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PLATO: A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00391872
Collaborator
(none)
18,624
Enrollment
672
Locations
2
Arms
29
Duration (Months)
27.7
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ticagrelor is a new, reversible binding, anti-platelet medication. Anti-platelet medications work to prevent the formation of blood clots. Ticagrelor is being developed as a treatment for patients with acute coronary syndrome (ACS). ACS is a term that is used to describe both heart attacks in progress or the imminent threat of a heart attack. ACS is usually caused by the formation of a blood clot in an artery that partially or totally blocks the blood supply to a portion of the heart muscle. Ticagrelor will be compared with clopidogrel to determine which drug, when either is used in conjunction with aspirin, is better at reducing deaths from vascular causes, future heart attacks and/or strokes in patients with ACS.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
18624 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomised, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of Ticagrelor Compared With Clopidogrel for Prevention of Vascular Events in Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS) [PLATO- a Study of PLATelet Inhibition and Patient Outcomes]
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Mar 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Clopidogrel

Oral treatment

Drug: Clopidogrel
Clopidogrel 75 mg once daily dose (ODD)
Other Names:
  • Plavix®

    		•
    Experimental: Ticagrelor

    Oral treatment

    Drug: Ticagrelor
    Ticagrelor (AZD6140) 90 mg twice daily dose (BD)
    Other Names:
  • AZD6140

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke [Randomization up to 12 months]

      Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. Intention To Treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee.

    2. Participants With Any Major Bleeding Event [First dosing up to 12 months]

      Participants with major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.

    Secondary Outcome Measures

    1. Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization [Randomization up to 12 months]

      Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of intent for invasive management population. Events were adjudicated by an endpoint committee.

    2. Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke [Randomization up to 12 months]

      Participants with death from any cause, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal of consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated by an endpoint committee.

    3. Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events. [Randomization up to 12 months]

      Participants with death from vascular causes, MI, stroke, recurrent ischemia, or other thrombotic events. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated.

    4. Participants With MI Event [Randomization up to 12 months]

      Participants with MI event. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.

    5. Participants With Death From Vascular Causes [Randomization up to 12 months]

      Participants with death from vascular causes. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.

    6. Participants With Stroke [Randomization up to 12 months]

      Participants with stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.

    7. Participants With Death From Any Cause [Randomization up to 12 months]

      Participants with death from any cause. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.

    8. Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding [First dosing up to 12 months]

      Participants with non CABG related major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.

    9. Participants With Major or Minor Bleeding [First dosing up to 12 months]

      Participants with major (fatal/life-threatening or other) or minor bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.

    10. Participants With Non-procedural Major Bleeding [First dosing up to 12 months]

      Participants with non-procedural major bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.

    11. Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding [First dosing up to 12 months]

      Participants with a major CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.

    12. Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding [First dosing up to 12 months]

      Number of participants with a major fatal/life-threatening CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.

    13. Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization [1-week period following randomization]

      Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by Thrombolysis in Myocardial Infarction (TIMI) group cardiologists.

    14. Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization [1-week period following randomization]

      Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by TIMI cardiologists.

    Eligibility Criteria

    Criteria

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

    • Male or female 18 years or older who has been hospitalised for chest pain and potential ACS

    • Females of child-bearing potential must have a negative pregnancy test at enrollment and be willing to use 2 methods of reliable contraception

    Exclusion Criteria:

    • Persons with moderate or severe liver disease

    • Persons who have already been treated with an invasive (angioplasty) procedure for the current episode of ACS

    • Persons who are being treated with blood clotting agents that cannot be stopped

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    551 Research Site Amadora Portugal
    552 Research Site Aveiro Portugal
    553 Research Site Braga Portugal
    554 Research Site Coimbra Portugal
    555 Research Site Leiria Portugal
    556 Research Site Lisboa Portugal
    557 Research Site Penafiel Portugal
    558 Research Site Santa Maria Da Feira Portugal
    559 Research Site Santarem Portugal
    560 Research Site Setubal Portugal
    561 Research Site Vila Nova de Gaia Portugal
    562 Research Site Vila Real Portugal
    563 Research Site San Juan Puerto Rico
    564 Research Site Pitesti Arges Romania
    565 Research Site Cluj Napoca Cluj Romania
    566 Research Site Braila Romania
    567 Research Site Brasov Romania
    568 Research Site Bucharest Romania
    569 Research Site Buzau Romania
    570 Research Site Craiova Romania
    571 Research Site Iasi Romania
    572 Research Site Suceava Romania
    573 Research Site Khanty-mansiysk Khanty-mansiysk Autonomous Dis Russian Federation
    574 Research Site Barnaul Russian Federation
    575 Research Site Ekaterinburg Russian Federation
    576 Research Site Irkutsk Russian Federation
    577 Research Site Kaliningrad Russian Federation
    578 Research Site Kazan Russian Federation
    579 Research Site Kemerovo Russian Federation
    580 Research Site Krasnodar Russian Federation
    581 Research Site Krasnoyarsk Russian Federation
    582 Research Site Moscow Russian Federation
    583 Research Site Murmansk Russian Federation
    584 Research Site Nizhniy Novgorod Russian Federation
    585 Research Site Novosibirsk Russian Federation
    586 Research Site Rostov-na-donu Russian Federation
    587 Research Site Samara Russian Federation
    588 Research Site St. Petersburg Russian Federation
    589 Research Site Tomsk Russian Federation
    590 Research Site Tyumen Russian Federation
    591 Research Site Vladivostok Russian Federation
    592 Research Site Singapore Singapore
    593 Research Site Bratislava Slovakia
    594 Research Site Kosice Slovakia
    595 Research Site Liptovsky Mikulas Slovakia
    596 Research Site Martin Slovakia
    597 Research Site Nitra Slovakia
    598 Research Site Nove Zamky Slovakia
    599 Research Site Piestany Slovakia
    600 Research Site Ruzomberok Slovakia
    601 Research Site Trnava Slovakia
    602 Research Site Zilina Slovakia
    603 Research Site Somerset West Cape Town South Africa
    604 Research Site Bloemfontein Free State South Africa
    605 Research Site Cape Town South Africa
    606 Research Site Pretoria South Africa
    607 Research Site Malaga Andalucia Spain
    608 Research Site Sevilla Andalucia Spain
    609 Research Site Gijon Asturias Spain
    610 Research Site Barcelona Cataluna Spain
    611 Research Site Lerida Cataluna Spain
    612 Research Site Terrassa Cataluna Spain
    613 Research Site Madrid Comunidad de Madrid Spain
    614 Research Site Valencia Comunidad Valenciana Spain
    615 Research Site Caceres Extremadura Spain
    616 Research Site Vigo(pontevedra) Galicia Spain
    617 Research Site Palma de Mallorca Islas Baleares Spain
    618 Research Site Boras Sweden
    619 Research Site Eksjo Sweden
    620 Research Site Eskilstuna Sweden
    621 Research Site Falun Sweden
    622 Research Site Halmstad Sweden
    623 Research Site Jonkoping Sweden
    624 Research Site Kalmar Sweden
    625 Research Site Karlskrona Sweden
    626 Research Site Lidkoping Sweden
    627 Research Site Linkoping Sweden
    628 Research Site Ljungby Sweden
    629 Research Site Lund Sweden
    630 Research Site Ostersund Sweden
    631 Research Site Skovde Sweden
    632 Research Site Stockholm Sweden
    633 Research Site Sundsvall Sweden
    634 Research Site Uppsala Sweden
    635 Research Site Vasteras Sweden
    636 Research Site Mendrisio Ticino Switzerland
    637 Research Site Bellinzona Switzerland
    638 Research Site Bern Switzerland
    639 Research Site Geneve Switzerland
    640 Research Site Kreuzlingen Switzerland
    641 Research Site Lugano Switzerland
    642 Research Site Niao-song-shiang Kaohsiung Taiwan
    643 Research Site Kweishan Shiang Taoyuan Hsien Taiwan
    644 Research Site Taipei Taiwan
    645 Research Site Bangkok Thailand
    646 Research Site Chiang Mai Thailand
    647 Research Site Khon Kaen Thailand
    648 Research Site Istanbul Kartal Turkey
    649 Research Site Ankara Sihhiye Turkey
    650 Research Site Adana Turkey
    651 Research Site Antalya Turkey
    652 Research Site Mersin Turkey
    653 Research Site Dnepropetrovsk Ukraine
    654 Research Site Donetsk Ukraine
    655 Research Site Kharkov Ukraine
    656 Research Site Kiev Ukraine
    657 Research Site Makiyivka Ukraine
    658 Research Site Airdrie Lanarkshire United Kingdom
    659 Research Site Belfast Northern Ireland United Kingdom
    660 Research Site Basingstoke United Kingdom
    661 Research Site Birmingham United Kingdom
    662 Research Site Blackpool United Kingdom
    663 Research Site Dundee United Kingdom
    664 Research Site Edinburgh United Kingdom
    665 Research Site Glasgow United Kingdom
    666 Research Site Leicester United Kingdom
    667 Research Site London United Kingdom
    668 Research Site Manchester United Kingdom
    669 Research Site Middlesborough United Kingdom
    670 Research Site Poole United Kingdom
    671 Research Site Sheffield United Kingdom
    672 Research Site Swansea United Kingdom

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Principal Investigator: Robert Harrington, MD, Duke Clinical Research Institute
    • Principal Investigator: Lars Wallentin, MD, Uppsala Clinical Research Centre
    • Study Director: Jonathan C. Fox, MD, AstraZeneca

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00391872
    Other Study ID Numbers:
    • D5130C05262
    • PLATO
    First Posted:
    Oct 25, 2006
    Last Update Posted:
    Mar 13, 2012
    Last Verified:
    Feb 1, 2012
    Keywords provided by AstraZeneca
    ACS
    Acute coronary syndrome
    Heart attack
    Unstable angina
    Coronary artery disease
    Additional relevant MeSH terms:
    Acute Coronary Syndrome
    Syndrome
    Clopidogrel
    Ticagrelor

    Study Results

    Participant Flow

    Recruitment Details The first participant was enrolled on 11 October 2006 and the last participant completed the study on 27 February 2009. Study participants were randomized from 855 centers in 43 countries.
    Pre-assignment Detail Participants will already be hospitalized due to their acute condition, and must be enrolled and randomized within 24 hours of the onset of their most recent cardiac ischemic symptoms. Randomization should take place as soon as possible after presentation.
    Arm/Group Title TICAGRELOR CLOPIDOGREL
    Arm/Group Description Ticagrelor 90 mg twice daily dose (BD) Clopidogrel 75 mg once daily dose (ODD)
    Period Title: Overall Study
    STARTED 9333 9291
    COMPLETED 9026 9036
    NOT COMPLETED 307 255

    Baseline Characteristics

    Arm/Group Title TICAGRELOR CLOPIDOGREL Total
    Arm/Group Description Ticagrelor 90 mg twice daily dose (BD) Clopidogrel 75 mg once daily dose (ODD) Total of all reporting groups
    Overall Participants 9333 9291 18624
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    62.1
    (11.21)
    62.3
    (11.21)
    62.2
    (22.42)
    Sex: Female, Male (Count of Participants)
    Female
    2655
    28.4%
    2633
    28.3%
    5288
    28.4%
    Male
    6678
    71.6%
    6658
    71.7%
    13336
    71.6%

    Outcome Measures

    1. Primary Outcome
    Title Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke
    Description Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. Intention To Treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee.
    Time Frame Randomization up to 12 months

    Outcome Measure Data

    Analysis Population Description
    The population was the full analysis set, which included all randomized patients
    Arm/Group Title TICAGRELOR CLOPIDOGREL
    Arm/Group Description Ticagrelor 90 mg twice daily dose (BD) Clopidogrel 75 mg once daily dose (ODD)
    Measure Participants 9333 9291
    Number [Participants]
    864
    9.3%
    1014
    10.9%
    2. Primary Outcome
    Title Participants With Any Major Bleeding Event
    Description Participants with major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.
    Time Frame First dosing up to 12 months

    Outcome Measure Data

    Analysis Population Description
    The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug
    Arm/Group Title TICAGRELOR CLOPIDOGREL
    Arm/Group Description Ticagrelor 90 mg twice daily dose (BD) Clopidogrel 75 mg once daily dose (ODD)
    Measure Participants 9235 9186
    Number [Participants]
    961
    10.3%
    929
    10%
    3. Secondary Outcome
    Title Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization
    Description Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of intent for invasive management population. Events were adjudicated by an endpoint committee.
    Time Frame Randomization up to 12 months

    Outcome Measure Data

    Analysis Population Description
    The subgroup of patients with intent for invasive management at randomization
    Arm/Group Title TICAGRELOR CLOPIDOGREL
    Arm/Group Description Ticagrelor 90 mg twice daily dose (BD) Clopidogrel 75 mg once daily dose (ODD)
    Measure Participants 6732 6676
    Number [Participants]
    569
    6.1%
    668
    7.2%
    4. Secondary Outcome
    Title Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke
    Description Participants with death from any cause, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal of consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated by an endpoint committee.
    Time Frame Randomization up to 12 months

    Outcome Measure Data

    Analysis Population Description
    The population was the full analysis set, which included all randomized patients
    Arm/Group Title TICAGRELOR CLOPIDOGREL
    Arm/Group Description Ticagrelor 90 mg twice daily dose (BD) Clopidogrel 75 mg once daily dose (ODD)
    Measure Participants 9333 9291
    Number [Participants]
    901
    9.7%
    1065
    11.5%
    5. Secondary Outcome
    Title Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events.
    Description Participants with death from vascular causes, MI, stroke, recurrent ischemia, or other thrombotic events. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated.
    Time Frame Randomization up to 12 months

    Outcome Measure Data

    Analysis Population Description
    The population was the full analysis set, which included all randomized patients
    Arm/Group Title TICAGRELOR CLOPIDOGREL
    Arm/Group Description Ticagrelor 90 mg twice daily dose (BD) Clopidogrel 75 mg once daily dose (ODD)
    Measure Participants 9333 9291
    Number [Participants]
    1290
    13.8%
    1456
    15.7%
    6. Secondary Outcome
    Title Participants With MI Event
    Description Participants with MI event. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.
    Time Frame Randomization up to 12 months

    Outcome Measure Data

    Analysis Population Description
    The population was the full analysis set, which included all randomized patients
    Arm/Group Title TICAGRELOR CLOPIDOGREL
    Arm/Group Description Ticagrelor 90 mg twice daily dose (BD) Clopidogrel 75 mg once daily dose (ODD)
    Measure Participants 9333 9291
    Number [Participants]
    504
    5.4%
    593
    6.4%
    7. Secondary Outcome
    Title Participants With Death From Vascular Causes
    Description Participants with death from vascular causes. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.
    Time Frame Randomization up to 12 months

    Outcome Measure Data

    Analysis Population Description
    The population was the full analysis set, which included all randomized patients
    Arm/Group Title TICAGRELOR CLOPIDOGREL
    Arm/Group Description Ticagrelor 90 mg twice daily dose (BD) Clopidogrel 75 mg once daily dose (ODD)
    Measure Participants 9333 9291
    Number [Participants]
    353
    3.8%
    442
    4.8%
    8. Secondary Outcome
    Title Participants With Stroke
    Description Participants with stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.
    Time Frame Randomization up to 12 months

    Outcome Measure Data

    Analysis Population Description
    The population was the full analysis set, which included all randomized patients
    Arm/Group Title TICAGRELOR CLOPIDOGREL
    Arm/Group Description Ticagrelor 90 mg twice daily dose (BD) Clopidogrel 75 mg once daily dose (ODD)
    Measure Participants 9333 9291
    Number [Participants]
    125
    1.3%
    106
    1.1%
    9. Secondary Outcome
    Title Participants With Death From Any Cause
    Description Participants with death from any cause. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.
    Time Frame Randomization up to 12 months

    Outcome Measure Data

    Analysis Population Description
    The population was the full analysis set, which included all randomized patients
    Arm/Group Title TICAGRELOR CLOPIDOGREL
    Arm/Group Description Ticagrelor 90 mg twice daily dose (BD) Clopidogrel 75 mg once daily dose (ODD)
    Measure Participants 9333 9291
    Number [Participants]
    399
    4.3%
    506
    5.4%
    10. Secondary Outcome
    Title Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding
    Description Participants with non CABG related major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.
    Time Frame First dosing up to 12 months

    Outcome Measure Data

    Analysis Population Description
    The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug
    Arm/Group Title TICAGRELOR CLOPIDOGREL
    Arm/Group Description Ticagrelor 90 mg twice daily dose (BD) Clopidogrel 75 mg once daily dose (ODD)
    Measure Participants 9235 9186
    Number [Participants]
    362
    3.9%
    306
    3.3%
    11. Secondary Outcome
    Title Participants With Major or Minor Bleeding
    Description Participants with major (fatal/life-threatening or other) or minor bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.
    Time Frame First dosing up to 12 months

    Outcome Measure Data

    Analysis Population Description
    The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug
    Arm/Group Title TICAGRELOR CLOPIDOGREL
    Arm/Group Description Ticagrelor 90 mg twice daily dose (BD) Clopidogrel 75 mg once daily dose (ODD)
    Measure Participants 9235 9186
    Number [Participants]
    1339
    14.3%
    1215
    13.1%
    12. Secondary Outcome
    Title Participants With Non-procedural Major Bleeding
    Description Participants with non-procedural major bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.
    Time Frame First dosing up to 12 months

    Outcome Measure Data

    Analysis Population Description
    The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug
    Arm/Group Title TICAGRELOR CLOPIDOGREL
    Arm/Group Description Ticagrelor 90 mg twice daily dose (BD) Clopidogrel 75 mg once daily dose (ODD)
    Measure Participants 9235 9186
    Number [Participants]
    235
    2.5%
    180
    1.9%
    13. Secondary Outcome
    Title Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding
    Description Participants with a major CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.
    Time Frame First dosing up to 12 months

    Outcome Measure Data

    Analysis Population Description
    Population is all patients who underwent CABG surgery within 7 days of last dose of active study medication.
    Arm/Group Title TICAGRELOR CLOPIDOGREL
    Arm/Group Description Ticagrelor 90 mg twice daily dose (BD) Clopidogrel 75 mg once daily dose (ODD)
    Measure Participants 770 814
    Number [Participants]
    619
    6.6%
    654
    7%
    14. Secondary Outcome
    Title Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding
    Description Number of participants with a major fatal/life-threatening CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.
    Time Frame First dosing up to 12 months

    Outcome Measure Data

    Analysis Population Description
    Population is all patients who underwent CABG surgery within 7 days of last dose of active study medication.
    Arm/Group Title TICAGRELOR CLOPIDOGREL
    Arm/Group Description Ticagrelor 90 mg twice daily dose (BD) Clopidogrel 75 mg once daily dose (ODD)
    Measure Participants 770 814
    Number [Participants]
    329
    3.5%
    341
    3.7%
    15. Secondary Outcome
    Title Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization
    Description Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by Thrombolysis in Myocardial Infarction (TIMI) group cardiologists.
    Time Frame 1-week period following randomization

    Outcome Measure Data

    Analysis Population Description
    Participants with Holter data in the week after Randomization
    Arm/Group Title TICAGRELOR CLOPIDOGREL
    Arm/Group Description Ticagrelor 90 mg twice daily dose (BD) Clopidogrel 75 mg once daily dose (ODD)
    Measure Participants 1451 1415
    Number [Participants]
    84
    0.9%
    51
    0.5%
    16. Secondary Outcome
    Title Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization
    Description Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by TIMI cardiologists.
    Time Frame 1-week period following randomization

    Outcome Measure Data

    Analysis Population Description
    Patients who were monitored for one week following randomization (and for one week one month later).
    Arm/Group Title TICAGRELOR CLOPIDOGREL
    Arm/Group Description Ticagrelor 90 mg twice daily dose (BD) Clopidogrel 75 mg once daily dose (ODD)
    Measure Participants 964 985
    Number [Participants]
    21
    0.2%
    16
    0.2%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title TICAGRELOR CLOPIDOGREL
    Arm/Group Description Ticagrelor 90 mg twice daily dose (BD) Clopidogrel 75 mg once daily dose (ODD)
    All Cause Mortality
    TICAGRELOR CLOPIDOGREL
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    TICAGRELOR CLOPIDOGREL
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2108/ (NaN) 2117/ (NaN)
    Blood and lymphatic system disorders
    Anaemia 35/9333 (0.4%) 25/9291 (0.3%)
    Thrombocytopenia 7/9333 (0.1%) 8/9291 (0.1%)
    Iron Deficiency Anaemia 2/9333 (0%) 6/9291 (0.1%)
    Leukopenia 1/9333 (0%) 2/9291 (0%)
    Lymphadenitis 2/9333 (0%) 0/9291 (0%)
    Microcytic Anaemia 1/9333 (0%) 2/9291 (0%)
    Spontaneous Haematoma 2/9333 (0%) 0/9291 (0%)
    Coagulopathy 1/9333 (0%) 0/9291 (0%)
    Disseminated Intravascular Coagulation 0/9333 (0%) 1/9291 (0%)
    Granulocytopenia 1/9333 (0%) 0/9291 (0%)
    Haemorrhagic Anaemia 1/9333 (0%) 0/9291 (0%)
    Hypochromic Anaemia 1/9333 (0%) 0/9291 (0%)
    Leukocytosis 0/9333 (0%) 1/9291 (0%)
    Lymphadenopathy 0/9333 (0%) 1/9291 (0%)
    Nephrogenic Anaemia 1/9333 (0%) 0/9291 (0%)
    Neutropenia 1/9333 (0%) 1/9291 (0%)
    Normochromic Normocytic Anaemia 1/9333 (0%) 0/9291 (0%)
    Pancytopenia 1/9333 (0%) 0/9291 (0%)
    Polycythaemia 1/9333 (0%) 1/9291 (0%)
    Splenic Lesion 1/9333 (0%) 0/9291 (0%)
    Thrombocythaemia 0/9333 (0%) 1/9291 (0%)
    Cardiac disorders
    Cardiac Failure 122/9333 (1.3%) 129/9291 (1.4%)
    Atrial Fibrillation 70/9333 (0.8%) 68/9291 (0.7%)
    Cardiogenic Shock 60/9333 (0.6%) 66/9291 (0.7%)
    Ventricular Fibrillation 48/9333 (0.5%) 64/9291 (0.7%)
    Cardiac Failure Congestive 51/9333 (0.5%) 46/9291 (0.5%)
    Cardiac Arrest 38/9333 (0.4%) 44/9291 (0.5%)
    Ventricular Tachycardia 29/9333 (0.3%) 33/9291 (0.4%)
    Bradycardia 26/9333 (0.3%) 31/9291 (0.3%)
    Atrioventricular Block Complete 19/9333 (0.2%) 19/9291 (0.2%)
    Cardiac Failure Acute 18/9333 (0.2%) 18/9291 (0.2%)
    Cardiac Tamponade 11/9333 (0.1%) 16/9291 (0.2%)
    Intracardiac Thrombus 13/9333 (0.1%) 15/9291 (0.2%)
    Angina Pectoris 7/9333 (0.1%) 14/9291 (0.2%)
    Cardio-Respiratory Arrest 8/9333 (0.1%) 12/9291 (0.1%)
    Atrial Flutter 11/9333 (0.1%) 7/9291 (0.1%)
    Left Ventricular Failure 10/9333 (0.1%) 5/9291 (0.1%)
    Pericardial Effusion 9/9333 (0.1%) 10/9291 (0.1%)
    Arrhythmia 8/9333 (0.1%) 4/9291 (0%)
    Palpitations 8/9333 (0.1%) 7/9291 (0.1%)
    Pericarditis 6/9333 (0.1%) 8/9291 (0.1%)
    Supraventricular Tachycardia 8/9333 (0.1%) 8/9291 (0.1%)
    Sick Sinus Syndrome 7/9333 (0.1%) 2/9291 (0%)
    Cardiac Asthma 3/9333 (0%) 6/9291 (0.1%)
    Mitral Valve Incompetence 4/9333 (0%) 6/9291 (0.1%)
    Ventricular Arrhythmia 3/9333 (0%) 6/9291 (0.1%)
    Ventricular Extrasystoles 6/9333 (0.1%) 1/9291 (0%)
    Atrioventricular Block 3/9333 (0%) 5/9291 (0.1%)
    Cardiac Failure Chronic 5/9333 (0.1%) 2/9291 (0%)
    Coronary Artery Disease 5/9333 (0.1%) 3/9291 (0%)
    Coronary Artery Dissection 5/9333 (0.1%) 3/9291 (0%)
    Atrioventricular Block Second Degree 4/9333 (0%) 0/9291 (0%)
    Electromechanical Dissociation 3/9333 (0%) 4/9291 (0%)
    Myocardial Rupture 2/9333 (0%) 4/9291 (0%)
    Sinus Bradycardia 1/9333 (0%) 4/9291 (0%)
    Tachyarrhythmia 4/9333 (0%) 4/9291 (0%)
    Tachycardia 1/9333 (0%) 4/9291 (0%)
    Acute Left Ventricular Failure 3/9333 (0%) 2/9291 (0%)
    Aortic Valve Stenosis 2/9333 (0%) 3/9291 (0%)
    Atrial Tachycardia 1/9333 (0%) 3/9291 (0%)
    Bradyarrhythmia 3/9333 (0%) 3/9291 (0%)
    Cardiac Aneurysm 1/9333 (0%) 3/9291 (0%)
    Cardiomyopathy 1/9333 (0%) 3/9291 (0%)
    Coronary Artery Perforation 3/9333 (0%) 0/9291 (0%)
    Coronary Artery Thrombosis 2/9333 (0%) 3/9291 (0%)
    Dressler's Syndrome 3/9333 (0%) 3/9291 (0%)
    Left Ventricular Dysfunction 3/9333 (0%) 3/9291 (0%)
    Pericardial Haemorrhage 3/9333 (0%) 2/9291 (0%)
    Sinus Arrest 1/9333 (0%) 3/9291 (0%)
    Ventricle Rupture 2/9333 (0%) 3/9291 (0%)
    Arrhythmia Supraventricular 1/9333 (0%) 2/9291 (0%)
    Arteriosclerosis Coronary Artery 0/9333 (0%) 2/9291 (0%)
    Cardiopulmonary Failure 1/9333 (0%) 2/9291 (0%)
    Coronary Artery Occlusion 0/9333 (0%) 2/9291 (0%)
    Coronary Artery Stenosis 2/9333 (0%) 1/9291 (0%)
    Nodal Rhythm 1/9333 (0%) 2/9291 (0%)
    Papillary Muscle Rupture 2/9333 (0%) 1/9291 (0%)
    Right Ventricular Failure 2/9333 (0%) 1/9291 (0%)
    Acute Coronary Syndrome 1/9333 (0%) 1/9291 (0%)
    Arteriospasm Coronary 1/9333 (0%) 0/9291 (0%)
    Atrial Rupture 1/9333 (0%) 0/9291 (0%)
    Bundle Branch Block 0/9333 (0%) 1/9291 (0%)
    Bundle Branch Block Left 0/9333 (0%) 1/9291 (0%)
    Cardiac Disorder 0/9333 (0%) 1/9291 (0%)
    Cardiac Valve Disease 1/9333 (0%) 0/9291 (0%)
    Cardiovascular Disorder 0/9333 (0%) 1/9291 (0%)
    Chordae Tendinae Rupture 0/9333 (0%) 1/9291 (0%)
    Coronary Artery Insufficiency 0/9333 (0%) 1/9291 (0%)
    Cyanosis 1/9333 (0%) 0/9291 (0%)
    Dissecting Coronary Artery Aneurysm 0/9333 (0%) 1/9291 (0%)
    Extrasystoles 1/9333 (0%) 1/9291 (0%)
    Hypertrophic Cardiomyopathy 1/9333 (0%) 1/9291 (0%)
    Interventricular Septum Rupture 1/9333 (0%) 0/9291 (0%)
    Ischaemic Cardiomyopathy 1/9333 (0%) 0/9291 (0%)
    Long Qt Syndrome 0/9333 (0%) 1/9291 (0%)
    Low Cardiac Output Syndrome 0/9333 (0%) 1/9291 (0%)
    Myocardial Infarction 0/9333 (0%) 1/9291 (0%)
    Myocardial Ischaemia 0/9333 (0%) 1/9291 (0%)
    Myocarditis 1/9333 (0%) 0/9291 (0%)
    Papillary Muscle Disorder 0/9333 (0%) 1/9291 (0%)
    Stress Cardiomyopathy 0/9333 (0%) 1/9291 (0%)
    Torsade De Pointes 0/9333 (0%) 1/9291 (0%)
    Ventricular Dysfunction 0/9333 (0%) 1/9291 (0%)
    Ventricular Tachyarrhythmia 0/9333 (0%) 1/9291 (0%)
    Congenital, familial and genetic disorders
    Carbohydrate Metabolism Disorder 0/9333 (0%) 2/9291 (0%)
    Diverticulitis Meckel's 1/9333 (0%) 0/9291 (0%)
    Gastrointestinal Angiodysplasia Haemorrhagic 0/9333 (0%) 1/9291 (0%)
    Haemorrhagic Arteriovenous Malformation 1/9333 (0%) 0/9291 (0%)
    Ventricular Septal Defect 0/9333 (0%) 1/9291 (0%)
    Ear and labyrinth disorders
    Vertigo 8/9333 (0.1%) 5/9291 (0.1%)
    Vestibular Neuronitis 1/9333 (0%) 3/9291 (0%)
    Hypoacusis 2/9333 (0%) 0/9291 (0%)
    Deafness 1/9333 (0%) 0/9291 (0%)
    Sudden Hearing Loss 0/9333 (0%) 1/9291 (0%)
    Tinnitus 1/9333 (0%) 0/9291 (0%)
    Vertigo Positional 1/9333 (0%) 0/9291 (0%)
    Endocrine disorders
    Hyperthyroidism 2/9333 (0%) 2/9291 (0%)
    Goitre 0/9333 (0%) 1/9291 (0%)
    Pituitary-Dependent Cushing's Syndrome 1/9333 (0%) 0/9291 (0%)
    Thyrotoxic Crisis 0/9333 (0%) 1/9291 (0%)
    Eye disorders
    Cataract 3/9333 (0%) 2/9291 (0%)
    Diplopia 2/9333 (0%) 1/9291 (0%)
    Retinal Detachment 2/9333 (0%) 2/9291 (0%)
    Amaurosis 1/9333 (0%) 0/9291 (0%)
    Amaurosis Fugax 0/9333 (0%) 1/9291 (0%)
    Blindness 1/9333 (0%) 0/9291 (0%)
    Cataract Nuclear 1/9333 (0%) 0/9291 (0%)
    Chorioretinitis 0/9333 (0%) 1/9291 (0%)
    Conjunctival Haemorrhage 1/9333 (0%) 0/9291 (0%)
    Diabetic Retinopathy 1/9333 (0%) 0/9291 (0%)
    Eye Haemorrhage 1/9333 (0%) 1/9291 (0%)
    Glaucoma 1/9333 (0%) 0/9291 (0%)
    Macular Degeneration 1/9333 (0%) 1/9291 (0%)
    Posterior Capsule Opacification 0/9333 (0%) 1/9291 (0%)
    Retinal Artery Embolism 0/9333 (0%) 1/9291 (0%)
    Visual Impairment 1/9333 (0%) 1/9291 (0%)
    Vitreous Haemorrhage 1/9333 (0%) 0/9291 (0%)
    Gastrointestinal disorders
    Gastrointestinal Haemorrhage 45/9333 (0.5%) 42/9291 (0.5%)
    Abdominal Pain 21/9333 (0.2%) 10/9291 (0.1%)
    Abdominal Pain Upper 9/9333 (0.1%) 15/9291 (0.2%)
    Diarrhoea 12/9333 (0.1%) 9/9291 (0.1%)
    Gastric Ulcer Haemorrhage 11/9333 (0.1%) 6/9291 (0.1%)
    Duodenal Ulcer Haemorrhage 10/9333 (0.1%) 2/9291 (0%)
    Melaena 10/9333 (0.1%) 3/9291 (0%)
    Vomiting 10/9333 (0.1%) 4/9291 (0%)
    Gastritis 8/9333 (0.1%) 9/9291 (0.1%)
    Upper Gastrointestinal Haemorrhage 9/9333 (0.1%) 7/9291 (0.1%)
    Gastrooesophageal Reflux Disease 4/9333 (0%) 7/9291 (0.1%)
    Rectal Haemorrhage 7/9333 (0.1%) 6/9291 (0.1%)
    Dyspepsia 6/9333 (0.1%) 5/9291 (0.1%)
    Haematemesis 5/9333 (0.1%) 3/9291 (0%)
    Pancreatitis 4/9333 (0%) 5/9291 (0.1%)
    Pancreatitis Acute 5/9333 (0.1%) 1/9291 (0%)
    Retroperitoneal Haemorrhage 5/9333 (0.1%) 3/9291 (0%)
    Gastric Haemorrhage 3/9333 (0%) 4/9291 (0%)
    Gastric Ulcer 4/9333 (0%) 2/9291 (0%)
    Gastritis Erosive 4/9333 (0%) 2/9291 (0%)
    Haematochezia 4/9333 (0%) 2/9291 (0%)
    Inguinal Hernia 4/9333 (0%) 4/9291 (0%)
    Lower Gastrointestinal Haemorrhage 1/9333 (0%) 4/9291 (0%)
    Nausea 3/9333 (0%) 4/9291 (0%)
    Anal Haemorrhage 0/9333 (0%) 3/9291 (0%)
    Diverticulum 3/9333 (0%) 0/9291 (0%)
    Duodenal Ulcer 3/9333 (0%) 2/9291 (0%)
    Enteritis 0/9333 (0%) 3/9291 (0%)
    Gastrointestinal Necrosis 3/9333 (0%) 0/9291 (0%)
    Haemorrhoidal Haemorrhage 2/9333 (0%) 3/9291 (0%)
    Peptic Ulcer Haemorrhage 3/9333 (0%) 1/9291 (0%)
    Peritonitis 1/9333 (0%) 3/9291 (0%)
    Retroperitoneal Haematoma 3/9333 (0%) 3/9291 (0%)
    Abdominal Discomfort 0/9333 (0%) 2/9291 (0%)
    Constipation 1/9333 (0%) 2/9291 (0%)
    Diverticulum Intestinal 2/9333 (0%) 0/9291 (0%)
    Diverticulum Intestinal Haemorrhagic 1/9333 (0%) 2/9291 (0%)
    Duodenitis 0/9333 (0%) 2/9291 (0%)
    Dysphagia 2/9333 (0%) 2/9291 (0%)
    Faeces Discoloured 2/9333 (0%) 0/9291 (0%)
    Gastric Disorder 0/9333 (0%) 2/9291 (0%)
    Gastritis Haemorrhagic 1/9333 (0%) 2/9291 (0%)
    Gastroduodenal Haemorrhage 2/9333 (0%) 0/9291 (0%)
    Ileus Paralytic 2/9333 (0%) 0/9291 (0%)
    Intestinal Haemorrhage 1/9333 (0%) 2/9291 (0%)
    Intestinal Ischaemia 0/9333 (0%) 2/9291 (0%)
    Large Intestine Perforation 2/9333 (0%) 1/9291 (0%)
    Oesophagitis 1/9333 (0%) 2/9291 (0%)
    Rectal Polyp 2/9333 (0%) 0/9291 (0%)
    Small Intestinal Obstruction 2/9333 (0%) 1/9291 (0%)
    Abdominal Hernia Obstructive 1/9333 (0%) 0/9291 (0%)
    Anal Fistula 0/9333 (0%) 1/9291 (0%)
    Appendicitis Perforated 1/9333 (0%) 0/9291 (0%)
    Ascites 0/9333 (0%) 1/9291 (0%)
    Colitis Ischaemic 0/9333 (0%) 1/9291 (0%)
    Colitis Ulcerative 0/9333 (0%) 1/9291 (0%)
    Colonic Polyp 1/9333 (0%) 1/9291 (0%)
    Dental Caries 0/9333 (0%) 1/9291 (0%)
    Diarrhoea Haemorrhagic 1/9333 (0%) 0/9291 (0%)
    Diverticular Perforation 0/9333 (0%) 1/9291 (0%)
    Diverticulitis Intestinal Haemorrhagic 1/9333 (0%) 0/9291 (0%)
    Enterocolitis Haemorrhagic 1/9333 (0%) 0/9291 (0%)
    Epigastric Discomfort 1/9333 (0%) 0/9291 (0%)
    Erosive Oesophagitis 1/9333 (0%) 0/9291 (0%)
    Faecal Incontinence 0/9333 (0%) 1/9291 (0%)
    Food Poisoning 0/9333 (0%) 1/9291 (0%)
    Gastritis Atrophic 0/9333 (0%) 1/9291 (0%)
    Gastrointestinal Disorder 1/9333 (0%) 1/9291 (0%)
    Gastrointestinal Pain 1/9333 (0%) 0/9291 (0%)
    Gastrointestinal Ulcer Haemorrhage 1/9333 (0%) 0/9291 (0%)
    Gingival Bleeding 1/9333 (0%) 0/9291 (0%)
    Gingivitis Ulcerative 0/9333 (0%) 1/9291 (0%)
    Haemorrhagic Erosive Gastritis 0/9333 (0%) 1/9291 (0%)
    Haemorrhoids 1/9333 (0%) 1/9291 (0%)
    Hiatus Hernia 0/9333 (0%) 1/9291 (0%)
    Inguinal Hernia Strangulated 0/9333 (0%) 1/9291 (0%)
    Intestinal Obstruction 0/9333 (0%) 1/9291 (0%)
    Intestinal Polyp 1/9333 (0%) 0/9291 (0%)
    Intra-Abdominal Haemorrhage 1/9333 (0%) 1/9291 (0%)
    Mallory-Weiss Syndrome 0/9333 (0%) 1/9291 (0%)
    Mesenteric Artery Embolism 0/9333 (0%) 1/9291 (0%)
    Mouth Haemorrhage 0/9333 (0%) 1/9291 (0%)
    Oesophageal Food Impaction 1/9333 (0%) 0/9291 (0%)
    Oesophageal Haemorrhage 0/9333 (0%) 1/9291 (0%)
    Oesophageal Pain 1/9333 (0%) 0/9291 (0%)
    Oesophageal Varices Haemorrhage 0/9333 (0%) 1/9291 (0%)
    Oesophagitis Haemorrhagic 1/9333 (0%) 0/9291 (0%)
    Pancreatic Disorder 0/9333 (0%) 1/9291 (0%)
    Pancreatic Haemorrhage 0/9333 (0%) 1/9291 (0%)
    Pancreatitis Chronic 1/9333 (0%) 0/9291 (0%)
    Peptic Ulcer 0/9333 (0%) 1/9291 (0%)
    Pneumoperitoneum 1/9333 (0%) 0/9291 (0%)
    Polyp Colorectal 0/9333 (0%) 1/9291 (0%)
    Proctitis 1/9333 (0%) 0/9291 (0%)
    Reflux Oesophagitis 1/9333 (0%) 0/9291 (0%)
    Retroperitoneal Fibrosis 1/9333 (0%) 0/9291 (0%)
    Small Intestinal Haemorrhage 1/9333 (0%) 0/9291 (0%)
    Small Intestinal Perforation 1/9333 (0%) 0/9291 (0%)
    Stomach Mass 1/9333 (0%) 0/9291 (0%)
    Subileus 1/9333 (0%) 0/9291 (0%)
    Thrombosis Mesenteric Vessel 0/9333 (0%) 1/9291 (0%)
    Tongue Oedema 1/9333 (0%) 0/9291 (0%)
    Toothache 1/9333 (0%) 0/9291 (0%)
    Volvulus 0/9333 (0%) 1/9291 (0%)
    General disorders
    Non-Cardiac Chest Pain 101/9333 (1.1%) 103/9291 (1.1%)
    Chest Pain 54/9333 (0.6%) 63/9291 (0.7%)
    Death 21/9333 (0.2%) 31/9291 (0.3%)
    Sudden Death 17/9333 (0.2%) 27/9291 (0.3%)
    Sudden Cardiac Death 14/9333 (0.2%) 25/9291 (0.3%)
    Vessel Puncture Site Haematoma 8/9333 (0.1%) 12/9291 (0.1%)
    Pyrexia 10/9333 (0.1%) 5/9291 (0.1%)
    Multi-Organ Failure 9/9333 (0.1%) 9/9291 (0.1%)
    Vessel Puncture Site Haemorrhage 9/9333 (0.1%) 6/9291 (0.1%)
    Asthenia 6/9333 (0.1%) 4/9291 (0%)
    Malaise 6/9333 (0.1%) 3/9291 (0%)
    General Physical Health Deterioration 1/9333 (0%) 5/9291 (0.1%)
    Chest Discomfort 4/9333 (0%) 2/9291 (0%)
    Impaired Healing 1/9333 (0%) 4/9291 (0%)
    Oedema Peripheral 4/9333 (0%) 1/9291 (0%)
    Puncture Site Haemorrhage 4/9333 (0%) 1/9291 (0%)
    Cardiac Death 3/9333 (0%) 1/9291 (0%)
    Catheter Site Haemorrhage 1/9333 (0%) 2/9291 (0%)
    Fatigue 1/9333 (0%) 2/9291 (0%)
    Systemic Inflammatory Response Syndrome 1/9333 (0%) 2/9291 (0%)
    Accidental Death 1/9333 (0%) 0/9291 (0%)
    Alcohol Interaction 1/9333 (0%) 0/9291 (0%)
    Application Site Inflammation 1/9333 (0%) 0/9291 (0%)
    Discomfort 1/9333 (0%) 0/9291 (0%)
    Foaming At Mouth 1/9333 (0%) 0/9291 (0%)
    Gait Disturbance 0/9333 (0%) 1/9291 (0%)
    Generalised Oedema 1/9333 (0%) 0/9291 (0%)
    Hernia 1/9333 (0%) 0/9291 (0%)
    Hypothermia 1/9333 (0%) 0/9291 (0%)
    Inflammation 0/9333 (0%) 1/9291 (0%)
    Inflammation Of Wound 1/9333 (0%) 0/9291 (0%)
    Injection Site Haemorrhage 1/9333 (0%) 0/9291 (0%)
    Injection Site Swelling 1/9333 (0%) 0/9291 (0%)
    Pain 0/9333 (0%) 1/9291 (0%)
    Pelvic Mass 0/9333 (0%) 1/9291 (0%)
    Ulcer Haemorrhage 1/9333 (0%) 1/9291 (0%)
    Unevaluable Event 1/9333 (0%) 0/9291 (0%)
    Hepatobiliary disorders
    Cholecystitis 7/9333 (0.1%) 10/9291 (0.1%)
    Cholelithiasis 9/9333 (0.1%) 9/9291 (0.1%)
    Cholecystitis Acute 5/9333 (0.1%) 7/9291 (0.1%)
    Hepatic Failure 2/9333 (0%) 4/9291 (0%)
    Bile Duct Stone 2/9333 (0%) 2/9291 (0%)
    Biliary Colic 1/9333 (0%) 2/9291 (0%)
    Cholangitis 1/9333 (0%) 2/9291 (0%)
    Hepatic Cirrhosis 1/9333 (0%) 2/9291 (0%)
    Jaundice 0/9333 (0%) 2/9291 (0%)
    Bile Duct Obstruction 1/9333 (0%) 0/9291 (0%)
    Cholecystitis Chronic 1/9333 (0%) 0/9291 (0%)
    Cholestasis 1/9333 (0%) 0/9291 (0%)
    Gallbladder Disorder 1/9333 (0%) 0/9291 (0%)
    Gallbladder Necrosis 1/9333 (0%) 0/9291 (0%)
    Hepatic Function Abnormal 1/9333 (0%) 0/9291 (0%)
    Hepatitis Toxic 1/9333 (0%) 0/9291 (0%)
    Hepatocellular Injury 1/9333 (0%) 0/9291 (0%)
    Ischaemic Hepatitis 1/9333 (0%) 0/9291 (0%)
    Liver Disorder 1/9333 (0%) 0/9291 (0%)
    Immune system disorders
    Anaphylactic Reaction 0/9333 (0%) 3/9291 (0%)
    Anaphylactic Shock 3/9333 (0%) 1/9291 (0%)
    Drug Hypersensitivity 1/9333 (0%) 3/9291 (0%)
    Hypersensitivity 1/9333 (0%) 2/9291 (0%)
    Allergy To Arthropod Bite 0/9333 (0%) 1/9291 (0%)
    Contrast Media Allergy 0/9333 (0%) 1/9291 (0%)
    Infections and infestations
    Pneumonia 69/9333 (0.7%) 95/9291 (1%)
    Sepsis 17/9333 (0.2%) 27/9291 (0.3%)
    Urinary Tract Infection 25/9333 (0.3%) 19/9291 (0.2%)
    Gastroenteritis 17/9333 (0.2%) 11/9291 (0.1%)
    Bronchitis 13/9333 (0.1%) 15/9291 (0.2%)
    Mediastinitis 11/9333 (0.1%) 4/9291 (0%)
    Bronchopneumonia 10/9333 (0.1%) 4/9291 (0%)
    Septic Shock 5/9333 (0.1%) 10/9291 (0.1%)
    Cellulitis 9/9333 (0.1%) 9/9291 (0.1%)
    Postoperative Wound Infection 9/9333 (0.1%) 3/9291 (0%)
    Respiratory Tract Infection 9/9333 (0.1%) 5/9291 (0.1%)
    Diverticulitis 7/9333 (0.1%) 8/9291 (0.1%)
    Wound Infection 7/9333 (0.1%) 8/9291 (0.1%)
    Appendicitis 6/9333 (0.1%) 2/9291 (0%)
    Infection 1/9333 (0%) 5/9291 (0.1%)
    Lung Infection 5/9333 (0.1%) 4/9291 (0%)
    Erysipelas 4/9333 (0%) 4/9291 (0%)
    Lower Respiratory Tract Infection 3/9333 (0%) 4/9291 (0%)
    Urosepsis 4/9333 (0%) 2/9291 (0%)
    Cystitis 3/9333 (0%) 2/9291 (0%)
    Endocarditis 3/9333 (0%) 2/9291 (0%)
    Gangrene 2/9333 (0%) 3/9291 (0%)
    Gastrointestinal Infection 3/9333 (0%) 1/9291 (0%)
    Osteomyelitis 3/9333 (0%) 3/9291 (0%)
    Pyelonephritis 3/9333 (0%) 2/9291 (0%)
    Staphylococcal Sepsis 3/9333 (0%) 1/9291 (0%)
    Upper Respiratory Tract Infection 3/9333 (0%) 3/9291 (0%)
    Abscess Limb 2/9333 (0%) 0/9291 (0%)
    Acute Tonsillitis 2/9333 (0%) 0/9291 (0%)
    Anal Abscess 2/9333 (0%) 2/9291 (0%)
    Bacteraemia 2/9333 (0%) 1/9291 (0%)
    Gastroenteritis Caliciviral 2/9333 (0%) 0/9291 (0%)
    Gastroenteritis Viral 2/9333 (0%) 0/9291 (0%)
    Incision Site Infection 2/9333 (0%) 1/9291 (0%)
    Lobar Pneumonia 0/9333 (0%) 2/9291 (0%)
    Localised Infection 0/9333 (0%) 2/9291 (0%)
    Sinusitis 2/9333 (0%) 0/9291 (0%)
    Skin Infection 2/9333 (0%) 2/9291 (0%)
    Staphylococcal Infection 2/9333 (0%) 0/9291 (0%)
    Tooth Abscess 0/9333 (0%) 2/9291 (0%)
    Abdominal Abscess 1/9333 (0%) 1/9291 (0%)
    Abdominal Wall Infection 0/9333 (0%) 1/9291 (0%)
    Abscess 1/9333 (0%) 0/9291 (0%)
    Acquired Immunodeficiency Syndrome 1/9333 (0%) 0/9291 (0%)
    Acute Sinusitis 1/9333 (0%) 0/9291 (0%)
    Arthritis Bacterial 1/9333 (0%) 0/9291 (0%)
    Arthritis Infective 1/9333 (0%) 1/9291 (0%)
    Bacterial Infection 1/9333 (0%) 1/9291 (0%)
    Breast Abscess 0/9333 (0%) 1/9291 (0%)
    Bronchiectasis 1/9333 (0%) 0/9291 (0%)
    Bronchitis Viral 0/9333 (0%) 1/9291 (0%)
    Catheter Related Infection 1/9333 (0%) 0/9291 (0%)
    Catheter Site Infection 0/9333 (0%) 1/9291 (0%)
    Cholecystitis Infective 0/9333 (0%) 1/9291 (0%)
    Clostridium Difficile Colitis 1/9333 (0%) 1/9291 (0%)
    Dengue Fever 0/9333 (0%) 1/9291 (0%)
    Device Related Infection 1/9333 (0%) 0/9291 (0%)
    Diarrhoea Infectious 1/9333 (0%) 0/9291 (0%)
    Endometritis 1/9333 (0%) 0/9291 (0%)
    Enterococcal Infection 0/9333 (0%) 1/9291 (0%)
    Enterocolitis Infectious 1/9333 (0%) 0/9291 (0%)
    Febrile Infection 1/9333 (0%) 0/9291 (0%)
    Gastric Infection 1/9333 (0%) 0/9291 (0%)
    Gastroenteritis Rotavirus 0/9333 (0%) 1/9291 (0%)
    Gastroenteritis Salmonella 1/9333 (0%) 0/9291 (0%)
    Groin Abscess 0/9333 (0%) 1/9291 (0%)
    Groin Infection 1/9333 (0%) 0/9291 (0%)
    Haematoma Infection 1/9333 (0%) 0/9291 (0%)
    Helicobacter Gastritis 1/9333 (0%) 1/9291 (0%)
    Hepatitis Viral 1/9333 (0%) 0/9291 (0%)
    Herpes Zoster 1/9333 (0%) 1/9291 (0%)
    Histoplasmosis 1/9333 (0%) 0/9291 (0%)
    Impetigo 0/9333 (0%) 1/9291 (0%)
    Incision Site Abscess 1/9333 (0%) 0/9291 (0%)
    Infected Skin Ulcer 1/9333 (0%) 0/9291 (0%)
    Infective Exacerbation Of Chronic Obstructive Airways Disease 1/9333 (0%) 0/9291 (0%)
    Infective Tenosynovitis 0/9333 (0%) 1/9291 (0%)
    Inguinal Hernia Gangrenous 0/9333 (0%) 1/9291 (0%)
    Injection Site Cellulitis 0/9333 (0%) 1/9291 (0%)
    Intervertebral Discitis 0/9333 (0%) 1/9291 (0%)
    Laryngitis 1/9333 (0%) 0/9291 (0%)
    Liver Abscess 1/9333 (0%) 0/9291 (0%)
    Lyme Disease 0/9333 (0%) 1/9291 (0%)
    Meningitis 0/9333 (0%) 1/9291 (0%)
    Necrotising Fasciitis 1/9333 (0%) 0/9291 (0%)
    Orchitis 0/9333 (0%) 1/9291 (0%)
    Pancreatic Abscess 1/9333 (0%) 0/9291 (0%)
    Perineal Abscess 1/9333 (0%) 0/9291 (0%)
    Pharyngitis 0/9333 (0%) 1/9291 (0%)
    Pneumococcal Sepsis 0/9333 (0%) 1/9291 (0%)
    Pneumonia Staphylococcal 0/9333 (0%) 1/9291 (0%)
    Post Procedural Cellulitis 0/9333 (0%) 1/9291 (0%)
    Post Procedural Infection 1/9333 (0%) 1/9291 (0%)
    Post Procedural Sepsis 0/9333 (0%) 1/9291 (0%)
    Pulmonary Sepsis 1/9333 (0%) 0/9291 (0%)
    Pulmonary Tuberculosis 1/9333 (0%) 0/9291 (0%)
    Puncture Site Abscess 1/9333 (0%) 0/9291 (0%)
    Puncture Site Infection 0/9333 (0%) 1/9291 (0%)
    Pyelonephritis Acute 1/9333 (0%) 1/9291 (0%)
    Pyothorax 1/9333 (0%) 0/9291 (0%)
    Rectal Abscess 0/9333 (0%) 1/9291 (0%)
    Renal Abscess 1/9333 (0%) 1/9291 (0%)
    Retroperitoneal Abscess 0/9333 (0%) 1/9291 (0%)
    Staphylococcal Mediastinitis 0/9333 (0%) 1/9291 (0%)
    Sternitis 1/9333 (0%) 1/9291 (0%)
    Subcutaneous Abscess 0/9333 (0%) 1/9291 (0%)
    Syphilis 1/9333 (0%) 0/9291 (0%)
    Tooth Infection 0/9333 (0%) 1/9291 (0%)
    Tracheitis 1/9333 (0%) 0/9291 (0%)
    Tracheobronchitis 1/9333 (0%) 1/9291 (0%)
    Viral Myocarditis 1/9333 (0%) 1/9291 (0%)
    Viral Pericarditis 0/9333 (0%) 1/9291 (0%)
    Injury, poisoning and procedural complications
    Thrombosis In Device 35/9333 (0.4%) 57/9291 (0.6%)
    Post Procedural Haemorrhage 56/9333 (0.6%) 47/9291 (0.5%)
    In-Stent Coronary Artery Restenosis 35/9333 (0.4%) 25/9291 (0.3%)
    Vascular Pseudoaneurysm 15/9333 (0.2%) 23/9291 (0.2%)
    In-Stent Arterial Restenosis 10/9333 (0.1%) 12/9291 (0.1%)
    Coronary Artery Restenosis 4/9333 (0%) 9/9291 (0.1%)
    Femur Fracture 3/9333 (0%) 7/9291 (0.1%)
    Post Procedural Haematoma 7/9333 (0.1%) 1/9291 (0%)
    Fall 1/9333 (0%) 5/9291 (0.1%)
    Femoral Neck Fracture 3/9333 (0%) 5/9291 (0.1%)
    Postpericardiotomy Syndrome 5/9333 (0.1%) 2/9291 (0%)
    Hip Fracture 4/9333 (0%) 2/9291 (0%)
    Lower Limb Fracture 0/9333 (0%) 4/9291 (0%)
    Post Procedural Complication 4/9333 (0%) 4/9291 (0%)
    Subdural Haematoma 4/9333 (0%) 2/9291 (0%)
    Wrist Fracture 4/9333 (0%) 0/9291 (0%)
    Hand Fracture 3/9333 (0%) 0/9291 (0%)
    Head Injury 1/9333 (0%) 3/9291 (0%)
    Injury 1/9333 (0%) 3/9291 (0%)
    Operative Haemorrhage 2/9333 (0%) 3/9291 (0%)
    Postoperative Thoracic Procedure Complication 3/9333 (0%) 3/9291 (0%)
    Postoperative Wound Complication 2/9333 (0%) 3/9291 (0%)
    Procedural Pain 3/9333 (0%) 0/9291 (0%)
    Subcutaneous Haematoma 3/9333 (0%) 0/9291 (0%)
    Wound Dehiscence 3/9333 (0%) 2/9291 (0%)
    Alcohol Poisoning 2/9333 (0%) 0/9291 (0%)
    Clavicle Fracture 0/9333 (0%) 2/9291 (0%)
    Concussion 2/9333 (0%) 2/9291 (0%)
    Facial Bones Fracture 2/9333 (0%) 1/9291 (0%)
    Foot Fracture 0/9333 (0%) 2/9291 (0%)
    Graft Thrombosis 0/9333 (0%) 2/9291 (0%)
    Humerus Fracture 2/9333 (0%) 1/9291 (0%)
    Ligament Rupture 2/9333 (0%) 0/9291 (0%)
    Limb Injury 2/9333 (0%) 0/9291 (0%)
    Limb Traumatic Amputation 2/9333 (0%) 0/9291 (0%)
    Overdose 2/9333 (0%) 0/9291 (0%)
    Postoperative Thrombosis 1/9333 (0%) 2/9291 (0%)
    Procedural Hypotension 0/9333 (0%) 2/9291 (0%)
    Renal Injury 1/9333 (0%) 2/9291 (0%)
    Spinal Compression Fracture 2/9333 (0%) 2/9291 (0%)
    Stent Occlusion 1/9333 (0%) 2/9291 (0%)
    Traumatic Haemorrhage 1/9333 (0%) 2/9291 (0%)
    Upper Limb Fracture 1/9333 (0%) 2/9291 (0%)
    Vascular Graft Occlusion 2/9333 (0%) 0/9291 (0%)
    Anaemia Postoperative 0/9333 (0%) 1/9291 (0%)
    Ankle Fracture 1/9333 (0%) 0/9291 (0%)
    Brain Contusion 1/9333 (0%) 0/9291 (0%)
    Cardiac Pacemaker Malfunction 1/9333 (0%) 0/9291 (0%)
    Cardiac Procedure Complication 1/9333 (0%) 0/9291 (0%)
    Chest Injury 1/9333 (0%) 0/9291 (0%)
    Contrast Media Reaction 0/9333 (0%) 1/9291 (0%)
    Contusion 0/9333 (0%) 1/9291 (0%)
    Coronary Artery Reocclusion 0/9333 (0%) 1/9291 (0%)
    Device Breakage 1/9333 (0%) 1/9291 (0%)
    Device Dislocation 1/9333 (0%) 0/9291 (0%)
    Device Malfunction 1/9333 (0%) 1/9291 (0%)
    Device Migration 0/9333 (0%) 1/9291 (0%)
    Fat Embolism 1/9333 (0%) 0/9291 (0%)
    Forearm Fracture 1/9333 (0%) 0/9291 (0%)
    Fracture 1/9333 (0%) 0/9291 (0%)
    Fractured Ischium 0/9333 (0%) 1/9291 (0%)
    Implantable Defibrillator Malfunction 0/9333 (0%) 1/9291 (0%)
    Incision Site Haemorrhage 0/9333 (0%) 1/9291 (0%)
    Incisional Hernia 0/9333 (0%) 1/9291 (0%)
    Joint Dislocation 1/9333 (0%) 1/9291 (0%)
    Joint Injury 0/9333 (0%) 1/9291 (0%)
    Joint Sprain 0/9333 (0%) 1/9291 (0%)
    Lumbar Vertebral Fracture 0/9333 (0%) 1/9291 (0%)
    Meniscus Lesion 1/9333 (0%) 0/9291 (0%)
    Open Wound 1/9333 (0%) 0/9291 (0%)
    Pelvic Fracture 1/9333 (0%) 1/9291 (0%)
    Post Procedural Haematuria 1/9333 (0%) 0/9291 (0%)
    Procedural Complication 0/9333 (0%) 1/9291 (0%)
    Radius Fracture 1/9333 (0%) 1/9291 (0%)
    Rib Fracture 0/9333 (0%) 1/9291 (0%)
    Road Traffic Accident 1/9333 (0%) 0/9291 (0%)
    Scrotal Haematoma 1/9333 (0%) 0/9291 (0%)
    Suture Rupture 0/9333 (0%) 1/9291 (0%)
    Tendon Rupture 0/9333 (0%) 1/9291 (0%)
    Thermal Burn 1/9333 (0%) 0/9291 (0%)
    Tibia Fracture 1/9333 (0%) 0/9291 (0%)
    Tracheal Haemorrhage 0/9333 (0%) 1/9291 (0%)
    Tracheal Obstruction 0/9333 (0%) 1/9291 (0%)
    Transfusion Reaction 0/9333 (0%) 1/9291 (0%)
    Traumatic Intracranial Haemorrhage 1/9333 (0%) 0/9291 (0%)
    Ulna Fracture 0/9333 (0%) 1/9291 (0%)
    Urinary Bladder Rupture 0/9333 (0%) 1/9291 (0%)
    Urinary Retention Postoperative 1/9333 (0%) 0/9291 (0%)
    Vascular Procedure Complication 1/9333 (0%) 0/9291 (0%)
    Vascular Pseudoaneurysm Ruptured 1/9333 (0%) 0/9291 (0%)
    Vertebral Injury 1/9333 (0%) 0/9291 (0%)
    Weaning Failure 1/9333 (0%) 0/9291 (0%)
    Wound Complication 0/9333 (0%) 1/9291 (0%)
    Haemoglobin Decreased 6/9333 (0.1%) 8/9291 (0.1%)
    Aspartate Aminotransferase Increased 1/9333 (0%) 4/9291 (0%)
    Alanine Aminotransferase Increased 1/9333 (0%) 3/9291 (0%)
    Blood Pressure Increased 3/9333 (0%) 3/9291 (0%)
    Liver Function Test Abnormal 2/9333 (0%) 3/9291 (0%)
    Angiogram 2/9333 (0%) 0/9291 (0%)
    Blood Glucose Increased 2/9333 (0%) 1/9291 (0%)
    Blood Potassium Increased 0/9333 (0%) 2/9291 (0%)
    Body Temperature Increased 2/9333 (0%) 0/9291 (0%)
    Hepatic Enzyme Increased 2/9333 (0%) 2/9291 (0%)
    International Normalised Ratio Increased 1/9333 (0%) 2/9291 (0%)
    Troponin Increased 1/9333 (0%) 2/9291 (0%)
    Antiphospholipid Antibodies 0/9333 (0%) 1/9291 (0%)
    Blood Creatine Phosphokinase Increased 1/9333 (0%) 1/9291 (0%)
    Blood Creatinine Increased 1/9333 (0%) 0/9291 (0%)
    Blood Potassium Decreased 1/9333 (0%) 0/9291 (0%)
    Blood Pressure Decreased 1/9333 (0%) 0/9291 (0%)
    Blood Sodium Decreased 1/9333 (0%) 0/9291 (0%)
    Blood Urine Present 1/9333 (0%) 0/9291 (0%)
    C-Reactive Protein Increased 1/9333 (0%) 0/9291 (0%)
    Cardiac Enzymes Increased 1/9333 (0%) 0/9291 (0%)
    Cardiac Stress Test Abnormal 1/9333 (0%) 0/9291 (0%)
    Electrocardiogram Qt Prolonged 1/9333 (0%) 1/9291 (0%)
    Electrocardiogram T Wave Inversion 1/9333 (0%) 0/9291 (0%)
    Fibrin D Dimer Increased 0/9333 (0%) 1/9291 (0%)
    Heart Rate Increased 0/9333 (0%) 1/9291 (0%)
    Intraocular Pressure Increased 0/9333 (0%) 1/9291 (0%)
    Occult Blood 1/9333 (0%) 0/9291 (0%)
    Pancreatic Enzymes Increased 0/9333 (0%) 1/9291 (0%)
    Platelet Count Decreased 0/9333 (0%) 1/9291 (0%)
    Prostatic Specific Antigen Abnormal 1/9333 (0%) 0/9291 (0%)
    Prostatic Specific Antigen Increased 1/9333 (0%) 0/9291 (0%)
    Weight Decreased 1/9333 (0%) 1/9291 (0%)
    Metabolism and nutrition disorders
    Dehydration 11/9333 (0.1%) 5/9291 (0.1%)
    Hypoglycaemia 11/9333 (0.1%) 8/9291 (0.1%)
    Diabetes Mellitus Inadequate Control 3/9333 (0%) 9/9291 (0.1%)
    Diabetes Mellitus 6/9333 (0.1%) 7/9291 (0.1%)
    Hyperglycaemia 7/9333 (0.1%) 2/9291 (0%)
    Hyperkalaemia 1/9333 (0%) 4/9291 (0%)
    Anorexia 3/9333 (0%) 0/9291 (0%)
    Hyponatraemia 3/9333 (0%) 1/9291 (0%)
    Diabetic Ketoacidosis 2/9333 (0%) 1/9291 (0%)
    Fluid Overload 0/9333 (0%) 2/9291 (0%)
    Gout 2/9333 (0%) 2/9291 (0%)
    Metabolic Acidosis 0/9333 (0%) 2/9291 (0%)
    Metabolic Disorder 0/9333 (0%) 2/9291 (0%)
    Type 2 Diabetes Mellitus 2/9333 (0%) 2/9291 (0%)
    Diabetic Foot 1/9333 (0%) 0/9291 (0%)
    Electrolyte Depletion 0/9333 (0%) 1/9291 (0%)
    Failure To Thrive 0/9333 (0%) 1/9291 (0%)
    Hyperosmolar State 0/9333 (0%) 1/9291 (0%)
    Hypokalaemia 1/9333 (0%) 1/9291 (0%)
    Hypovolaemia 1/9333 (0%) 0/9291 (0%)
    Ketoacidosis 1/9333 (0%) 0/9291 (0%)
    Metabolic Syndrome 0/9333 (0%) 1/9291 (0%)
    Musculoskeletal and connective tissue disorders
    Musculoskeletal Chest Pain 15/9333 (0.2%) 16/9291 (0.2%)
    Osteoarthritis 7/9333 (0.1%) 5/9291 (0.1%)
    Back Pain 3/9333 (0%) 6/9291 (0.1%)
    Musculoskeletal Pain 5/9333 (0.1%) 4/9291 (0%)
    Arthralgia 3/9333 (0%) 4/9291 (0%)
    Myalgia 3/9333 (0%) 3/9291 (0%)
    Pain In Extremity 3/9333 (0%) 2/9291 (0%)
    Arthritis 2/9333 (0%) 2/9291 (0%)
    Bone Pain 1/9333 (0%) 2/9291 (0%)
    Bursitis 2/9333 (0%) 1/9291 (0%)
    Costochondritis 2/9333 (0%) 1/9291 (0%)
    Gouty Arthritis 2/9333 (0%) 0/9291 (0%)
    Myalgia Intercostal 2/9333 (0%) 0/9291 (0%)
    Neck Pain 1/9333 (0%) 2/9291 (0%)
    Chondropathy 0/9333 (0%) 1/9291 (0%)
    Dupuytren's Contracture 0/9333 (0%) 1/9291 (0%)
    Groin Pain 1/9333 (0%) 0/9291 (0%)
    Intervertebral Disc Degeneration 0/9333 (0%) 1/9291 (0%)
    Intervertebral Disc Disorder 0/9333 (0%) 1/9291 (0%)
    Intervertebral Disc Protrusion 1/9333 (0%) 1/9291 (0%)
    Joint Swelling 1/9333 (0%) 0/9291 (0%)
    Lumbar Spinal Stenosis 0/9333 (0%) 1/9291 (0%)
    Monarthritis 1/9333 (0%) 0/9291 (0%)
    Muscle Tightness 1/9333 (0%) 0/9291 (0%)
    Muscular Weakness 1/9333 (0%) 1/9291 (0%)
    Myositis 0/9333 (0%) 1/9291 (0%)
    Osteochondrosis 1/9333 (0%) 0/9291 (0%)
    Osteolysis 1/9333 (0%) 0/9291 (0%)
    Osteoporosis 0/9333 (0%) 1/9291 (0%)
    Pain In Jaw 1/9333 (0%) 0/9291 (0%)
    Pathological Fracture 0/9333 (0%) 1/9291 (0%)
    Polyarthritis 1/9333 (0%) 0/9291 (0%)
    Polymyalgia Rheumatica 1/9333 (0%) 0/9291 (0%)
    Polymyositis 0/9333 (0%) 1/9291 (0%)
    Rhabdomyolysis 1/9333 (0%) 1/9291 (0%)
    Rheumatoid Arthritis 1/9333 (0%) 0/9291 (0%)
    Spinal Disorder 1/9333 (0%) 0/9291 (0%)
    Spinal Osteoarthritis 0/9333 (0%) 1/9291 (0%)
    Wrist Deformity 0/9333 (0%) 1/9291 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon Cancer 10/9333 (0.1%) 3/9291 (0%)
    Lung Neoplasm Malignant 6/9333 (0.1%) 10/9291 (0.1%)
    Breast Cancer 3/9333 (0%) 9/9291 (0.1%)
    Prostate Cancer 6/9333 (0.1%) 8/9291 (0.1%)
    Lung Neoplasm 7/9333 (0.1%) 5/9291 (0.1%)
    Bladder Cancer 2/9333 (0%) 6/9291 (0.1%)
    Colon Neoplasm 1/9333 (0%) 5/9291 (0.1%)
    Renal Neoplasm 5/9333 (0.1%) 3/9291 (0%)
    Bladder Neoplasm 0/9333 (0%) 3/9291 (0%)
    Brain Neoplasm 1/9333 (0%) 3/9291 (0%)
    Bronchial Carcinoma 1/9333 (0%) 3/9291 (0%)
    Gastric Cancer 3/9333 (0%) 3/9291 (0%)
    Metastases To Liver 0/9333 (0%) 3/9291 (0%)
    Rectal Cancer 3/9333 (0%) 2/9291 (0%)
    Bladder Transitional Cell Carcinoma 2/9333 (0%) 1/9291 (0%)
    Chronic Lymphocytic Leukaemia 2/9333 (0%) 1/9291 (0%)
    Gastrointestinal Neoplasm 2/9333 (0%) 0/9291 (0%)
    Hepatic Cancer Metastatic 2/9333 (0%) 1/9291 (0%)
    Laryngeal Cancer 0/9333 (0%) 2/9291 (0%)
    Lung Adenocarcinoma 2/9333 (0%) 0/9291 (0%)
    Lymphoma 2/9333 (0%) 1/9291 (0%)
    Malignant Melanoma 1/9333 (0%) 2/9291 (0%)
    Metastases To Bone 1/9333 (0%) 2/9291 (0%)
    Metastases To Lung 0/9333 (0%) 2/9291 (0%)
    Metastatic Neoplasm 2/9333 (0%) 0/9291 (0%)
    Oesophageal Carcinoma 0/9333 (0%) 2/9291 (0%)
    Ovarian Cancer 2/9333 (0%) 1/9291 (0%)
    Renal Cancer 2/9333 (0%) 1/9291 (0%)
    Abdominal Neoplasm 1/9333 (0%) 0/9291 (0%)
    Acute Myeloid Leukaemia 1/9333 (0%) 0/9291 (0%)
    Adenocarcinoma 1/9333 (0%) 0/9291 (0%)
    Adenocarcinoma Pancreas 0/9333 (0%) 1/9291 (0%)
    B-Cell Lymphoma 0/9333 (0%) 1/9291 (0%)
    Benign Duodenal Neoplasm 1/9333 (0%) 0/9291 (0%)
    Benign Neoplasm Of Skin 0/9333 (0%) 1/9291 (0%)
    Benign Uterine Neoplasm 0/9333 (0%) 1/9291 (0%)
    Bladder Cancer Recurrent 0/9333 (0%) 1/9291 (0%)
    Bone Neoplasm Malignant 0/9333 (0%) 1/9291 (0%)
    Brain Cancer Metastatic 0/9333 (0%) 1/9291 (0%)
    Breast Cancer Metastatic 1/9333 (0%) 0/9291 (0%)
    Bronchial Neoplasm 1/9333 (0%) 0/9291 (0%)
    Carcinoid Tumour Of The Caecum 1/9333 (0%) 1/9291 (0%)
    Carcinoid Tumour Of The Duodenum 0/9333 (0%) 1/9291 (0%)
    Chronic Leukaemia 1/9333 (0%) 1/9291 (0%)
    Colon Adenoma 1/9333 (0%) 1/9291 (0%)
    Colorectal Cancer 1/9333 (0%) 1/9291 (0%)
    Endometrial Cancer 1/9333 (0%) 0/9291 (0%)
    Extranodal Marginal Zone B-Cell Lymphoma (Malt Type) 1/9333 (0%) 0/9291 (0%)
    Gastric Neoplasm 1/9333 (0%) 0/9291 (0%)
    Gastrointestinal Carcinoma 1/9333 (0%) 1/9291 (0%)
    Glioblastoma 1/9333 (0%) 0/9291 (0%)
    Haemangioma Of Liver 1/9333 (0%) 0/9291 (0%)
    Hepatic Neoplasm 0/9333 (0%) 1/9291 (0%)
    Intestinal Adenocarcinoma 0/9333 (0%) 1/9291 (0%)
    Lip And/Or Oral Cavity Cancer 0/9333 (0%) 1/9291 (0%)
    Lung Cancer Metastatic 1/9333 (0%) 0/9291 (0%)
    Lymphangiosis Carcinomatosa 0/9333 (0%) 1/9291 (0%)
    Lymphocytic Lymphoma 1/9333 (0%) 0/9291 (0%)
    Malignant Pleural Effusion 1/9333 (0%) 0/9291 (0%)
    Meningioma 1/9333 (0%) 0/9291 (0%)
    Metastases To Central Nervous System 0/9333 (0%) 1/9291 (0%)
    Metastases To Lymph Nodes 1/9333 (0%) 0/9291 (0%)
    Myelodysplastic Syndrome 0/9333 (0%) 1/9291 (0%)
    Neoplasm Malignant 0/9333 (0%) 1/9291 (0%)
    Neoplasm Prostate 0/9333 (0%) 1/9291 (0%)
    Nipple Neoplasm 0/9333 (0%) 1/9291 (0%)
    Pancreatic Carcinoma Recurrent 1/9333 (0%) 0/9291 (0%)
    Pleural Mesothelioma 1/9333 (0%) 1/9291 (0%)
    Polycythaemia Vera 1/9333 (0%) 0/9291 (0%)
    Prostate Cancer Metastatic 1/9333 (0%) 1/9291 (0%)
    Prostate Cancer Recurrent 1/9333 (0%) 0/9291 (0%)
    Prostatic Adenoma 1/9333 (0%) 1/9291 (0%)
    Rectal Cancer Metastatic 1/9333 (0%) 0/9291 (0%)
    Renal Cancer Metastatic 0/9333 (0%) 1/9291 (0%)
    Retroperitoneal Neoplasm 0/9333 (0%) 1/9291 (0%)
    Small Cell Lung Cancer Metastatic 0/9333 (0%) 1/9291 (0%)
    Small Cell Lung Cancer Stage Unspecified 1/9333 (0%) 1/9291 (0%)
    Spinal Cord Neoplasm 0/9333 (0%) 1/9291 (0%)
    Squamous Cell Carcinoma 0/9333 (0%) 1/9291 (0%)
    Testis Cancer 1/9333 (0%) 0/9291 (0%)
    Thyroid Adenoma 1/9333 (0%) 0/9291 (0%)
    Thyroid Cancer Metastatic 1/9333 (0%) 0/9291 (0%)
    Thyroid Neoplasm 0/9333 (0%) 1/9291 (0%)
    Tongue Neoplasm 0/9333 (0%) 1/9291 (0%)
    Transitional Cell Carcinoma 0/9333 (0%) 1/9291 (0%)
    Uterine Leiomyoma 1/9333 (0%) 0/9291 (0%)
    Nervous system disorders
    Cerebrovascular Accident 75/9333 (0.8%) 50/9291 (0.5%)
    Syncope 32/9333 (0.3%) 30/9291 (0.3%)
    Ischaemic Stroke 20/9333 (0.2%) 28/9291 (0.3%)
    Transient Ischaemic Attack 19/9333 (0.2%) 23/9291 (0.2%)
    Dizziness 13/9333 (0.1%) 7/9291 (0.1%)
    Cerebral Haemorrhage 9/9333 (0.1%) 3/9291 (0%)
    Cerebral Infarction 7/9333 (0.1%) 8/9291 (0.1%)
    Presyncope 8/9333 (0.1%) 2/9291 (0%)
    Haemorrhagic Stroke 6/9333 (0.1%) 7/9291 (0.1%)
    Headache 6/9333 (0.1%) 3/9291 (0%)
    Haemorrhage Intracranial 5/9333 (0.1%) 2/9291 (0%)
    Paraesthesia 5/9333 (0.1%) 4/9291 (0%)
    Hemiparesis 4/9333 (0%) 2/9291 (0%)
    Loss Of Consciousness 4/9333 (0%) 2/9291 (0%)
    Parkinson's Disease 1/9333 (0%) 4/9291 (0%)
    Subarachnoid Haemorrhage 4/9333 (0%) 2/9291 (0%)
    Syncope Vasovagal 4/9333 (0%) 2/9291 (0%)
    Carotid Artery Stenosis 3/9333 (0%) 2/9291 (0%)
    Convulsion 3/9333 (0%) 3/9291 (0%)
    Depressed Level Of Consciousness 0/9333 (0%) 3/9291 (0%)
    Hypoaesthesia 2/9333 (0%) 3/9291 (0%)
    Hypotonia 3/9333 (0%) 0/9291 (0%)
    Migraine 3/9333 (0%) 1/9291 (0%)
    Altered State Of Consciousness 0/9333 (0%) 2/9291 (0%)
    Brain Stem Ischaemia 0/9333 (0%) 2/9291 (0%)
    Cerebral Ischaemia 2/9333 (0%) 1/9291 (0%)
    Cerebrovascular Disorder 0/9333 (0%) 2/9291 (0%)
    Dementia 0/9333 (0%) 2/9291 (0%)
    Encephalopathy 2/9333 (0%) 1/9291 (0%)
    Hypoxic Encephalopathy 0/9333 (0%) 2/9291 (0%)
    Neuralgia 2/9333 (0%) 0/9291 (0%)
    Partial Seizures 2/9333 (0%) 0/9291 (0%)
    Balance Disorder 1/9333 (0%) 0/9291 (0%)
    Brain Oedema 1/9333 (0%) 0/9291 (0%)
    Brain Stem Infarction 0/9333 (0%) 1/9291 (0%)
    Brain Stem Stroke 0/9333 (0%) 1/9291 (0%)
    Carotid Artery Disease 0/9333 (0%) 1/9291 (0%)
    Carotid Artery Occlusion 0/9333 (0%) 1/9291 (0%)
    Carotid Artery Thrombosis 0/9333 (0%) 1/9291 (0%)
    Carotid Sinus Syndrome 1/9333 (0%) 0/9291 (0%)
    Central Nervous System Lesion 1/9333 (0%) 0/9291 (0%)
    Cerebellar Infarction 1/9333 (0%) 0/9291 (0%)
    Cerebral Atrophy 0/9333 (0%) 1/9291 (0%)
    Cerebral Disorder 1/9333 (0%) 0/9291 (0%)
    Cerebrovascular Insufficiency 1/9333 (0%) 0/9291 (0%)
    Cervicobrachial Syndrome 0/9333 (0%) 1/9291 (0%)
    Cognitive Disorder 0/9333 (0%) 1/9291 (0%)
    Complex Partial Seizures 0/9333 (0%) 1/9291 (0%)
    Diabetic Hyperosmolar Coma 1/9333 (0%) 0/9291 (0%)
    Diabetic Neuropathy 1/9333 (0%) 0/9291 (0%)
    Dysphasia 0/9333 (0%) 1/9291 (0%)
    Embolic Cerebral Infarction 1/9333 (0%) 0/9291 (0%)
    Encephalitis 0/9333 (0%) 1/9291 (0%)
    Epilepsy 1/9333 (0%) 1/9291 (0%)
    Extrapyramidal Disorder 0/9333 (0%) 1/9291 (0%)
    Facial Paresis 1/9333 (0%) 0/9291 (0%)
    Febrile Convulsion 1/9333 (0%) 0/9291 (0%)
    Haemorrhagic Cerebral Infarction 1/9333 (0%) 0/9291 (0%)
    Hepatic Encephalopathy 0/9333 (0%) 1/9291 (0%)
    Intracranial Haematoma 0/9333 (0%) 1/9291 (0%)
    Ischaemic Cerebral Infarction 1/9333 (0%) 1/9291 (0%)
    Lacunar Infarction 1/9333 (0%) 0/9291 (0%)
    Lumbar Radiculopathy 1/9333 (0%) 0/9291 (0%)
    Mental Impairment 0/9333 (0%) 1/9291 (0%)
    Myelitis Transverse 0/9333 (0%) 1/9291 (0%)
    Narcolepsy 0/9333 (0%) 1/9291 (0%)
    Parkinsonism 0/9333 (0%) 1/9291 (0%)
    Phrenic Nerve Paralysis 1/9333 (0%) 0/9291 (0%)
    Post Herpetic Neuralgia 0/9333 (0%) 1/9291 (0%)
    Progressive Supranuclear Palsy 0/9333 (0%) 1/9291 (0%)
    Psychomotor Hyperactivity 0/9333 (0%) 1/9291 (0%)
    Sciatica 0/9333 (0%) 1/9291 (0%)
    Speech Disorder 1/9333 (0%) 0/9291 (0%)
    Spinal Cord Compression 0/9333 (0%) 1/9291 (0%)
    Spinal Cord Disorder 1/9333 (0%) 0/9291 (0%)
    Thalamus Haemorrhage 1/9333 (0%) 0/9291 (0%)
    Thrombotic Stroke 1/9333 (0%) 0/9291 (0%)
    Vascular Encephalopathy 1/9333 (0%) 0/9291 (0%)
    Vertebrobasilar Insufficiency 1/9333 (0%) 1/9291 (0%)
    Vith Nerve Paralysis 0/9333 (0%) 1/9291 (0%)
    Vocal Cord Paresis 1/9333 (0%) 0/9291 (0%)
    Psychiatric disorders
    Anxiety 9/9333 (0.1%) 6/9291 (0.1%)
    Depression 9/9333 (0.1%) 7/9291 (0.1%)
    Confusional State 4/9333 (0%) 2/9291 (0%)
    Suicide Attempt 1/9333 (0%) 2/9291 (0%)
    Acute Stress Disorder 1/9333 (0%) 1/9291 (0%)
    Agitation 1/9333 (0%) 0/9291 (0%)
    Alcohol Abuse 1/9333 (0%) 0/9291 (0%)
    Alcoholism 0/9333 (0%) 1/9291 (0%)
    Anxiety Disorder 1/9333 (0%) 1/9291 (0%)
    Completed Suicide 1/9333 (0%) 1/9291 (0%)
    Delirium 1/9333 (0%) 1/9291 (0%)
    Drug Abuse 0/9333 (0%) 1/9291 (0%)
    Insomnia 1/9333 (0%) 0/9291 (0%)
    Mania 1/9333 (0%) 0/9291 (0%)
    Mental Disorder 0/9333 (0%) 1/9291 (0%)
    Nervousness 0/9333 (0%) 1/9291 (0%)
    Neurosis 0/9333 (0%) 1/9291 (0%)
    Panic Attack 1/9333 (0%) 0/9291 (0%)
    Post-Traumatic Amnestic Disorder 1/9333 (0%) 0/9291 (0%)
    Psychotic Disorder 1/9333 (0%) 0/9291 (0%)
    Schizophrenia, Paranoid Type 0/9333 (0%) 1/9291 (0%)
    Sleep Disorder 1/9333 (0%) 0/9291 (0%)
    Suicidal Ideation 1/9333 (0%) 1/9291 (0%)
    Tension 1/9333 (0%) 0/9291 (0%)
    Transient Psychosis 1/9333 (0%) 0/9291 (0%)
    Renal and urinary disorders
    Renal Failure Acute 34/9333 (0.4%) 25/9291 (0.3%)
    Renal Failure 25/9333 (0.3%) 24/9291 (0.3%)
    Haematuria 15/9333 (0.2%) 10/9291 (0.1%)
    Renal Failure Chronic 7/9333 (0.1%) 7/9291 (0.1%)
    Urinary Retention 3/9333 (0%) 7/9291 (0.1%)
    Renal Impairment 5/9333 (0.1%) 4/9291 (0%)
    Calculus Ureteric 2/9333 (0%) 4/9291 (0%)
    Calculus Urinary 0/9333 (0%) 3/9291 (0%)
    Haemorrhage Urinary Tract 3/9333 (0%) 1/9291 (0%)
    Nephrolithiasis 3/9333 (0%) 3/9291 (0%)
    Nephropathy Toxic 3/9333 (0%) 2/9291 (0%)
    Renal Artery Stenosis 2/9333 (0%) 3/9291 (0%)
    Renal Colic 3/9333 (0%) 1/9291 (0%)
    Azotaemia 2/9333 (0%) 1/9291 (0%)
    Urinary Bladder Haemorrhage 2/9333 (0%) 0/9291 (0%)
    Urinary Bladder Polyp 0/9333 (0%) 2/9291 (0%)
    Anuria 1/9333 (0%) 1/9291 (0%)
    Bladder Mass 1/9333 (0%) 0/9291 (0%)
    Bladder Prolapse 0/9333 (0%) 1/9291 (0%)
    Bladder Tamponade 1/9333 (0%) 1/9291 (0%)
    Calculus Bladder 0/9333 (0%) 1/9291 (0%)
    Calculus Urethral 0/9333 (0%) 1/9291 (0%)
    Cystitis Haemorrhagic 0/9333 (0%) 1/9291 (0%)
    Cystitis Noninfective 0/9333 (0%) 1/9291 (0%)
    Dysuria 1/9333 (0%) 0/9291 (0%)
    Glomerulonephritis 1/9333 (0%) 0/9291 (0%)
    Glomerulonephritis Membranous 0/9333 (0%) 1/9291 (0%)
    Glomerulonephritis Minimal Lesion 0/9333 (0%) 1/9291 (0%)
    Hydronephrosis 0/9333 (0%) 1/9291 (0%)
    Nephritis Autoimmune 1/9333 (0%) 0/9291 (0%)
    Nephrotic Syndrome 0/9333 (0%) 1/9291 (0%)
    Obstructive Uropathy 0/9333 (0%) 1/9291 (0%)
    Oliguria 1/9333 (0%) 0/9291 (0%)
    Renal Artery Thrombosis 1/9333 (0%) 0/9291 (0%)
    Renal Disorder 1/9333 (0%) 0/9291 (0%)
    Renal Haemorrhage 1/9333 (0%) 0/9291 (0%)
    Renal Mass 1/9333 (0%) 1/9291 (0%)
    Urethral Haemorrhage 1/9333 (0%) 0/9291 (0%)
    Urinary Incontinence 0/9333 (0%) 1/9291 (0%)
    Urinary Tract Obstruction 0/9333 (0%) 1/9291 (0%)
    Reproductive system and breast disorders
    Benign Prostatic Hyperplasia 5/9333 (0.1%) 3/9291 (0%)
    Epididymitis 3/9333 (0%) 1/9291 (0%)
    Prostatitis 1/9333 (0%) 2/9291 (0%)
    Balanitis 0/9333 (0%) 1/9291 (0%)
    Cervical Dysplasia 1/9333 (0%) 0/9291 (0%)
    Menometrorrhagia 0/9333 (0%) 1/9291 (0%)
    Ovarian Cyst 0/9333 (0%) 1/9291 (0%)
    Prostatic Haemorrhage 1/9333 (0%) 1/9291 (0%)
    Prostatism 1/9333 (0%) 0/9291 (0%)
    Spermatocele 0/9333 (0%) 1/9291 (0%)
    Uterine Haemorrhage 1/9333 (0%) 0/9291 (0%)
    Vaginal Haemorrhage 0/9333 (0%) 1/9291 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 75/9333 (0.8%) 50/9291 (0.5%)
    Pulmonary Oedema 33/9333 (0.4%) 53/9291 (0.6%)
    Acute Pulmonary Oedema 20/9333 (0.2%) 32/9291 (0.3%)
    Pulmonary Embolism 31/9333 (0.3%) 20/9291 (0.2%)
    Chronic Obstructive Pulmonary Disease 22/9333 (0.2%) 17/9291 (0.2%)
    Pleural Effusion 21/9333 (0.2%) 19/9291 (0.2%)
    Respiratory Failure 16/9333 (0.2%) 16/9291 (0.2%)
    Epistaxis 15/9333 (0.2%) 9/9291 (0.1%)
    Pneumothorax 3/9333 (0%) 9/9291 (0.1%)
    Haemoptysis 7/9333 (0.1%) 8/9291 (0.1%)
    Acute Respiratory Failure 5/9333 (0.1%) 6/9291 (0.1%)
    Pneumonia Aspiration 3/9333 (0%) 6/9291 (0.1%)
    Asthma 5/9333 (0.1%) 3/9291 (0%)
    Hydrothorax 2/9333 (0%) 5/9291 (0.1%)
    Pulmonary Congestion 5/9333 (0.1%) 3/9291 (0%)
    Acute Respiratory Distress Syndrome 4/9333 (0%) 3/9291 (0%)
    Aspiration 0/9333 (0%) 3/9291 (0%)
    Cough 3/9333 (0%) 0/9291 (0%)
    Dyspnoea Exertional 3/9333 (0%) 2/9291 (0%)
    Haemothorax 0/9333 (0%) 3/9291 (0%)
    Pleuritic Pain 0/9333 (0%) 3/9291 (0%)
    Pneumonitis 3/9333 (0%) 0/9291 (0%)
    Pulmonary Mass 3/9333 (0%) 0/9291 (0%)
    Respiratory Arrest 2/9333 (0%) 3/9291 (0%)
    Bronchospasm 2/9333 (0%) 1/9291 (0%)
    Hyperventilation 2/9333 (0%) 1/9291 (0%)
    Lung Disorder 2/9333 (0%) 1/9291 (0%)
    Pleurisy 2/9333 (0%) 2/9291 (0%)
    Pulmonary Haemorrhage 1/9333 (0%) 2/9291 (0%)
    Alveolitis Fibrosing 0/9333 (0%) 1/9291 (0%)
    Apnoea 0/9333 (0%) 1/9291 (0%)
    Atelectasis 1/9333 (0%) 0/9291 (0%)
    Brain Hypoxia 0/9333 (0%) 1/9291 (0%)
    Bronchial Haemorrhage 1/9333 (0%) 0/9291 (0%)
    Bronchial Obstruction 1/9333 (0%) 0/9291 (0%)
    Bronchitis Chronic 1/9333 (0%) 0/9291 (0%)
    Dyspnoea Paroxysmal Nocturnal 0/9333 (0%) 1/9291 (0%)
    Emphysema 1/9333 (0%) 0/9291 (0%)
    Hypoxia 0/9333 (0%) 1/9291 (0%)
    Interstitial Lung Disease 0/9333 (0%) 1/9291 (0%)
    Laryngeal Leukoplakia 1/9333 (0%) 0/9291 (0%)
    Laryngeal Oedema 1/9333 (0%) 1/9291 (0%)
    Laryngeal Stenosis 0/9333 (0%) 1/9291 (0%)
    Laryngospasm 1/9333 (0%) 0/9291 (0%)
    Lower Respiratory Tract Inflammation 1/9333 (0%) 0/9291 (0%)
    Lung Consolidation 1/9333 (0%) 0/9291 (0%)
    Mediastinal Haematoma 0/9333 (0%) 1/9291 (0%)
    Mediastinal Haemorrhage 0/9333 (0%) 1/9291 (0%)
    Nasal Polyps 0/9333 (0%) 1/9291 (0%)
    Nocturnal Dyspnoea 1/9333 (0%) 0/9291 (0%)
    Pulmonary Alveolar Haemorrhage 1/9333 (0%) 0/9291 (0%)
    Pulmonary Fibrosis 1/9333 (0%) 0/9291 (0%)
    Pulmonary Haematoma 0/9333 (0%) 1/9291 (0%)
    Respiratory Distress 1/9333 (0%) 0/9291 (0%)
    Respiratory Tract Haemorrhage 1/9333 (0%) 1/9291 (0%)
    Rhinorrhoea 1/9333 (0%) 0/9291 (0%)
    Systemic Sclerosis Pulmonary 0/9333 (0%) 1/9291 (0%)
    Tachypnoea 1/9333 (0%) 0/9291 (0%)
    Thoracic Haemorrhage 0/9333 (0%) 1/9291 (0%)
    Tonsillar Disorder 1/9333 (0%) 0/9291 (0%)
    Tracheal Stenosis 0/9333 (0%) 1/9291 (0%)
    Vocal Cord Polyp 1/9333 (0%) 1/9291 (0%)
    Wegener's Granulomatosis 0/9333 (0%) 1/9291 (0%)
    Wheezing 1/9333 (0%) 0/9291 (0%)
    Skin and subcutaneous tissue disorders
    Dermatitis Allergic 1/9333 (0%) 6/9291 (0.1%)
    Angioedema 3/9333 (0%) 4/9291 (0%)
    Rash 4/9333 (0%) 3/9291 (0%)
    Urticaria 3/9333 (0%) 4/9291 (0%)
    Pruritus 1/9333 (0%) 3/9291 (0%)
    Skin Ulcer 3/9333 (0%) 0/9291 (0%)
    Decubitus Ulcer 2/9333 (0%) 0/9291 (0%)
    Hyperhidrosis 2/9333 (0%) 0/9291 (0%)
    Skin Necrosis 2/9333 (0%) 1/9291 (0%)
    Alopecia 0/9333 (0%) 1/9291 (0%)
    Blister 0/9333 (0%) 1/9291 (0%)
    Dermatitis 1/9333 (0%) 0/9291 (0%)
    Dermatomyositis 1/9333 (0%) 0/9291 (0%)
    Dry Gangrene 1/9333 (0%) 1/9291 (0%)
    Eczema Nummular 0/9333 (0%) 1/9291 (0%)
    Erythema 0/9333 (0%) 1/9291 (0%)
    Hypoaesthesia Facial 0/9333 (0%) 1/9291 (0%)
    Increased Tendency To Bruise 1/9333 (0%) 0/9291 (0%)
    Leukocytoclastic Vasculitis 0/9333 (0%) 1/9291 (0%)
    Pruritus Generalised 1/9333 (0%) 0/9291 (0%)
    Rash Erythematous 1/9333 (0%) 0/9291 (0%)
    Rash Generalised 1/9333 (0%) 0/9291 (0%)
    Seborrhoeic Dermatitis 0/9333 (0%) 1/9291 (0%)
    Skin Inflammation 1/9333 (0%) 0/9291 (0%)
    Wound Haemorrhage 1/9333 (0%) 0/9291 (0%)
    Surgical and medical procedures
    Cardiac Pacemaker Insertion 1/9333 (0%) 0/9291 (0%)
    Coronary Artery Bypass 1/9333 (0%) 1/9291 (0%)
    Implantable Defibrillator Insertion 0/9333 (0%) 1/9291 (0%)
    Leg Amputation 1/9333 (0%) 0/9291 (0%)
    Thoracic Cavity Drainage 0/9333 (0%) 1/9291 (0%)
    Vascular disorders
    Hypertension 17/9333 (0.2%) 24/9291 (0.3%)
    Hypotension 18/9333 (0.2%) 21/9291 (0.2%)
    Hypertensive Crisis 7/9333 (0.1%) 12/9291 (0.1%)
    Peripheral Ischaemia 10/9333 (0.1%) 7/9291 (0.1%)
    Haematoma 3/9333 (0%) 8/9291 (0.1%)
    Aortic Aneurysm 0/9333 (0%) 7/9291 (0.1%)
    Shock 7/9333 (0.1%) 3/9291 (0%)
    Deep Vein Thrombosis 6/9333 (0.1%) 6/9291 (0.1%)
    Intermittent Claudication 6/9333 (0.1%) 6/9291 (0.1%)
    Accelerated Hypertension 1/9333 (0%) 5/9291 (0.1%)
    Arterial Thrombosis Limb 5/9333 (0.1%) 4/9291 (0%)
    Peripheral Arterial Occlusive Disease 4/9333 (0%) 5/9291 (0.1%)
    Peripheral Vascular Disorder 5/9333 (0.1%) 3/9291 (0%)
    Aortic Dissection 2/9333 (0%) 4/9291 (0%)
    Arterial Thrombosis 1/9333 (0%) 4/9291 (0%)
    Circulatory Collapse 4/9333 (0%) 0/9291 (0%)
    Orthostatic Hypotension 4/9333 (0%) 3/9291 (0%)
    Aortic Stenosis 0/9333 (0%) 3/9291 (0%)
    Arteriosclerosis 3/9333 (0%) 3/9291 (0%)
    Femoral Artery Aneurysm 1/9333 (0%) 3/9291 (0%)
    Haemorrhage 2/9333 (0%) 3/9291 (0%)
    Hypertensive Emergency 3/9333 (0%) 3/9291 (0%)
    Hypovolaemic Shock 3/9333 (0%) 2/9291 (0%)
    Thrombophlebitis 2/9333 (0%) 3/9291 (0%)
    Venous Thrombosis 2/9333 (0%) 3/9291 (0%)
    Aortic Aneurysm Rupture 2/9333 (0%) 1/9291 (0%)
    Arterial Occlusive Disease 2/9333 (0%) 2/9291 (0%)
    Arteriosclerosis Obliterans 1/9333 (0%) 2/9291 (0%)
    Arteriovenous Fistula 2/9333 (0%) 1/9291 (0%)
    Artery Dissection 2/9333 (0%) 0/9291 (0%)
    Cardiovascular Insufficiency 2/9333 (0%) 1/9291 (0%)
    Femoral Artery Occlusion 2/9333 (0%) 2/9291 (0%)
    Iliac Artery Stenosis 1/9333 (0%) 2/9291 (0%)
    Leriche Syndrome 2/9333 (0%) 1/9291 (0%)
    Shock Haemorrhagic 2/9333 (0%) 0/9291 (0%)
    Thrombophlebitis Superficial 2/9333 (0%) 1/9291 (0%)
    Thrombosis 2/9333 (0%) 0/9291 (0%)
    Venous Thrombosis Limb 0/9333 (0%) 2/9291 (0%)
    Aneurysm 0/9333 (0%) 1/9291 (0%)
    Aneurysm Ruptured 1/9333 (0%) 0/9291 (0%)
    Angiodysplasia 1/9333 (0%) 0/9291 (0%)
    Aortic Dilatation 1/9333 (0%) 1/9291 (0%)
    Arterial Disorder 1/9333 (0%) 0/9291 (0%)
    Arterial Rupture 0/9333 (0%) 1/9291 (0%)
    Arteritis 0/9333 (0%) 1/9291 (0%)
    Bleeding Varicose Vein 1/9333 (0%) 0/9291 (0%)
    Blood Pressure Inadequately Controlled 0/9333 (0%) 1/9291 (0%)
    Embolism 1/9333 (0%) 0/9291 (0%)
    Embolism Venous 1/9333 (0%) 0/9291 (0%)
    Extremity Necrosis 1/9333 (0%) 1/9291 (0%)
    Femoral Arterial Stenosis 0/9333 (0%) 1/9291 (0%)
    Haemodynamic Instability 1/9333 (0%) 0/9291 (0%)
    Iliac Artery Occlusion 0/9333 (0%) 1/9291 (0%)
    Iliac Artery Thrombosis 1/9333 (0%) 0/9291 (0%)
    Peripheral Artery Aneurysm 0/9333 (0%) 1/9291 (0%)
    Peripheral Artery Dissection 1/9333 (0%) 0/9291 (0%)
    Peripheral Embolism 1/9333 (0%) 1/9291 (0%)
    Phlebitis 0/9333 (0%) 1/9291 (0%)
    Reperfusion Injury 0/9333 (0%) 1/9291 (0%)
    Subclavian Artery Stenosis 0/9333 (0%) 1/9291 (0%)
    Subclavian Artery Thrombosis 0/9333 (0%) 1/9291 (0%)
    Subclavian Vein Thrombosis 1/9333 (0%) 0/9291 (0%)
    Vascular Occlusion 1/9333 (0%) 0/9291 (0%)
    Vasculitis 1/9333 (0%) 0/9291 (0%)
    Vena Cava Thrombosis 1/9333 (0%) 0/9291 (0%)
    Venous Insufficiency 0/9333 (0%) 1/9291 (0%)
    Other (Not Including Serious) Adverse Events
    TICAGRELOR CLOPIDOGREL
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2278/ (NaN) 1665/ (NaN)
    Nervous system disorders
    Headache 621/9333 (6.7%) 565/9291 (6.1%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 1106/9333 (11.9%) 623/9291 (6.7%)
    Epistaxis 566/9333 (6.1%) 317/9291 (3.4%)
    Cough 490/9333 (5.3%) 467/9291 (5%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    An Investigator agrees to provide a copy of the publication to AstraZeneca (AZ) for review at least 60 days in advance of submission for publication. Investigators in multicenter (MC) studies agree to postpone MC publications until the earlier of the date of the first AZ-authorized MC publication or a period up to 18 months from study completion at all sites.

    Results Point of Contact

    Name/Title Gerard Lynch
    Organization AstraZeneca
    Phone
    Email aztrial_results_posting@astrazeneca.com
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00391872
    Other Study ID Numbers:
    • D5130C05262
    • PLATO
    First Posted:
    Oct 25, 2006
    Last Update Posted:
    Mar 13, 2012
    Last Verified:
    Feb 1, 2012