Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT00097591
Recruitment Status : Completed
First Posted : November 25, 2004
Results First Posted : September 16, 2010
Last Update Posted : September 16, 2010
Sponsor:
Collaborator:
Daiichi Sankyo, Inc.
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Coronary Arteriosclerosis
Acute Coronary Syndromes
Interventions Drug: Prasugrel
Drug: Clopidogrel
Enrollment 13619
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 Details  
Arm/Group Title Prasugrel Clopidogrel
Hide 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 [1] 6795 [2]
Completed 6403 6401
Not Completed 410 394
Reason Not Completed
Withdrawal of consent             342             323
Less than 6 months on study drug             9             7
Unable to attend termination visit             53             51
Lost to follow up             6             10
Other             0             3
[1]
7 subjects randomized but not analyzed due to an incomplete informed consent document
[2]
4 subjects randomized but not analyzed due to an incomplete informed consent document
Arm/Group Title Prasugrel Clopidogrel Total
Hide 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 Number of Baseline Participants 6813 6795 13608
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6813 participants 6795 participants 13608 participants
60.9  (11.2) 60.9  (11.4) 60.9  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6813 participants 6795 participants 13608 participants
Female
1705
  25.0%
1818
  26.8%
3523
  25.9%
Male
5108
  75.0%
4977
  73.2%
10085
  74.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6813 participants 6795 participants 13608 participants
Caucasian 6263 6274 12537
African 205 187 392
Hispanic 269 256 525
Asian 60 64 124
Other 16 14 30
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6813 participants 6795 participants 13608 participants
North America 2164 2146 4310
South America 270 264 534
Europe 3436 3439 6875
Middle East 606 613 1219
Africa 204 200 404
Pacifica 133 133 266
1.Primary Outcome
Title Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 6813 6795
Measure Type: Number
Unit of Measure: Participants
UA/NSTEMI (n=5044, n=5030) 469 565
STEMI (n=1769, n=1765) 174 216
All ACS (n=6813, n=6795) 643 781
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
Comments For UA/NSTEMI population
Type of Statistical Test Superiority or Other
Comments [Not Specified]
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 [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.820
Confidence Interval (2-Sided) 95%
0.726 to 0.927
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
Comments For STEMI population
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method Gehan-Wilcoxon
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.793
Confidence Interval (2-Sided) 95%
0.649 to 0.968
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
Comments For All ACS population
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
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
Estimation Comments [Not Specified]
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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 6741 6716
Measure Type: Number
Unit of Measure: Participants
TIMI Major or Minor Bleeding 303 231
TIMI Major Bleeding 146 111
TIMI Major Bleeding - Life-threatening (LT) 85 56
LT - Fatal 21 5
LT - Symptomatic intracranial hemorrage (ICH) 19 17
LT - Requiring inotropes 21 8
LT - Requiring surgical intervention 19 19
LT - Requiring transfusion (>=4 units) 45 30
TIMI Minor Bleeding 164 125
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.736
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.995
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.084
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
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
Estimation Comments [Not Specified]
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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 6813 6795
Measure Type: Number
Unit of Measure: Participants
All ACS (Through 30 days) 399 504
All ACS (Through 90 days) 472 588
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
Comments Through 30 days
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments 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
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
Comments Through 90 days
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments 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
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 6813 6795
Measure Type: Number
Unit of Measure: Participants
All ACS (Through 30 days) 389 502
All ACS (Through 90 days) 462 573
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
Comments Through 30 days
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments 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
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
Comments Through 90 days
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments 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
Estimation Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 6813 6795
Measure Type: Number
Unit of Measure: Participants
797 938
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments 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
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Subjects Reaching the Composite Endpoint of All-Cause Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 6813 6795
Measure Type: Number
Unit of Measure: Participants
692 822
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments 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
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prasugrel Clopidogrel
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Prasugrel Clopidogrel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1731/6741 (25.68%)      1675/6716 (24.94%)    
Blood and lymphatic system disorders     
Anaemia  1  39/6741 (0.58%)  39 34/6716 (0.51%)  35
Anaemia of chronic disease  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Disseminated intravascular coagulation  1  1/6741 (0.01%)  1 2/6716 (0.03%)  2
Eosinophilia  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Hypochromic anaemia  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Iron deficiency anaemia  1  8/6741 (0.12%)  8 4/6716 (0.06%)  4
Leukocytosis  1  1/6741 (0.01%)  1 2/6716 (0.03%)  2
Leukopenia  1  0/6741 (0.00%)  0 3/6716 (0.04%)  3
Lymphadenopathy  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Microcytic anaemia  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Neutropenia  1  0/6741 (0.00%)  0 5/6716 (0.07%)  5
Normochromic normocytic anaemia  1  0/6741 (0.00%)  0 2/6716 (0.03%)  2
Pernicious anaemia  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Splenic infarction  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Spontaneous haematoma  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Thrombocytopenia  1  15/6741 (0.22%)  15 15/6716 (0.22%)  15
Cardiac disorders     
Acute coronary syndrome  1  2/6741 (0.03%)  2 3/6716 (0.04%)  3
Acute left ventricular failure  1  1/6741 (0.01%)  2 2/6716 (0.03%)  2
Acute myocardial infarction  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Angina pectoris  1  85/6741 (1.26%)  87 86/6716 (1.28%)  95
Angina unstable  1  25/6741 (0.37%)  27 37/6716 (0.55%)  39
Aortic valve incompetence  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Aortic valve stenosis  1  2/6741 (0.03%)  2 3/6716 (0.04%)  3
Arrhythmia  1  1/6741 (0.01%)  1 3/6716 (0.04%)  4
Arteriosclerosis coronary artery  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Arteriospasm coronary  1  2/6741 (0.03%)  2 4/6716 (0.06%)  4
Atrial fibrillation  1  50/6741 (0.74%)  51 52/6716 (0.77%)  56
Atrial flutter  1  12/6741 (0.18%)  12 4/6716 (0.06%)  4
Atrial tachycardia  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Atrial thrombosis  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Atrioventricular block  1  1/6741 (0.01%)  1 4/6716 (0.06%)  4
Atrioventricular block second degree  1  3/6741 (0.04%)  3 5/6716 (0.07%)  5
Atrioventricular block third degree  1  11/6741 (0.16%)  11 11/6716 (0.16%)  11
Bradyarrhythmia  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Bradycardia  1  14/6741 (0.21%)  14 11/6716 (0.16%)  11
Bundle branch block left  1  0/6741 (0.00%)  0 2/6716 (0.03%)  2
Cardiac aneurysm  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Cardiac arrest  1  10/6741 (0.15%)  10 10/6716 (0.15%)  12
Cardiac asthma  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Cardiac discomfort  1  0/6741 (0.00%)  0 2/6716 (0.03%)  2
Cardiac failure  1  22/6741 (0.33%)  24 41/6716 (0.61%)  42
Cardiac failure acute  1  3/6741 (0.04%)  3 3/6716 (0.04%)  4
Cardiac failure chronic  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Cardiac failure congestive  1  46/6741 (0.68%)  48 47/6716 (0.70%)  48
Cardiac perforation  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Cardiac pseudoaneurysm  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Cardiac tamponade  1  5/6741 (0.07%)  5 4/6716 (0.06%)  4
Cardiac valve disease  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Cardio-respiratory arrest  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Cardiogenic shock  1  13/6741 (0.19%)  14 8/6716 (0.12%)  8
Cardiomyopathy  1  2/6741 (0.03%)  2 2/6716 (0.03%)  2
Cardiopulmonary failure  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Cardiovascular disorder  1  4/6741 (0.06%)  4 2/6716 (0.03%)  2
Coronary artery aneurysm  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Coronary artery disease  1  14/6741 (0.21%)  14 17/6716 (0.25%)  17
Coronary artery dissection  1  5/6741 (0.07%)  5 11/6716 (0.16%)  11
Coronary artery occlusion  1  8/6741 (0.12%)  8 7/6716 (0.10%)  7
Coronary artery perforation  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Coronary artery restenosis  1  107/6741 (1.59%)  118 111/6716 (1.65%)  118
Coronary artery stenosis  1  52/6741 (0.77%)  54 64/6716 (0.95%)  65
Coronary artery thrombosis  1  2/6741 (0.03%)  2 2/6716 (0.03%)  4
Dressler's syndrome  1  4/6741 (0.06%)  4 2/6716 (0.03%)  2
Electromechanical dissociation  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
In-stent arterial restenosis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Interventricular septum rupture  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Intracardiac thrombus  1  9/6741 (0.13%)  9 4/6716 (0.06%)  4
Ischaemic cardiomyopathy  1  6/6741 (0.09%)  6 3/6716 (0.04%)  3
Left ventricular failure  1  1/6741 (0.01%)  2 4/6716 (0.06%)  4
Low cardiac output syndrome  1  3/6741 (0.04%)  3 2/6716 (0.03%)  2
Mitral valve disease  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Mitral valve incompetence  1  6/6741 (0.09%)  6 3/6716 (0.04%)  3
Myocardial infarction  1  0/6741 (0.00%)  0 2/6716 (0.03%)  2
Myocardial ischaemia  1  12/6741 (0.18%)  13 17/6716 (0.25%)  17
Myocardial rupture  1  0/6741 (0.00%)  0 2/6716 (0.03%)  2
Myopericarditis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Nodal arrhythmia  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Palpitations  1  3/6741 (0.04%)  3 0/6716 (0.00%)  0
Papillary muscle disorder  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Papillary muscle rupture  1  3/6741 (0.04%)  3 1/6716 (0.01%)  1
Pericardial effusion  1  8/6741 (0.12%)  11 1/6716 (0.01%)  1
Pericardial haemorrhage  1  5/6741 (0.07%)  5 7/6716 (0.10%)  8
Pericarditis  1  3/6741 (0.04%)  4 8/6716 (0.12%)  9
Pleuropericarditis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  2
Prinzmetal angina  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Sick sinus syndrome  1  1/6741 (0.01%)  1 5/6716 (0.07%)  5
Sinoatrial block  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Sinus arrest  1  2/6741 (0.03%)  2 2/6716 (0.03%)  2
Sinus bradycardia  1  0/6741 (0.00%)  0 6/6716 (0.09%)  6
Sinus tachycardia  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Supraventricular tachycardia  1  8/6741 (0.12%)  10 5/6716 (0.07%)  6
Tachyarrhythmia  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Tachycardia  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Torsade de pointes  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Ventricular arrhythmia  1  3/6741 (0.04%)  3 1/6716 (0.01%)  1
Ventricular dysfunction  1  1/6741 (0.01%)  1 4/6716 (0.06%)  4
Ventricular extrasystoles  1  6/6741 (0.09%)  6 3/6716 (0.04%)  3
Ventricular fibrillation  1  18/6741 (0.27%)  19 25/6716 (0.37%)  25
Ventricular flutter  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Ventricular septal defect acquired  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Ventricular tachycardia  1  24/6741 (0.36%)  27 25/6716 (0.37%)  30
Congenital, familial and genetic disorders     
Arteriovenous malformation  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Gastrointestinal angiodysplasia  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Gilbert's syndrome  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Haemorrhagic arteriovenous malformation  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Laryngocele  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Ventricular septal defect  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Ear and labyrinth disorders     
Auricular perichondritis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Deafness unilateral  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Sudden hearing loss  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Vertigo  1  3/6741 (0.04%)  3 3/6716 (0.04%)  3
Vestibular neuronitis  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Endocrine disorders     
Adrenal insufficiency  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Hyperthyroidism  1  3/6741 (0.04%)  3 1/6716 (0.01%)  1
Eye disorders     
Cataract  1  4/6741 (0.06%)  4 3/6716 (0.04%)  3
Conjunctival haemorrhage  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Eye haemorrhage  1  4/6741 (0.06%)  4 0/6716 (0.00%)  0
Eye inflammation  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Glaucoma  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Hyphaema  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Macular hole  1  1/6741 (0.01%)  2 0/6716 (0.00%)  0
Maculopathy  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Ocular hyperaemia  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Retinal detachment  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Retinal haemorrhage  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Retinal vein occlusion  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Vision blurred  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Vitreous haemorrhage  1  2/6741 (0.03%)  3 4/6716 (0.06%)  4
Gastrointestinal disorders     
Abdominal discomfort  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Abdominal haematoma  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Abdominal pain  1  7/6741 (0.10%)  8 10/6716 (0.15%)  10
Abdominal pain lower  1  1/6741 (0.01%)  1 2/6716 (0.03%)  2
Abdominal pain upper  1  4/6741 (0.06%)  5 7/6716 (0.10%)  7
Abdominal strangulated hernia  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Anal fistula  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Anal haemorrhage  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Ascites  1  0/6741 (0.00%)  0 1/6716 (0.01%)  3
Colitis  1  3/6741 (0.04%)  3 0/6716 (0.00%)  0
Colitis ischaemic  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Colitis ulcerative  1  1/6741 (0.01%)  1 2/6716 (0.03%)  2
Colonic obstruction  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Colonic polyp  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Constipation  1  0/6741 (0.00%)  0 5/6716 (0.07%)  5
Crohn's disease  1  0/6741 (0.00%)  0 2/6716 (0.03%)  2
Diabetic gastroparesis  1  1/6741 (0.01%)  2 0/6716 (0.00%)  0
Diarrhoea  1  3/6741 (0.04%)  3 1/6716 (0.01%)  1
Diverticular perforation  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Diverticulitis intestinal haemorrhagic  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Diverticulum  1  3/6741 (0.04%)  3 0/6716 (0.00%)  0
Diverticulum intestinal  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Diverticulum intestinal haemorrhagic  1  1/6741 (0.01%)  1 4/6716 (0.06%)  4
Duodenal ulcer  1  2/6741 (0.03%)  2 2/6716 (0.03%)  2
Duodenal ulcer haemorrhage  1  3/6741 (0.04%)  3 3/6716 (0.04%)  3
Duodenitis  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Duodenitis haemorrhagic  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Dyspepsia  1  1/6741 (0.01%)  1 5/6716 (0.07%)  5
Dysphagia  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Enteritis  1  3/6741 (0.04%)  3 1/6716 (0.01%)  1
Enterocolitis haemorrhagic  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Epigastric discomfort  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Erosive duodenitis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Erosive oesophagitis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Faecal incontinence  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Faeces discoloured  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Femoral hernia  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Gastric haemorrhage  1  3/6741 (0.04%)  3 8/6716 (0.12%)  8
Gastric polyps  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Gastric ulcer  1  8/6741 (0.12%)  8 6/6716 (0.09%)  6
Gastric ulcer haemorrhage  1  5/6741 (0.07%)  5 5/6716 (0.07%)  5
Gastritis  1  7/6741 (0.10%)  7 7/6716 (0.10%)  8
Gastritis erosive  1  7/6741 (0.10%)  7 3/6716 (0.04%)  3
Gastritis haemorrhagic  1  0/6741 (0.00%)  0 3/6716 (0.04%)  3
Gastroduodenitis  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Gastrointestinal haemorrhage  1  91/6741 (1.35%)  95 55/6716 (0.82%)  61
Gastrooesophageal reflux disease  1  6/6741 (0.09%)  6 11/6716 (0.16%)  11
Gastrooesophagitis  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Haematemesis  1  3/6741 (0.04%)  3 2/6716 (0.03%)  2
Haematochezia  1  4/6741 (0.06%)  4 1/6716 (0.01%)  1
Haemorrhoidal haemorrhage  1  6/6741 (0.09%)  6 3/6716 (0.04%)  3
Haemorrhoids  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Hiatus hernia  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Ileus  1  3/6741 (0.04%)  3 0/6716 (0.00%)  0
Inguinal hernia  1  2/6741 (0.03%)  2 5/6716 (0.07%)  5
Intestinal haemorrhage  1  4/6741 (0.06%)  4 0/6716 (0.00%)  0
Intestinal ischaemia  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Intestinal obstruction  1  2/6741 (0.03%)  3 0/6716 (0.00%)  0
Intra-abdominal haemorrhage  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Irritable bowel syndrome  1  2/6741 (0.03%)  2 2/6716 (0.03%)  2
Large intestine perforation  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Lower gastrointestinal haemorrhage  1  7/6741 (0.10%)  8 10/6716 (0.15%)  11
Mallory-weiss syndrome  1  3/6741 (0.04%)  3 2/6716 (0.03%)  2
Melaena  1  6/6741 (0.09%)  6 6/6716 (0.09%)  6
Mesenteric artery thrombosis  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Mouth haemorrhage  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Nausea  1  3/6741 (0.04%)  3 2/6716 (0.03%)  2
Oesophageal achalasia  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Oesophageal stenosis  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Oesophageal ulcer  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Oesophagitis  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Pancreatitis  1  6/6741 (0.09%)  6 3/6716 (0.04%)  4
Pancreatitis acute  1  5/6741 (0.07%)  5 5/6716 (0.07%)  5
Pancreatitis chronic  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Pancreatitis relapsing  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Peptic ulcer  1  1/6741 (0.01%)  1 3/6716 (0.04%)  3
Peptic ulcer haemorrhage  1  2/6741 (0.03%)  2 3/6716 (0.04%)  3
Peptic ulcer perforation  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Peritoneal haemorrhage  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Peritonitis  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Polyp colorectal  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Proctitis  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Rectal haemorrhage  1  11/6741 (0.16%)  11 5/6716 (0.07%)  5
Rectal prolapse  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Rectal ulcer haemorrhage  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Reflux oesophagitis  1  2/6741 (0.03%)  2 3/6716 (0.04%)  3
Retroperitoneal haematoma  1  5/6741 (0.07%)  5 4/6716 (0.06%)  4
Retroperitoneal haemorrhage  1  15/6741 (0.22%)  16 9/6716 (0.13%)  9
Small intestinal obstruction  1  4/6741 (0.06%)  4 2/6716 (0.03%)  2
Subileus  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Toothache  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Umbilical hernia  1  0/6741 (0.00%)  0 2/6716 (0.03%)  2
Upper gastrointestinal haemorrhage  1  15/6741 (0.22%)  16 8/6716 (0.12%)  8
Vomiting  1  2/6741 (0.03%)  2 2/6716 (0.03%)  2
General disorders     
Abasia  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Adverse drug reaction  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Asthenia  1  4/6741 (0.06%)  4 3/6716 (0.04%)  3
Catheter site haemorrhage  1  1/6741 (0.01%)  2 1/6716 (0.01%)  1
Chest discomfort  1  7/6741 (0.10%)  7 7/6716 (0.10%)  8
Chest pain  1  91/6741 (1.35%)  98 73/6716 (1.09%)  78
Exercise tolerance decreased  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Fatigue  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Gait disturbance  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
General physical health deterioration  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Generalised oedema  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Heparin-induced thrombocytopenia  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Hernia  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Inflammation  1  0/6741 (0.00%)  0 3/6716 (0.04%)  3
Ischaemic ulcer  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Malaise  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Multi-organ disorder  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Multi-organ failure  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Necrosis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Non-cardiac chest pain  1  138/6741 (2.05%)  155 167/6716 (2.49%)  179
Oedema peripheral  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Puncture site haemorrhage  1  30/6741 (0.45%)  30 18/6716 (0.27%)  18
Pyrexia  1  12/6741 (0.18%)  13 6/6716 (0.09%)  6
Submandibular mass  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Sudden cardiac death  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Systemic inflammatory response syndrome  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Ulcer  1  1/6741 (0.01%)  1 2/6716 (0.03%)  2
Vessel puncture site haematoma  1  21/6741 (0.31%)  21 14/6716 (0.21%)  14
Vessel puncture site haemorrhage  1  13/6741 (0.19%)  13 10/6716 (0.15%)  10
Hepatobiliary disorders     
Acute hepatic failure  1  0/6741 (0.00%)  0 2/6716 (0.03%)  2
Autoimmune hepatitis  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Bile duct stone  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Biliary cirrhosis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Biliary colic  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Biliary dyskinesia  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Cholaemia  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Cholangitis acute  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Cholecystitis  1  5/6741 (0.07%)  5 5/6716 (0.07%)  5
Cholecystitis acute  1  4/6741 (0.06%)  4 7/6716 (0.10%)  7
Cholecystitis chronic  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Cholelithiasis  1  10/6741 (0.15%)  10 13/6716 (0.19%)  13
Cholelithiasis obstructive  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Cholestasis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Gallbladder disorder  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Hepatic failure  1  1/6741 (0.01%)  1 2/6716 (0.03%)  2
Hepatic steatosis  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Hepatitis cholestatic  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Ischaemic hepatitis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Jaundice  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Liver disorder  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Portal hypertension  1  0/6741 (0.00%)  0 1/6716 (0.01%)  2
Immune system disorders     
Anaphylactic reaction  1  1/6741 (0.01%)  1 2/6716 (0.03%)  2
Anaphylactic shock  1  2/6741 (0.03%)  2 2/6716 (0.03%)  2
Drug hypersensitivity  1  1/6741 (0.01%)  1 3/6716 (0.04%)  3
Hypersensitivity  1  3/6741 (0.04%)  3 2/6716 (0.03%)  3
Polyarteritis nodosa  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Infections and infestations     
Abscess  1  1/6741 (0.01%)  1 2/6716 (0.03%)  2
Abscess limb  1  0/6741 (0.00%)  0 2/6716 (0.03%)  2
Anal abscess  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Appendicitis  1  5/6741 (0.07%)  5 2/6716 (0.03%)  2
Arthritis bacterial  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Arthritis infective  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Bacteraemia  1  3/6741 (0.04%)  3 1/6716 (0.01%)  1
Bacterial pyelonephritis  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Bronchitis  1  3/6741 (0.04%)  3 5/6716 (0.07%)  5
Bronchitis acute  1  9/6741 (0.13%)  9 3/6716 (0.04%)  3
Bronchitis chronic  1  0/6741 (0.00%)  0 3/6716 (0.04%)  3
Bronchopneumonia  1  5/6741 (0.07%)  5 2/6716 (0.03%)  2
Catheter site infection  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Cellulitis  1  11/6741 (0.16%)  12 6/6716 (0.09%)  6
Cholecystitis infective  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Chronic sinusitis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Clostridium difficile colitis  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Diabetic gangrene  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Diverticulitis  1  8/6741 (0.12%)  10 5/6716 (0.07%)  5
Endocarditis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Endocarditis bacterial  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Enterocolitis infectious  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Erysipelas  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Febrile infection  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Gangrene  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Gas gangrene  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Gastritis viral  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Gastroenteritis  1  10/6741 (0.15%)  10 6/6716 (0.09%)  6
Gastroenteritis viral  1  1/6741 (0.01%)  1 2/6716 (0.03%)  2
Gastrointestinal infection  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Giardiasis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Groin abscess  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Helicobacter gastritis  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Hepatitis c  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Hepatitis viral  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Herpes zoster oticus  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Infection  1  0/6741 (0.00%)  0 3/6716 (0.04%)  3
Infective exacerbation of chronic obstructive airways disease  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Influenza  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Intervertebral discitis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Lobar pneumonia  1  5/6741 (0.07%)  5 6/6716 (0.09%)  6
Localised infection  1  0/6741 (0.00%)  0 3/6716 (0.04%)  3
Lung infection  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Lymphangitis  1  0/6741 (0.00%)  0 2/6716 (0.03%)  2
Mediastinitis  1  0/6741 (0.00%)  0 3/6716 (0.04%)  3
Meningitis viral  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Neuroborreliosis  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Oral infection  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Osteomyelitis  1  1/6741 (0.01%)  1 2/6716 (0.03%)  2
Otitis externa  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Parotitis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Penile infection  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Perianal abscess  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Peritonitis bacterial  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Peritonsillar abscess  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Pharyngitis  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Pneumonia  1  43/6741 (0.64%)  45 52/6716 (0.77%)  54
Pneumonia bacterial  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Pneumonia streptococcal  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Pneumonia viral  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Postoperative wound infection  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Pulmonary tuberculosis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Pyelonephritis  1  2/6741 (0.03%)  2 2/6716 (0.03%)  2
Pyelonephritis acute  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Pyothorax  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Rectal abscess  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Respiratory tract infection  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Salmonellosis  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Salpingitis  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Scrotal abscess  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Sepsis  1  8/6741 (0.12%)  8 9/6716 (0.13%)  9
Sepsis syndrome  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Septic shock  1  1/6741 (0.01%)  1 2/6716 (0.03%)  2
Sinusitis  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Skin infection  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Staphylococcal bacteraemia  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Staphylococcal infection  1  2/6741 (0.03%)  2 2/6716 (0.03%)  2
Staphylococcal sepsis  1  4/6741 (0.06%)  4 0/6716 (0.00%)  0
Streptococcal sepsis  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Tracheobronchitis  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Upper respiratory tract infection  1  1/6741 (0.01%)  1 6/6716 (0.09%)  6
Urinary tract infection  1  15/6741 (0.22%)  17 19/6716 (0.28%)  19
Urosepsis  1  6/6741 (0.09%)  6 3/6716 (0.04%)  3
Viral diarrhoea  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Viral infection  1  4/6741 (0.06%)  4 3/6716 (0.04%)  3
Viral pericarditis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Viral upper respiratory tract infection  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Wound infection  1  0/6741 (0.00%)  0 3/6716 (0.04%)  3
Wound infection staphylococcal  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Injury, poisoning and procedural complications     
Abdominal injury  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Accidental overdose  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Alcohol poisoning  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Anaemia postoperative  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Ankle fracture  1  2/6741 (0.03%)  2 2/6716 (0.03%)  2
Aortic injury  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Arterial injury  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Arteriovenous fistula thrombosis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Arteriovenous graft thrombosis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Bronchial injury  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Cartilage injury  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Chest injury  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Clavicle fracture  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Concussion  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Contusion  1  6/6741 (0.09%)  7 0/6716 (0.00%)  0
Coronary artery reocclusion  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Device dislocation  1  0/6741 (0.00%)  0 3/6716 (0.04%)  3
Eyeball rupture  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Face injury  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Facial bones fracture  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Failure of implant  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Fall  1  11/6741 (0.16%)  12 12/6716 (0.18%)  12
Fat embolism  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Femoral neck fracture  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Femur fracture  1  2/6741 (0.03%)  2 2/6716 (0.03%)  2
Fibula fracture  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Foot fracture  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Foreign body trauma  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Graft thrombosis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Hand fracture  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Heat exhaustion  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Hepatic trauma  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Hip fracture  1  4/6741 (0.06%)  4 6/6716 (0.09%)  6
Humerus fracture  1  3/6741 (0.04%)  3 0/6716 (0.00%)  0
Incision site haemorrhage  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Incisional hernia  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Injury  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Intentional overdose  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Intervertebral disc injury  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Jaw fracture  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Joint dislocation  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Joint sprain  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Ligament injury  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Limb injury  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Lower limb fracture  1  2/6741 (0.03%)  2 2/6716 (0.03%)  2
Lumbar vertebral fracture  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Meniscus lesion  1  3/6741 (0.04%)  3 1/6716 (0.01%)  1
Muscle rupture  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Operative haemorrhage  1  17/6741 (0.25%)  18 7/6716 (0.10%)  7
Pelvic fracture  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Polytraumatism  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Post procedural haematoma  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Post procedural haemorrhage  1  20/6741 (0.30%)  20 8/6716 (0.12%)  8
Postpericardiotomy syndrome  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Pubic rami fracture  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Radius fracture  1  4/6741 (0.06%)  4 1/6716 (0.01%)  1
Renal haematoma  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Rib fracture  1  2/6741 (0.03%)  3 1/6716 (0.01%)  1
Road traffic accident  1  4/6741 (0.06%)  4 1/6716 (0.01%)  1
Skeletal injury  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Skull fractured base  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Spinal compression fracture  1  2/6741 (0.03%)  2 4/6716 (0.06%)  4
Splenic rupture  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Stent occlusion  1  2/6741 (0.03%)  2 3/6716 (0.04%)  3
Subcutaneous haematoma  1  5/6741 (0.07%)  5 0/6716 (0.00%)  0
Subdural haematoma  1  1/6741 (0.01%)  1 6/6716 (0.09%)  6
Tendon rupture  1  0/6741 (0.00%)  0 2/6716 (0.03%)  2
Therapeutic agent toxicity  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Thoracic vertebral fracture  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Thrombosis in device  1  7/6741 (0.10%)  7 10/6716 (0.15%)  10
Tibia fracture  1  0/6741 (0.00%)  0 3/6716 (0.04%)  3
Traumatic haematoma  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Traumatic intracranial haemorrhage  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Upper limb fracture  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Vascular graft occlusion  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Venous injury  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Wound  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Wrist fracture  1  0/6741 (0.00%)  0 1/6716 (0.01%)  2
Investigations     
Angiogram  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Blood creatine phosphokinase increased  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Blood creatinine increased  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Blood pressure decreased  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Blood pressure increased  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
C-reactive protein increased  1  0/6741 (0.00%)  0 2/6716 (0.03%)  2
Cardiac enzymes increased  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Ejection fraction decreased  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Electrocardiogram abnormal  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Electrocardiogram change  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Electrocardiogram st segment elevation  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Haematocrit decreased  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Haemoglobin abnormal  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Haemoglobin decreased  1  10/6741 (0.15%)  10 6/6716 (0.09%)  6
Hepatic enzyme increased  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
International normalised ratio increased  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Liver function test abnormal  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Occult blood positive  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Platelet count decreased  1  1/6741 (0.01%)  1 2/6716 (0.03%)  2
Prostate examination abnormal  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Renal function test abnormal  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Transaminases increased  1  0/6741 (0.00%)  0 3/6716 (0.04%)  3
Troponin increased  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Weight decreased  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Metabolism and nutrition disorders     
Anorexia  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Dehydration  1  14/6741 (0.21%)  14 9/6716 (0.13%)  9
Diabetes mellitus  1  4/6741 (0.06%)  4 7/6716 (0.10%)  7
Diabetes mellitus inadequate control  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Diabetes mellitus non-insulin-dependent  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Diabetic foot  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Diabetic ketoacidosis  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Electrolyte imbalance  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Glucose tolerance impaired  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Gout  1  0/6741 (0.00%)  0 2/6716 (0.03%)  2
Hyperglycaemia  1  4/6741 (0.06%)  4 3/6716 (0.04%)  4
Hyperglycaemic hyperosmolar nonketotic syndrome  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Hyperkalaemia  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Hyperosmolar state  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Hypervolaemia  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Hypoglycaemia  1  6/6741 (0.09%)  6 9/6716 (0.13%)  9
Hypokalaemia  1  1/6741 (0.01%)  1 4/6716 (0.06%)  4
Hyponatraemia  1  4/6741 (0.06%)  4 5/6716 (0.07%)  5
Hypovolaemia  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Vitamin b12 deficiency  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/6741 (0.03%)  2 3/6716 (0.04%)  3
Arthritis  1  3/6741 (0.04%)  3 3/6716 (0.04%)  3
Back pain  1  5/6741 (0.07%)  5 1/6716 (0.01%)  1
Bone pain  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Cervical spinal stenosis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Compartment syndrome  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Fistula  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Gouty arthritis  1  2/6741 (0.03%)  4 1/6716 (0.01%)  1
Haemarthrosis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Intervertebral disc degeneration  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Intervertebral disc disorder  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Intervertebral disc protrusion  1  4/6741 (0.06%)  4 6/6716 (0.09%)  6
Limb discomfort  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Lumbar spinal stenosis  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Metatarsalgia  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Muscle haemorrhage  1  3/6741 (0.04%)  3 1/6716 (0.01%)  1
Musculoskeletal chest pain  1  10/6741 (0.15%)  10 15/6716 (0.22%)  15
Musculoskeletal pain  1  1/6741 (0.01%)  1 7/6716 (0.10%)  7
Myalgia  1  2/6741 (0.03%)  2 8/6716 (0.12%)  8
Myositis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Neck pain  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Osteoarthritis  1  8/6741 (0.12%)  8 9/6716 (0.13%)  9
Osteonecrosis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Pain in extremity  1  5/6741 (0.07%)  5 5/6716 (0.07%)  5
Pain in jaw  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Polyarthritis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Polymyositis  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Rhabdomyolysis  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Rotator cuff syndrome  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Scoliosis  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Spinal column stenosis  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Spinal osteoarthritis  1  3/6741 (0.04%)  3 3/6716 (0.04%)  3
Synovial cyst  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Tendon disorder  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Tendon pain  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Tenosynovitis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Adenocarcinoma  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Adenocarcinoma pancreas  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Adenoma benign  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Adrenal neoplasm  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Basal cell carcinoma  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Benign lung neoplasm  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Bladder cancer  1  2/6741 (0.03%)  2 4/6716 (0.06%)  4
Bladder neoplasm  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Bladder papilloma  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Bladder transitional cell carcinoma stage iii  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Bone neoplasm  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Bone neoplasm malignant  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Brain neoplasm  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Breast cancer  1  4/6741 (0.06%)  4 1/6716 (0.01%)  1
Bronchial carcinoma  1  1/6741 (0.01%)  1 2/6716 (0.03%)  2
Carcinoid tumour pulmonary  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Cervix carcinoma  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Chronic lymphocytic leukaemia  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Chronic myeloid leukaemia  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Clear cell carcinoma of the kidney  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Colon adenoma  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Colon cancer  1  10/6741 (0.15%)  10 2/6716 (0.03%)  2
Colon cancer metastatic  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Colon neoplasm  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Colorectal cancer  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Gallbladder cancer  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Gastric cancer  1  6/6741 (0.09%)  6 7/6716 (0.10%)  7
Gastric neoplasm  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Gastrointestinal carcinoma  1  1/6741 (0.01%)  1 2/6716 (0.03%)  2
Gastrointestinal tract adenoma  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Haemangioma  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Hepatic cancer metastatic  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Hepatic neoplasm  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Laryngeal cancer  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Lung adenocarcinoma  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Lung neoplasm  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Lung neoplasm malignant  1  4/6741 (0.06%)  4 2/6716 (0.03%)  2
Lung squamous cell carcinoma stage unspecified  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Lymphocytic leukaemia  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Malignant ascites  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Malignant melanoma  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Mesothelioma malignant  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Metastases to adrenals  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Metastases to bone  1  1/6741 (0.01%)  1 2/6716 (0.03%)  2
Metastases to liver  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Metastases to lung  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Metastatic neoplasm  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Myelodysplastic syndrome  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Nasal neoplasm  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Non-hodgkin's lymphoma  1  0/6741 (0.00%)  0 2/6716 (0.03%)  3
Non-small cell lung cancer  1  2/6741 (0.03%)  2 2/6716 (0.03%)  2
Oesophageal adenocarcinoma  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Oesophageal cancer metastatic  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Oesophageal carcinoma  1  1/6741 (0.01%)  1 3/6716 (0.04%)  3
Ovarian neoplasm  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Pancreatic carcinoma  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Papillary thyroid cancer  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Papilloma  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Peripheral t-cell lymphoma unspecified  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Pituitary tumour benign  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Prostate cancer  1  6/6741 (0.09%)  6 7/6716 (0.10%)  7
Prostate cancer metastatic  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Prostatic adenoma  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Rectal cancer  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Rectal neoplasm  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Renal cell carcinoma stage unspecified  1  1/6741 (0.01%)  1 2/6716 (0.03%)  2
Renal neoplasm  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Salivary gland neoplasm  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Sarcoma  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Small cell lung cancer metastatic  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Small cell lung cancer stage unspecified  1  1/6741 (0.01%)  1 3/6716 (0.04%)  3
Squamous cell carcinoma  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Thymoma  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Thyroid cancer  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Transitional cell carcinoma  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Uterine leiomyoma  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Nervous system disorders     
Ageusia  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Amyotrophic lateral sclerosis  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Anoxic encephalopathy  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Carotid artery aneurysm  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Carotid artery disease  1  0/6741 (0.00%)  0 1/6716 (0.01%)  2
Carotid artery occlusion  1  1/6741 (0.01%)  1 1/6716 (0.01%)  2
Carotid artery stenosis  1  18/6741 (0.27%)  19 10/6716 (0.15%)  12
Carpal tunnel syndrome  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Cerebellar haemorrhage  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Cerebral arteriosclerosis  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Cerebral haemorrhage  1  5/6741 (0.07%)  5 2/6716 (0.03%)  2
Cerebrovascular insufficiency  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Cervicobrachial syndrome  1  0/6741 (0.00%)  0 2/6716 (0.03%)  2
Coma  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Complex partial seizures  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Convulsion  1  2/6741 (0.03%)  2 3/6716 (0.04%)  3
Coordination abnormal  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Dementia  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Diabetic neuropathy  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Dizziness  1  5/6741 (0.07%)  5 8/6716 (0.12%)  8
Dizziness postural  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Encephalopathy  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Epilepsy  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Facial palsy  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Global amnesia  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Grand mal convulsion  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Guillain-barre syndrome  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Haemorrhage intracranial  1  5/6741 (0.07%)  5 4/6716 (0.06%)  4
Haemorrhagic stroke  1  3/6741 (0.04%)  3 4/6716 (0.06%)  4
Haemorrhagic transformation stroke  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Headache  1  1/6741 (0.01%)  1 2/6716 (0.03%)  2
Hemiparesis  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Hepatic encephalopathy  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Hypoaesthesia  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Hypotonia  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Hypoxic encephalopathy  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Iiird nerve paralysis  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Lethargy  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Loss of consciousness  1  0/6741 (0.00%)  0 3/6716 (0.04%)  3
Migraine  1  0/6741 (0.00%)  0 2/6716 (0.03%)  3
Monoparesis  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Myoclonus  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Neurological symptom  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Neuropathy peripheral  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Paraesthesia  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Periodic limb movement disorder  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Peroneal nerve palsy  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Presyncope  1  11/6741 (0.16%)  11 8/6716 (0.12%)  8
Radicular syndrome  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Restless legs syndrome  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Ruptured cerebral aneurysm  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Sciatica  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Senile dementia  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Status epilepticus  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Subarachnoid haemorrhage  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Syncope  1  35/6741 (0.52%)  35 29/6716 (0.43%)  31
Syncope vasovagal  1  4/6741 (0.06%)  4 4/6716 (0.06%)  4
Tension headache  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Transient ischaemic attack  1  16/6741 (0.24%)  17 22/6716 (0.33%)  23
Tremor  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Unresponsive to stimuli  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Vascular encephalopathy  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Vertebrobasilar insufficiency  1  2/6741 (0.03%)  2 2/6716 (0.03%)  2
Psychiatric disorders     
Alcohol withdrawal syndrome  1  0/6741 (0.00%)  0 2/6716 (0.03%)  2
Alcoholism  1  1/6741 (0.01%)  1 3/6716 (0.04%)  3
Anxiety  1  5/6741 (0.07%)  5 7/6716 (0.10%)  7
Anxiety disorder  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Bipolar disorder  1  3/6741 (0.04%)  3 0/6716 (0.00%)  0
Confusional state  1  2/6741 (0.03%)  2 2/6716 (0.03%)  2
Delirium  1  1/6741 (0.01%)  1 1/6716 (0.01%)  2
Depression  1  5/6741 (0.07%)  5 5/6716 (0.07%)  5
Disorientation  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Drug dependence  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Fear  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Major depression  1  3/6741 (0.04%)  3 0/6716 (0.00%)  0
Mental status changes  1  0/6741 (0.00%)  0 2/6716 (0.03%)  2
Neurosis  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Post-traumatic stress disorder  1  0/6741 (0.00%)  0 1/6716 (0.01%)  1
Psychotic disorder  1  2/6741 (0.03%)  2 1/6716 (0.01%)  1
Suicidal ideation  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Suicide attempt  1  3/6741 (0.04%)  3 1/6716 (0.01%)  1
Renal and urinary disorders     
Azotaemia  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Calculus ureteric  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Calculus urinary  1  1/6741 (0.01%)  1 1/6716 (0.01%)  1
Crush syndrome  1  2/6741 (0.03%)  2 0/6716 (0.00%)  0
Cystitis noninfective  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Glomerulonephritis membranous  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Haematuria  1  27/6741 (0.40%)  31 12/6716 (0.18%)  14
Haemorrhage urinary tract  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Hydronephrosis  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Hypertensive nephropathy  1  1/6741 (0.01%)  1 0/6716 (0.00%)  0
Nephrolithiasis  1  7/6741 (0.10%)  7