Clincosm LogoSign in Get a demo

A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00097591
Collaborator
Daiichi Sankyo, Inc. (Industry)
13,619
Enrollment
1
Location
2
Arms
31.9
Duration (Months)
426.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel was compared with Clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
13619 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention
Study Start Date :
Nov 1, 2004
Actual Primary Completion Date :
Jul 1, 2007
Actual Study Completion Date :
Jul 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prasugrel

Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily

Drug: Prasugrel
Administered orally
Other Names:
  • CS-747
  • LY640315
  • Effient
  • Efient

    		•
    Active Comparator: Clopidogrel

    Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily

    Drug: Clopidogrel
    Administered orally

    Outcome Measures

    Primary Outcome Measures

    1. Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke [Randomization up to 15 months]

      The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. The data is presented by the study population, which is represented as follows: 1) subjects who presented with unstable angina and non-ST-segment elevation myocardial infarction (UA/NSTEMI), 2) subjects who presented with ST segment elevation myocardial infarction (STEMI), and 3) all subjects with acute coronary syndromes (ACS) (i.e. all subjects with UA/NSTEMI or STEMI).

    Secondary Outcome Measures

    1. Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events [First dose of study drug up to 15 months (while at risk)]

      TIMI classification for major and minor bleeding in the subset of subjects who did not undergo a coronary artery bypass operation (CABG) were defined as follows: Major bleeding: any intracranial hemorrhage (ICH) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 grams/deciliter (gm/dL)from baseline. Minor Bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 gm/dL but <5 gm/dL from baseline. Major bleeding events were further examined as events that were deemed life threatening and/or fatal.

    2. Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR) [Randomization to 30 days; randomization to 90 days]

      The endpoint in this measure is a combination of CV death, nonfatal MI, or UTVR. Results are reported for the All ACS subject population for the 30 and 90 day periods.

    3. Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke [Randomization to 30 days; randomization to 90 days]

      The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population for the 30 and 90 day periods.

    4. Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Rehospitalization for Cardiac Ischemic Events [Randomization up to 15 months]

      The endpoint in this measure is a combination of CV death, nonfatal MI, nonfatal stroke, or rehospitalization for cardiac ischemic events. Results are reported for the All ACS population.

    5. Number of Subjects Reaching the Composite Endpoint of All-Cause Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke [Randomization up to 15 months]

      The endpoint in this measure is a combination of all-cause death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • A person who has been diagnosed with acute coronary syndrome and is to undergo a percutaneous coronary intervention.

    • A person who is of the legal age of 18 and is mentally competent to provide a signed written informed consent.

    • If a woman is of childbearing potential (i.e., before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control.

    Exclusion Criteria:

    • A person who has had an ischemic stroke within the last 3 months or a hemorrhagic stroke at any time in the past.

    • A person who has active internal bleeding or has a history of a bleeding disorder.

    • Individuals who are at an increased risk of bleeding based on laboratory criteria evaluated by the treatment physician or on medication that can cause bleeding.

    • A person who has liver disease; for example, cirrhosis.

    • A person who has a condition such as alcoholism, mental illness, or is drug dependent.

    • A person who has cardiogenic shock, a refractory ventricular arrhythmia, or congestive heart failure (class IV).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For more information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Global Quintiles Study Line (1-866-615-4672) or speak with your physician Indianapolis Indiana United States

    Sponsors and Collaborators

    • Eli Lilly and Company
    • Daiichi Sankyo, Inc.

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00097591
    Other Study ID Numbers:
    • 8695
    • H7T-MC-TAAL
    First Posted:
    Nov 25, 2004
    Last Update Posted:
    Sep 16, 2010
    Last Verified:
    Aug 1, 2010
    Additional relevant MeSH terms:
    Acute Coronary Syndrome
    Arteriosclerosis
    Coronary Artery Disease
    Myocardial Ischemia
    Syndrome
    Clopidogrel
    Prasugrel Hydrochloride

    Study Results

    Participant Flow

    Recruitment Details Acute Coronary Syndromes (ACS) includes subjects presenting with unstable angina (UA), non-ST-segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI).
    Pre-assignment Detail
    Arm/Group Title Prasugrel Clopidogrel
    Arm/Group Description Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
    Period Title: Overall Study
    STARTED 6813 6795
    COMPLETED 6403 6401
    NOT COMPLETED 410 394

    Baseline Characteristics

    Arm/Group Title Prasugrel Clopidogrel Total
    Arm/Group Description Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily Total of all reporting groups
    Overall Participants 6813 6795 13608
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    60.9
    (11.2)
    60.9
    (11.4)
    60.9
    (11.3)
    Sex: Female, Male (Count of Participants)
    Female
    1705
    25%
    1818
    26.8%
    3523
    25.9%
    Male
    5108
    75%
    4977
    73.2%
    10085
    74.1%
    Race/Ethnicity, Customized (Number) [Number]
    Caucasian
    6263
    91.9%
    6274
    92.3%
    12537
    92.1%
    African
    205
    3%
    187
    2.8%
    392
    2.9%
    Hispanic
    269
    3.9%
    256
    3.8%
    525
    3.9%
    Asian
    60
    0.9%
    64
    0.9%
    124
    0.9%
    Other
    16
    0.2%
    14
    0.2%
    30
    0.2%
    Region of Enrollment (participants) [Number]
    North America
    2164
    31.8%
    2146
    31.6%
    4310
    31.7%
    South America
    270
    4%
    264
    3.9%
    534
    3.9%
    Europe
    3436
    50.4%
    3439
    50.6%
    6875
    50.5%
    Middle East
    606
    8.9%
    613
    9%
    1219
    9%
    Africa
    204
    3%
    200
    2.9%
    404
    3%
    Pacifica
    133
    2%
    133
    2%
    266
    2%

    Outcome Measures

    1. Primary Outcome
    Title Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke
    Description The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. The data is presented by the study population, which is represented as follows: 1) subjects who presented with unstable angina and non-ST-segment elevation myocardial infarction (UA/NSTEMI), 2) subjects who presented with ST segment elevation myocardial infarction (STEMI), and 3) all subjects with acute coronary syndromes (ACS) (i.e. all subjects with UA/NSTEMI or STEMI).
    Time Frame Randomization up to 15 months

    Outcome Measure Data

    Analysis Population Description
    Intention-to-treat (ITT) population consisting of all subjects with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) who may or may not have received study drug
    Arm/Group Title Prasugrel Clopidogrel
    Arm/Group Description Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
    Measure Participants 6813 6795
    UA/NSTEMI (n=5044, n=5030)
    469
    6.9%
    565
    8.3%
    STEMI (n=1769, n=1765)
    174
    2.6%
    216
    3.2%
    All ACS (n=6813, n=6795)
    643
    9.4%
    781
    11.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
    Comments For UA/NSTEMI population
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments The primary outcome measure was analyzed first in the UA/NSTEMI population, followed by All ACS subjects, followed by the STEMI population.
    Method Gehan-Wilcoxon
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.820
    Confidence Interval (2-Sided) 95%
    0.726 to 0.927
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
    Comments For STEMI population
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.019
    Comments
    Method Gehan-Wilcoxon
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.793
    Confidence Interval (2-Sided) 95%
    0.649 to 0.968
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
    Comments For All ACS population
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Gehan-Wilcoxon
    Comments Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.812
    Confidence Interval (2-Sided) 95%
    0.732 to 0.902
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events
    Description TIMI classification for major and minor bleeding in the subset of subjects who did not undergo a coronary artery bypass operation (CABG) were defined as follows: Major bleeding: any intracranial hemorrhage (ICH) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 grams/deciliter (gm/dL)from baseline. Minor Bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 gm/dL but <5 gm/dL from baseline. Major bleeding events were further examined as events that were deemed life threatening and/or fatal.
    Time Frame First dose of study drug up to 15 months (while at risk)

    Outcome Measure Data

    Analysis Population Description
    Treated subjects with adverse events were considered "at risk" from the first dose of study drug up through 7 days after permanent study drug discontinuation, or the subjects' discontinuation visit; or from randomization through 464 days, whichever is earlier. Adverse events classified as "study drug related" were included in the "at risk" set.
    Arm/Group Title Prasugrel Clopidogrel
    Arm/Group Description Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
    Measure Participants 6741 6716
    TIMI Major or Minor Bleeding
    303
    4.4%
    231
    3.4%
    TIMI Major Bleeding
    146
    2.1%
    111
    1.6%
    TIMI Major Bleeding - Life-threatening (LT)
    85
    1.2%
    56
    0.8%
    LT - Fatal
    21
    0.3%
    5
    0.1%
    LT - Symptomatic intracranial hemorrage (ICH)
    19
    0.3%
    17
    0.3%
    LT - Requiring inotropes
    21
    0.3%
    8
    0.1%
    LT - Requiring surgical intervention
    19
    0.3%
    19
    0.3%
    LT - Requiring transfusion (>=4 units)
    45
    0.7%
    30
    0.4%
    TIMI Minor Bleeding
    164
    2.4%
    125
    1.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
    Comments For non-CABG TIMI Major or Minor Bleeding
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments
    Method Log Rank
    Comments Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.314
    Confidence Interval (2-Sided) 95%
    1.107 to 1.559
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
    Comments For non-CABG TIMI Major Bleeding
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.029
    Comments
    Method Log Rank
    Comments Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.315
    Confidence Interval (2-Sided) 95%
    1.028 to 1.683
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
    Comments For the subset of non-CABG TIMI Major Bleeding - Life-threatening events (LT)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.015
    Comments
    Method Log Rank
    Comments Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.517
    Confidence Interval (2-Sided) 95%
    1.083 to 2.126
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
    Comments For the subset of non-CABG TIMI Major Bleeding - LT - Fatal
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments
    Method Log Rank
    Comments Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 4.191
    Confidence Interval (2-Sided) 95%
    1.1580 to 11.113
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
    Comments For the subset of non-CABG TIMI Major Bleeding - LT - Symptomatic intracranial hemorrage (ICH)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.736
    Comments
    Method Log Rank
    Comments Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.119
    Confidence Interval (2-Sided) 95%
    0.582 to 2.152
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
    Comments For the subset of non-CABG TIMI Major Bleeding - LT - Requiring inotropes
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.016
    Comments
    Method Log Rank
    Comments Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 2.617
    Confidence Interval (2-Sided) 95%
    1.159 to 5.908
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
    Comments For the subset of non-CABG TIMI Major Bleeding - LT - Requiring surgical intervention
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.995
    Comments
    Method Log Rank
    Comments Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.998
    Confidence Interval (2-Sided) 95%
    0.528 to 1.885
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
    Comments For the subset of non-CABG TIMI Major Bleeding - LT - Requiring transfusion (>=4 units)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.084
    Comments
    Method Log Rank
    Comments Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.499
    Confidence Interval (2-Sided) 95%
    0.945 to 2.379
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
    Comments For the subset of non-CABG TIMI Minor Bleeding
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.022
    Comments
    Method Log Rank
    Comments Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.313
    Confidence Interval (2-Sided) 95%
    1.040 to 1.656
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR)
    Description The endpoint in this measure is a combination of CV death, nonfatal MI, or UTVR. Results are reported for the All ACS subject population for the 30 and 90 day periods.
    Time Frame Randomization to 30 days; randomization to 90 days

    Outcome Measure Data

    Analysis Population Description
    Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.
    Arm/Group Title Prasugrel Clopidogrel
    Arm/Group Description Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
    Measure Participants 6813 6795
    All ACS (Through 30 days)
    399
    5.9%
    504
    7.4%
    All ACS (Through 90 days)
    472
    6.9%
    588
    8.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
    Comments Through 30 days
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Log Rank
    Comments Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.784
    Confidence Interval (2-Sided) 95%
    0.688 to 0.894
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
    Comments Through 90 days
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Log Rank
    Comments Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.794
    Confidence Interval (2-Sided) 95%
    0.703 to 0.896
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke
    Description The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population for the 30 and 90 day periods.
    Time Frame Randomization to 30 days; randomization to 90 days

    Outcome Measure Data

    Analysis Population Description
    Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.
    Arm/Group Title Prasugrel Clopidogrel
    Arm/Group Description Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
    Measure Participants 6813 6795
    All ACS (Through 30 days)
    389
    5.7%
    502
    7.4%
    All ACS (Through 90 days)
    462
    6.8%
    573
    8.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
    Comments Through 30 days
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Log Rank
    Comments Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.767
    Confidence Interval (2-Sided) 95%
    0.672 to 0.876
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
    Comments Through 90 days
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Log Rank
    Comments Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.797
    Confidence Interval (2-Sided) 95%
    0.705 to 0.901
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Rehospitalization for Cardiac Ischemic Events
    Description The endpoint in this measure is a combination of CV death, nonfatal MI, nonfatal stroke, or rehospitalization for cardiac ischemic events. Results are reported for the All ACS population.
    Time Frame Randomization up to 15 months

    Outcome Measure Data

    Analysis Population Description
    Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.
    Arm/Group Title Prasugrel Clopidogrel
    Arm/Group Description Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
    Measure Participants 6813 6795
    Number [Participants]
    797
    11.7%
    938
    13.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Log Rank
    Comments Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.838
    Confidence Interval (2-Sided) 95%
    0.762 to 0.921
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Number of Subjects Reaching the Composite Endpoint of All-Cause Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke
    Description The endpoint in this measure is a combination of all-cause death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population.
    Time Frame Randomization up to 15 months

    Outcome Measure Data

    Analysis Population Description
    Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.
    Arm/Group Title Prasugrel Clopidogrel
    Arm/Group Description Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
    Measure Participants 6813 6795
    Number [Participants]
    692
    10.2%
    822
    12.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Log Rank
    Comments Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.831
    Confidence Interval (2-Sided) 95%
    0.751 to 0.919
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Prasugrel Clopidogrel
    Arm/Group Description Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
    All Cause Mortality
    Prasugrel Clopidogrel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Prasugrel Clopidogrel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1731/6741 (25.7%) 1675/6716 (24.9%)
    Blood and lymphatic system disorders
    Anaemia 39/6741 (0.6%) 39 34/6716 (0.5%) 35
    Anaemia of chronic disease 1/6741 (0%) 1 0/6716 (0%) 0
    Disseminated intravascular coagulation 1/6741 (0%) 1 2/6716 (0%) 2
    Eosinophilia 0/6741 (0%) 0 1/6716 (0%) 1
    Hypochromic anaemia 0/6741 (0%) 0 1/6716 (0%) 1
    Iron deficiency anaemia 8/6741 (0.1%) 8 4/6716 (0.1%) 4
    Leukocytosis 1/6741 (0%) 1 2/6716 (0%) 2
    Leukopenia 0/6741 (0%) 0 3/6716 (0%) 3
    Lymphadenopathy 0/6741 (0%) 0 1/6716 (0%) 1
    Microcytic anaemia 1/6741 (0%) 1 1/6716 (0%) 1
    Neutropenia 0/6741 (0%) 0 5/6716 (0.1%) 5
    Normochromic normocytic anaemia 0/6741 (0%) 0 2/6716 (0%) 2
    Pernicious anaemia 0/6741 (0%) 0 1/6716 (0%) 1
    Splenic infarction 0/6741 (0%) 0 1/6716 (0%) 1
    Spontaneous haematoma 1/6741 (0%) 1 0/6716 (0%) 0
    Thrombocytopenia 15/6741 (0.2%) 15 15/6716 (0.2%) 15
    Cardiac disorders
    Acute coronary syndrome 2/6741 (0%) 2 3/6716 (0%) 3
    Acute left ventricular failure 1/6741 (0%) 2 2/6716 (0%) 2
    Acute myocardial infarction 1/6741 (0%) 1 1/6716 (0%) 1
    Angina pectoris 85/6741 (1.3%) 87 86/6716 (1.3%) 95
    Angina unstable 25/6741 (0.4%) 27 37/6716 (0.6%) 39
    Aortic valve incompetence 1/6741 (0%) 1 0/6716 (0%) 0
    Aortic valve stenosis 2/6741 (0%) 2 3/6716 (0%) 3
    Arrhythmia 1/6741 (0%) 1 3/6716 (0%) 4
    Arteriosclerosis coronary artery 0/6741 (0%) 0 1/6716 (0%) 1
    Arteriospasm coronary 2/6741 (0%) 2 4/6716 (0.1%) 4
    Atrial fibrillation 50/6741 (0.7%) 51 52/6716 (0.8%) 56
    Atrial flutter 12/6741 (0.2%) 12 4/6716 (0.1%) 4
    Atrial tachycardia 1/6741 (0%) 1 1/6716 (0%) 1
    Atrial thrombosis 1/6741 (0%) 1 0/6716 (0%) 0
    Atrioventricular block 1/6741 (0%) 1 4/6716 (0.1%) 4
    Atrioventricular block second degree 3/6741 (0%) 3 5/6716 (0.1%) 5
    Atrioventricular block third degree 11/6741 (0.2%) 11 11/6716 (0.2%) 11
    Bradyarrhythmia 0/6741 (0%) 0 1/6716 (0%) 1
    Bradycardia 14/6741 (0.2%) 14 11/6716 (0.2%) 11
    Bundle branch block left 0/6741 (0%) 0 2/6716 (0%) 2
    Cardiac aneurysm 0/6741 (0%) 0 1/6716 (0%) 1
    Cardiac arrest 10/6741 (0.1%) 10 10/6716 (0.1%) 12
    Cardiac asthma 1/6741 (0%) 1 0/6716 (0%) 0
    Cardiac discomfort 0/6741 (0%) 0 2/6716 (0%) 2
    Cardiac failure 22/6741 (0.3%) 24 41/6716 (0.6%) 42
    Cardiac failure acute 3/6741 (0%) 3 3/6716 (0%) 4
    Cardiac failure chronic 0/6741 (0%) 0 1/6716 (0%) 1
    Cardiac failure congestive 46/6741 (0.7%) 48 47/6716 (0.7%) 48
    Cardiac perforation 0/6741 (0%) 0 1/6716 (0%) 1
    Cardiac pseudoaneurysm 1/6741 (0%) 1 0/6716 (0%) 0
    Cardiac tamponade 5/6741 (0.1%) 5 4/6716 (0.1%) 4
    Cardiac valve disease 1/6741 (0%) 1 0/6716 (0%) 0
    Cardio-respiratory arrest 1/6741 (0%) 1 1/6716 (0%) 1
    Cardiogenic shock 13/6741 (0.2%) 14 8/6716 (0.1%) 8
    Cardiomyopathy 2/6741 (0%) 2 2/6716 (0%) 2
    Cardiopulmonary failure 1/6741 (0%) 1 0/6716 (0%) 0
    Cardiovascular disorder 4/6741 (0.1%) 4 2/6716 (0%) 2
    Coronary artery aneurysm 1/6741 (0%) 1 0/6716 (0%) 0
    Coronary artery disease 14/6741 (0.2%) 14 17/6716 (0.3%) 17
    Coronary artery dissection 5/6741 (0.1%) 5 11/6716 (0.2%) 11
    Coronary artery occlusion 8/6741 (0.1%) 8 7/6716 (0.1%) 7
    Coronary artery perforation 2/6741 (0%) 2 1/6716 (0%) 1
    Coronary artery restenosis 107/6741 (1.6%) 118 111/6716 (1.7%) 118
    Coronary artery stenosis 52/6741 (0.8%) 54 64/6716 (1%) 65
    Coronary artery thrombosis 2/6741 (0%) 2 2/6716 (0%) 4
    Dressler's syndrome 4/6741 (0.1%) 4 2/6716 (0%) 2
    Electromechanical dissociation 1/6741 (0%) 1 1/6716 (0%) 1
    In-stent arterial restenosis 0/6741 (0%) 0 1/6716 (0%) 1
    Interventricular septum rupture 1/6741 (0%) 1 0/6716 (0%) 0
    Intracardiac thrombus 9/6741 (0.1%) 9 4/6716 (0.1%) 4
    Ischaemic cardiomyopathy 6/6741 (0.1%) 6 3/6716 (0%) 3
    Left ventricular failure 1/6741 (0%) 2 4/6716 (0.1%) 4
    Low cardiac output syndrome 3/6741 (0%) 3 2/6716 (0%) 2
    Mitral valve disease 1/6741 (0%) 1 0/6716 (0%) 0
    Mitral valve incompetence 6/6741 (0.1%) 6 3/6716 (0%) 3
    Myocardial infarction 0/6741 (0%) 0 2/6716 (0%) 2
    Myocardial ischaemia 12/6741 (0.2%) 13 17/6716 (0.3%) 17
    Myocardial rupture 0/6741 (0%) 0 2/6716 (0%) 2
    Myopericarditis 0/6741 (0%) 0 1/6716 (0%) 1
    Nodal arrhythmia 2/6741 (0%) 2 0/6716 (0%) 0
    Palpitations 3/6741 (0%) 3 0/6716 (0%) 0
    Papillary muscle disorder 0/6741 (0%) 0 1/6716 (0%) 1
    Papillary muscle rupture 3/6741 (0%) 3 1/6716 (0%) 1
    Pericardial effusion 8/6741 (0.1%) 11 1/6716 (0%) 1
    Pericardial haemorrhage 5/6741 (0.1%) 5 7/6716 (0.1%) 8
    Pericarditis 3/6741 (0%) 4 8/6716 (0.1%) 9
    Pleuropericarditis 0/6741 (0%) 0 1/6716 (0%) 2
    Prinzmetal angina 0/6741 (0%) 0 1/6716 (0%) 1
    Sick sinus syndrome 1/6741 (0%) 1 5/6716 (0.1%) 5
    Sinoatrial block 1/6741 (0%) 1 0/6716 (0%) 0
    Sinus arrest 2/6741 (0%) 2 2/6716 (0%) 2
    Sinus bradycardia 0/6741 (0%) 0 6/6716 (0.1%) 6
    Sinus tachycardia 1/6741 (0%) 1 0/6716 (0%) 0
    Supraventricular tachycardia 8/6741 (0.1%) 10 5/6716 (0.1%) 6
    Tachyarrhythmia 1/6741 (0%) 1 0/6716 (0%) 0
    Tachycardia 1/6741 (0%) 1 1/6716 (0%) 1
    Torsade de pointes 2/6741 (0%) 2 1/6716 (0%) 1
    Ventricular arrhythmia 3/6741 (0%) 3 1/6716 (0%) 1
    Ventricular dysfunction 1/6741 (0%) 1 4/6716 (0.1%) 4
    Ventricular extrasystoles 6/6741 (0.1%) 6 3/6716 (0%) 3
    Ventricular fibrillation 18/6741 (0.3%) 19 25/6716 (0.4%) 25
    Ventricular flutter 1/6741 (0%) 1 0/6716 (0%) 0
    Ventricular septal defect acquired 1/6741 (0%) 1 0/6716 (0%) 0
    Ventricular tachycardia 24/6741 (0.4%) 27 25/6716 (0.4%) 30
    Congenital, familial and genetic disorders
    Arteriovenous malformation 0/6741 (0%) 0 1/6716 (0%) 1
    Gastrointestinal angiodysplasia 1/6741 (0%) 1 0/6716 (0%) 0
    Gilbert's syndrome 0/6741 (0%) 0 1/6716 (0%) 1
    Haemorrhagic arteriovenous malformation 0/6741 (0%) 0 1/6716 (0%) 1
    Laryngocele 1/6741 (0%) 1 0/6716 (0%) 0
    Ventricular septal defect 1/6741 (0%) 1 0/6716 (0%) 0
    Ear and labyrinth disorders
    Auricular perichondritis 0/6741 (0%) 0 1/6716 (0%) 1
    Deafness unilateral 0/6741 (0%) 0 1/6716 (0%) 1
    Sudden hearing loss 1/6741 (0%) 1 0/6716 (0%) 0
    Vertigo 3/6741 (0%) 3 3/6716 (0%) 3
    Vestibular neuronitis 1/6741 (0%) 1 0/6716 (0%) 0
    Endocrine disorders
    Adrenal insufficiency 0/6741 (0%) 0 1/6716 (0%) 1
    Hyperthyroidism 3/6741 (0%) 3 1/6716 (0%) 1
    Eye disorders
    Cataract 4/6741 (0.1%) 4 3/6716 (0%) 3
    Conjunctival haemorrhage 1/6741 (0%) 1 0/6716 (0%) 0
    Eye haemorrhage 4/6741 (0.1%) 4 0/6716 (0%) 0
    Eye inflammation 1/6741 (0%) 1 0/6716 (0%) 0
    Glaucoma 2/6741 (0%) 2 1/6716 (0%) 1
    Hyphaema 1/6741 (0%) 1 0/6716 (0%) 0
    Macular hole 1/6741 (0%) 2 0/6716 (0%) 0
    Maculopathy 1/6741 (0%) 1 0/6716 (0%) 0
    Ocular hyperaemia 0/6741 (0%) 0 1/6716 (0%) 1
    Retinal detachment 1/6741 (0%) 1 0/6716 (0%) 0
    Retinal haemorrhage 0/6741 (0%) 0 1/6716 (0%) 1
    Retinal vein occlusion 0/6741 (0%) 0 1/6716 (0%) 1
    Vision blurred 1/6741 (0%) 1 0/6716 (0%) 0
    Vitreous haemorrhage 2/6741 (0%) 3 4/6716 (0.1%) 4
    Gastrointestinal disorders
    Abdominal discomfort 0/6741 (0%) 0 1/6716 (0%) 1
    Abdominal haematoma 2/6741 (0%) 2 1/6716 (0%) 1
    Abdominal pain 7/6741 (0.1%) 8 10/6716 (0.1%) 10
    Abdominal pain lower 1/6741 (0%) 1 2/6716 (0%) 2
    Abdominal pain upper 4/6741 (0.1%) 5 7/6716 (0.1%) 7
    Abdominal strangulated hernia 0/6741 (0%) 0 1/6716 (0%) 1
    Anal fistula 0/6741 (0%) 0 1/6716 (0%) 1
    Anal haemorrhage 1/6741 (0%) 1 1/6716 (0%) 1
    Ascites 0/6741 (0%) 0 1/6716 (0%) 3
    Colitis 3/6741 (0%) 3 0/6716 (0%) 0
    Colitis ischaemic 0/6741 (0%) 0 1/6716 (0%) 1
    Colitis ulcerative 1/6741 (0%) 1 2/6716 (0%) 2
    Colonic obstruction 1/6741 (0%) 1 0/6716 (0%) 0
    Colonic polyp 2/6741 (0%) 2 0/6716 (0%) 0
    Constipation 0/6741 (0%) 0 5/6716 (0.1%) 5
    Crohn's disease 0/6741 (0%) 0 2/6716 (0%) 2
    Diabetic gastroparesis 1/6741 (0%) 2 0/6716 (0%) 0
    Diarrhoea 3/6741 (0%) 3 1/6716 (0%) 1
    Diverticular perforation 0/6741 (0%) 0 1/6716 (0%) 1
    Diverticulitis intestinal haemorrhagic 1/6741 (0%) 1 1/6716 (0%) 1
    Diverticulum 3/6741 (0%) 3 0/6716 (0%) 0
    Diverticulum intestinal 0/6741 (0%) 0 1/6716 (0%) 1
    Diverticulum intestinal haemorrhagic 1/6741 (0%) 1 4/6716 (0.1%) 4
    Duodenal ulcer 2/6741 (0%) 2 2/6716 (0%) 2
    Duodenal ulcer haemorrhage 3/6741 (0%) 3 3/6716 (0%) 3
    Duodenitis 2/6741 (0%) 2 1/6716 (0%) 1
    Duodenitis haemorrhagic 0/6741 (0%) 0 1/6716 (0%) 1
    Dyspepsia 1/6741 (0%) 1 5/6716 (0.1%) 5
    Dysphagia 1/6741 (0%) 1 1/6716 (0%) 1
    Enteritis 3/6741 (0%) 3 1/6716 (0%) 1
    Enterocolitis haemorrhagic 0/6741 (0%) 0 1/6716 (0%) 1
    Epigastric discomfort 2/6741 (0%) 2 0/6716 (0%) 0
    Erosive duodenitis 0/6741 (0%) 0 1/6716 (0%) 1
    Erosive oesophagitis 0/6741 (0%) 0 1/6716 (0%) 1
    Faecal incontinence 0/6741 (0%) 0 1/6716 (0%) 1
    Faeces discoloured 1/6741 (0%) 1 0/6716 (0%) 0
    Femoral hernia 0/6741 (0%) 0 1/6716 (0%) 1
    Gastric haemorrhage 3/6741 (0%) 3 8/6716 (0.1%) 8
    Gastric polyps 0/6741 (0%) 0 1/6716 (0%) 1
    Gastric ulcer 8/6741 (0.1%) 8 6/6716 (0.1%) 6
    Gastric ulcer haemorrhage 5/6741 (0.1%) 5 5/6716 (0.1%) 5
    Gastritis 7/6741 (0.1%) 7 7/6716 (0.1%) 8
    Gastritis erosive 7/6741 (0.1%) 7 3/6716 (0%) 3
    Gastritis haemorrhagic 0/6741 (0%) 0 3/6716 (0%) 3
    Gastroduodenitis 1/6741 (0%) 1 0/6716 (0%) 0
    Gastrointestinal haemorrhage 91/6741 (1.3%) 95 55/6716 (0.8%) 61
    Gastrooesophageal reflux disease 6/6741 (0.1%) 6 11/6716 (0.2%) 11
    Gastrooesophagitis 1/6741 (0%) 1 0/6716 (0%) 0
    Haematemesis 3/6741 (0%) 3 2/6716 (0%) 2
    Haematochezia 4/6741 (0.1%) 4 1/6716 (0%) 1
    Haemorrhoidal haemorrhage 6/6741 (0.1%) 6 3/6716 (0%) 3
    Haemorrhoids 0/6741 (0%) 0 1/6716 (0%) 1
    Hiatus hernia 1/6741 (0%) 1 1/6716 (0%) 1
    Ileus 3/6741 (0%) 3 0/6716 (0%) 0
    Inguinal hernia 2/6741 (0%) 2 5/6716 (0.1%) 5
    Intestinal haemorrhage 4/6741 (0.1%) 4 0/6716 (0%) 0
    Intestinal ischaemia 0/6741 (0%) 0 1/6716 (0%) 1
    Intestinal obstruction 2/6741 (0%) 3 0/6716 (0%) 0
    Intra-abdominal haemorrhage 2/6741 (0%) 2 0/6716 (0%) 0
    Irritable bowel syndrome 2/6741 (0%) 2 2/6716 (0%) 2
    Large intestine perforation 1/6741 (0%) 1 0/6716 (0%) 0
    Lower gastrointestinal haemorrhage 7/6741 (0.1%) 8 10/6716 (0.1%) 11
    Mallory-weiss syndrome 3/6741 (0%) 3 2/6716 (0%) 2
    Melaena 6/6741 (0.1%) 6 6/6716 (0.1%) 6
    Mesenteric artery thrombosis 1/6741 (0%) 1 0/6716 (0%) 0
    Mouth haemorrhage 0/6741 (0%) 0 1/6716 (0%) 1
    Nausea 3/6741 (0%) 3 2/6716 (0%) 2
    Oesophageal achalasia 1/6741 (0%) 1 0/6716 (0%) 0
    Oesophageal stenosis 2/6741 (0%) 2 0/6716 (0%) 0
    Oesophageal ulcer 1/6741 (0%) 1 0/6716 (0%) 0
    Oesophagitis 2/6741 (0%) 2 1/6716 (0%) 1
    Pancreatitis 6/6741 (0.1%) 6 3/6716 (0%) 4
    Pancreatitis acute 5/6741 (0.1%) 5 5/6716 (0.1%) 5
    Pancreatitis chronic 0/6741 (0%) 0 1/6716 (0%) 1
    Pancreatitis relapsing 1/6741 (0%) 1 0/6716 (0%) 0
    Peptic ulcer 1/6741 (0%) 1 3/6716 (0%) 3
    Peptic ulcer haemorrhage 2/6741 (0%) 2 3/6716 (0%) 3
    Peptic ulcer perforation 0/6741 (0%) 0 1/6716 (0%) 1
    Peritoneal haemorrhage 1/6741 (0%) 1 0/6716 (0%) 0
    Peritonitis 2/6741 (0%) 2 0/6716 (0%) 0
    Polyp colorectal 1/6741 (0%) 1 1/6716 (0%) 1
    Proctitis 1/6741 (0%) 1 0/6716 (0%) 0
    Rectal haemorrhage 11/6741 (0.2%) 11 5/6716 (0.1%) 5
    Rectal prolapse 0/6741 (0%) 0 1/6716 (0%) 1
    Rectal ulcer haemorrhage 0/6741 (0%) 0 1/6716 (0%) 1
    Reflux oesophagitis 2/6741 (0%) 2 3/6716 (0%) 3
    Retroperitoneal haematoma 5/6741 (0.1%) 5 4/6716 (0.1%) 4
    Retroperitoneal haemorrhage 15/6741 (0.2%) 16 9/6716 (0.1%) 9
    Small intestinal obstruction 4/6741 (0.1%) 4 2/6716 (0%) 2
    Subileus 1/6741 (0%) 1 0/6716 (0%) 0
    Toothache 1/6741 (0%) 1 0/6716 (0%) 0
    Umbilical hernia 0/6741 (0%) 0 2/6716 (0%) 2
    Upper gastrointestinal haemorrhage 15/6741 (0.2%) 16 8/6716 (0.1%) 8
    Vomiting 2/6741 (0%) 2 2/6716 (0%) 2
    General disorders
    Abasia 0/6741 (0%) 0 1/6716 (0%) 1
    Adverse drug reaction 1/6741 (0%) 1 1/6716 (0%) 1
    Asthenia 4/6741 (0.1%) 4 3/6716 (0%) 3
    Catheter site haemorrhage 1/6741 (0%) 2 1/6716 (0%) 1
    Chest discomfort 7/6741 (0.1%) 7 7/6716 (0.1%) 8
    Chest pain 91/6741 (1.3%) 98 73/6716 (1.1%) 78
    Exercise tolerance decreased 0/6741 (0%) 0 1/6716 (0%) 1
    Fatigue 0/6741 (0%) 0 1/6716 (0%) 1
    Gait disturbance 0/6741 (0%) 0 1/6716 (0%) 1
    General physical health deterioration 1/6741 (0%) 1 1/6716 (0%) 1
    Generalised oedema 0/6741 (0%) 0 1/6716 (0%) 1
    Heparin-induced thrombocytopenia 1/6741 (0%) 1 1/6716 (0%) 1
    Hernia 1/6741 (0%) 1 0/6716 (0%) 0
    Inflammation 0/6741 (0%) 0 3/6716 (0%) 3
    Ischaemic ulcer 1/6741 (0%) 1 0/6716 (0%) 0
    Malaise 0/6741 (0%) 0 1/6716 (0%) 1
    Multi-organ disorder 0/6741 (0%) 0 1/6716 (0%) 1
    Multi-organ failure 2/6741 (0%) 2 1/6716 (0%) 1
    Necrosis 0/6741 (0%) 0 1/6716 (0%) 1
    Non-cardiac chest pain 138/6741 (2%) 155 167/6716 (2.5%) 179
    Oedema peripheral 2/6741 (0%) 2 1/6716 (0%) 1
    Puncture site haemorrhage 30/6741 (0.4%) 30 18/6716 (0.3%) 18
    Pyrexia 12/6741 (0.2%) 13 6/6716 (0.1%) 6
    Submandibular mass 0/6741 (0%) 0 1/6716 (0%) 1
    Sudden cardiac death 0/6741 (0%) 0 1/6716 (0%) 1
    Systemic inflammatory response syndrome 0/6741 (0%) 0 1/6716 (0%) 1
    Ulcer 1/6741 (0%) 1 2/6716 (0%) 2
    Vessel puncture site haematoma 21/6741 (0.3%) 21 14/6716 (0.2%) 14
    Vessel puncture site haemorrhage 13/6741 (0.2%) 13 10/6716 (0.1%) 10
    Hepatobiliary disorders
    Acute hepatic failure 0/6741 (0%) 0 2/6716 (0%) 2
    Autoimmune hepatitis 1/6741 (0%) 1 0/6716 (0%) 0
    Bile duct stone 0/6741 (0%) 0 1/6716 (0%) 1
    Biliary cirrhosis 0/6741 (0%) 0 1/6716 (0%) 1
    Biliary colic 2/6741 (0%) 2 0/6716 (0%) 0
    Biliary dyskinesia 1/6741 (0%) 1 0/6716 (0%) 0
    Cholaemia 0/6741 (0%) 0 1/6716 (0%) 1
    Cholangitis acute 2/6741 (0%) 2 0/6716 (0%) 0
    Cholecystitis 5/6741 (0.1%) 5 5/6716 (0.1%) 5
    Cholecystitis acute 4/6741 (0.1%) 4 7/6716 (0.1%) 7
    Cholecystitis chronic 1/6741 (0%) 1 0/6716 (0%) 0
    Cholelithiasis 10/6741 (0.1%) 10 13/6716 (0.2%) 13
    Cholelithiasis obstructive 1/6741 (0%) 1 0/6716 (0%) 0
    Cholestasis 0/6741 (0%) 0 1/6716 (0%) 1
    Gallbladder disorder 2/6741 (0%) 2 0/6716 (0%) 0
    Hepatic failure 1/6741 (0%) 1 2/6716 (0%) 2
    Hepatic steatosis 2/6741 (0%) 2 0/6716 (0%) 0
    Hepatitis cholestatic 1/6741 (0%) 1 0/6716 (0%) 0
    Ischaemic hepatitis 0/6741 (0%) 0 1/6716 (0%) 1
    Jaundice 1/6741 (0%) 1 0/6716 (0%) 0
    Liver disorder 0/6741 (0%) 0 1/6716 (0%) 1
    Portal hypertension 0/6741 (0%) 0 1/6716 (0%) 2
    Immune system disorders
    Anaphylactic reaction 1/6741 (0%) 1 2/6716 (0%) 2
    Anaphylactic shock 2/6741 (0%) 2 2/6716 (0%) 2
    Drug hypersensitivity 1/6741 (0%) 1 3/6716 (0%) 3
    Hypersensitivity 3/6741 (0%) 3 2/6716 (0%) 3
    Polyarteritis nodosa 1/6741 (0%) 1 0/6716 (0%) 0
    Infections and infestations
    Abscess 1/6741 (0%) 1 2/6716 (0%) 2
    Abscess limb 0/6741 (0%) 0 2/6716 (0%) 2
    Anal abscess 1/6741 (0%) 1 0/6716 (0%) 0
    Appendicitis 5/6741 (0.1%) 5 2/6716 (0%) 2
    Arthritis bacterial 0/6741 (0%) 0 1/6716 (0%) 1
    Arthritis infective 0/6741 (0%) 0 1/6716 (0%) 1
    Bacteraemia 3/6741 (0%) 3 1/6716 (0%) 1
    Bacterial pyelonephritis 1/6741 (0%) 1 0/6716 (0%) 0
    Bronchitis 3/6741 (0%) 3 5/6716 (0.1%) 5
    Bronchitis acute 9/6741 (0.1%) 9 3/6716 (0%) 3
    Bronchitis chronic 0/6741 (0%) 0 3/6716 (0%) 3
    Bronchopneumonia 5/6741 (0.1%) 5 2/6716 (0%) 2
    Catheter site infection 1/6741 (0%) 1 0/6716 (0%) 0
    Cellulitis 11/6741 (0.2%) 12 6/6716 (0.1%) 6
    Cholecystitis infective 0/6741 (0%) 0 1/6716 (0%) 1
    Chronic sinusitis 0/6741 (0%) 0 1/6716 (0%) 1
    Clostridium difficile colitis 2/6741 (0%) 2 0/6716 (0%) 0
    Diabetic gangrene 0/6741 (0%) 0 1/6716 (0%) 1
    Diverticulitis 8/6741 (0.1%) 10 5/6716 (0.1%) 5
    Endocarditis 0/6741 (0%) 0 1/6716 (0%) 1
    Endocarditis bacterial 1/6741 (0%) 1 1/6716 (0%) 1
    Enterocolitis infectious 0/6741 (0%) 0 1/6716 (0%) 1
    Erysipelas 1/6741 (0%) 1 1/6716 (0%) 1
    Febrile infection 1/6741 (0%) 1 0/6716 (0%) 0
    Gangrene 1/6741 (0%) 1 0/6716 (0%) 0
    Gas gangrene 1/6741 (0%) 1 0/6716 (0%) 0
    Gastritis viral 1/6741 (0%) 1 0/6716 (0%) 0
    Gastroenteritis 10/6741 (0.1%) 10 6/6716 (0.1%) 6
    Gastroenteritis viral 1/6741 (0%) 1 2/6716 (0%) 2
    Gastrointestinal infection 0/6741 (0%) 0 1/6716 (0%) 1
    Giardiasis 0/6741 (0%) 0 1/6716 (0%) 1
    Groin abscess 1/6741 (0%) 1 0/6716 (0%) 0
    Helicobacter gastritis 2/6741 (0%) 2 0/6716 (0%) 0
    Hepatitis c 0/6741 (0%) 0 1/6716 (0%) 1
    Hepatitis viral 0/6741 (0%) 0 1/6716 (0%) 1
    Herpes zoster oticus 0/6741 (0%) 0 1/6716 (0%) 1
    Infection 0/6741 (0%) 0 3/6716 (0%) 3
    Infective exacerbation of chronic obstructive airways disease 1/6741 (0%) 1 0/6716 (0%) 0
    Influenza 0/6741 (0%) 0 1/6716 (0%) 1
    Intervertebral discitis 0/6741 (0%) 0 1/6716 (0%) 1
    Lobar pneumonia 5/6741 (0.1%) 5 6/6716 (0.1%) 6
    Localised infection 0/6741 (0%) 0 3/6716 (0%) 3
    Lung infection 0/6741 (0%) 0 1/6716 (0%) 1
    Lymphangitis 0/6741 (0%) 0 2/6716 (0%) 2
    Mediastinitis 0/6741 (0%) 0 3/6716 (0%) 3
    Meningitis viral 1/6741 (0%) 1 0/6716 (0%) 0
    Neuroborreliosis 1/6741 (0%) 1 0/6716 (0%) 0
    Oral infection 1/6741 (0%) 1 0/6716 (0%) 0
    Osteomyelitis 1/6741 (0%) 1 2/6716 (0%) 2
    Otitis externa 0/6741 (0%) 0 1/6716 (0%) 1
    Parotitis 0/6741 (0%) 0 1/6716 (0%) 1
    Penile infection 0/6741 (0%) 0 1/6716 (0%) 1
    Perianal abscess 2/6741 (0%) 2 0/6716 (0%) 0
    Peritonitis bacterial 1/6741 (0%) 1 0/6716 (0%) 0
    Peritonsillar abscess 0/6741 (0%) 0 1/6716 (0%) 1
    Pharyngitis 1/6741 (0%) 1 0/6716 (0%) 0
    Pneumonia 43/6741 (0.6%) 45 52/6716 (0.8%) 54
    Pneumonia bacterial 0/6741 (0%) 0 1/6716 (0%) 1
    Pneumonia streptococcal 1/6741 (0%) 1 1/6716 (0%) 1
    Pneumonia viral 1/6741 (0%) 1 0/6716 (0%) 0
    Postoperative wound infection 1/6741 (0%) 1 0/6716 (0%) 0
    Pulmonary tuberculosis 0/6741 (0%) 0 1/6716 (0%) 1
    Pyelonephritis 2/6741 (0%) 2 2/6716 (0%) 2
    Pyelonephritis acute 2/6741 (0%) 2 1/6716 (0%) 1
    Pyothorax 0/6741 (0%) 0 1/6716 (0%) 1
    Rectal abscess 1/6741 (0%) 1 0/6716 (0%) 0
    Respiratory tract infection 2/6741 (0%) 2 1/6716 (0%) 1
    Salmonellosis 1/6741 (0%) 1 0/6716 (0%) 0
    Salpingitis 1/6741 (0%) 1 0/6716 (0%) 0
    Scrotal abscess 0/6741 (0%) 0 1/6716 (0%) 1
    Sepsis 8/6741 (0.1%) 8 9/6716 (0.1%) 9
    Sepsis syndrome 1/6741 (0%) 1 0/6716 (0%) 0
    Septic shock 1/6741 (0%) 1 2/6716 (0%) 2
    Sinusitis 1/6741 (0%) 1 0/6716 (0%) 0
    Skin infection 1/6741 (0%) 1 1/6716 (0%) 1
    Staphylococcal bacteraemia 2/6741 (0%) 2 1/6716 (0%) 1
    Staphylococcal infection 2/6741 (0%) 2 2/6716 (0%) 2
    Staphylococcal sepsis 4/6741 (0.1%) 4 0/6716 (0%) 0
    Streptococcal sepsis 1/6741 (0%) 1 0/6716 (0%) 0
    Tracheobronchitis 1/6741 (0%) 1 1/6716 (0%) 1
    Upper respiratory tract infection 1/6741 (0%) 1 6/6716 (0.1%) 6
    Urinary tract infection 15/6741 (0.2%) 17 19/6716 (0.3%) 19
    Urosepsis 6/6741 (0.1%) 6 3/6716 (0%) 3
    Viral diarrhoea 0/6741 (0%) 0 1/6716 (0%) 1
    Viral infection 4/6741 (0.1%) 4 3/6716 (0%) 3
    Viral pericarditis 0/6741 (0%) 0 1/6716 (0%) 1
    Viral upper respiratory tract infection 0/6741 (0%) 0 1/6716 (0%) 1
    Wound infection 0/6741 (0%) 0 3/6716 (0%) 3
    Wound infection staphylococcal 1/6741 (0%) 1 0/6716 (0%) 0
    Injury, poisoning and procedural complications
    Abdominal injury 1/6741 (0%) 1 1/6716 (0%) 1
    Accidental overdose 1/6741 (0%) 1 0/6716 (0%) 0
    Alcohol poisoning 2/6741 (0%) 2 1/6716 (0%) 1
    Anaemia postoperative 2/6741 (0%) 2 0/6716 (0%) 0
    Ankle fracture 2/6741 (0%) 2 2/6716 (0%) 2
    Aortic injury 1/6741 (0%) 1 0/6716 (0%) 0
    Arterial injury 2/6741 (0%) 2 1/6716 (0%) 1
    Arteriovenous fistula thrombosis 0/6741 (0%) 0 1/6716 (0%) 1
    Arteriovenous graft thrombosis 0/6741 (0%) 0 1/6716 (0%) 1
    Bronchial injury 0/6741 (0%) 0 1/6716 (0%) 1
    Cartilage injury 1/6741 (0%) 1 0/6716 (0%) 0
    Chest injury 0/6741 (0%) 0 1/6716 (0%) 1
    Clavicle fracture 0/6741 (0%) 0 1/6716 (0%) 1
    Concussion 1/6741 (0%) 1 1/6716 (0%) 1
    Contusion 6/6741 (0.1%) 7 0/6716 (0%) 0
    Coronary artery reocclusion 0/6741 (0%) 0 1/6716 (0%) 1
    Device dislocation 0/6741 (0%) 0 3/6716 (0%) 3
    Eyeball rupture 1/6741 (0%) 1 0/6716 (0%) 0
    Face injury 1/6741 (0%) 1 0/6716 (0%) 0
    Facial bones fracture 1/6741 (0%) 1 0/6716 (0%) 0
    Failure of implant 0/6741 (0%) 0 1/6716 (0%) 1
    Fall 11/6741 (0.2%) 12 12/6716 (0.2%) 12
    Fat embolism 0/6741 (0%) 0 1/6716 (0%) 1
    Femoral neck fracture 1/6741 (0%) 1 0/6716 (0%) 0
    Femur fracture 2/6741 (0%) 2 2/6716 (0%) 2
    Fibula fracture 0/6741 (0%) 0 1/6716 (0%) 1
    Foot fracture 0/6741 (0%) 0 1/6716 (0%) 1
    Foreign body trauma 1/6741 (0%) 1 0/6716 (0%) 0
    Graft thrombosis 0/6741 (0%) 0 1/6716 (0%) 1
    Hand fracture 1/6741 (0%) 1 0/6716 (0%) 0
    Heat exhaustion 2/6741 (0%) 2 0/6716 (0%) 0
    Hepatic trauma 2/6741 (0%) 2 0/6716 (0%) 0
    Hip fracture 4/6741 (0.1%) 4 6/6716 (0.1%) 6
    Humerus fracture 3/6741 (0%) 3 0/6716 (0%) 0
    Incision site haemorrhage 1/6741 (0%) 1 0/6716 (0%) 0
    Incisional hernia 1/6741 (0%) 1 0/6716 (0%) 0
    Injury 2/6741 (0%) 2 0/6716 (0%) 0
    Intentional overdose 1/6741 (0%) 1 0/6716 (0%) 0
    Intervertebral disc injury 1/6741 (0%) 1 0/6716 (0%) 0
    Jaw fracture 1/6741 (0%) 1 0/6716 (0%) 0
    Joint dislocation 2/6741 (0%) 2 0/6716 (0%) 0
    Joint sprain 1/6741 (0%) 1 0/6716 (0%) 0
    Ligament injury 0/6741 (0%) 0 1/6716 (0%) 1
    Limb injury 1/6741 (0%) 1 0/6716 (0%) 0
    Lower limb fracture 2/6741 (0%) 2 2/6716 (0%) 2
    Lumbar vertebral fracture 0/6741 (0%) 0 1/6716 (0%) 1
    Meniscus lesion 3/6741 (0%) 3 1/6716 (0%) 1
    Muscle rupture 1/6741 (0%) 1 0/6716 (0%) 0
    Operative haemorrhage 17/6741 (0.3%) 18 7/6716 (0.1%) 7
    Pelvic fracture 1/6741 (0%) 1 0/6716 (0%) 0
    Polytraumatism 0/6741 (0%) 0 1/6716 (0%) 1
    Post procedural haematoma 2/6741 (0%) 2 1/6716 (0%) 1
    Post procedural haemorrhage 20/6741 (0.3%) 20 8/6716 (0.1%) 8
    Postpericardiotomy syndrome 0/6741 (0%) 0 1/6716 (0%) 1
    Pubic rami fracture 1/6741 (0%) 1 1/6716 (0%) 1
    Radius fracture 4/6741 (0.1%) 4 1/6716 (0%) 1
    Renal haematoma 1/6741 (0%) 1 0/6716 (0%) 0
    Rib fracture 2/6741 (0%) 3 1/6716 (0%) 1
    Road traffic accident 4/6741 (0.1%) 4 1/6716 (0%) 1
    Skeletal injury 1/6741 (0%) 1 0/6716 (0%) 0
    Skull fractured base 1/6741 (0%) 1 0/6716 (0%) 0
    Spinal compression fracture 2/6741 (0%) 2 4/6716 (0.1%) 4
    Splenic rupture 1/6741 (0%) 1 0/6716 (0%) 0
    Stent occlusion 2/6741 (0%) 2 3/6716 (0%) 3
    Subcutaneous haematoma 5/6741 (0.1%) 5 0/6716 (0%) 0
    Subdural haematoma 1/6741 (0%) 1 6/6716 (0.1%) 6
    Tendon rupture 0/6741 (0%) 0 2/6716 (0%) 2
    Therapeutic agent toxicity 1/6741 (0%) 1 0/6716 (0%) 0
    Thoracic vertebral fracture 1/6741 (0%) 1 0/6716 (0%) 0
    Thrombosis in device 7/6741 (0.1%) 7 10/6716 (0.1%) 10
    Tibia fracture 0/6741 (0%) 0 3/6716 (0%) 3
    Traumatic haematoma 1/6741 (0%) 1 0/6716 (0%) 0
    Traumatic intracranial haemorrhage 1/6741 (0%) 1 0/6716 (0%) 0
    Upper limb fracture 2/6741 (0%) 2 0/6716 (0%) 0
    Vascular graft occlusion 1/6741 (0%) 1 0/6716 (0%) 0
    Venous injury 1/6741 (0%) 1 1/6716 (0%) 1
    Wound 1/6741 (0%) 1 0/6716 (0%) 0
    Wrist fracture 0/6741 (0%) 0 1/6716 (0%) 2
    Investigations
    Angiogram 1/6741 (0%) 1 1/6716 (0%) 1
    Blood creatine phosphokinase increased 1/6741 (0%) 1 1/6716 (0%) 1
    Blood creatinine increased 0/6741 (0%) 0 1/6716 (0%) 1
    Blood pressure decreased 1/6741 (0%) 1 0/6716 (0%) 0
    Blood pressure increased 0/6741 (0%) 0 1/6716 (0%) 1
    C-reactive protein increased 0/6741 (0%) 0 2/6716 (0%) 2
    Cardiac enzymes increased 2/6741 (0%) 2 0/6716 (0%) 0
    Ejection fraction decreased 1/6741 (0%) 1 1/6716 (0%) 1
    Electrocardiogram abnormal 2/6741 (0%) 2 0/6716 (0%) 0
    Electrocardiogram change 0/6741 (0%) 0 1/6716 (0%) 1
    Electrocardiogram st segment elevation 0/6741 (0%) 0 1/6716 (0%) 1
    Haematocrit decreased 1/6741 (0%) 1 0/6716 (0%) 0
    Haemoglobin abnormal 1/6741 (0%) 1 0/6716 (0%) 0
    Haemoglobin decreased 10/6741 (0.1%) 10 6/6716 (0.1%) 6
    Hepatic enzyme increased 1/6741 (0%) 1 0/6716 (0%) 0
    International normalised ratio increased 1/6741 (0%) 1 0/6716 (0%) 0
    Liver function test abnormal 2/6741 (0%) 2 0/6716 (0%) 0
    Occult blood positive 0/6741 (0%) 0 1/6716 (0%) 1
    Platelet count decreased 1/6741 (0%) 1 2/6716 (0%) 2
    Prostate examination abnormal 2/6741 (0%) 2 0/6716 (0%) 0
    Renal function test abnormal 0/6741 (0%) 0 1/6716 (0%) 1
    Transaminases increased 0/6741 (0%) 0 3/6716 (0%) 3
    Troponin increased 1/6741 (0%) 1 0/6716 (0%) 0
    Weight decreased 0/6741 (0%) 0 1/6716 (0%) 1
    Metabolism and nutrition disorders
    Anorexia 1/6741 (0%) 1 0/6716 (0%) 0
    Dehydration 14/6741 (0.2%) 14 9/6716 (0.1%) 9
    Diabetes mellitus 4/6741 (0.1%) 4 7/6716 (0.1%) 7
    Diabetes mellitus inadequate control 1/6741 (0%) 1 1/6716 (0%) 1
    Diabetes mellitus non-insulin-dependent 0/6741 (0%) 0 1/6716 (0%) 1
    Diabetic foot 1/6741 (0%) 1 1/6716 (0%) 1
    Diabetic ketoacidosis 2/6741 (0%) 2 1/6716 (0%) 1
    Electrolyte imbalance 0/6741 (0%) 0 1/6716 (0%) 1
    Glucose tolerance impaired 0/6741 (0%) 0 1/6716 (0%) 1
    Gout 0/6741 (0%) 0 2/6716 (0%) 2
    Hyperglycaemia 4/6741 (0.1%) 4 3/6716 (0%) 4
    Hyperglycaemic hyperosmolar nonketotic syndrome 1/6741 (0%) 1 0/6716 (0%) 0
    Hyperkalaemia 2/6741 (0%) 2 1/6716 (0%) 1
    Hyperosmolar state 0/6741 (0%) 0 1/6716 (0%) 1
    Hypervolaemia 1/6741 (0%) 1 1/6716 (0%) 1
    Hypoglycaemia 6/6741 (0.1%) 6 9/6716 (0.1%) 9
    Hypokalaemia 1/6741 (0%) 1 4/6716 (0.1%) 4
    Hyponatraemia 4/6741 (0.1%) 4 5/6716 (0.1%) 5
    Hypovolaemia 0/6741 (0%) 0 1/6716 (0%) 1
    Vitamin b12 deficiency 0/6741 (0%) 0 1/6716 (0%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 2/6741 (0%) 2 3/6716 (0%) 3
    Arthritis 3/6741 (0%) 3 3/6716 (0%) 3
    Back pain 5/6741 (0.1%) 5 1/6716 (0%) 1
    Bone pain 0/6741 (0%) 0 1/6716 (0%) 1
    Cervical spinal stenosis 0/6741 (0%) 0 1/6716 (0%) 1
    Compartment syndrome 0/6741 (0%) 0 1/6716 (0%) 1
    Fistula 1/6741 (0%) 1 0/6716 (0%) 0
    Gouty arthritis 2/6741 (0%) 4 1/6716 (0%) 1
    Haemarthrosis 0/6741 (0%) 0 1/6716 (0%) 1
    Intervertebral disc degeneration 0/6741 (0%) 0 1/6716 (0%) 1
    Intervertebral disc disorder 2/6741 (0%) 2 1/6716 (0%) 1
    Intervertebral disc protrusion 4/6741 (0.1%) 4 6/6716 (0.1%) 6
    Limb discomfort 1/6741 (0%) 1 0/6716 (0%) 0
    Lumbar spinal stenosis 2/6741 (0%) 2 1/6716 (0%) 1
    Metatarsalgia 1/6741 (0%) 1 0/6716 (0%) 0
    Muscle haemorrhage 3/6741 (0%) 3 1/6716 (0%) 1
    Musculoskeletal chest pain 10/6741 (0.1%) 10 15/6716 (0.2%) 15
    Musculoskeletal pain 1/6741 (0%) 1 7/6716 (0.1%) 7
    Myalgia 2/6741 (0%) 2 8/6716 (0.1%) 8
    Myositis 0/6741 (0%) 0 1/6716 (0%) 1
    Neck pain 0/6741 (0%) 0 1/6716 (0%) 1
    Osteoarthritis 8/6741 (0.1%) 8 9/6716 (0.1%) 9
    Osteonecrosis 0/6741 (0%) 0 1/6716 (0%) 1
    Pain in extremity 5/6741 (0.1%) 5 5/6716 (0.1%) 5
    Pain in jaw 0/6741 (0%) 0 1/6716 (0%) 1
    Polyarthritis 0/6741 (0%) 0 1/6716 (0%) 1
    Polymyositis 1/6741 (0%) 1 0/6716 (0%) 0
    Rhabdomyolysis 1/6741 (0%) 1 1/6716 (0%) 1
    Rotator cuff syndrome 1/6741 (0%) 1 0/6716 (0%) 0
    Scoliosis 1/6741 (0%) 1 0/6716 (0%) 0
    Spinal column stenosis 1/6741 (0%) 1 1/6716 (0%) 1
    Spinal osteoarthritis 3/6741 (0%) 3 3/6716 (0%) 3
    Synovial cyst 2/6741 (0%) 2 0/6716 (0%) 0
    Tendon disorder 1/6741 (0%) 1 0/6716 (0%) 0
    Tendon pain 1/6741 (0%) 1 0/6716 (0%) 0
    Tenosynovitis 0/6741 (0%) 0 1/6716 (0%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia 1/6741 (0%) 1 0/6716 (0%) 0
    Adenocarcinoma 2/6741 (0%) 2 0/6716 (0%) 0
    Adenocarcinoma pancreas 0/6741 (0%) 0 1/6716 (0%) 1
    Adenoma benign 1/6741 (0%) 1 0/6716 (0%) 0
    Adrenal neoplasm 0/6741 (0%) 0 1/6716 (0%) 1
    Basal cell carcinoma 1/6741 (0%) 1 1/6716 (0%) 1
    Benign lung neoplasm 1/6741 (0%) 1 0/6716 (0%) 0
    Bladder cancer 2/6741 (0%) 2 4/6716 (0.1%) 4
    Bladder neoplasm 1/6741 (0%) 1 1/6716 (0%) 1
    Bladder papilloma 1/6741 (0%) 1 0/6716 (0%) 0
    Bladder transitional cell carcinoma stage iii 0/6741 (0%) 0 1/6716 (0%) 1
    Bone neoplasm 1/6741 (0%) 1 0/6716 (0%) 0
    Bone neoplasm malignant 1/6741 (0%) 1 0/6716 (0%) 0
    Brain neoplasm 2/6741 (0%) 2 1/6716 (0%) 1
    Breast cancer 4/6741 (0.1%) 4 1/6716 (0%) 1
    Bronchial carcinoma 1/6741 (0%) 1 2/6716 (0%) 2
    Carcinoid tumour pulmonary 0/6741 (0%) 0 1/6716 (0%) 1
    Cervix carcinoma 1/6741 (0%) 1 0/6716 (0%) 0
    Chronic lymphocytic leukaemia 1/6741 (0%) 1 0/6716 (0%) 0
    Chronic myeloid leukaemia 0/6741 (0%) 0 1/6716 (0%) 1
    Clear cell carcinoma of the kidney 2/6741 (0%) 2 0/6716 (0%) 0
    Colon adenoma 1/6741 (0%) 1 1/6716 (0%) 1
    Colon cancer 10/6741 (0.1%) 10 2/6716 (0%) 2
    Colon cancer metastatic 0/6741 (0%) 0 1/6716 (0%) 1
    Colon neoplasm 1/6741 (0%) 1 0/6716 (0%) 0
    Colorectal cancer 1/6741 (0%) 1 0/6716 (0%) 0
    Gallbladder cancer 1/6741 (0%) 1 0/6716 (0%) 0
    Gastric cancer 6/6741 (0.1%) 6 7/6716 (0.1%) 7
    Gastric neoplasm 0/6741 (0%) 0 1/6716 (0%) 1
    Gastrointestinal carcinoma 1/6741 (0%) 1 2/6716 (0%) 2
    Gastrointestinal tract adenoma 1/6741 (0%) 1 0/6716 (0%) 0
    Haemangioma 1/6741 (0%) 1 0/6716 (0%) 0
    Hepatic cancer metastatic 0/6741 (0%) 0 1/6716 (0%) 1
    Hepatic neoplasm 0/6741 (0%) 0 1/6716 (0%) 1
    Laryngeal cancer 0/6741 (0%) 0 1/6716 (0%) 1
    Lung adenocarcinoma 1/6741 (0%) 1 0/6716 (0%) 0
    Lung neoplasm 1/6741 (0%) 1 1/6716 (0%) 1
    Lung neoplasm malignant 4/6741 (0.1%) 4 2/6716 (0%) 2
    Lung squamous cell carcinoma stage unspecified 2/6741 (0%) 2 1/6716 (0%) 1
    Lymphocytic leukaemia 0/6741 (0%) 0 1/6716 (0%) 1
    Malignant ascites 1/6741 (0%) 1 0/6716 (0%) 0
    Malignant melanoma 0/6741 (0%) 0 1/6716 (0%) 1
    Mesothelioma malignant 1/6741 (0%) 1 0/6716 (0%) 0
    Metastases to adrenals 0/6741 (0%) 0 1/6716 (0%) 1
    Metastases to bone 1/6741 (0%) 1 2/6716 (0%) 2
    Metastases to liver 1/6741 (0%) 1 1/6716 (0%) 1
    Metastases to lung 2/6741 (0%) 2 0/6716 (0%) 0
    Metastatic neoplasm 2/6741 (0%) 2 0/6716 (0%) 0
    Myelodysplastic syndrome 0/6741 (0%) 0 1/6716 (0%) 1
    Nasal neoplasm 1/6741 (0%) 1 0/6716 (0%) 0
    Non-hodgkin's lymphoma 0/6741 (0%) 0 2/6716 (0%) 3
    Non-small cell lung cancer 2/6741 (0%) 2 2/6716 (0%) 2
    Oesophageal adenocarcinoma 1/6741 (0%) 1 0/6716 (0%) 0
    Oesophageal cancer metastatic 1/6741 (0%) 1 0/6716 (0%) 0
    Oesophageal carcinoma 1/6741 (0%) 1 3/6716 (0%) 3
    Ovarian neoplasm 1/6741 (0%) 1 0/6716 (0%) 0
    Pancreatic carcinoma 1/6741 (0%) 1 1/6716 (0%) 1
    Papillary thyroid cancer 1/6741 (0%) 1 0/6716 (0%) 0
    Papilloma 1/6741 (0%) 1 0/6716 (0%) 0
    Peripheral t-cell lymphoma unspecified 1/6741 (0%) 1 0/6716 (0%) 0
    Pituitary tumour benign 1/6741 (0%) 1 0/6716 (0%) 0
    Prostate cancer 6/6741 (0.1%) 6 7/6716 (0.1%) 7
    Prostate cancer metastatic 2/6741 (0%) 2 1/6716 (0%) 1
    Prostatic adenoma 1/6741 (0%) 1 0/6716 (0%) 0
    Rectal cancer 1/6741 (0%) 1 0/6716 (0%) 0
    Rectal neoplasm 1/6741 (0%) 1 0/6716 (0%) 0
    Renal cell carcinoma stage unspecified 1/6741 (0%) 1 2/6716 (0%) 2
    Renal neoplasm 2/6741 (0%) 2 0/6716 (0%) 0
    Salivary gland neoplasm 1/6741 (0%) 1 0/6716 (0%) 0
    Sarcoma 1/6741 (0%) 1 0/6716 (0%) 0
    Small cell lung cancer metastatic 0/6741 (0%) 0 1/6716 (0%) 1
    Small cell lung cancer stage unspecified 1/6741 (0%) 1 3/6716 (0%) 3
    Squamous cell carcinoma 2/6741 (0%) 2 1/6716 (0%) 1
    Thymoma 0/6741 (0%) 0 1/6716 (0%) 1
    Thyroid cancer 1/6741 (0%) 1 0/6716 (0%) 0
    Transitional cell carcinoma 1/6741 (0%) 1 0/6716 (0%) 0
    Uterine leiomyoma 1/6741 (0%) 1 0/6716 (0%) 0
    Nervous system disorders
    Ageusia 0/6741 (0%) 0 1/6716 (0%) 1
    Amyotrophic lateral sclerosis 0/6741 (0%) 0 1/6716 (0%) 1
    Anoxic encephalopathy 0/6741 (0%) 0 1/6716 (0%) 1
    Carotid artery aneurysm 1/6741 (0%) 1 0/6716 (0%) 0
    Carotid artery disease 0/6741 (0%) 0 1/6716 (0%) 2
    Carotid artery occlusion 1/6741 (0%) 1 1/6716 (0%) 2
    Carotid artery stenosis 18/6741 (0.3%) 19 10/6716 (0.1%) 12
    Carpal tunnel syndrome 1/6741 (0%) 1 0/6716 (0%) 0
    Cerebellar haemorrhage 2/6741 (0%) 2 0/6716 (0%) 0
    Cerebral arteriosclerosis 1/6741 (0%) 1 0/6716 (0%) 0
    Cerebral haemorrhage 5/6741 (0.1%) 5 2/6716 (0%) 2
    Cerebrovascular insufficiency 1/6741 (0%) 1 0/6716 (0%) 0
    Cervicobrachial syndrome 0/6741 (0%) 0 2/6716 (0%) 2
    Coma 1/6741 (0%) 1 0/6716 (0%) 0
    Complex partial seizures 0/6741 (0%) 0 1/6716 (0%) 1
    Convulsion 2/6741 (0%) 2 3/6716 (0%) 3
    Coordination abnormal 0/6741 (0%) 0 1/6716 (0%) 1
    Dementia 0/6741 (0%) 0 1/6716 (0%) 1
    Diabetic neuropathy 1/6741 (0%) 1 0/6716 (0%) 0
    Dizziness 5/6741 (0.1%) 5 8/6716 (0.1%) 8
    Dizziness postural 0/6741 (0%) 0 1/6716 (0%) 1
    Encephalopathy 1/6741 (0%) 1 1/6716 (0%) 1
    Epilepsy 0/6741 (0%) 0 1/6716 (0%) 1
    Facial palsy 0/6741 (0%) 0 1/6716 (0%) 1
    Global amnesia 0/6741 (0%) 0 1/6716 (0%) 1
    Grand mal convulsion 0/6741 (0%) 0 1/6716 (0%) 1
    Guillain-barre syndrome 1/6741 (0%) 1 1/6716 (0%) 1
    Haemorrhage intracranial 5/6741 (0.1%) 5 4/6716 (0.1%) 4
    Haemorrhagic stroke 3/6741 (0%) 3 4/6716 (0.1%) 4
    Haemorrhagic transformation stroke 0/6741 (0%) 0 1/6716 (0%) 1
    Headache 1/6741 (0%) 1 2/6716 (0%) 2
    Hemiparesis 2/6741 (0%) 2 0/6716 (0%) 0
    Hepatic encephalopathy 0/6741 (0%) 0 1/6716 (0%) 1
    Hypoaesthesia 0/6741 (0%) 0 1/6716 (0%) 1
    Hypotonia 1/6741 (0%) 1 0/6716 (0%) 0
    Hypoxic encephalopathy 2/6741 (0%) 2 0/6716 (0%) 0
    Iiird nerve paralysis 1/6741 (0%) 1 0/6716 (0%) 0
    Lethargy 1/6741 (0%) 1 0/6716 (0%) 0
    Loss of consciousness 0/6741 (0%) 0 3/6716 (0%) 3
    Migraine 0/6741 (0%) 0 2/6716 (0%) 3
    Monoparesis 1/6741 (0%) 1 0/6716 (0%) 0
    Myoclonus 0/6741 (0%) 0 1/6716 (0%) 1
    Neurological symptom 1/6741 (0%) 1 0/6716 (0%) 0
    Neuropathy peripheral 1/6741 (0%) 1 0/6716 (0%) 0
    Paraesthesia 1/6741 (0%) 1 0/6716 (0%) 0
    Periodic limb movement disorder 0/6741 (0%) 0 1/6716 (0%) 1
    Peroneal nerve palsy 1/6741 (0%) 1 0/6716 (0%) 0
    Presyncope 11/6741 (0.2%) 11 8/6716 (0.1%) 8
    Radicular syndrome 0/6741 (0%) 0 1/6716 (0%) 1
    Restless legs syndrome 0/6741 (0%) 0 1/6716 (0%) 1
    Ruptured cerebral aneurysm 1/6741 (0%) 1 1/6716 (0%) 1
    Sciatica 2/6741 (0%) 2 1/6716 (0%) 1
    Senile dementia 1/6741 (0%) 1 0/6716 (0%) 0
    Status epilepticus 0/6741 (0%) 0 1/6716 (0%) 1
    Subarachnoid haemorrhage 1/6741 (0%) 1 0/6716 (0%) 0
    Syncope 35/6741 (0.5%) 35 29/6716 (0.4%) 31
    Syncope vasovagal 4/6741 (0.1%) 4 4/6716 (0.1%) 4
    Tension headache 0/6741 (0%) 0 1/6716 (0%) 1
    Transient ischaemic attack 16/6741 (0.2%) 17 22/6716 (0.3%) 23
    Tremor 1/6741 (0%) 1 0/6716 (0%) 0
    Unresponsive to stimuli 0/6741 (0%) 0 1/6716 (0%) 1
    Vascular encephalopathy 0/6741 (0%) 0 1/6716 (0%) 1
    Vertebrobasilar insufficiency 2/6741 (0%) 2 2/6716 (0%) 2
    Psychiatric disorders
    Alcohol withdrawal syndrome 0/6741 (0%) 0 2/6716 (0%) 2
    Alcoholism 1/6741 (0%) 1 3/6716 (0%) 3
    Anxiety 5/6741 (0.1%) 5 7/6716 (0.1%) 7
    Anxiety disorder 0/6741 (0%) 0 1/6716 (0%) 1
    Bipolar disorder 3/6741 (0%) 3 0/6716 (0%) 0
    Confusional state 2/6741 (0%) 2 2/6716 (0%) 2
    Delirium 1/6741 (0%) 1 1/6716 (0%) 2
    Depression 5/6741 (0.1%) 5 5/6716 (0.1%) 5
    Disorientation 1/6741 (0%) 1 0/6716 (0%) 0
    Drug dependence 1/6741 (0%) 1 0/6716 (0%) 0
    Fear 1/6741 (0%) 1 0/6716 (0%) 0
    Major depression 3/6741 (0%) 3 0/6716 (0%) 0
    Mental status changes 0/6741 (0%) 0 2/6716 (0%) 2
    Neurosis 1/6741 (0%) 1 0/6716 (0%) 0
    Post-traumatic stress disorder 0/6741 (0%) 0 1/6716 (0%) 1
    Psychotic disorder 2/6741 (0%) 2 1/6716 (0%) 1
    Suicidal ideation 1/6741 (0%) 1 0/6716 (0%) 0
    Suicide attempt 3/6741 (0%) 3 1/6716 (0%) 1
    Renal and urinary disorders
    Azotaemia 1/6741 (0%) 1 1/6716 (0%) 1
    Calculus ureteric 1/6741 (0%) 1 1/6716 (0%) 1
    Calculus urinary 1/6741 (0%) 1 1/6716 (0%) 1
    Crush syndrome 2/6741 (0%) 2 0/6716 (0%) 0
    Cystitis noninfective 1/6741 (0%) 1 0/6716 (0%) 0
    Glomerulonephritis membranous 1/6741 (0%) 1 0/6716 (0%) 0
    Haematuria 27/6741 (0.4%) 31 12/6716 (0.2%) 14
    Haemorrhage urinary tract 1/6741 (0%) 1 0/6716 (0%) 0
    Hydronephrosis 1/6741 (0%) 1 0/6716 (0%) 0
    Hypertensive nephropathy 1/6741 (0%) 1 0/6716 (0%) 0
    Nephrolithiasis 7/6741 (0.1%) 7 2/6716 (0%) 2
    Nephropathy 1/6741 (0%) 1 2/6716 (0%) 2
    Obstructive uropathy 0/6741 (0%) 0 1/6716 (0%) 1
    Renal artery occlusion 0/6741 (0%) 0 1/6716 (0%) 1
    Renal artery stenosis 2/6741 (0%) 2 2/6716 (0%) 2
    Renal colic 1/6741 (0%) 1 1/6716 (0%) 1
    Renal cyst ruptured 1/6741 (0%) 1 0/6716 (0%) 0
    Renal failure 15/6741 (0.2%) 15 17/6716 (0.3%) 17
    Renal failure acute 22/6741 (0.3%) 22 12/6716 (0.2%) 12
    Renal failure chronic 3/6741 (0%) 3 4/6716 (0.1%) 4
    Renal impairment 3/6741 (0%) 3 1/6716 (0%) 1
    Renal tubular necrosis 1/6741 (0%) 1 2/6716 (0%) 2
    Ureteric obstruction 1/6741 (0%) 1 0/6716 (0%) 0
    Urethral stenosis 0/6741 (0%) 0 1/6716 (0%) 1
    Urinary bladder haemorrhage 1/6741 (0%) 2 0/6716 (0%) 0
    Urinary retention 3/6741 (0%) 3 3/6716 (0%) 3
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 5/6741 (0.1%) 5 5/6716 (0.1%) 5
    Cervical dysplasia 0/6741 (0%) 0 1/6716 (0%) 1
    Cystocele 1/6741 (0%) 1 0/6716 (0%) 0
    Dysfunctional uterine bleeding 1/6741 (0%) 1 1/6716 (0%) 1
    Epididymitis 2/6741 (0%) 2 0/6716 (0%) 0
    Gynaecomastia 2/6741 (0%) 2 0/6716 (0%) 0
    Menorrhagia 2/6741 (0%) 2 0/6716 (0%) 0
    Metrorrhagia 1/6741 (0%) 1 2/6716 (0%) 2
    Ovarian cyst 1/6741 (0%) 1 0/6716 (0%) 0
    Prostatitis 0/6741 (0%) 0 3/6716 (0%) 3
    Uterine haemorrhage 0/6741 (0%) 0 1/6716 (0%) 1
    Vaginal haemorrhage 3/6741 (0%) 3 1/6716 (0%) 1
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema 3/6741 (0%) 4 8/6716 (0.1%) 8
    Acute respiratory distress syndrome 2/6741 (0%) 2 2/6716 (0%) 2
    Acute respiratory failure 1/6741 (0%) 1 2/6716 (0%) 2
    Apnoea 0/6741 (0%) 0 1/6716 (0%) 1
    Asthma 7/6741 (0.1%) 7 2/6716 (0%) 2
    Bronchial disorder 0/6741 (0%) 0 1/6716 (0%) 1
    Bronchial haemorrhage 0/6741 (0%) 0 1/6716 (0%) 1
    Bronchospasm 0/6741 (0%) 0 1/6716 (0%) 1
    Chronic obstructive pulmonary disease 17/6741 (0.3%) 17 13/6716 (0.2%) 13
    Diaphragmatic hernia 0/6741 (0%) 0 2/6716 (0%) 2
    Dyspnoea 11/6741 (0.2%) 11 21/6716 (0.3%) 21
    Dyspnoea exertional 1/6741 (0%) 1 3/6716 (0%) 3
    Epistaxis 29/6741 (0.4%) 31 22/6716 (0.3%) 23
    Haemoptysis 6/6741 (0.1%) 8 3/6716 (0%) 3
    Hydrothorax 1/6741 (0%) 1 0/6716 (0%) 0
    Hypoxia 1/6741 (0%) 1 0/6716 (0%) 0
    Interstitial lung disease 1/6741 (0%) 1 1/6716 (0%) 1
    Lung disorder 2/6741 (0%) 2 0/6716 (0%) 0
    Lung infiltration 1/6741 (0%) 1 0/6716 (0%) 0
    Mediastinal mass 0/6741 (0%) 0 1/6716 (0%) 1
    Orthopnoea 1/6741 (0%) 1 1/6716 (0%) 1
    Pharyngeal haemorrhage 1/6741 (0%) 1 0/6716 (0%) 0
    Pharyngolaryngeal pain 1/6741 (0%) 1 0/6716 (0%) 0
    Pleural effusion 6/6741 (0.1%) 6 10/6716 (0.1%) 10
    Pleurisy 0/6741 (0%) 0 2/6716 (0%) 2
    Pleuritic pain 2/6741 (0%) 2 2/6716 (0%) 2
    Pneumonia aspiration 1/6741 (0%) 1 1/6716 (0%) 1
    Pneumothorax 1/6741 (0%) 1 2/6716 (0%) 2
    Pulmonary alveolar haemorrhage 2/6741 (0%) 2 0/6716 (0%) 0
    Pulmonary congestion 2/6741 (0%) 2 4/6716 (0.1%) 4
    Pulmonary embolism 9/6741 (0.1%) 9 4/6716 (0.1%) 4
    Pulmonary fibrosis 0/6741 (0%) 0 1/6716 (0%) 1
    Pulmonary haemorrhage 0/6741 (0%) 0 1/6716 (0%) 1
    Pulmonary mass 1/6741 (0%) 1 0/6716 (0%) 0
    Pulmonary oedema 31/6741 (0.5%) 38 27/6716 (0.4%) 29
    Respiratory arrest 2/6741 (0%) 2 0/6716 (0%) 0
    Respiratory depression 1/6741 (0%) 1 0/6716 (0%) 0
    Respiratory distress 0/6741 (0%) 0 4/6716 (0.1%) 4
    Respiratory failure 15/6741 (0.2%) 15 6/6716 (0.1%) 6
    Sleep apnoea syndrome 0/6741 (0%) 0 2/6716 (0%) 2
    Status asthmaticus 1/6741 (0%) 1 0/6716 (0%) 0
    Tracheal stenosis 0/6741 (0%) 0 1/6716 (0%) 1
    Vocal cord disorder 0/6741 (0%) 0 1/6716 (0%) 1
    Skin and subcutaneous tissue disorders
    Angioneurotic oedema 1/6741 (0%) 1 2/6716 (0%) 2
    Dermatitis 2/6741 (0%) 2 1/6716 (0%) 1
    Dermatitis allergic 3/6741 (0%) 3 2/6716 (0%) 3
    Dermatitis contact 1/6741 (0%) 1 0/6716 (0%) 0
    Dermatitis exfoliative 1/6741 (0%) 1 0/6716 (0%) 0
    Drug eruption 1/6741 (0%) 1 0/6716 (0%) 0
    Ecchymosis 3/6741 (0%) 3 2/6716 (0%) 2
    Eczema 0/6741 (0%) 0 1/6716 (0%) 1
    Haemorrhage subcutaneous 1/6741 (0%) 1 0/6716 (0%) 0
    Hyperhidrosis 1/6741 (0%) 1 0/6716 (0%) 0
    Pruritus 1/6741 (0%) 1 2/6716 (0%) 2
    Purpura 2/6741 (0%) 2 0/6716 (0%) 0
    Rash 1/6741 (0%) 1 2/6716 (0%) 2
    Rash generalised 0/6741 (0%) 0 1/6716 (0%) 1
    Rash maculo-papular 1/6741 (0%) 1 0/6716 (0%) 0
    Skin necrosis 0/6741 (0%) 0 1/6716 (0%) 1
    Stevens-johnson syndrome 1/6741 (0%) 1 0/6716 (0%) 0
    Toxic skin eruption 0/6741 (0%) 0 2/6716 (0%) 2
    Urticaria 3/6741 (0%) 3 1/6716 (0%) 1
    Surgical and medical procedures
    Carotid endarterectomy 1/6741 (0%) 1 0/6716 (0%) 0
    Cataract operation 1/6741 (0%) 1 0/6716 (0%) 0
    Coronary revascularisation 0/6741 (0%) 0 1/6716 (0%) 1
    Dental operation 1/6741 (0%) 1 1/6716 (0%) 1
    Eye operation 1/6741 (0%) 1 0/6716 (0%) 0
    Finger amputation 1/6741 (0%) 1 0/6716 (0%) 0
    Hernia repair 1/6741 (0%) 1 0/6716 (0%) 0
    Hip arthroplasty 1/6741 (0%) 1 1/6716 (0%) 1
    Incisional drainage 1/6741 (0%) 1 0/6716 (0%) 0
    Knee arthroplasty 2/6741 (0%) 2 2/6716 (0%) 2
    Open reduction of fracture 0/6741 (0%) 0 1/6716 (0%) 1
    Percutaneous coronary intervention 1/6741 (0%) 1 1/6716 (0%) 1
    Thrombectomy 1/6741 (0%) 1 0/6716 (0%) 0
    Transurethral prostatectomy 0/6741 (0%) 0 1/6716 (0%) 1
    Tumour excision 1/6741 (0%) 1 0/6716 (0%) 0
    Wound drainage 0/6741 (0%) 0 1/6716 (0%) 1
    Vascular disorders
    Accelerated hypertension 0/6741 (0%) 0 2/6716 (0%) 2
    Aneurysm 0/6741 (0%) 0 1/6716 (0%) 1
    Aneurysm ruptured 1/6741 (0%) 1 0/6716 (0%) 0
    Angiodysplasia 1/6741 (0%) 1 0/6716 (0%) 0
    Aortic aneurysm 4/6741 (0.1%) 4 2/6716 (0%) 2
    Aortic aneurysm rupture 1/6741 (0%) 1 1/6716 (0%) 1
    Aortic dissection 1/6741 (0%) 1 1/6716 (0%) 1
    Aortic rupture 1/6741 (0%) 1 0/6716 (0%) 0
    Aortic stenosis 0/6741 (0%) 0 1/6716 (0%) 1
    Arterial haemorrhage 0/6741 (0%) 0 1/6716 (0%) 1
    Arterial occlusive disease 1/6741 (0%) 1 0/6716 (0%) 0
    Arterial restenosis 0/6741 (0%) 0 1/6716 (0%) 1
    Arterial rupture 0/6741 (0%) 0 1/6716 (0%) 1
    Arterial stenosis limb 2/6741 (0%) 2 1/6716 (0%) 1
    Arterial thrombosis limb 1/6741 (0%) 1 1/6716 (0%) 1
    Arteriosclerosis 1/6741 (0%) 1 1/6716 (0%) 1
    Arteriovenous fistula 0/6741 (0%) 0 3/6716 (0%) 3
    Artery dissection 0/6741 (0%) 0 1/6716 (0%) 1
    Blood pressure inadequately controlled 1/6741 (0%) 1 0/6716 (0%) 0
    Cardiovascular insufficiency 1/6741 (0%) 1 0/6716 (0%) 0
    Circulatory collapse 2/6741 (0%) 2 1/6716 (0%) 1
    Deep vein thrombosis 13/6741 (0.2%) 13 10/6716 (0.1%) 10
    Extremity necrosis 1/6741 (0%) 1 1/6716 (0%) 1
    Femoral arterial stenosis 2/6741 (0%) 3 4/6716 (0.1%) 5
    Femoral artery aneurysm 1/6741 (0%) 1 0/6716 (0%) 0
    Femoral artery dissection 0/6741 (0%) 0 1/6716 (0%) 1
    Femoral artery occlusion 4/6741 (0.1%) 4 3/6716 (0%) 3
    Haematoma 16/6741 (0.2%) 16 17/6716 (0.3%) 17
    Haemodynamic instability 1/6741 (0%) 1 0/6716 (0%) 0
    Haemorrhage 8/6741 (0.1%) 8 5/6716 (0.1%) 5
    Hypertension 17/6741 (0.3%) 17 16/6716 (0.2%) 16
    Hypertensive crisis 13/6741 (0.2%) 13 15/6716 (0.2%) 15
    Hypertensive emergency 1/6741 (0%) 1 2/6716 (0%) 2
    Hypotension 15/6741 (0.2%) 15 4/6716 (0.1%) 4
    Hypovolaemic shock 1/6741 (0%) 1 0/6716 (0%) 0
    Iliac artery occlusion 3/6741 (0%) 3 5/6716 (0.1%) 5
    Iliac artery stenosis 2/6741 (0%) 2 6/6716 (0.1%) 7
    Intermittent claudication 5/6741 (0.1%) 5 3/6716 (0%) 4
    Ischaemia 1/6741 (0%) 1 1/6716 (0%) 1
    Jugular vein thrombosis 1/6741 (0%) 1 0/6716 (0%) 0
    Malignant hypertension 0/6741 (0%) 0 1/6716 (0%) 1
    Orthostatic hypotension 1/6741 (0%) 1 0/6716 (0%) 0
    Peripheral arterial occlusive disease 5/6741 (0.1%) 5 3/6716 (0%) 3
    Peripheral artery aneurysm 0/6741 (0%) 0 1/6716 (0%) 1
    Peripheral artery dissection 0/6741 (0%) 0 1/6716 (0%) 1
    Peripheral ischaemia 0/6741 (0%) 0 3/6716 (0%) 4
    Peripheral vascular disorder 8/6741 (0.1%) 8 11/6716 (0.2%) 11
    Reperfusion injury 1/6741 (0%) 1 1/6716 (0%) 1
    Shock 1/6741 (0%) 1 1/6716 (0%) 1
    Shock haemorrhagic 1/6741 (0%) 1 1/6716 (0%) 1
    Thrombophlebitis 1/6741 (0%) 1 0/6716 (0%) 0
    Thrombosis 2/6741 (0%) 2 0/6716 (0%) 0
    Varicose vein 0/6741 (0%) 0 1/6716 (0%) 1
    Vascular pseudoaneurysm 25/6741 (0.4%) 26 26/6716 (0.4%) 26
    Vascular stenosis 0/6741 (0%) 0 1/6716 (0%) 1
    Vasospasm 0/6741 (0%) 0 1/6716 (0%) 1
    Venous insufficiency 0/6741 (0%) 0 1/6716 (0%) 1
    Wound haemorrhage 1/6741 (0%) 1 1/6716 (0%) 1
    Other (Not Including Serious) Adverse Events
    Prasugrel Clopidogrel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 5217/6741 (77.4%) 5187/6716 (77.2%)
    Cardiac disorders
    Angina pectoris 302/6741 (4.5%) 340 334/6716 (5%) 382
    Gastrointestinal disorders
    Nausea 308/6741 (4.6%) 327 290/6716 (4.3%) 306
    General disorders
    Chest pain 690/6741 (10.2%) 818 643/6716 (9.6%) 771
    Fatigue 249/6741 (3.7%) 261 324/6716 (4.8%) 339
    Injury, poisoning and procedural complications
    Contusion 464/6741 (6.9%) 529 262/6716 (3.9%) 302
    Metabolism and nutrition disorders
    Hypercholesterolaemia 325/6741 (4.8%) 325 325/6716 (4.8%) 325
    Musculoskeletal and connective tissue disorders
    Back pain 336/6741 (5%) 358 304/6716 (4.5%) 326
    Nervous system disorders
    Dizziness 271/6741 (4%) 298 300/6716 (4.5%) 325
    Headache 372/6741 (5.5%) 402 353/6716 (5.3%) 388
    Respiratory, thoracic and mediastinal disorders
    Cough 264/6741 (3.9%) 277 274/6716 (4.1%) 281
    Dyspnoea 319/6741 (4.7%) 339 284/6716 (4.2%) 295
    Epistaxis 398/6741 (5.9%) 480 204/6716 (3%) 251
    Surgical and medical procedures
    Coronary revascularisation 313/6741 (4.6%) 346 389/6716 (5.8%) 427
    Percutaneous coronary intervention 668/6741 (9.9%) 748 690/6716 (10.3%) 779
    Vascular disorders
    Haematoma 426/6741 (6.3%) 474 357/6716 (5.3%) 378
    Hypertension 490/6741 (7.3%) 495 460/6716 (6.8%) 468

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00097591
    Other Study ID Numbers:
    • 8695
    • H7T-MC-TAAL
    First Posted:
    Nov 25, 2004
    Last Update Posted:
    Sep 16, 2010
    Last Verified:
    Aug 1, 2010