percentage of Participants
19.2 17.5
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 0.038
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%
0.84 to 1.00
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 MI Within 2 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 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 2 years from randomization.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Overall Number of Participants Analyzed 6471 6473
Measure Type: Number
Unit of Measure: Percentage of Participants
14.9 13.5
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 0.027
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%
0.81 to 0.99
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 All-cause Death, MI, Stroke, RIR, or UCR Within 2 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: all-cause death, MI, stroke, RIR, 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 all-cause death, MI, stroke, RIR, or UCR within 2 years from randomization.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Overall Number of Participants Analyzed 6471 6473
Measure Type: Number
Unit of Measure: Percentage of Participants
21.5 20.6
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 0.174
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 0.94
Confidence Interval (2-Sided) 95%
0.87 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.
8.Secondary Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced All-cause Death, MI, Stroke, or UCR Within 2 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: all-cause 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). The Kaplan-Meier estimate reports the percentage of participants who experienced all-cause Death, MI, stroke, or UCR I within 2 years from randomization.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Overall Number of Participants Analyzed 6471 6473
Measure Type: Number
Unit of Measure: Percentage of Participants
20.8 19.6
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 0.93
Confidence Interval (2-Sided) 95%
0.86 to 1.02
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 Within 2 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 2 years from randomization.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Overall Number of Participants Analyzed 6471 6473
Measure Type: Number
Unit of Measure: Percentage of Participants
3.8 3.8
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 0.963
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 1.00
Confidence Interval (2-Sided) 95%
0.83 to 1.22
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 an MI Within 2 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 2 years from randomization.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Overall Number of Participants Analyzed 6471 6473
Measure Type: Number
Unit of Measure: Percentage of Participants
12.5 11.1
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 0.021
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%
0.79 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.
11.Secondary Outcome
Title Kaplan-Meier Estimate of the Percentage of Participants Who Experienced RIR Within 2 Years From Randomization
Hide Description The time (in days) from study start to the first occurrence of RIR 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 RIR within 2 years from randomization.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Overall Number of Participants Analyzed 6471 6473
Measure Type: Number
Unit of Measure: Percentage of Participants
1.5 1.6
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 0.418
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 1.14
Confidence Interval (2-Sided) 95%
0.83 to 1.58
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 2 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 2 years from randomization.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Overall Number of Participants Analyzed 6471 6473
Measure Type: Number
Unit of Measure: Percentage of Participants
3.5 3.8
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 0.493
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 1.07
Confidence Interval (2-Sided) 95%
0.88 to 1.31
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 Died From Any Cause Within 2 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 2 years from randomization.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Overall Number of Participants Analyzed 6471 6473
Measure Type: Number
Unit of Measure: Percentage of Participants
6.1 6.5
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 0.515
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 1.05
Confidence Interval (2-Sided) 95%
0.90 to 1.23
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 Experienced a Stroke Within 2 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 2 years from randomization.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.
Arm/Group Title Placebo Vorapaxar
Hide Arm/Group Description:
Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Overall Number of Participants Analyzed 6471 6473
Measure Type: Number
Unit of Measure: Percentage of Participants
2.1 1.9
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 0.606
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 0.93
Confidence Interval (2-Sided) 95%
0.70 to 1.23
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 [Not Specified]
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 Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care. Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
All-Cause Mortality
Placebo Vorapaxar
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Placebo Vorapaxar
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1718/6441 (26.67%)      1866/6446 (28.95%)    
Blood and lymphatic system disorders     
ANAEMIA  1  28/6441 (0.43%)  29 55/6446 (0.85%)  59
COAGULOPATHY  1  2/6441 (0.03%)  2 3/6446 (0.05%)  3
DISSEMINATED INTRAVASCULAR COAGULATION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
EOSINOPHILIA  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
FEBRILE NEUTROPENIA  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
GRANULOCYTOPENIA  1  1/6441 (0.02%)  2 0/6446 (0.00%)  0
HAEMORRHAGIC ANAEMIA  1  1/6441 (0.02%)  1 3/6446 (0.05%)  3
HAEMORRHAGIC DIATHESIS  1  1/6441 (0.02%)  1 10/6446 (0.16%)  10
HEPARIN-INDUCED THROMBOCYTOPENIA  1  3/6441 (0.05%)  3 1/6446 (0.02%)  1
HYPOCHROMIC ANAEMIA  1  0/6441 (0.00%)  0 2/6446 (0.03%)  3
IDIOPATHIC THROMBOCYTOPENIC PURPURA  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
IRON DEFICIENCY ANAEMIA  1  1/6441 (0.02%)  1 8/6446 (0.12%)  8
LEUKOCYTOSIS  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
LYMPHADENOPATHY  1  2/6441 (0.03%)  2 1/6446 (0.02%)  1
LYMPHADENOPATHY MEDIASTINAL  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
MICROCYTIC ANAEMIA  1  3/6441 (0.05%)  3 2/6446 (0.03%)  2
NORMOCHROMIC NORMOCYTIC ANAEMIA  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
SPLENIC INFARCTION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
SPONTANEOUS HAEMATOMA  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
THROMBOCYTOPENIA  1  34/6441 (0.53%)  34 30/6446 (0.47%)  30
THROMBOCYTOSIS  1  2/6441 (0.03%)  2 2/6446 (0.03%)  2
Cardiac disorders     
ANGINA PECTORIS  1  3/6441 (0.05%)  3 6/6446 (0.09%)  6
ANGINA UNSTABLE  1  0/6441 (0.00%)  0 2/6446 (0.03%)  2
AORTIC VALVE DISEASE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
AORTIC VALVE INCOMPETENCE  1  0/6441 (0.00%)  0 3/6446 (0.05%)  3
AORTIC VALVE STENOSIS  1  1/6441 (0.02%)  1 2/6446 (0.03%)  2
ARRHYTHMIA  1  5/6441 (0.08%)  5 6/6446 (0.09%)  6
ARRHYTHMIA SUPRAVENTRICULAR  1  1/6441 (0.02%)  1 3/6446 (0.05%)  5
ARTERIOSCLEROSIS CORONARY ARTERY  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
ARTERIOSPASM CORONARY  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
ATRIAL FIBRILLATION  1  93/6441 (1.44%)  100 96/6446 (1.49%)  113
ATRIAL FLUTTER  1  17/6441 (0.26%)  17 17/6446 (0.26%)  18
ATRIAL RUPTURE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
ATRIAL THROMBOSIS  1  3/6441 (0.05%)  3 0/6446 (0.00%)  0
ATRIOVENTRICULAR BLOCK  1  1/6441 (0.02%)  1 4/6446 (0.06%)  4
ATRIOVENTRICULAR BLOCK COMPLETE  1  9/6441 (0.14%)  9 9/6446 (0.14%)  9
ATRIOVENTRICULAR BLOCK SECOND DEGREE  1  6/6441 (0.09%)  6 7/6446 (0.11%)  7
ATRIOVENTRICULAR DISSOCIATION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
BIFASCICULAR BLOCK  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
BRADYARRHYTHMIA  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
BRADYCARDIA  1  26/6441 (0.40%)  26 14/6446 (0.22%)  14
BUNDLE BRANCH BLOCK LEFT  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
CARDIAC ARREST  1  12/6441 (0.19%)  12 9/6446 (0.14%)  9
CARDIAC ASTHMA  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
CARDIAC FAILURE  1  146/6441 (2.27%)  191 142/6446 (2.20%)  191
CARDIAC FAILURE ACUTE  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
CARDIAC FAILURE CHRONIC  1  4/6441 (0.06%)  5 1/6446 (0.02%)  1
CARDIAC FAILURE CONGESTIVE  1  35/6441 (0.54%)  46 45/6446 (0.70%)  53
CARDIAC HYPERTROPHY  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
CARDIAC PERFORATION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
CARDIAC TAMPONADE  1  5/6441 (0.08%)  5 4/6446 (0.06%)  4
CARDIAC VALVE DISEASE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
CARDIO-RESPIRATORY ARREST  1  3/6441 (0.05%)  3 2/6446 (0.03%)  2
CARDIOGENIC SHOCK  1  39/6441 (0.61%)  41 24/6446 (0.37%)  24
CARDIOMEGALY  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
CARDIOMYOPATHY  1  4/6441 (0.06%)  4 1/6446 (0.02%)  1
CARDIOPULMONARY FAILURE  1  3/6441 (0.05%)  3 3/6446 (0.05%)  3
CARDIOVASCULAR INSUFFICIENCY  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
CHORDAE TENDINAE RUPTURE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
CONGESTIVE CARDIOMYOPATHY  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
COR PULMONALE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
CORONARY ARTERY DISEASE  1  6/6441 (0.09%)  6 5/6446 (0.08%)  5
CORONARY ARTERY DISSECTION  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
CORONARY ARTERY INSUFFICIENCY  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
CORONARY ARTERY OCCLUSION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
DRESSLER'S SYNDROME  1  1/6441 (0.02%)  1 2/6446 (0.03%)  2
EXTRASYSTOLES  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
GASTROCARDIAC SYNDROME  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
HEART VALVE CALCIFICATION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
INTRACARDIAC THROMBUS  1  4/6441 (0.06%)  4 2/6446 (0.03%)  2
ISCHAEMIC CARDIOMYOPATHY  1  4/6441 (0.06%)  4 2/6446 (0.03%)  2
LEFT VENTRICULAR DYSFUNCTION  1  1/6441 (0.02%)  1 3/6446 (0.05%)  3
LEFT VENTRICULAR FAILURE  1  0/6441 (0.00%)  0 2/6446 (0.03%)  3
MITRAL VALVE INCOMPETENCE  1  6/6441 (0.09%)  6 5/6446 (0.08%)  5
MYOCARDIAL RUPTURE  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
MYOCARDITIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
MYOPERICARDITIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
NODAL ARRHYTHMIA  1  2/6441 (0.03%)  2 1/6446 (0.02%)  1
NODAL RHYTHM  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
PALPITATIONS  1  6/6441 (0.09%)  6 8/6446 (0.12%)  8
PAPILLARY MUSCLE RUPTURE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
PERICARDIAL EFFUSION  1  7/6441 (0.11%)  7 7/6446 (0.11%)  7
PERICARDIAL HAEMORRHAGE  1  8/6441 (0.12%)  8 18/6446 (0.28%)  19
PERICARDITIS  1  5/6441 (0.08%)  5 3/6446 (0.05%)  3
PERICARDITIS CONSTRICTIVE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
PLEUROPERICARDITIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
PRINZMETAL ANGINA  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
PULSELESS ELECTRICAL ACTIVITY  1  2/6441 (0.03%)  2 2/6446 (0.03%)  2
RESTRICTIVE CARDIOMYOPATHY  1  0/6441 (0.00%)  0 1/6446 (0.02%)  2
RIGHT VENTRICULAR DYSFUNCTION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
RIGHT VENTRICULAR FAILURE  1  3/6441 (0.05%)  3 0/6446 (0.00%)  0
SICK SINUS SYNDROME  1  8/6441 (0.12%)  8 7/6446 (0.11%)  8
SINOATRIAL BLOCK  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
SINUS ARREST  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
SINUS ARRHYTHMIA  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
SINUS BRADYCARDIA  1  3/6441 (0.05%)  3 3/6446 (0.05%)  3
SINUS TACHYCARDIA  1  0/6441 (0.00%)  0 2/6446 (0.03%)  2
STRESS CARDIOMYOPATHY  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
SUPRAVENTRICULAR TACHYARRHYTHMIA  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
SUPRAVENTRICULAR TACHYCARDIA  1  15/6441 (0.23%)  15 9/6446 (0.14%)  11
TACHYCARDIA  1  2/6441 (0.03%)  2 2/6446 (0.03%)  3
TORSADE DE POINTES  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
TRICUSPID VALVE INCOMPETENCE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
TRIFASCICULAR BLOCK  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
VENTRICLE RUPTURE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
VENTRICULAR ARRHYTHMIA  1  1/6441 (0.02%)  1 3/6446 (0.05%)  3
VENTRICULAR DYSFUNCTION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
VENTRICULAR EXTRASYSTOLES  1  1/6441 (0.02%)  1 4/6446 (0.06%)  4
VENTRICULAR FIBRILLATION  1  28/6441 (0.43%)  33 30/6446 (0.47%)  32
VENTRICULAR TACHYARRHYTHMIA  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
VENTRICULAR TACHYCARDIA  1  36/6441 (0.56%)  41 23/6446 (0.36%)  29
Congenital, familial and genetic disorders     
ARTERIOVENOUS MALFORMATION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
ATRIAL SEPTAL DEFECT  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
GASTROINTESTINAL ANGIODYSPLASIA  1  1/6441 (0.02%)  1 2/6446 (0.03%)  2
GASTROINTESTINAL ANGIODYSPLASIA HAEMORRHAGIC  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
GASTROINTESTINAL ARTERIOVENOUS MALFORMATION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
HYDROCELE  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
PHIMOSIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
Ear and labyrinth disorders     
DEAFNESS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
DEAFNESS NEUROSENSORY  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
EAR HAEMORRHAGE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
SUDDEN HEARING LOSS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
TINNITUS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
VERTIGO  1  10/6441 (0.16%)  10 9/6446 (0.14%)  9
VERTIGO POSITIONAL  1  3/6441 (0.05%)  3 0/6446 (0.00%)  0
VESTIBULAR DISORDER  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
Endocrine disorders     
ADRENAL INSUFFICIENCY  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
GOITRE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
HYPERTHYROIDISM  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
HYPOTHYROIDISM  1  1/6441 (0.02%)  1 2/6446 (0.03%)  2
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
TOXIC NODULAR GOITRE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
Eye disorders     
ABNORMAL SENSATION IN EYE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
CATARACT  1  6/6441 (0.09%)  7 4/6446 (0.06%)  5
CONJUNCTIVITIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
DIPLOPIA  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
EYE HAEMORRHAGE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
GLAUCOMA  1  2/6441 (0.03%)  3 0/6446 (0.00%)  0
MACULAR HOLE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
OPTIC ISCHAEMIC NEUROPATHY  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
RETINAL ARTERY OCCLUSION  1  1/6441 (0.02%)  1 2/6446 (0.03%)  2
RETINAL DETACHMENT  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
RETINAL VASCULAR THROMBOSIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
STRABISMUS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
ULCERATIVE KERATITIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
VISUAL IMPAIRMENT  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
Gastrointestinal disorders     
ABDOMINAL DISCOMFORT  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
ABDOMINAL HERNIA  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
ABDOMINAL PAIN  1  11/6441 (0.17%)  15 11/6446 (0.17%)  12
ABDOMINAL PAIN UPPER  1  4/6441 (0.06%)  4 9/6446 (0.14%)  9
ABDOMINAL STRANGULATED HERNIA  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
ABDOMINAL WALL HAEMATOMA  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
ACUTE ABDOMEN  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
ANAL FISTULA  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
ANAL HAEMORRHAGE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
ASCITES  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
COELIAC DISEASE  1  1/6441 (0.02%)  3 0/6446 (0.00%)  0
COLITIS  1  2/6441 (0.03%)  2 1/6446 (0.02%)  1
COLITIS ISCHAEMIC  1  5/6441 (0.08%)  7 1/6446 (0.02%)  1
COLITIS ULCERATIVE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
COLONIC POLYP  1  1/6441 (0.02%)  1 2/6446 (0.03%)  2
CONSTIPATION  1  7/6441 (0.11%)  9 6/6446 (0.09%)  6
CROHN'S DISEASE  1  1/6441 (0.02%)  3 2/6446 (0.03%)  2
DIABETIC GASTROPARESIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
DIARRHOEA  1  5/6441 (0.08%)  6 8/6446 (0.12%)  9
DIARRHOEA HAEMORRHAGIC  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
DIVERTICULAR PERFORATION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
DIVERTICULUM  1  2/6441 (0.03%)  2 1/6446 (0.02%)  1
DIVERTICULUM INTESTINAL  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
DIVERTICULUM INTESTINAL HAEMORRHAGIC  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
DUODENAL ULCER  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
DUODENAL ULCER HAEMORRHAGE  1  1/6441 (0.02%)  1 2/6446 (0.03%)  2
DUODENITIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
DYSPEPSIA  1  1/6441 (0.02%)  1 2/6446 (0.03%)  2
DYSPHAGIA  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
ENTERITIS  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
ENTEROVESICAL FISTULA  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
EROSIVE OESOPHAGITIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
FAECALOMA  1  1/6441 (0.02%)  1 2/6446 (0.03%)  2
FOOD POISONING  1  0/6441 (0.00%)  0 2/6446 (0.03%)  2
GASTRIC HAEMORRHAGE  1  4/6441 (0.06%)  4 3/6446 (0.05%)  4
GASTRIC POLYPS  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
GASTRIC ULCER  1  7/6441 (0.11%)  8 7/6446 (0.11%)  7
GASTRIC ULCER HAEMORRHAGE  1  3/6441 (0.05%)  3 2/6446 (0.03%)  2
GASTRIC ULCER PERFORATION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
GASTRIC VARICES HAEMORRHAGE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
GASTRITIS  1  5/6441 (0.08%)  6 14/6446 (0.22%)  14
GASTRITIS EROSIVE  1  3/6441 (0.05%)  3 5/6446 (0.08%)  5
GASTRITIS HAEMORRHAGIC  1  1/6441 (0.02%)  1 3/6446 (0.05%)  3
GASTRODUODENITIS  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
GASTROINTESTINAL DISORDER  1  1/6441 (0.02%)  1 2/6446 (0.03%)  2
GASTROINTESTINAL EROSION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
GASTROINTESTINAL HAEMORRHAGE  1  13/6441 (0.20%)  13 26/6446 (0.40%)  28
GASTROINTESTINAL NECROSIS  1  0/6441 (0.00%)  0 3/6446 (0.05%)  3
GASTROINTESTINAL PERFORATION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
GASTROINTESTINAL ULCER  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
GASTROOESOPHAGEAL REFLUX DISEASE  1  10/6441 (0.16%)  10 7/6446 (0.11%)  7
GINGIVAL BLEEDING  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
HAEMATEMESIS  1  10/6441 (0.16%)  10 12/6446 (0.19%)  12
HAEMATOCHEZIA  1  5/6441 (0.08%)  5 10/6446 (0.16%)  10
HAEMORRHAGIC EROSIVE GASTRITIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
HAEMORRHOIDAL HAEMORRHAGE  1  3/6441 (0.05%)  3 4/6446 (0.06%)  4
HAEMORRHOIDS  1  3/6441 (0.05%)  3 1/6446 (0.02%)  1
HYPERCHLORHYDRIA  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
ILEUS  1  3/6441 (0.05%)  3 4/6446 (0.06%)  4
ILEUS PARALYTIC  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
INGUINAL HERNIA  1  6/6441 (0.09%)  6 16/6446 (0.25%)  16
INGUINAL HERNIA, OBSTRUCTIVE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
INTESTINAL HAEMATOMA  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
INTESTINAL HAEMORRHAGE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
INTESTINAL ISCHAEMIA  1  3/6441 (0.05%)  3 5/6446 (0.08%)  5
INTESTINAL OBSTRUCTION  1  4/6441 (0.06%)  4 4/6446 (0.06%)  4
INTESTINAL PERFORATION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
LARGE INTESTINAL HAEMORRHAGE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
LARGE INTESTINAL OBSTRUCTION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
LOCALISED INTRAABDOMINAL FLUID COLLECTION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
LOWER GASTROINTESTINAL HAEMORRHAGE  1  4/6441 (0.06%)  4 3/6446 (0.05%)  3
MECHANICAL ILEUS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
MELAENA  1  26/6441 (0.40%)  28 38/6446 (0.59%)  40
MESENTERIC VEIN THROMBOSIS  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
NAUSEA  1  3/6441 (0.05%)  3 1/6446 (0.02%)  1
OESOPHAGEAL PERFORATION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
OESOPHAGEAL STENOSIS  1  0/6441 (0.00%)  0 2/6446 (0.03%)  2
OESOPHAGEAL ULCER  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
OESOPHAGEAL ULCER HAEMORRHAGE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
OESOPHAGITIS  1  0/6441 (0.00%)  0 5/6446 (0.08%)  5
OESOPHAGITIS HAEMORRHAGIC  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
PANCREATIC CYST  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
PANCREATITIS  1  6/6441 (0.09%)  6 10/6446 (0.16%)  10
PANCREATITIS ACUTE  1  4/6441 (0.06%)  4 4/6446 (0.06%)  4
PEPTIC ULCER  1  2/6441 (0.03%)  2 3/6446 (0.05%)  3
PERIODONTITIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
PERITONEAL HAEMATOMA  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
PERITONITIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
PHARYNGOESOPHAGEAL DIVERTICULUM  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
RECTAL HAEMORRHAGE  1  22/6441 (0.34%)  22 26/6446 (0.40%)  29
REFLUX OESOPHAGITIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
RETROPERITONEAL FIBROSIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
RETROPERITONEAL HAEMATOMA  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
RETROPERITONEAL HAEMORRHAGE  1  6/6441 (0.09%)  6 7/6446 (0.11%)  7
SMALL INTESTINAL HAEMORRHAGE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
SMALL INTESTINAL OBSTRUCTION  1  5/6441 (0.08%)  5 1/6446 (0.02%)  1
SUBILEUS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
TONGUE DISORDER  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
TOOTHACHE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
UMBILICAL HERNIA  1  2/6441 (0.03%)  2 1/6446 (0.02%)  1
UMBILICAL HERNIA, OBSTRUCTIVE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
UPPER GASTROINTESTINAL HAEMORRHAGE  1  6/6441 (0.09%)  7 10/6446 (0.16%)  10
VOMITING  1  8/6441 (0.12%)  8 3/6446 (0.05%)  3
General disorders     
ASTHENIA  1  3/6441 (0.05%)  3 4/6446 (0.06%)  4
BLOODY DISCHARGE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
CATHETER SITE HAEMATOMA  1  16/6441 (0.25%)  16 13/6446 (0.20%)  13
CATHETER SITE HAEMORRHAGE  1  17/6441 (0.26%)  17 23/6446 (0.36%)  23
CHEST DISCOMFORT  1  5/6441 (0.08%)  5 6/6446 (0.09%)  6
CHEST PAIN  1  33/6441 (0.51%)  42 29/6446 (0.45%)  30
CYST  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
DEVICE BREAKAGE  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
DEVICE DISLOCATION  1  1/6441 (0.02%)  1 2/6446 (0.03%)  2
DEVICE MALFUNCTION  1  0/6441 (0.00%)  0 2/6446 (0.03%)  2
DRUG INTOLERANCE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
EXERCISE TOLERANCE DECREASED  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
FATIGUE  1  0/6441 (0.00%)  0 3/6446 (0.05%)  3
GAIT DISTURBANCE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
GENERAL PHYSICAL HEALTH DETERIORATION  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
GENERALISED OEDEMA  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
HERNIA  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
HERNIA OBSTRUCTIVE  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
HYPOTHERMIA  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
IMPAIRED HEALING  1  1/6441 (0.02%)  1 6/6446 (0.09%)  6
INFLAMMATION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
INFLUENZA LIKE ILLNESS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
INJECTION SITE HAEMORRHAGE  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
LOCAL SWELLING  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
MALAISE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
MEDICAL DEVICE COMPLICATION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
MUCOSAL INFLAMMATION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
MULTI-ORGAN DISORDER  1  2/6441 (0.03%)  2 4/6446 (0.06%)  4
MULTI-ORGAN FAILURE  1  11/6441 (0.17%)  11 7/6446 (0.11%)  7
NECROSIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
NON-CARDIAC CHEST PAIN  1  112/6441 (1.74%)  127 141/6446 (2.19%)  158
OEDEMA PERIPHERAL  1  3/6441 (0.05%)  3 4/6446 (0.06%)  4
PAIN  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
POLYP  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
PUNCTURE SITE REACTION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
PYREXIA  1  6/6441 (0.09%)  6 4/6446 (0.06%)  4
SECRETION DISCHARGE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
SENSATION OF PRESSURE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
SUDDEN CARDIAC DEATH  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
THROMBOSIS IN DEVICE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
ULCER  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
Hepatobiliary disorders     
ACUTE HEPATIC FAILURE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
BILE DUCT OBSTRUCTION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
BILE DUCT STONE  1  2/6441 (0.03%)  2 4/6446 (0.06%)  4
BILIARY COLIC  1  2/6441 (0.03%)  2 1/6446 (0.02%)  1
BILIARY DYSKINESIA  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
CHOLANGITIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
CHOLANGITIS ACUTE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
CHOLECYSTITIS  1  18/6441 (0.28%)  18 9/6446 (0.14%)  9
CHOLECYSTITIS ACUTE  1  10/6441 (0.16%)  10 10/6446 (0.16%)  10
CHOLELITHIASIS  1  15/6441 (0.23%)  15 13/6446 (0.20%)  13
GALLBLADDER DISORDER  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
HEPATIC CIRRHOSIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
HEPATIC FAILURE  1  4/6441 (0.06%)  4 2/6446 (0.03%)  2
HEPATIC STEATOSIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
HEPATITIS  1  0/6441 (0.00%)  0 3/6446 (0.05%)  3
HEPATITIS ACUTE  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
HEPATITIS TOXIC  1  0/6441 (0.00%)  0 2/6446 (0.03%)  2
JAUNDICE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
LIVER DISORDER  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
Immune system disorders     
ALLERGY TO CHEMICALS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
AMYLOIDOSIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
ANAPHYLACTIC REACTION  1  2/6441 (0.03%)  2 1/6446 (0.02%)  1
ANAPHYLACTIC SHOCK  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
ANTIPHOSPHOLIPID SYNDROME  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
CONTRAST MEDIA ALLERGY  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
DRUG HYPERSENSITIVITY  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
HYPERSENSITIVITY  1  1/6441 (0.02%)  1 3/6446 (0.05%)  3
SARCOIDOSIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
Infections and infestations     
ABDOMINAL ABSCESS  1  2/6441 (0.03%)  2 3/6446 (0.05%)  3
ABDOMINAL INFECTION  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
ABDOMINAL SEPSIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
ABSCESS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
ABSCESS LIMB  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
ABSCESS ORAL  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
ANAL ABSCESS  1  2/6441 (0.03%)  3 4/6446 (0.06%)  4
APPENDICITIS  1  4/6441 (0.06%)  4 9/6446 (0.14%)  9
APPENDICITIS PERFORATED  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
ARTERIOVENOUS GRAFT SITE INFECTION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
ARTERITIS INFECTIVE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
ARTHRITIS INFECTIVE  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
BACTERAEMIA  1  1/6441 (0.02%)  1 2/6446 (0.03%)  2
BACTERIAL INFECTION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
BACTERIAL SEPSIS  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
BORRELIA INFECTION  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
BRONCHITIS  1  11/6441 (0.17%)  12 18/6446 (0.28%)  18
BRONCHITIS VIRAL  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
BRONCHOPNEUMONIA  1  4/6441 (0.06%)  4 2/6446 (0.03%)  2
CELLULITIS  1  16/6441 (0.25%)  16 25/6446 (0.39%)  26
CHEST WALL ABSCESS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
CHOLECYSTITIS INFECTIVE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
CLOSTRIDIAL INFECTION  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
CLOSTRIDIUM DIFFICILE COLITIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
CYSTITIS  1  2/6441 (0.03%)  2 2/6446 (0.03%)  2
CYTOMEGALOVIRUS INFECTION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
DEVICE RELATED INFECTION  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
DIABETIC FOOT INFECTION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
DIVERTICULITIS  1  8/6441 (0.12%)  9 13/6446 (0.20%)  14
ENDOCARDITIS  1  3/6441 (0.05%)  3 2/6446 (0.03%)  2
ENTEROCOCCAL INFECTION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
ENTEROCOCCAL SEPSIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
ERYSIPELAS  1  5/6441 (0.08%)  5 3/6446 (0.05%)  4
ESCHERICHIA SEPSIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
ESCHERICHIA URINARY TRACT INFECTION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
EYE INFECTION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
GANGRENE  1  4/6441 (0.06%)  5 0/6446 (0.00%)  0
GASTROENTERITIS  1  8/6441 (0.12%)  9 12/6446 (0.19%)  13
GASTROENTERITIS NOROVIRUS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
GASTROENTERITIS SALMONELLA  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
GASTROENTERITIS VIRAL  1  3/6441 (0.05%)  3 4/6446 (0.06%)  4
GRAFT INFECTION  1  0/6441 (0.00%)  0 2/6446 (0.03%)  2
GROIN ABSCESS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
GROIN INFECTION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
H1N1 INFLUENZA  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
HAEMATOMA INFECTION  1  2/6441 (0.03%)  2 1/6446 (0.02%)  1
HEPATITIS B  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
HEPATITIS C  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
HERPES SIMPLEX  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
HERPES ZOSTER  1  1/6441 (0.02%)  1 3/6446 (0.05%)  3
HIV INFECTION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
IMPLANT SITE INFECTION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
INCISION SITE INFECTION  1  3/6441 (0.05%)  3 2/6446 (0.03%)  2
INFECTED CYST  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
INFECTED SEBACEOUS CYST  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
INFECTED SKIN ULCER  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
INFECTION  1  3/6441 (0.05%)  3 0/6446 (0.00%)  0
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE  1  1/6441 (0.02%)  1 1/6446 (0.02%)  2
INFLUENZA  1  1/6441 (0.02%)  1 2/6446 (0.03%)  2
INJECTION SITE ABSCESS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
INTERVERTEBRAL DISCITIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
KIDNEY INFECTION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
LEISHMANIASIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
LEPROSY  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
LIP INFECTION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
LOBAR PNEUMONIA  1  5/6441 (0.08%)  5 6/6446 (0.09%)  6
LOCALISED INFECTION  1  1/6441 (0.02%)  1 4/6446 (0.06%)  4
LOWER RESPIRATORY TRACT INFECTION  1  3/6441 (0.05%)  3 3/6446 (0.05%)  3
LUNG INFECTION  1  6/6441 (0.09%)  6 1/6446 (0.02%)  1
LUNG INFECTION PSEUDOMONAL  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
LYMPH NODE ABSCESS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
MEDIASTINITIS  1  4/6441 (0.06%)  4 5/6446 (0.08%)  5
MENINGITIS ASEPTIC  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
METAPNEUMOVIRUS INFECTION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
NECROTISING FASCIITIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
NOCARDIOSIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
ORCHITIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
OSTEOMYELITIS  1  7/6441 (0.11%)  7 6/6446 (0.09%)  6
OSTEOMYELITIS CHRONIC  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
OTITIS MEDIA  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
OTITIS MEDIA CHRONIC  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
PELVIC ABSCESS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
PERICARDITIS TUBERCULOUS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
PERIDIVERTICULAR ABSCESS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
PERIRECTAL ABSCESS  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
PERITONEAL ABSCESS  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
PNEUMONIA  1  83/6441 (1.29%)  93 100/6446 (1.55%)  111
PNEUMONIA BACTERIAL  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
PNEUMONIA HAEMOPHILUS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
PNEUMONIA INFLUENZAL  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
PNEUMONIA KLEBSIELLA  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
PNEUMONIA PNEUMOCOCCAL  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
PNEUMONIA PRIMARY ATYPICAL  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
POST PROCEDURAL INFECTION  1  3/6441 (0.05%)  4 3/6446 (0.05%)  3
POSTOPERATIVE WOUND INFECTION  1  6/6441 (0.09%)  6 9/6446 (0.14%)  9
PSEUDOMEMBRANOUS COLITIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  2
PSEUDOMONAS BRONCHITIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
PSOAS ABSCESS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
PYELONEPHRITIS  1  5/6441 (0.08%)  5 1/6446 (0.02%)  1
PYOTHORAX  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
RESPIRATORY TRACT INFECTION  1  7/6441 (0.11%)  7 4/6446 (0.06%)  4
RESPIRATORY TRACT INFECTION VIRAL  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
SCROTAL ABSCESS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
SEPSIS  1  23/6441 (0.36%)  23 24/6446 (0.37%)  25
SEPTIC SHOCK  1  18/6441 (0.28%)  18 11/6446 (0.17%)  11
SERRATIA INFECTION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
SHUNT INFECTION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
SIALOADENITIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
SINUSITIS  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
SKIN INFECTION  1  1/6441 (0.02%)  1 3/6446 (0.05%)  3
SMALL INTESTINE GANGRENE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
STAPHYLOCOCCAL ABSCESS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
STAPHYLOCOCCAL BACTERAEMIA  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
STAPHYLOCOCCAL INFECTION  1  2/6441 (0.03%)  2 3/6446 (0.05%)  3
STAPHYLOCOCCAL MEDIASTINITIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
STAPHYLOCOCCAL SEPSIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
STERNITIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
STITCH ABSCESS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
STREPTOCOCCAL SEPSIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
UPPER RESPIRATORY TRACT INFECTION  1  6/6441 (0.09%)  6 3/6446 (0.05%)  3
URINARY TRACT INFECTION  1  26/6441 (0.40%)  27 23/6446 (0.36%)  25
UROSEPSIS  1  2/6441 (0.03%)  2 8/6446 (0.12%)  8
VESTIBULAR NEURONITIS  1  1/6441 (0.02%)  1 2/6446 (0.03%)  2
VIRAL INFECTION  1  3/6441 (0.05%)  3 2/6446 (0.03%)  2
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
WOUND INFECTION  1  12/6441 (0.19%)  12 7/6446 (0.11%)  7
WOUND INFECTION STAPHYLOCOCCAL  1  1/6441 (0.02%)  2 0/6446 (0.00%)  0
WOUND SEPSIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
Injury, poisoning and procedural complications     
ABDOMINAL INJURY  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
ABDOMINAL WOUND DEHISCENCE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
ACCIDENTAL OVERDOSE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
ALCOHOL POISONING  1  4/6441 (0.06%)  4 2/6446 (0.03%)  2
ANAEMIA POSTOPERATIVE  1  3/6441 (0.05%)  3 0/6446 (0.00%)  0
ANKLE FRACTURE  1  3/6441 (0.05%)  3 3/6446 (0.05%)  3
ARTERIAL INJURY  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
ARTERIOVENOUS FISTULA SITE HAEMORRHAGE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
BACK INJURY  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
CARDIAC PROCEDURE COMPLICATION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
CARDIAC VALVE RUPTURE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
CEREBRAL HAEMORRHAGE TRAUMATIC  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
CLAVICLE FRACTURE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
COLLAPSE OF LUNG  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
COMMINUTED FRACTURE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
CONCUSSION  1  3/6441 (0.05%)  3 0/6446 (0.00%)  0
CONFUSION POSTOPERATIVE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
CONTUSION  1  1/6441 (0.02%)  1 6/6446 (0.09%)  8
CRUSH INJURY  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
EXTRADURAL HAEMATOMA  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
FACE INJURY  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
FACIAL BONES FRACTURE  1  0/6441 (0.00%)  0 3/6446 (0.05%)  3
FALL  1  16/6441 (0.25%)  16 22/6446 (0.34%)  22
FEMORAL NECK FRACTURE  1  2/6441 (0.03%)  2 4/6446 (0.06%)  4
FEMUR FRACTURE  1  4/6441 (0.06%)  4 9/6446 (0.14%)  9
FIBULA FRACTURE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
FOOT FRACTURE  1  3/6441 (0.05%)  3 2/6446 (0.03%)  2
FOREARM FRACTURE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
GASTROINTESTINAL STOMA COMPLICATION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
GUN SHOT WOUND  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
HEAD INJURY  1  3/6441 (0.05%)  3 4/6446 (0.06%)  4
HEPATIC HAEMATOMA  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
HEPATIC RUPTURE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
HIP FRACTURE  1  5/6441 (0.08%)  5 7/6446 (0.11%)  7
HUMERUS FRACTURE  1  3/6441 (0.05%)  3 4/6446 (0.06%)  4
INCISION SITE COMPLICATION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
INCISION SITE HAEMORRHAGE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
INCISIONAL HERNIA  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
INFLAMMATION OF WOUND  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
JOINT DISLOCATION  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
LACERATION  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
LIMB INJURY  1  1/6441 (0.02%)  1 2/6446 (0.03%)  2
LIMB TRAUMATIC AMPUTATION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
LUMBAR VERTEBRAL FRACTURE  1  0/6441 (0.00%)  0 3/6446 (0.05%)  3
MENISCUS LESION  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
MULTIPLE FRACTURES  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
MUSCLE STRAIN  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
OPEN FRACTURE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
OPERATIVE HAEMORRHAGE  1  11/6441 (0.17%)  12 10/6446 (0.16%)  10
OVERDOSE  1  2/6441 (0.03%)  2 4/6446 (0.06%)  4
PATELLA FRACTURE  1  0/6441 (0.00%)  0 2/6446 (0.03%)  2
PELVIC FRACTURE  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
PERIPROSTHETIC FRACTURE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
POST PROCEDURAL COMPLICATION  1  6/6441 (0.09%)  6 3/6446 (0.05%)  3
POST PROCEDURAL DISCHARGE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
POST PROCEDURAL HAEMATOMA  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
POST PROCEDURAL HAEMORRHAGE  1  91/6441 (1.41%)  91 112/6446 (1.74%)  114
POSTOPERATIVE HERNIA  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
POSTOPERATIVE ILEUS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
POSTOPERATIVE THORACIC PROCEDURE COMPLICATION  1  5/6441 (0.08%)  5 4/6446 (0.06%)  4
POSTOPERATIVE WOUND COMPLICATION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
POSTPERICARDIOTOMY SYNDROME  1  4/6441 (0.06%)  4 3/6446 (0.05%)  3
PROCEDURAL PAIN  1  1/6441 (0.02%)  1 2/6446 (0.03%)  2
PUBIS FRACTURE  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
RADIUS FRACTURE  1  3/6441 (0.05%)  3 2/6446 (0.03%)  2
RIB FRACTURE  1  0/6441 (0.00%)  0 3/6446 (0.05%)  3
ROAD TRAFFIC ACCIDENT  1  2/6441 (0.03%)  2 7/6446 (0.11%)  8
SHUNT MALFUNCTION  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
SKULL FRACTURE  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
SKULL FRACTURED BASE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
SOFT TISSUE INJURY  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
SPINAL COMPRESSION FRACTURE  1  2/6441 (0.03%)  2 2/6446 (0.03%)  3
SPINAL FRACTURE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
SPLENIC RUPTURE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
STAB WOUND  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
STERNAL FRACTURE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
SUBDURAL HAEMATOMA  1  2/6441 (0.03%)  2 9/6446 (0.14%)  9
SUBDURAL HAEMORRHAGE  1  0/6441 (0.00%)  0 2/6446 (0.03%)  2
TENDON INJURY  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
TENDON RUPTURE  1  3/6441 (0.05%)  3 1/6446 (0.02%)  1
THERMAL BURN  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
TIBIA FRACTURE  1  1/6441 (0.02%)  1 2/6446 (0.03%)  2
TOXICITY TO VARIOUS AGENTS  1  5/6441 (0.08%)  5 0/6446 (0.00%)  0
TRANSPLANT FAILURE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
TRAUMATIC LIVER INJURY  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
TRAUMATIC LUNG INJURY  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
UPPER LIMB FRACTURE  1  1/6441 (0.02%)  1 4/6446 (0.06%)  4
URINARY RETENTION POSTOPERATIVE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
VASCULAR PROCEDURE COMPLICATION  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
VASCULAR PSEUDOANEURYSM  1  5/6441 (0.08%)  5 17/6446 (0.26%)  17
VASOPLEGIA SYNDROME  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
VENA CAVA INJURY  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
WOUND  1  1/6441 (0.02%)  1 2/6446 (0.03%)  2
WOUND COMPLICATION  1  0/6441 (0.00%)  0 2/6446 (0.03%)  2
WOUND DEHISCENCE  1  4/6441 (0.06%)  4 0/6446 (0.00%)  0
WOUND HAEMORRHAGE  1  3/6441 (0.05%)  3 2/6446 (0.03%)  2
WOUND SECRETION  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
WRIST FRACTURE  1  6/6441 (0.09%)  6 0/6446 (0.00%)  0
Investigations     
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
ALANINE AMINOTRANSFERASE INCREASED  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
BLEEDING TIME PROLONGED  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
BLOOD ALKALINE PHOSPHATASE INCREASED  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
BLOOD BILIRUBIN INCREASED  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
BLOOD CREATINE PHOSPHOKINASE INCREASED  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
BLOOD CREATINE PHOSPHOKINASE MB INCREASED  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
BLOOD CREATININE INCREASED  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
BLOOD CULTURE POSITIVE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
BLOOD GLUCOSE ABNORMAL  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
BLOOD GLUCOSE INCREASED  1  3/6441 (0.05%)  3 1/6446 (0.02%)  2
BLOOD POTASSIUM DECREASED  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
BLOOD PRESSURE INCREASED  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
C-REACTIVE PROTEIN INCREASED  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
CARDIAC MONITORING ABNORMAL  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
CAROTID BRUIT  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
EJECTION FRACTION DECREASED  1  3/6441 (0.05%)  3 2/6446 (0.03%)  2
ELECTROCARDIOGRAM QRS COMPLEX PROLONGED  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  3/6441 (0.05%)  3 0/6446 (0.00%)  0
HAEMOGLOBIN DECREASED  1  11/6441 (0.17%)  11 12/6446 (0.19%)  12
HEART RATE IRREGULAR  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
HEPATIC ENZYME INCREASED  1  4/6441 (0.06%)  4 4/6446 (0.06%)  4
LIPOPROTEIN (A) INCREASED  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
LIVER FUNCTION TEST ABNORMAL  1  2/6441 (0.03%)  2 1/6446 (0.02%)  1
OCCULT BLOOD POSITIVE  1  0/6441 (0.00%)  0 3/6446 (0.05%)  3
PLATELET COUNT DECREASED  1  4/6441 (0.06%)  5 4/6446 (0.06%)  4
TRANSAMINASES INCREASED  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
TROPONIN INCREASED  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
URINE OUTPUT DECREASED  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
WEIGHT DECREASED  1  0/6441 (0.00%)  0 2/6446 (0.03%)  2
WEIGHT INCREASED  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
Metabolism and nutrition disorders     
CACHEXIA  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
DEHYDRATION  1  10/6441 (0.16%)  10 7/6446 (0.11%)  9
DIABETES MELLITUS  1  11/6441 (0.17%)  13 6/6446 (0.09%)  6
DIABETES MELLITUS INADEQUATE CONTROL  1  5/6441 (0.08%)  5 9/6446 (0.14%)  9
DIABETIC FOOT  1  2/6441 (0.03%)  2 3/6446 (0.05%)  3
DIABETIC KETOACIDOSIS  1  4/6441 (0.06%)  4 3/6446 (0.05%)  8
ELECTROLYTE IMBALANCE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
FAILURE TO THRIVE  1  2/6441 (0.03%)  2 1/6446 (0.02%)  1
FLUID OVERLOAD  1  6/6441 (0.09%)  7 2/6446 (0.03%)  2
FLUID RETENTION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
GOUT  1  2/6441 (0.03%)  2 2/6446 (0.03%)  2
HYPERGLYCAEMIA  1  8/6441 (0.12%)  8 7/6446 (0.11%)  7
HYPERGLYCAEMIC HYPEROSMOLAR NONKETOTIC SYNDROME  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
HYPERKALAEMIA  1  9/6441 (0.14%)  10 5/6446 (0.08%)  5
HYPOCALCAEMIA  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
HYPOGLYCAEMIA  1  11/6441 (0.17%)  11 10/6446 (0.16%)  12
HYPOGLYCAEMIC UNCONSCIOUSNESS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
HYPOKALAEMIA  1  2/6441 (0.03%)  2 2/6446 (0.03%)  2
HYPONATRAEMIA  1  4/6441 (0.06%)  4 4/6446 (0.06%)  4
IRON DEFICIENCY  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
LACTIC ACIDOSIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
OBESITY  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
TYPE 2 DIABETES MELLITUS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  5/6441 (0.08%)  5 4/6446 (0.06%)  4
ARTHRITIS  1  4/6441 (0.06%)  4 5/6446 (0.08%)  5
ARTHRITIS REACTIVE  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
ARTHROPATHY  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
ARTICULAR CALCIFICATION  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
BACK PAIN  1  8/6441 (0.12%)  8 8/6446 (0.12%)  8
BONE PAIN  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
BURSITIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
CERVICAL SPINAL STENOSIS  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
CHONDRITIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
COMPARTMENT SYNDROME  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
CRYSTAL ARTHROPATHY  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
GROIN PAIN  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
HAEMARTHROSIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
INTERVERTEBRAL DISC PROTRUSION  1  9/6441 (0.14%)  9 3/6446 (0.05%)  3
JOINT EFFUSION  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
KYPHOSIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
LUMBAR SPINAL STENOSIS  1  0/6441 (0.00%)  0 4/6446 (0.06%)  4
MUSCLE HAEMORRHAGE  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
MUSCLE TIGHTNESS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
MUSCULAR WEAKNESS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
MUSCULOSKELETAL CHEST PAIN  1  19/6441 (0.29%)  19 14/6446 (0.22%)  16
MUSCULOSKELETAL PAIN  1  5/6441 (0.08%)  5 10/6446 (0.16%)  10
MYALGIA  1  4/6441 (0.06%)  4 4/6446 (0.06%)  6
MYALGIA INTERCOSTAL  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
MYOPATHY  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
MYOSCLEROSIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
NECK PAIN  1  5/6441 (0.08%)  5 2/6446 (0.03%)  2
OSTEOARTHRITIS  1  22/6441 (0.34%)  22 16/6446 (0.25%)  16
OSTEONECROSIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
PAIN IN EXTREMITY  1  2/6441 (0.03%)  3 4/6446 (0.06%)  5
POLYARTHRITIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
RHABDOMYOLYSIS  1  3/6441 (0.05%)  3 0/6446 (0.00%)  0
RHEUMATOID ARTHRITIS  1  3/6441 (0.05%)  3 1/6446 (0.02%)  1
ROTATOR CUFF SYNDROME  1  2/6441 (0.03%)  2 1/6446 (0.02%)  1
SCOLIOSIS  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
SPINAL COLUMN STENOSIS  1  3/6441 (0.05%)  3 2/6446 (0.03%)  2
SPINAL DISORDER  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
SPONDYLOLISTHESIS  1  2/6441 (0.03%)  2 1/6446 (0.02%)  1
SYMPATHETIC POSTERIOR CERVICAL SYNDROME  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
SYNOVIAL CYST  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
TENDONITIS  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
TRIGGER FINGER  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
ABDOMINAL NEOPLASM  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
ADENOCARCINOMA  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
ADRENAL ADENOMA  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
ADRENAL NEOPLASM  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
B-CELL LYMPHOMA  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
BASAL CELL CARCINOMA  1  2/6441 (0.03%)  3 3/6446 (0.05%)  3
BENIGN LUNG NEOPLASM  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
BENIGN NEOPLASM  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
BENIGN NEOPLASM OF BLADDER  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
BENIGN OESOPHAGEAL NEOPLASM  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
BILE DUCT CANCER  1  2/6441 (0.03%)  2 1/6446 (0.02%)  1
BLADDER CANCER  1  5/6441 (0.08%)  5 9/6446 (0.14%)  9
BLADDER NEOPLASM  1  2/6441 (0.03%)  2 4/6446 (0.06%)  5
BLADDER TRANSITIONAL CELL CARCINOMA  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
BRAIN NEOPLASM BENIGN  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
BREAST CANCER  1  2/6441 (0.03%)  2 3/6446 (0.05%)  3
BREAST NEOPLASM  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
BRONCHIAL CARCINOMA  1  2/6441 (0.03%)  2 1/6446 (0.02%)  1
CANCER PAIN  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
CARDIAC VALVE FIBROELASTOMA  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
CEREBRAL HAEMANGIOMA  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
CHRONIC LYMPHOCYTIC LEUKAEMIA  1  2/6441 (0.03%)  2 0/6446 (0.00%)  0
CHRONIC MYELOMONOCYTIC LEUKAEMIA  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
COLON ADENOMA  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
COLON CANCER  1  10/6441 (0.16%)  10 20/6446 (0.31%)  20
COLON CANCER STAGE II  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
COLON CANCER STAGE III  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
COLON NEOPLASM  1  1/6441 (0.02%)  1 2/6446 (0.03%)  2
COLORECTAL CANCER  1  1/6441 (0.02%)  1 0/6446 (0.00%)  0
ENDOMETRIAL CANCER  1  1/6441 (0.02%)  1 1/6446 (0.02%)  1
ENDOMETRIAL CANCER STAGE I  1  0/6441 (0.00%)  0 2/6446 (0.03%)  2
ENDOMETRIAL NEOPLASM  1  0/6441 (0.00%)  0 1/6446 (0.02%)  1
FIBROMA