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DAPA-HF: Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT03036124
Collaborator
(none)
4,744
Enrollment
419
Locations
2
Arms
29.2
Actual Duration (Months)
11.3
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of worsening heart failure or cardiovascular death in patients with chronic heart failure with reduced ejection fraction

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This is an international, multicentre, parallel group, event-driven, randomized, double-blind, placebo-controlled study in patients with chronic heart failure with reduced ejection fraction (HFrEF), evaluating the effect of dapagliflozin versus placebo, given once daily in addition to background regional standard of care therapy, for the prevention of cardiovascular (CV) death or reduction of heart failure (HF) events.

Study Design

Study Type:
Interventional
Actual Enrollment :
4744 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure With Reduced Ejection Fraction
Actual Study Start Date :
Feb 8, 2017
Actual Primary Completion Date :
Jul 17, 2019
Actual Study Completion Date :
Jul 17, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dapagliflozin

Patients will be randomized 1:1 to either dapagliflozin or placebo.

Drug: Dapagliflozin
10 mg or 5 mg tablets given once daily, per oral use.
Other Names:
  • Forxiga TM
  • Farxiga TM

    		•
    Placebo Comparator: Placebo

    Placebo matching dapagliflozin.

    Drug: Placebo
    Placebo matching dapagliflozin 10 mg or 5 mg.

    Outcome Measures

    Primary Outcome Measures

    1. Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure. [Up to 27.8 months.]

      Primary efficacy

    Secondary Outcome Measures

    1. Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure. [Up to 27.8 months.]

      Secondary

    2. Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death. [Up to 27.8 months.]

      Secondary

    3. Change From Baseline in the KCCQ Total Symptom Score [Baseline and 8 months or death before 8 months]

      KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ total symptom score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

    4. Subjects Included in the Composite Endpoint of ≥50% Sustained Decline in eGFR, ESRD or Renal Death. [Up to 27.8 months.]

      Secondary

    5. Subjects Included in the Endpoint of All-cause Mortality. [Up to 27.8 months.]

      Secondary

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 130 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Provision of signed informed consent prior to any study specific procedures

    • Male or female, aged ≥18 years

    • Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months

    • LVEF≤40%

    • Elevated NT-proBNP levels

    • Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines

    • eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)

    Exclusion Criteria:

    • Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor

    • Type 1 diabetes mellitus

    • Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2

    • Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment

    • MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment

    • Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization

    • Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device

    • Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization

    • HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease

    • Symptomatic bradycardia or second or third degree heart block without a pacemaker

    • Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization

    Contacts and Locations

    Locations

    Site City State Country Postal Code
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    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT03036124
    Other Study ID Numbers:
    • D1699C00001
    • 2016-003897-41
    First Posted:
    Jan 30, 2017
    Last Update Posted:
    Sep 1, 2020
    Last Verified:
    Aug 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AstraZeneca
    HFrEF
    Heart Failure (HF)
    Cardiovascular Events (CV)
    Phase III outcome trial
    Additional relevant MeSH terms:
    Heart Failure
    Dapagliflozin

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Dapa 10mg Placebo
    Arm/Group Description Dapagliflozin 10 mg, given once daily per oral use. Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
    Period Title: Overall Study
    STARTED 2373 2371
    COMPLETED 2368 2365
    NOT COMPLETED 5 6

    Baseline Characteristics

    Arm/Group Title Dapa 10mg Placebo Total
    Arm/Group Description Dapagliflozin 10 mg, given once daily per oral use. Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use. Total of all reporting groups
    Overall Participants 2373 2371 4744
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    66.2
    (11.0)
    66.5
    (10.8)
    66.3
    (10.9)
    Age, Customized (Count of Participants)
    <=50
    208
    8.8%
    188
    7.9%
    396
    8.3%
    >50
    2165
    91.2%
    2183
    92.1%
    4348
    91.7%
    Age, Customized (Count of Participants)
    <=65
    1032
    43.5%
    998
    42.1%
    2030
    42.8%
    >65
    1341
    56.5%
    1373
    57.9%
    2714
    57.2%
    Age, Customized (Count of Participants)
    <=65
    1032
    43.5%
    998
    42.1%
    2030
    42.8%
    66 - 75
    825
    34.8%
    886
    37.4%
    1711
    36.1%
    >75
    516
    21.7%
    487
    20.5%
    1003
    21.1%
    Sex: Female, Male (Count of Participants)
    Female
    564
    23.8%
    545
    23%
    1109
    23.4%
    Male
    1809
    76.2%
    1826
    77%
    3635
    76.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    381
    16.1%
    387
    16.3%
    768
    16.2%
    Not Hispanic or Latino
    1992
    83.9%
    1984
    83.7%
    3976
    83.8%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    White
    1662
    70%
    1671
    70.5%
    3333
    70.3%
    Black or African American
    122
    5.1%
    104
    4.4%
    226
    4.8%
    Asian
    552
    23.3%
    564
    23.8%
    1116
    23.5%
    Native Hawaiian or other Pacific Islander
    0
    0%
    2
    0.1%
    2
    0%
    American Indian or Alaska Native
    3
    0.1%
    1
    0%
    4
    0.1%
    Other
    34
    1.4%
    29
    1.2%
    63
    1.3%
    Main etiology of HF (Count of Participants)
    Ischaemic
    1316
    55.5%
    1358
    57.3%
    2674
    56.4%
    Non-Ischaemic
    857
    36.1%
    830
    35%
    1687
    35.6%
    Unknown
    200
    8.4%
    183
    7.7%
    383
    8.1%
    Prior HF hospitalization (Count of Participants)
    Yes
    1124
    47.4%
    1127
    47.5%
    2251
    47.4%
    NYHA class at enrollment (Count of Participants)
    II
    1606
    67.7%
    1597
    67.4%
    3203
    67.5%
    III
    747
    31.5%
    751
    31.7%
    1498
    31.6%
    IV
    20
    0.8%
    23
    1%
    43
    0.9%
    Type 2 diabetes at baseline (Count of Participants)
    Yes
    1075
    45.3%
    1064
    44.9%
    2139
    45.1%
    No
    1298
    54.7%
    1307
    55.1%
    2605
    54.9%
    LVEF (Percentage of blood leaving the heart) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Percentage of blood leaving the heart]
    31.2
    (6.7)
    30.9
    (6.9)
    31.1
    (6.8)

    Outcome Measures

    1. Primary Outcome
    Title Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.
    Description Primary efficacy
    Time Frame Up to 27.8 months.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Dapa 10 mg Placebo
    Arm/Group Description Dapagliflozin 10 mg tablets administered orally once daily Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
    Measure Participants 2373 2371
    Count of Participants [Participants]
    386
    16.3%
    502
    21.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Regression, Cox
    Comments Stratified by Type 2 Diabetes status at randomization and including the history of hospitalizations due to Heart failure as a factor.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.74
    Confidence Interval () 95%
    0.65 to 0.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.
    Description Secondary
    Time Frame Up to 27.8 months.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Dapa 10 mg Placebo
    Arm/Group Description Dapagliflozin 10 mg tablets administered orally once daily Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
    Measure Participants 2373 2371
    Count of Participants [Participants]
    382
    16.1%
    495
    20.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Regression, Cox
    Comments Stratified by Type 2 Diabetes status at randomization and including the history of hospitalizations due to Heart failure as a factor.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.75
    Confidence Interval () 95%
    0.65 to 0.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death.
    Description Secondary
    Time Frame Up to 27.8 months.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Dapa 10 mg Placebo
    Arm/Group Description Dapagliflozin 10 mg tablets administered orally once daily Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
    Measure Participants 2373 2371
    Number [events]
    567
    742
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method LWYY proportional rates model
    Comments Stratified by Type 2 Diabetes status at randomization and including the history of hospitalizations due to Heart failure as a factor.
    Method of Estimation Estimation Parameter Rate Ratio (RR)
    Estimated Value 0.75
    Confidence Interval () 95%
    0.65 to 0.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Change From Baseline in the KCCQ Total Symptom Score
    Description KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ total symptom score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
    Time Frame Baseline and 8 months or death before 8 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Dapa 10 mg Placebo
    Arm/Group Description Dapagliflozin 10 mg tablets administered orally once daily Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
    Measure Participants 2373 2371
    Mean (Standard Deviation) [Scores on a scale]
    6.1
    (18.6)
    3.3
    (19.2)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments The p-value is obtained from a rank ANCOVA adjusted for baseline KCCQ score and stratified by T2DM status at randomization.
    Method Win Ratio
    Comments Stratified by Type 2 Diabetes status at randomization and including baseline score as a covariate.
    Method of Estimation Estimation Parameter Win Ratio (WR)
    Estimated Value 1.18
    Confidence Interval () 95%
    1.11 to 1.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments The composite of change from baseline in total symptom score at 8 months, or death before 8 months.
    5. Secondary Outcome
    Title Subjects Included in the Composite Endpoint of ≥50% Sustained Decline in eGFR, ESRD or Renal Death.
    Description Secondary
    Time Frame Up to 27.8 months.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Dapa 10 mg Placebo
    Arm/Group Description Dapagliflozin 10 mg tablets administered orally once daily Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
    Measure Participants 2373 2371
    Count of Participants [Participants]
    28
    1.2%
    39
    1.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1681
    Comments
    Method Regression, Cox
    Comments Stratified by Type 2 Diabetes status at randomization and including baseline eGFR as a covariate.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.71
    Confidence Interval () 95%
    0.44 to 1.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Subjects Included in the Endpoint of All-cause Mortality.
    Description Secondary
    Time Frame Up to 27.8 months.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Dapa 10 mg Placebo
    Arm/Group Description Dapagliflozin 10 mg tablets administered orally once daily Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
    Measure Participants 2373 2371
    Count of Participants [Participants]
    276
    11.6%
    329
    13.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0217
    Comments
    Method Regression, Cox
    Comments Stratified by Type 2 Diabetes status at randomization.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.83
    Confidence Interval () 95%
    0.71 to 0.97
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame Up to 28.3 months.
    Adverse Event Reporting Description For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
    Arm/Group Title Dapa 10mg Placebo
    Arm/Group Description Dapagliflozin 10 mg, given once daily per oral use. Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
    All Cause Mortality
    Dapa 10mg Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 286/2368 (12.1%) 333/2368 (14.1%)
    Serious Adverse Events
    Dapa 10mg Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 895/2368 (37.8%) 994/2368 (42%)
    Blood and lymphatic system disorders
    Anaemia 3/2368 (0.1%) 4 11/2368 (0.5%) 13
    Blood loss anaemia 1/2368 (0%) 1 2/2368 (0.1%) 2
    Coagulopathy 0/2368 (0%) 0 1/2368 (0%) 1
    Febrile neutropenia 1/2368 (0%) 1 1/2368 (0%) 1
    Iron deficiency anaemia 2/2368 (0.1%) 2 0/2368 (0%) 0
    Leukopenia 1/2368 (0%) 1 1/2368 (0%) 1
    Splenic infarction 1/2368 (0%) 1 0/2368 (0%) 0
    Cardiac disorders
    Acute coronary syndrome 5/2368 (0.2%) 6 3/2368 (0.1%) 3
    Acute left ventricular failure 2/2368 (0.1%) 2 5/2368 (0.2%) 5
    Acute myocardial infarction 37/2368 (1.6%) 37 38/2368 (1.6%) 40
    Angina pectoris 12/2368 (0.5%) 12 12/2368 (0.5%) 12
    Angina unstable 21/2368 (0.9%) 24 30/2368 (1.3%) 31
    Aortic valve incompetence 1/2368 (0%) 1 1/2368 (0%) 1
    Aortic valve stenosis 1/2368 (0%) 1 0/2368 (0%) 0
    Arrhythmia 2/2368 (0.1%) 2 8/2368 (0.3%) 8
    Arteriosclerosis coronary artery 0/2368 (0%) 0 2/2368 (0.1%) 2
    Atrial fibrillation 26/2368 (1.1%) 27 39/2368 (1.6%) 43
    Atrial flutter 8/2368 (0.3%) 9 3/2368 (0.1%) 3
    Atrial tachycardia 0/2368 (0%) 0 2/2368 (0.1%) 2
    Atrial thrombosis 1/2368 (0%) 1 0/2368 (0%) 0
    Atrioventricular block complete 3/2368 (0.1%) 3 4/2368 (0.2%) 4
    Atrioventricular block second degree 1/2368 (0%) 1 1/2368 (0%) 1
    Bradyarrhythmia 0/2368 (0%) 0 1/2368 (0%) 1
    Bradycardia 2/2368 (0.1%) 2 7/2368 (0.3%) 7
    Bundle branch block left 1/2368 (0%) 1 0/2368 (0%) 0
    Cardiac aneurysm 1/2368 (0%) 1 0/2368 (0%) 0
    Cardiac arrest 9/2368 (0.4%) 9 10/2368 (0.4%) 10
    Cardiac disorder 1/2368 (0%) 1 0/2368 (0%) 0
    Cardiac failure 262/2368 (11.1%) 380 351/2368 (14.8%) 523
    Cardiac failure acute 42/2368 (1.8%) 58 59/2368 (2.5%) 75
    Cardiac failure chronic 27/2368 (1.1%) 32 33/2368 (1.4%) 46
    Cardiac failure congestive 65/2368 (2.7%) 102 70/2368 (3%) 106
    Cardiac tamponade 1/2368 (0%) 1 0/2368 (0%) 0
    Cardiac valve disease 0/2368 (0%) 0 1/2368 (0%) 1
    Cardio-respiratory arrest 2/2368 (0.1%) 2 2/2368 (0.1%) 2
    Cardiogenic shock 9/2368 (0.4%) 10 15/2368 (0.6%) 16
    Cardiomyopathy 2/2368 (0.1%) 2 0/2368 (0%) 0
    Cardiopulmonary failure 2/2368 (0.1%) 2 1/2368 (0%) 1
    Cardiorenal syndrome 1/2368 (0%) 1 3/2368 (0.1%) 3
    Cardiovascular insufficiency 1/2368 (0%) 1 0/2368 (0%) 0
    Chronic left ventricular failure 2/2368 (0.1%) 2 0/2368 (0%) 0
    Congestive cardiomyopathy 2/2368 (0.1%) 2 4/2368 (0.2%) 4
    Coronary artery disease 9/2368 (0.4%) 10 8/2368 (0.3%) 8
    Coronary artery insufficiency 0/2368 (0%) 0 2/2368 (0.1%) 2
    Coronary artery stenosis 1/2368 (0%) 1 3/2368 (0.1%) 3
    Extrasystoles 1/2368 (0%) 1 1/2368 (0%) 1
    Frederick's syndrome 1/2368 (0%) 1 0/2368 (0%) 0
    Ischaemic cardiomyopathy 2/2368 (0.1%) 2 1/2368 (0%) 1
    Left ventricular dysfunction 1/2368 (0%) 1 0/2368 (0%) 0
    Left ventricular failure 2/2368 (0.1%) 2 4/2368 (0.2%) 5
    Low cardiac output syndrome 0/2368 (0%) 0 1/2368 (0%) 1
    Mitral valve incompetence 0/2368 (0%) 0 3/2368 (0.1%) 3
    Myocardial fibrosis 1/2368 (0%) 1 0/2368 (0%) 0
    Myocardial infarction 16/2368 (0.7%) 16 17/2368 (0.7%) 17
    Myocardial ischaemia 3/2368 (0.1%) 3 4/2368 (0.2%) 4
    Palpitations 1/2368 (0%) 1 2/2368 (0.1%) 2
    Pericardial effusion 1/2368 (0%) 1 1/2368 (0%) 1
    Pericarditis 1/2368 (0%) 1 1/2368 (0%) 1
    Prosthetic cardiac valve thrombosis 0/2368 (0%) 0 2/2368 (0.1%) 2
    Pulseless electrical activity 1/2368 (0%) 1 0/2368 (0%) 0
    Right ventricular failure 1/2368 (0%) 1 3/2368 (0.1%) 3
    Sinus node dysfunction 3/2368 (0.1%) 3 1/2368 (0%) 1
    Sinus tachycardia 1/2368 (0%) 1 0/2368 (0%) 0
    Supraventricular tachycardia 3/2368 (0.1%) 3 3/2368 (0.1%) 3
    Tachyarrhythmia 1/2368 (0%) 1 2/2368 (0.1%) 2
    Tachycardia 0/2368 (0%) 0 2/2368 (0.1%) 2
    Torsade de pointes 2/2368 (0.1%) 2 0/2368 (0%) 0
    Tricuspid valve incompetence 1/2368 (0%) 1 0/2368 (0%) 0
    Ventricular arrhythmia 6/2368 (0.3%) 6 7/2368 (0.3%) 8
    Ventricular extrasystoles 4/2368 (0.2%) 4 1/2368 (0%) 1
    Ventricular fibrillation 11/2368 (0.5%) 11 6/2368 (0.3%) 7
    Ventricular tachyarrhythmia 1/2368 (0%) 1 0/2368 (0%) 0
    Ventricular tachycardia 34/2368 (1.4%) 41 54/2368 (2.3%) 65
    Ear and labyrinth disorders
    Vertigo 0/2368 (0%) 0 2/2368 (0.1%) 2
    Vertigo positional 1/2368 (0%) 1 3/2368 (0.1%) 3
    Vestibular disorder 1/2368 (0%) 1 0/2368 (0%) 0
    Endocrine disorders
    Hyperthyroidism 2/2368 (0.1%) 2 1/2368 (0%) 1
    Hypothyroidism 0/2368 (0%) 0 1/2368 (0%) 1
    Eye disorders
    Angle closure glaucoma 1/2368 (0%) 1 0/2368 (0%) 0
    Cataract 4/2368 (0.2%) 4 8/2368 (0.3%) 8
    Diabetic retinopathy 0/2368 (0%) 0 1/2368 (0%) 2
    Glaucoma 1/2368 (0%) 1 3/2368 (0.1%) 3
    Optic ischaemic neuropathy 1/2368 (0%) 1 0/2368 (0%) 0
    Retinal artery occlusion 1/2368 (0%) 1 0/2368 (0%) 0
    Retinal detachment 0/2368 (0%) 0 1/2368 (0%) 1
    Strabismus 0/2368 (0%) 0 1/2368 (0%) 1
    Vision blurred 0/2368 (0%) 0 1/2368 (0%) 1
    Vitreous haemorrhage 0/2368 (0%) 0 2/2368 (0.1%) 2
    Gastrointestinal disorders
    Abdominal adhesions 1/2368 (0%) 1 0/2368 (0%) 0
    Abdominal distension 0/2368 (0%) 0 1/2368 (0%) 1
    Abdominal pain 4/2368 (0.2%) 4 3/2368 (0.1%) 4
    Abdominal wall haematoma 0/2368 (0%) 0 1/2368 (0%) 1
    Ascites 2/2368 (0.1%) 2 1/2368 (0%) 1
    Chronic gastritis 1/2368 (0%) 1 2/2368 (0.1%) 2
    Constipation 1/2368 (0%) 1 1/2368 (0%) 1
    Diarrhoea 4/2368 (0.2%) 4 4/2368 (0.2%) 4
    Diverticulum intestinal 1/2368 (0%) 1 2/2368 (0.1%) 2
    Diverticulum intestinal haemorrhagic 1/2368 (0%) 1 0/2368 (0%) 0
    Duodenal ulcer haemorrhage 0/2368 (0%) 0 1/2368 (0%) 1
    Duodenal ulcer perforation 1/2368 (0%) 1 1/2368 (0%) 1
    Duodenitis 0/2368 (0%) 0 1/2368 (0%) 1
    Dyspepsia 2/2368 (0.1%) 2 1/2368 (0%) 1
    Enteritis 0/2368 (0%) 0 1/2368 (0%) 1
    Gastric haemorrhage 1/2368 (0%) 1 0/2368 (0%) 0
    Gastric ulcer 1/2368 (0%) 1 1/2368 (0%) 1
    Gastric ulcer haemorrhage 2/2368 (0.1%) 2 2/2368 (0.1%) 2
    Gastritis 2/2368 (0.1%) 2 5/2368 (0.2%) 5
    Gastritis erosive 2/2368 (0.1%) 2 0/2368 (0%) 0
    Gastritis haemorrhagic 1/2368 (0%) 1 0/2368 (0%) 0
    Gastrointestinal angiectasia 0/2368 (0%) 0 1/2368 (0%) 1
    Gastrointestinal angiodysplasia 1/2368 (0%) 1 0/2368 (0%) 0
    Gastrointestinal disorder 0/2368 (0%) 0 1/2368 (0%) 1
    Gastrointestinal haemorrhage 4/2368 (0.2%) 5 7/2368 (0.3%) 7
    Gastrointestinal obstruction 0/2368 (0%) 0 1/2368 (0%) 1
    Gastrointestinal polyp haemorrhage 2/2368 (0.1%) 2 0/2368 (0%) 0
    Gastrointestinal ulcer 0/2368 (0%) 0 1/2368 (0%) 1
    Gastrooesophageal reflux disease 1/2368 (0%) 1 0/2368 (0%) 0
    Haematemesis 0/2368 (0%) 0 1/2368 (0%) 1
    Haematochezia 1/2368 (0%) 1 1/2368 (0%) 1
    Haemorrhoidal haemorrhage 0/2368 (0%) 0 1/2368 (0%) 1
    Ileus 2/2368 (0.1%) 2 0/2368 (0%) 0
    Ileus paralytic 0/2368 (0%) 0 1/2368 (0%) 1
    Inguinal hernia 9/2368 (0.4%) 9 5/2368 (0.2%) 5
    Intestinal haemorrhage 0/2368 (0%) 0 1/2368 (0%) 1
    Intestinal ischaemia 1/2368 (0%) 1 0/2368 (0%) 0
    Intestinal obstruction 1/2368 (0%) 1 0/2368 (0%) 0
    Intestinal perforation 1/2368 (0%) 1 0/2368 (0%) 0
    Large intestine polyp 2/2368 (0.1%) 2 1/2368 (0%) 1
    Lower gastrointestinal haemorrhage 2/2368 (0.1%) 2 1/2368 (0%) 1
    Megacolon 0/2368 (0%) 0 1/2368 (0%) 1
    Melaena 0/2368 (0%) 0 1/2368 (0%) 1
    Mesenteric artery thrombosis 0/2368 (0%) 0 1/2368 (0%) 1
    Nausea 1/2368 (0%) 1 1/2368 (0%) 1
    Obstructive pancreatitis 1/2368 (0%) 1 0/2368 (0%) 0
    Oesophageal ulcer 1/2368 (0%) 1 0/2368 (0%) 0
    Pancreatic disorder 0/2368 (0%) 0 1/2368 (0%) 1
    Pancreatic mass 0/2368 (0%) 0 1/2368 (0%) 1
    Pancreatitis 1/2368 (0%) 1 0/2368 (0%) 0
    Pancreatitis acute 6/2368 (0.3%) 6 4/2368 (0.2%) 4
    Pancreatitis chronic 1/2368 (0%) 1 2/2368 (0.1%) 2
    Rectal polyp 1/2368 (0%) 1 1/2368 (0%) 1
    Retroperitoneal haemorrhage 1/2368 (0%) 1 2/2368 (0.1%) 2
    Small intestinal obstruction 2/2368 (0.1%) 2 0/2368 (0%) 0
    Thrombosis mesenteric vessel 1/2368 (0%) 1 0/2368 (0%) 0
    Umbilical hernia 2/2368 (0.1%) 2 0/2368 (0%) 0
    Upper gastrointestinal haemorrhage 2/2368 (0.1%) 2 0/2368 (0%) 0
    Vomiting 1/2368 (0%) 1 4/2368 (0.2%) 4
    General disorders
    Asthenia 1/2368 (0%) 1 0/2368 (0%) 0
    Cardiac death 0/2368 (0%) 0 2/2368 (0.1%) 2
    Chest discomfort 0/2368 (0%) 0 1/2368 (0%) 1
    Chest pain 4/2368 (0.2%) 4 5/2368 (0.2%) 5
    Complication associated with device 0/2368 (0%) 0 1/2368 (0%) 1
    Death 48/2368 (2%) 48 48/2368 (2%) 48
    General physical health deterioration 1/2368 (0%) 1 0/2368 (0%) 0
    Implant site haemorrhage 1/2368 (0%) 1 0/2368 (0%) 0
    Malaise 2/2368 (0.1%) 2 0/2368 (0%) 0
    Medical device site inflammation 0/2368 (0%) 0 2/2368 (0.1%) 2
    Multiple organ dysfunction syndrome 1/2368 (0%) 1 1/2368 (0%) 1
    Necrosis 0/2368 (0%) 0 1/2368 (0%) 1
    Non-cardiac chest pain 6/2368 (0.3%) 6 16/2368 (0.7%) 19
    Pyrexia 0/2368 (0%) 0 1/2368 (0%) 1
    Sudden cardiac death 18/2368 (0.8%) 18 27/2368 (1.1%) 27
    Sudden death 19/2368 (0.8%) 19 10/2368 (0.4%) 10
    Ulcer haemorrhage 0/2368 (0%) 0 1/2368 (0%) 1
    Vascular stent occlusion 1/2368 (0%) 1 0/2368 (0%) 0
    Vascular stent stenosis 0/2368 (0%) 0 1/2368 (0%) 1
    Vascular stent thrombosis 0/2368 (0%) 0 1/2368 (0%) 2
    Hepatobiliary disorders
    Bile duct obstruction 0/2368 (0%) 0 1/2368 (0%) 1
    Bile duct stenosis 1/2368 (0%) 1 1/2368 (0%) 1
    Bile duct stone 1/2368 (0%) 1 4/2368 (0.2%) 4
    Biliary dilatation 0/2368 (0%) 0 1/2368 (0%) 1
    Cholangitis 0/2368 (0%) 0 1/2368 (0%) 2
    Cholangitis acute 1/2368 (0%) 1 1/2368 (0%) 2
    Cholecystitis 3/2368 (0.1%) 3 5/2368 (0.2%) 5
    Cholecystitis acute 6/2368 (0.3%) 6 8/2368 (0.3%) 8
    Cholecystitis chronic 1/2368 (0%) 1 1/2368 (0%) 1
    Cholelithiasis 2/2368 (0.1%) 2 1/2368 (0%) 1
    Cryptogenic cirrhosis 1/2368 (0%) 3 0/2368 (0%) 0
    Drug-induced liver injury 0/2368 (0%) 0 1/2368 (0%) 1
    Gallbladder enlargement 1/2368 (0%) 1 0/2368 (0%) 0
    Hepatic cirrhosis 1/2368 (0%) 1 0/2368 (0%) 0
    Hepatic failure 1/2368 (0%) 1 0/2368 (0%) 0
    Hepatitis 1/2368 (0%) 1 0/2368 (0%) 0
    Hepatitis acute 1/2368 (0%) 1 0/2368 (0%) 0
    Ischaemic hepatitis 1/2368 (0%) 1 0/2368 (0%) 0
    Jaundice 0/2368 (0%) 0 1/2368 (0%) 1
    Jaundice cholestatic 1/2368 (0%) 1 0/2368 (0%) 0
    Immune system disorders
    Heart transplant rejection 1/2368 (0%) 1 0/2368 (0%) 0
    Infections and infestations
    Abdominal abscess 0/2368 (0%) 0 1/2368 (0%) 1
    Abdominal wall abscess 0/2368 (0%) 0 1/2368 (0%) 1
    Abscess 0/2368 (0%) 0 1/2368 (0%) 1
    Abscess limb 0/2368 (0%) 0 1/2368 (0%) 1
    Acute sinusitis 1/2368 (0%) 1 0/2368 (0%) 0
    Anal abscess 1/2368 (0%) 1 2/2368 (0.1%) 2
    Appendicitis 1/2368 (0%) 1 2/2368 (0.1%) 2
    Bacteraemia 1/2368 (0%) 1 0/2368 (0%) 0
    Bacterial sepsis 0/2368 (0%) 0 2/2368 (0.1%) 2
    Biliary sepsis 0/2368 (0%) 0 1/2368 (0%) 1
    Bronchitis 12/2368 (0.5%) 13 6/2368 (0.3%) 6
    Bursitis infective 0/2368 (0%) 0 1/2368 (0%) 1
    Cardiac infection 0/2368 (0%) 0 1/2368 (0%) 1
    Cellulitis 9/2368 (0.4%) 11 10/2368 (0.4%) 12
    Cellulitis gangrenous 1/2368 (0%) 1 0/2368 (0%) 0
    Cervicitis 1/2368 (0%) 1 0/2368 (0%) 0
    Clostridial infection 1/2368 (0%) 1 0/2368 (0%) 0
    Clostridium difficile colitis 1/2368 (0%) 1 0/2368 (0%) 0
    Clostridium difficile infection 0/2368 (0%) 0 1/2368 (0%) 1
    Cystitis 0/2368 (0%) 0 1/2368 (0%) 1
    Dengue fever 1/2368 (0%) 1 1/2368 (0%) 1
    Device related infection 3/2368 (0.1%) 3 3/2368 (0.1%) 3
    Diabetic foot infection 1/2368 (0%) 1 0/2368 (0%) 0
    Diabetic gangrene 1/2368 (0%) 1 0/2368 (0%) 0
    Disseminated tuberculosis 0/2368 (0%) 0 1/2368 (0%) 1
    Diverticulitis 1/2368 (0%) 1 2/2368 (0.1%) 2
    Endocarditis 1/2368 (0%) 1 4/2368 (0.2%) 4
    Endocarditis bacterial 0/2368 (0%) 0 1/2368 (0%) 1
    Endotoxic shock 0/2368 (0%) 0 1/2368 (0%) 1
    Enteritis infectious 0/2368 (0%) 0 1/2368 (0%) 1
    Enterococcal bacteraemia 0/2368 (0%) 0 1/2368 (0%) 1
    Epididymitis 0/2368 (0%) 0 3/2368 (0.1%) 3
    Erysipelas 1/2368 (0%) 2 4/2368 (0.2%) 4
    Fournier's gangrene 0/2368 (0%) 0 1/2368 (0%) 1
    Furuncle 0/2368 (0%) 0 1/2368 (0%) 1
    Gangrene 2/2368 (0.1%) 5 6/2368 (0.3%) 7
    Gastroenteritis 3/2368 (0.1%) 3 6/2368 (0.3%) 6
    Gastroenteritis rotavirus 0/2368 (0%) 0 1/2368 (0%) 1
    Gastrointestinal infection 1/2368 (0%) 1 0/2368 (0%) 0
    Gastrointestinal viral infection 1/2368 (0%) 1 0/2368 (0%) 0
    Hiv infection 0/2368 (0%) 0 1/2368 (0%) 1
    Herpes zoster 1/2368 (0%) 1 0/2368 (0%) 0
    Herpes zoster oticus 1/2368 (0%) 1 0/2368 (0%) 0
    Implant site infection 1/2368 (0%) 1 0/2368 (0%) 0
    Infected dermal cyst 1/2368 (0%) 1 0/2368 (0%) 0
    Infected skin ulcer 1/2368 (0%) 2 1/2368 (0%) 1
    Infection 2/2368 (0.1%) 2 2/2368 (0.1%) 2
    Infectious pleural effusion 1/2368 (0%) 1 0/2368 (0%) 0
    Influenza 2/2368 (0.1%) 2 3/2368 (0.1%) 3
    Intestinal sepsis 0/2368 (0%) 0 1/2368 (0%) 1
    Liver abscess 1/2368 (0%) 1 0/2368 (0%) 0
    Localised infection 1/2368 (0%) 1 0/2368 (0%) 0
    Lower respiratory tract infection 1/2368 (0%) 1 1/2368 (0%) 1
    Lung infection 4/2368 (0.2%) 7 4/2368 (0.2%) 4
    Lyme disease 1/2368 (0%) 1 0/2368 (0%) 0
    Mediastinal abscess 1/2368 (0%) 1 0/2368 (0%) 0
    Medical device site infection 1/2368 (0%) 1 0/2368 (0%) 0
    Meningitis tuberculous 0/2368 (0%) 0 1/2368 (0%) 1
    Metapneumovirus infection 0/2368 (0%) 0 1/2368 (0%) 1
    Nasopharyngitis 0/2368 (0%) 0 1/2368 (0%) 1
    Oral candidiasis 0/2368 (0%) 0 1/2368 (0%) 1
    Oropharyngeal candidiasis 1/2368 (0%) 1 0/2368 (0%) 0
    Osteomyelitis 7/2368 (0.3%) 9 1/2368 (0%) 1
    Otitis media 1/2368 (0%) 1 0/2368 (0%) 0
    Otitis media acute 0/2368 (0%) 0 1/2368 (0%) 1
    Perichondritis 1/2368 (0%) 1 0/2368 (0%) 0
    Periodontitis 1/2368 (0%) 1 0/2368 (0%) 0
    Peritonitis 2/2368 (0.1%) 2 2/2368 (0.1%) 2
    Peritonsillar abscess 0/2368 (0%) 0 1/2368 (0%) 1
    Pneumonia 76/2368 (3.2%) 83 82/2368 (3.5%) 87
    Pneumonia bacterial 1/2368 (0%) 1 2/2368 (0.1%) 2
    Postoperative abscess 0/2368 (0%) 0 1/2368 (0%) 1
    Postoperative wound infection 3/2368 (0.1%) 3 1/2368 (0%) 1
    Pulmonary sepsis 1/2368 (0%) 1 2/2368 (0.1%) 2
    Pulmonary tuberculosis 0/2368 (0%) 0 2/2368 (0.1%) 2
    Pyelocystitis 1/2368 (0%) 1 0/2368 (0%) 0
    Pyelonephritis 1/2368 (0%) 1 1/2368 (0%) 1
    Pyelonephritis acute 2/2368 (0.1%) 2 0/2368 (0%) 0
    Rectal abscess 1/2368 (0%) 1 0/2368 (0%) 0
    Renal abscess 0/2368 (0%) 0 1/2368 (0%) 2
    Renal cyst infection 0/2368 (0%) 0 1/2368 (0%) 1
    Respiratory syncytial virus infection 1/2368 (0%) 1 1/2368 (0%) 1
    Respiratory tract infection 3/2368 (0.1%) 3 5/2368 (0.2%) 5
    Rickettsiosis 1/2368 (0%) 1 0/2368 (0%) 0
    Sepsis 13/2368 (0.5%) 13 14/2368 (0.6%) 14
    Septic shock 8/2368 (0.3%) 9 8/2368 (0.3%) 9
    Sinusitis 0/2368 (0%) 0 1/2368 (0%) 1
    Skin infection 0/2368 (0%) 0 1/2368 (0%) 1
    Staphylococcal infection 0/2368 (0%) 0 1/2368 (0%) 1
    Subdiaphragmatic abscess 1/2368 (0%) 2 1/2368 (0%) 1
    Systemic candida 0/2368 (0%) 0 1/2368 (0%) 1
    Tracheobronchitis 3/2368 (0.1%) 3 0/2368 (0%) 0
    Tuberculosis 0/2368 (0%) 0 1/2368 (0%) 1
    Upper respiratory tract infection 2/2368 (0.1%) 2 0/2368 (0%) 0
    Urinary tract infection 11/2368 (0.5%) 13 17/2368 (0.7%) 17
    Urinary tract infection staphylococcal 0/2368 (0%) 0 1/2368 (0%) 1
    Urosepsis 4/2368 (0.2%) 4 7/2368 (0.3%) 7
    Wound infection 5/2368 (0.2%) 5 0/2368 (0%) 0
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence 0/2368 (0%) 0 1/2368 (0%) 1
    Accidental overdose 3/2368 (0.1%) 3 2/2368 (0.1%) 2
    Acetabulum fracture 1/2368 (0%) 1 1/2368 (0%) 1
    Alcohol poisoning 1/2368 (0%) 1 0/2368 (0%) 0
    Ankle fracture 2/2368 (0.1%) 2 0/2368 (0%) 0
    Bone contusion 0/2368 (0%) 0 1/2368 (0%) 1
    Brain contusion 0/2368 (0%) 0 1/2368 (0%) 1
    Brain herniation 0/2368 (0%) 0 1/2368 (0%) 1
    Cardiac valve rupture 0/2368 (0%) 0 1/2368 (0%) 1
    Compression fracture 1/2368 (0%) 1 0/2368 (0%) 0
    Craniocerebral injury 1/2368 (0%) 1 1/2368 (0%) 1
    Fall 2/2368 (0.1%) 2 1/2368 (0%) 1
    Femoral neck fracture 3/2368 (0.1%) 3 2/2368 (0.1%) 2
    Femur fracture 4/2368 (0.2%) 4 3/2368 (0.1%) 3
    Fibula fracture 0/2368 (0%) 0 1/2368 (0%) 1
    Foot fracture 0/2368 (0%) 0 2/2368 (0.1%) 2
    Head injury 1/2368 (0%) 1 1/2368 (0%) 1
    Hip fracture 7/2368 (0.3%) 7 2/2368 (0.1%) 2
    Humerus fracture 2/2368 (0.1%) 2 1/2368 (0%) 1
    Joint dislocation 1/2368 (0%) 3 1/2368 (0%) 1
    Limb injury 1/2368 (0%) 1 0/2368 (0%) 0
    Lower limb fracture 1/2368 (0%) 1 0/2368 (0%) 0
    Lumbar vertebral fracture 1/2368 (0%) 1 1/2368 (0%) 1
    Multiple fractures 3/2368 (0.1%) 3 2/2368 (0.1%) 2
    Overdose 0/2368 (0%) 0 1/2368 (0%) 1
    Patella fracture 1/2368 (0%) 1 0/2368 (0%) 0
    Pelvic fracture 0/2368 (0%) 0 1/2368 (0%) 1
    Poisoning 0/2368 (0%) 0 1/2368 (0%) 1
    Post procedural haematoma 1/2368 (0%) 1 0/2368 (0%) 0
    Post procedural haematuria 1/2368 (0%) 3 0/2368 (0%) 0
    Post procedural haemorrhage 1/2368 (0%) 1 2/2368 (0.1%) 2
    Postoperative wound complication 1/2368 (0%) 1 0/2368 (0%) 0
    Rib fracture 1/2368 (0%) 1 1/2368 (0%) 2
    Road traffic accident 1/2368 (0%) 1 1/2368 (0%) 1
    Skin injury 1/2368 (0%) 1 0/2368 (0%) 0
    Skull fracture 0/2368 (0%) 0 1/2368 (0%) 1
    Skull fractured base 0/2368 (0%) 0 1/2368 (0%) 1
    Spinal compression fracture 0/2368 (0%) 0 1/2368 (0%) 1
    Spinal fracture 0/2368 (0%) 0 1/2368 (0%) 1
    Splenic injury 1/2368 (0%) 1 0/2368 (0%) 0
    Subdural haematoma 4/2368 (0.2%) 4 4/2368 (0.2%) 4
    Subdural haemorrhage 0/2368 (0%) 0 1/2368 (0%) 1
    Tendon injury 0/2368 (0%) 0 1/2368 (0%) 1
    Thermal burn 1/2368 (0%) 1 1/2368 (0%) 1
    Thoracic vertebral fracture 0/2368 (0%) 0 3/2368 (0.1%) 3
    Toxicity to various agents 1/2368 (0%) 4 0/2368 (0%) 0
    Traumatic haematoma 1/2368 (0%) 1 1/2368 (0%) 1
    Traumatic intracranial haemorrhage 1/2368 (0%) 1 0/2368 (0%) 0
    Upper limb fracture 2/2368 (0.1%) 2 0/2368 (0%) 0
    Wrist fracture 1/2368 (0%) 1 1/2368 (0%) 1
    Investigations
    Blood creatinine increased 4/2368 (0.2%) 4 3/2368 (0.1%) 3
    Blood glucose increased 1/2368 (0%) 1 2/2368 (0.1%) 2
    Blood pressure increased 0/2368 (0%) 0 1/2368 (0%) 1
    Ejection fraction decreased 1/2368 (0%) 1 2/2368 (0.1%) 2
    Glomerular filtration rate decreased 0/2368 (0%) 0 2/2368 (0.1%) 2
    International normalised ratio increased 0/2368 (0%) 0 1/2368 (0%) 1
    Pulmonary arterial pressure increased 1/2368 (0%) 1 0/2368 (0%) 0
    Transaminases increased 1/2368 (0%) 1 0/2368 (0%) 0
    Troponin increased 2/2368 (0.1%) 2 0/2368 (0%) 0
    Metabolism and nutrition disorders
    Cachexia 0/2368 (0%) 0 1/2368 (0%) 1
    Decreased appetite 1/2368 (0%) 1 0/2368 (0%) 0
    Dehydration 10/2368 (0.4%) 10 8/2368 (0.3%) 8
    Diabetes mellitus 5/2368 (0.2%) 6 4/2368 (0.2%) 4
    Diabetes mellitus inadequate control 0/2368 (0%) 0 2/2368 (0.1%) 2
    Diabetic ketoacidosis 2/2368 (0.1%) 3 1/2368 (0%) 1
    Diabetic ketosis 0/2368 (0%) 0 1/2368 (0%) 1
    Diabetic metabolic decompensation 6/2368 (0.3%) 6 2/2368 (0.1%) 2
    Fluid overload 0/2368 (0%) 0 1/2368 (0%) 1
    Fluid retention 1/2368 (0%) 3 0/2368 (0%) 0
    Gout 2/2368 (0.1%) 2 4/2368 (0.2%) 4
    Hyperglycaemia 3/2368 (0.1%) 3 5/2368 (0.2%) 5
    Hyperglycaemic hyperosmolar nonketotic syndrome 0/2368 (0%) 0 1/2368 (0%) 1
    Hyperkalaemia 2/2368 (0.1%) 2 5/2368 (0.2%) 5
    Hypoglycaemia 1/2368 (0%) 1 4/2368 (0.2%) 4
    Hypokalaemia 2/2368 (0.1%) 2 0/2368 (0%) 0
    Hypomagnesaemia 1/2368 (0%) 1 1/2368 (0%) 1
    Hyponatraemia 4/2368 (0.2%) 4 1/2368 (0%) 1
    Hypovolaemia 3/2368 (0.1%) 3 2/2368 (0.1%) 2
    Ketoacidosis 2/2368 (0.1%) 2 0/2368 (0%) 0
    Lactic acidosis 0/2368 (0%) 0 1/2368 (0%) 1
    Steroid diabetes 0/2368 (0%) 0 1/2368 (0%) 1
    Type 2 diabetes mellitus 1/2368 (0%) 1 2/2368 (0.1%) 2
    Musculoskeletal and connective tissue disorders
    Arthritis 2/2368 (0.1%) 2 1/2368 (0%) 1
    Arthritis reactive 1/2368 (0%) 1 0/2368 (0%) 0
    Back pain 2/2368 (0.1%) 2 5/2368 (0.2%) 6
    Chondrocalcinosis pyrophosphate 1/2368 (0%) 1 0/2368 (0%) 0
    Dupuytren's contracture 0/2368 (0%) 0 1/2368 (0%) 2
    Gouty arthritis 1/2368 (0%) 1 3/2368 (0.1%) 3
    Intervertebral disc degeneration 1/2368 (0%) 1 0/2368 (0%) 0
    Intervertebral disc protrusion 2/2368 (0.1%) 2 2/2368 (0.1%) 3
    Joint effusion 1/2368 (0%) 1 0/2368 (0%) 0
    Lumbar spinal stenosis 2/2368 (0.1%) 2 1/2368 (0%) 1
    Muscle spasms 1/2368 (0%) 1 0/2368 (0%) 0
    Muscular weakness 1/2368 (0%) 1 0/2368 (0%) 0
    Musculoskeletal chest pain 2/2368 (0.1%) 2 4/2368 (0.2%) 4
    Musculoskeletal pain 1/2368 (0%) 1 0/2368 (0%) 0
    Myalgia 0/2368 (0%) 0 2/2368 (0.1%) 3
    Osteoarthritis 5/2368 (0.2%) 6 7/2368 (0.3%) 7
    Osteonecrosis of jaw 1/2368 (0%) 1 1/2368 (0%) 1
    Pain in extremity 0/2368 (0%) 0 1/2368 (0%) 1
    Pleural mass 1/2368 (0%) 1 0/2368 (0%) 0
    Polymyalgia rheumatica 0/2368 (0%) 0 1/2368 (0%) 1
    Pseudarthrosis 0/2368 (0%) 0 1/2368 (0%) 1
    Spinal pain 2/2368 (0.1%) 3 1/2368 (0%) 1
    Spinal stenosis 1/2368 (0%) 1 0/2368 (0%) 0
    Spondyloarthropathy 1/2368 (0%) 1 0/2368 (0%) 0
    Spondylolisthesis 0/2368 (0%) 0 1/2368 (0%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Abdominal neoplasm 1/2368 (0%) 1 0/2368 (0%) 0
    Acute myeloid leukaemia 2/2368 (0.1%) 2 0/2368 (0%) 0
    Adenocarcinoma of colon 2/2368 (0.1%) 2 2/2368 (0.1%) 2
    Basal cell carcinoma 1/2368 (0%) 1 1/2368 (0%) 1
    Benign breast neoplasm 0/2368 (0%) 0 1/2368 (0%) 1
    Benign neoplasm of bladder 1/2368 (0%) 1 0/2368 (0%) 0
    Benign uterine neoplasm 0/2368 (0%) 0 1/2368 (0%) 1
    Bladder cancer 1/2368 (0%) 1 2/2368 (0.1%) 2
    Bladder neoplasm 1/2368 (0%) 1 1/2368 (0%) 1
    Bladder transitional cell carcinoma 1/2368 (0%) 1 2/2368 (0.1%) 2
    Breast cancer 0/2368 (0%) 0 2/2368 (0.1%) 2
    Breast cancer female 1/2368 (0%) 1 2/2368 (0.1%) 2
    Breast cancer recurrent 0/2368 (0%) 0 1/2368 (0%) 1
    Brenner tumour 1/2368 (0%) 1 0/2368 (0%) 0
    Cervix carcinoma 0/2368 (0%) 0 1/2368 (0%) 1
    Cholangiocarcinoma 2/2368 (0.1%) 2 0/2368 (0%) 0
    Chronic lymphocytic leukaemia 2/2368 (0.1%) 2 0/2368 (0%) 0
    Chronic myeloid leukaemia 0/2368 (0%) 0 1/2368 (0%) 1
    Colon cancer 1/2368 (0%) 1 3/2368 (0.1%) 3
    Colon cancer metastatic 1/2368 (0%) 1 0/2368 (0%) 0
    Colon neoplasm 1/2368 (0%) 1 0/2368 (0%) 0
    Colorectal adenocarcinoma 0/2368 (0%) 0 1/2368 (0%) 1
    Colorectal cancer metastatic 0/2368 (0%) 0 1/2368 (0%) 1
    Ductal adenocarcinoma of pancreas 0/2368 (0%) 0 1/2368 (0%) 1
    Gastric cancer 3/2368 (0.1%) 3 0/2368 (0%) 0
    Gastrointestinal cancer metastatic 0/2368 (0%) 0 1/2368 (0%) 1
    Glioblastoma 1/2368 (0%) 1 0/2368 (0%) 0
    Glioblastoma multiforme 1/2368 (0%) 1 0/2368 (0%) 0
    Hepatocellular carcinoma 1/2368 (0%) 1 0/2368 (0%) 0
    Large intestine benign neoplasm 1/2368 (0%) 1 0/2368 (0%) 0
    Laryngeal cancer 1/2368 (0%) 1 0/2368 (0%) 0
    Leukaemia 0/2368 (0%) 0 1/2368 (0%) 1
    Leukaemia recurrent 1/2368 (0%) 1 0/2368 (0%) 0
    Lung adenocarcinoma 1/2368 (0%) 1 2/2368 (0.1%) 2
    Lung cancer metastatic 3/2368 (0.1%) 3 0/2368 (0%) 0
    Lung neoplasm malignant 6/2368 (0.3%) 6 4/2368 (0.2%) 4
    Malignant melanoma 0/2368 (0%) 0 2/2368 (0.1%) 2
    Malignant neoplasm of unknown primary site 1/2368 (0%) 1 0/2368 (0%) 0
    Meningioma 0/2368 (0%) 0 1/2368 (0%) 1
    Metastases to central nervous system 1/2368 (0%) 1 0/2368 (0%) 0
    Metastases to liver 0/2368 (0%) 0 1/2368 (0%) 1
    Metastatic carcinoma of the bladder 1/2368 (0%) 1 0/2368 (0%) 0
    Metastatic malignant melanoma 1/2368 (0%) 1 0/2368 (0%) 0
    Myelodysplastic syndrome 0/2368 (0%) 0 1/2368 (0%) 1
    Myelofibrosis 1/2368 (0%) 1 0/2368 (0%) 0
    Nasal cavity cancer 1/2368 (0%) 1 0/2368 (0%) 0
    Non-small cell lung cancer 0/2368 (0%) 0 1/2368 (0%) 1
    Oesophageal carcinoma 0/2368 (0%) 0 1/2368 (0%) 1
    Ovarian cancer 1/2368 (0%) 1 0/2368 (0%) 0
    Pancreatic carcinoma 0/2368 (0%) 0 3/2368 (0.1%) 3
    Pancreatic neoplasm 1/2368 (0%) 1 1/2368 (0%) 1
    Papillary renal cell carcinoma 1/2368 (0%) 1 0/2368 (0%) 0
    Pituitary tumour benign 0/2368 (0%) 0 1/2368 (0%) 1
    Plasma cell myeloma 1/2368 (0%) 1 0/2368 (0%) 0
    Pleomorphic adenoma 0/2368 (0%) 0 1/2368 (0%) 1
    Polycythaemia vera 1/2368 (0%) 1 0/2368 (0%) 0
    Prostate cancer 6/2368 (0.3%) 6 1/2368 (0%) 1
    Rectal cancer 0/2368 (0%) 0 1/2368 (0%) 1
    Renal cancer 1/2368 (0%) 1 0/2368 (0%) 0
    Renal neoplasm 1/2368 (0%) 1 1/2368 (0%) 1
    Squamous cell carcinoma 2/2368 (0.1%) 2 0/2368 (0%) 0
    Squamous cell carcinoma of lung 0/2368 (0%) 0 3/2368 (0.1%) 3
    Squamous cell carcinoma of the tongue 0/2368 (0%) 0 2/2368 (0.1%) 2
    Tonsil cancer 0/2368 (0%) 0 1/2368 (0%) 1
    Transitional cell carcinoma 2/2368 (0.1%) 2 2/2368 (0.1%) 2
    Nervous system disorders
    Brain injury 0/2368 (0%) 0 1/2368 (0%) 1
    Brain oedema 1/2368 (0%) 1 0/2368 (0%) 0
    Brain stem infarction 1/2368 (0%) 1 0/2368 (0%) 0
    Carotid artery stenosis 3/2368 (0.1%) 3 2/2368 (0.1%) 2
    Cerebellar stroke 0/2368 (0%) 0 1/2368 (0%) 1
    Cerebral haematoma 1/2368 (0%) 1 0/2368 (0%) 0
    Cerebral haemorrhage 0/2368 (0%) 0 2/2368 (0.1%) 2
    Cerebral infarction 8/2368 (0.3%) 9 11/2368 (0.5%) 12
    Cerebral ischaemia 1/2368 (0%) 1 1/2368 (0%) 1
    Cerebral thrombosis 0/2368 (0%) 0 1/2368 (0%) 1
    Cerebrovascular accident 7/2368 (0.3%) 7 5/2368 (0.2%) 5
    Diabetic ketoacidotic hyperglycaemic coma 1/2368 (0%) 1 0/2368 (0%) 0
    Dizziness 0/2368 (0%) 0 3/2368 (0.1%) 3
    Embolic stroke 1/2368 (0%) 1 3/2368 (0.1%) 3
    Epilepsy 0/2368 (0%) 0 1/2368 (0%) 1
    Facial paralysis 1/2368 (0%) 1 0/2368 (0%) 0
    Generalised tonic-clonic seizure 1/2368 (0%) 1 1/2368 (0%) 1
    Haemorrhage intracranial 2/2368 (0.1%) 2 2/2368 (0.1%) 2
    Haemorrhagic stroke 3/2368 (0.1%) 3 1/2368 (0%) 1
    Haemorrhagic transformation stroke 2/2368 (0.1%) 2 0/2368 (0%) 0
    Headache 1/2368 (0%) 1 2/2368 (0.1%) 2
    Iiird nerve paresis 1/2368 (0%) 1 0/2368 (0%) 0
    Ischaemic cerebral infarction 1/2368 (0%) 1 0/2368 (0%) 0
    Ischaemic stroke 24/2368 (1%) 26 26/2368 (1.1%) 28
    Loss of consciousness 1/2368 (0%) 1 0/2368 (0%) 0
    Nervous system disorder 1/2368 (0%) 1 0/2368 (0%) 0
    Neuralgia 0/2368 (0%) 0 1/2368 (0%) 1
    Parkinson's disease 0/2368 (0%) 0 1/2368 (0%) 2
    Peroneal nerve palsy 0/2368 (0%) 0 1/2368 (0%) 1
    Post herpetic neuralgia 1/2368 (0%) 1 0/2368 (0%) 0
    Presyncope 0/2368 (0%) 0 3/2368 (0.1%) 3
    Sciatica 1/2368 (0%) 1 1/2368 (0%) 1
    Subarachnoid haemorrhage 2/2368 (0.1%) 2 1/2368 (0%) 1
    Syncope 7/2368 (0.3%) 7 13/2368 (0.5%) 14
    Transient ischaemic attack 13/2368 (0.5%) 13 7/2368 (0.3%) 7
    Vascular dementia 0/2368 (0%) 0 1/2368 (0%) 1
    Vascular encephalopathy 1/2368 (0%) 1 0/2368 (0%) 0
    Vertebral artery occlusion 0/2368 (0%) 0 1/2368 (0%) 1
    Vertebral artery stenosis 0/2368 (0%) 0 1/2368 (0%) 1
    Vertebrobasilar insufficiency 1/2368 (0%) 2 0/2368 (0%) 0
    Product Issues
    Device dislocation 1/2368 (0%) 1 0/2368 (0%) 0
    Device failure 0/2368 (0%) 0 2/2368 (0.1%) 2
    Device inappropriate shock delivery 0/2368 (0%) 0 1/2368 (0%) 1
    Device lead issue 0/2368 (0%) 0 1/2368 (0%) 1
    Device malfunction 1/2368 (0%) 1 2/2368 (0.1%) 2
    Lead dislodgement 0/2368 (0%) 0 1/2368 (0%) 1
    Psychiatric disorders
    Alcohol withdrawal syndrome 2/2368 (0.1%) 2 0/2368 (0%) 0
    Anxiety disorder 0/2368 (0%) 0 1/2368 (0%) 1
    Bipolar i disorder 0/2368 (0%) 0 1/2368 (0%) 1
    Completed suicide 0/2368 (0%) 0 2/2368 (0.1%) 2
    Confusional state 1/2368 (0%) 1 0/2368 (0%) 0
    Delirium 0/2368 (0%) 0 1/2368 (0%) 1
    Depression 1/2368 (0%) 1 0/2368 (0%) 0
    Mental status changes 1/2368 (0%) 1 2/2368 (0.1%) 2
    Suicide attempt 1/2368 (0%) 1 0/2368 (0%) 0
    Renal and urinary disorders
    Acute kidney injury 23/2368 (1%) 25 46/2368 (1.9%) 49
    Anuria 1/2368 (0%) 1 0/2368 (0%) 0
    Bladder neck obstruction 0/2368 (0%) 0 2/2368 (0.1%) 3
    Chronic kidney disease 4/2368 (0.2%) 4 8/2368 (0.3%) 10
    Cystitis noninfective 1/2368 (0%) 1 0/2368 (0%) 0
    End stage renal disease 2/2368 (0.1%) 2 1/2368 (0%) 1
    Haematuria 2/2368 (0.1%) 2 1/2368 (0%) 1
    Hydronephrosis 2/2368 (0.1%) 2 0/2368 (0%) 0
    Nephrolithiasis 1/2368 (0%) 1 1/2368 (0%) 1
    Nephropathy 0/2368 (0%) 0 1/2368 (0%) 1
    Nephropathy toxic 0/2368 (0%) 0 1/2368 (0%) 1
    Postrenal failure 1/2368 (0%) 1 0/2368 (0%) 0
    Prerenal failure 1/2368 (0%) 1 0/2368 (0%) 0
    Renal artery stenosis 1/2368 (0%) 1 1/2368 (0%) 1
    Renal colic 1/2368 (0%) 1 0/2368 (0%) 0
    Renal cyst 1/2368 (0%) 1 0/2368 (0%) 0
    Renal disorder 0/2368 (0%) 0 1/2368 (0%) 1
    Renal failure 8/2368 (0.3%) 8 8/2368 (0.3%) 9
    Renal impairment 7/2368 (0.3%) 7 13/2368 (0.5%) 14
    Renal injury 1/2368 (0%) 1 0/2368 (0%) 0
    Ureterolithiasis 3/2368 (0.1%) 3 0/2368 (0%) 0
    Urethral stenosis 1/2368 (0%) 1 1/2368 (0%) 1
    Urinary retention 0/2368 (0%) 0 2/2368 (0.1%) 2
    Reproductive system and breast disorders
    Acquired hydrocele 0/2368 (0%) 0 3/2368 (0.1%) 3
    Adenomyosis 1/2368 (0%) 1 0/2368 (0%) 0
    Balanoposthitis 0/2368 (0%) 0 1/2368 (0%) 1
    Benign prostatic hyperplasia 5/2368 (0.2%) 5 2/2368 (0.1%) 2
    Endometrial hyperplasia 0/2368 (0%) 0 1/2368 (0%) 1
    Metrorrhagia 0/2368 (0%) 0 1/2368 (0%) 1
    Orchitis noninfective 1/2368 (0%) 1 0/2368 (0%) 0
    Ovarian cyst 0/2368 (0%) 0 1/2368 (0%) 1
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema 1/2368 (0%) 1 4/2368 (0.2%) 5
    Acute respiratory failure 7/2368 (0.3%) 9 14/2368 (0.6%) 16
    Aspiration 1/2368 (0%) 1 0/2368 (0%) 0
    Asthma 2/2368 (0.1%) 2 2/2368 (0.1%) 2
    Bronchiectasis 1/2368 (0%) 1 0/2368 (0%) 0
    Chronic obstructive pulmonary disease 14/2368 (0.6%) 16 22/2368 (0.9%) 34
    Chronic respiratory failure 0/2368 (0%) 0 2/2368 (0.1%) 2
    Dyspnoea 4/2368 (0.2%) 4 6/2368 (0.3%) 6
    Eosinophilic pneumonia 0/2368 (0%) 0 1/2368 (0%) 1
    Epistaxis 2/2368 (0.1%) 2 3/2368 (0.1%) 3
    Haemoptysis 2/2368 (0.1%) 2 0/2368 (0%) 0
    Hypoxia 1/2368 (0%) 1 1/2368 (0%) 1
    Interstitial lung disease 0/2368 (0%) 0 3/2368 (0.1%) 3
    Lung cyst 1/2368 (0%) 1 0/2368 (0%) 0
    Pharyngeal lesion 0/2368 (0%) 0 1/2368 (0%) 1
    Pleural effusion 2/2368 (0.1%) 2 3/2368 (0.1%) 3
    Pleurisy 1/2368 (0%) 1 2/2368 (0.1%) 2
    Pleuritic pain 0/2368 (0%) 0 1/2368 (0%) 1
    Pneumomediastinum 0/2368 (0%) 0 1/2368 (0%) 1
    Pneumonia aspiration 3/2368 (0.1%) 3 4/2368 (0.2%) 4
    Pneumonitis 1/2368 (0%) 1 0/2368 (0%) 0
    Pneumothorax 1/2368 (0%) 1 1/2368 (0%) 1
    Pneumothorax spontaneous 1/2368 (0%) 1 0/2368 (0%) 0
    Pulmonary alveolar haemorrhage 1/2368 (0%) 1 0/2368 (0%) 0
    Pulmonary congestion 0/2368 (0%) 0 2/2368 (0.1%) 2
    Pulmonary embolism 7/2368 (0.3%) 7 14/2368 (0.6%) 14
    Pulmonary hypertension 1/2368 (0%) 1 0/2368 (0%) 0
    Pulmonary mass 0/2368 (0%) 0 1/2368 (0%) 1
    Pulmonary oedema 3/2368 (0.1%) 4 5/2368 (0.2%) 5
    Pulmonary toxicity 0/2368 (0%) 0 1/2368 (0%) 1
    Pulmonary vasculitis 1/2368 (0%) 1 0/2368 (0%) 0
    Respiratory failure 3/2368 (0.1%) 3 7/2368 (0.3%) 7
    Skin and subcutaneous tissue disorders
    Blister 1/2368 (0%) 1 1/2368 (0%) 1
    Decubitus ulcer 1/2368 (0%) 1 0/2368 (0%) 0
    Dermatitis allergic 1/2368 (0%) 1 0/2368 (0%) 0
    Diabetic foot 2/2368 (0.1%) 3 2/2368 (0.1%) 2
    Drug eruption 1/2368 (0%) 1 0/2368 (0%) 0
    Eczema 0/2368 (0%) 0 1/2368 (0%) 1
    Petechiae 0/2368 (0%) 0 1/2368 (0%) 1
    Psoriasis 1/2368 (0%) 1 0/2368 (0%) 0
    Rash 0/2368 (0%) 0 1/2368 (0%) 1
    Skin haemorrhage 0/2368 (0%) 0 1/2368 (0%) 1
    Skin necrosis 1/2368 (0%) 1 0/2368 (0%) 0
    Skin ulcer 2/2368 (0.1%) 2 1/2368 (0%) 1
    Urticaria 1/2368 (0%) 1 0/2368 (0%) 0
    Vascular disorders
    Accelerated hypertension 1/2368 (0%) 1 0/2368 (0%) 0
    Angiodysplasia 0/2368 (0%) 0 1/2368 (0%) 1
    Aortic aneurysm 2/2368 (0.1%) 2 2/2368 (0.1%) 2
    Aortic aneurysm rupture 0/2368 (0%) 0 2/2368 (0.1%) 2
    Aortic dissection 1/2368 (0%) 1 0/2368 (0%) 0
    Aortic stenosis 1/2368 (0%) 1 3/2368 (0.1%) 3
    Circulatory collapse 1/2368 (0%) 1 3/2368 (0.1%) 3
    Deep vein thrombosis 3/2368 (0.1%) 3 6/2368 (0.3%) 7
    Diabetic vascular disorder 0/2368 (0%) 0 1/2368 (0%) 1
    Dry gangrene 1/2368 (0%) 2 0/2368 (0%) 0
    Embolism arterial 0/2368 (0%) 0 1/2368 (0%) 1
    Essential hypertension 0/2368 (0%) 0 1/2368 (0%) 1
    Extremity necrosis 1/2368 (0%) 1 0/2368 (0%) 0
    Haematocoele 0/2368 (0%) 0 1/2368 (0%) 1
    Haematoma 0/2368 (0%) 0 2/2368 (0.1%) 2
    Hypertension 2/2368 (0.1%) 2 2/2368 (0.1%) 2
    Hypertensive crisis 3/2368 (0.1%) 3 3/2368 (0.1%) 3
    Hypertensive emergency 0/2368 (0%) 0 2/2368 (0.1%) 2
    Hypertensive urgency 0/2368 (0%) 0 1/2368 (0%) 1
    Hypotension 7/2368 (0.3%) 9 11/2368 (0.5%) 12
    Hypovolaemic shock 0/2368 (0%) 0 1/2368 (0%) 1
    Iliac artery occlusion 0/2368 (0%) 0 1/2368 (0%) 1
    Orthostatic hypotension 2/2368 (0.1%) 2 5/2368 (0.2%) 6
    Peripheral arterial occlusive disease 11/2368 (0.5%) 11 10/2368 (0.4%) 11
    Peripheral artery occlusion 1/2368 (0%) 1 2/2368 (0.1%) 2
    Peripheral artery stenosis 1/2368 (0%) 1 0/2368 (0%) 0
    Peripheral embolism 0/2368 (0%) 0 1/2368 (0%) 1
    Peripheral ischaemia 9/2368 (0.4%) 11 5/2368 (0.2%) 8
    Peripheral vascular disorder 1/2368 (0%) 1 0/2368 (0%) 0
    Shock 1/2368 (0%) 1 0/2368 (0%) 0
    Thrombophlebitis 0/2368 (0%) 0 1/2368 (0%) 1
    Thrombophlebitis superficial 0/2368 (0%) 0 1/2368 (0%) 1
    Thrombosis 1/2368 (0%) 1 0/2368 (0%) 0
    Vasculitis 1/2368 (0%) 1 1/2368 (0%) 1
    Venous thrombosis limb 1/2368 (0%) 1 0/2368 (0%) 0
    Other (Not Including Serious) Adverse Events
    Dapa 10mg Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 299/2368 (12.6%) 325/2368 (13.7%)
    Cardiac disorders
    Atrial fibrillation 58/2368 (2.4%) 63 52/2368 (2.2%) 55
    Cardiac failure 76/2368 (3.2%) 90 130/2368 (5.5%) 154
    Infections and infestations
    Nasopharyngitis 63/2368 (2.7%) 84 76/2368 (3.2%) 100
    Renal and urinary disorders
    Renal impairment 63/2368 (2.7%) 67 56/2368 (2.4%) 60
    Vascular disorders
    Hypotension 88/2368 (3.7%) 98 73/2368 (3.1%) 81

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title AstraZeneca Clinical Study Information Center
    Organization AstraZeneca
    Phone +1-877-240-9479
    Email information.center@astrazeneca.com
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT03036124
    Other Study ID Numbers:
    • D1699C00001
    • 2016-003897-41
    First Posted:
    Jan 30, 2017
    Last Update Posted:
    Sep 1, 2020
    Last Verified:
    Aug 1, 2020