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ASTRONAUT: Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00894387
Collaborator
(none)
1,639
Enrollment
308
Locations
2
Arms
39
Duration (Months)
5.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluated the effect of early initiation of aliskiren therapy, compared to standard therapy, in the reduction of cardiovascular death and heart failure re-hospitalization events within 6 months, in congestive heart failure (CHF) patients hospitalized for an episode of acute decompensated heart failure.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1639 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the 6 Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality When Initiated Early After Hospitalization for Acute Decompensated Heart Failure
Study Start Date :
May 1, 2009
Actual Primary Completion Date :
Aug 1, 2012
Actual Study Completion Date :
Aug 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Aliskiren

Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.

Drug: Aliskiren
Aliskiren 150 mg and Aliskiren 300 mg
Other Names:
  • Aliskiren®,
  • Tekturna®,
  • Rasilez®,
  • SPP100

    		•
    Placebo Comparator: Placebo

    Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.

    Drug: Placebo
    Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 6 Months [6 months]

      Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months of randomization was the primary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 190 (189 days from randomization). The primary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 6 months.

    Secondary Outcome Measures

    1. Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months [12 months]

      Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 12 months of randomization was the key secondary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 395 (394 days from randomization). The secondary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 12 months.

    2. Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months [Baseline, 1 months, 6 months and 12 months]

      Symptom reduction and reduction in physical limitations was assessed using the clinical summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a self-administered questionnaire and contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Health-Related Quality of Life (QoL), including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Each scale score was calculated as the mean of its item scores and transformed to a 0-100 scale, with higher score indicating higher level of functioning. A score of 100 represents perfect health whereas a score of 0 represents death. A positive change in score from baseline indicates an improvement.

    3. Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months [6 months]

      A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.

    4. Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months [12 months]

    5. Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months [Baseline, 1 month, 6 months and 12 months]

      The reported Least square means, and Confidential Interval were from a repeated measures model on log transformed NT-proBNP data containing treatment, visit, and region as factors, log baseline NT-proBNP as a continuous covariate and treatment by visit and visit by log baseline NT-proBNP as interaction terms.

    6. Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months [12 months]

      A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.

    Eligibility Criteria

    Criteria

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

    • Patient hospitalized with a primary diagnosis of worsening heart failure ≥ 18 years of age, male or female.

    • Patients with a diagnosis of acute heart failure expressed by symptoms (dyspnea or fatigability - NYHA Class III-IV) and signs of fluid overload (i.e., jugular venous distension, edema or positive rales auscultation or pulmonary congestion on chest x-ray) at the time of hospitalization.

    • LVEF < 40% (measured within the last 6 months).

    • Hospitalization for ADHF and remain "stabilized" for at least 6 hours (defined as SBP ≥ 110 mm Hg after acute decompensated episode) and did not receive IV vasodilators (other than nitrates) and/or IV inotropic drugs at anytime from ADHF presentation to time of randomization.

    • Elevated BNP at Visit 1 or at randomization (BNP ≥ 400 pg/ml).

    • Patients with a history of chronic heart failure on standard therapy defined as requiring HF treatment for at least 30 days before the current hospitalization (NYHA Class II - IV).

    Exclusion Criteria:

    • Patients that required any use of IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for worsening HF to randomization.

    • Concomitant use of ACEI and ARB at randomization.

    • Right heart failure due to pulmonary disease.

    • Diagnosis of postpartum cardiomyopathy.

    • Myocardial infarction or cardiac surgery, including percutaneous transluminal coronary angioplasty (PTCA), within past 3 months.

    • Patients with a history of heart transplant or who are on a transplant list.

    • Unstable angina or coronary artery disease likely to require coronary artery bypass graft (CABG) or PTCA before randomization.

    Other protocol-defined inclusion/exclusion criteria applied.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Mobile Alabama United States 36608
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    239 Novartis Investigative Site Moscow Russian Federation 109377
    240 Novartis Investigative Site Moscow Russian Federation 111539
    241 Novartis Investigative Site Moscow Russian Federation 115487
    242 Novartis Investigative Site Moscow Russian Federation 117198
    243 Novartis Investigative Site Moscow Russian Federation 119881
    244 Novartis Investigative Site Moscow Russian Federation 121552
    245 Novartis Investigative Site Moscow Russian Federation 127473
    246 Novartis Investigative Site Moscow Russian Federation 127644
    247 Novartis Investigative Site Nizhnii Novgorod Russian Federation 603000
    248 Novartis Investigative Site S.-Petersburg Russian Federation 192242
    249 Novartis Investigative Site S.-Petersburg Russian Federation 195197
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    262 Novartis Investigative Site Singapore Singapore 119074
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    265 Novartis Investigative Site Liptovsky Mikulas Slovak Republic Slovakia 831 23
    266 Novartis Investigative Site Presov Slovak Republic Slovakia 081 81
    267 Novartis Investigative Site Bratislava Slovakia 813 69
    268 Novartis Investigative Site Bratislava Slovakia 833 48
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    270 Novartis Investigative Site Kosice-Saca Slovakia 040 01
    271 Novartis Investigative Site Kosice Slovakia 040 01
    272 Novartis Investigative Site Levice Slovakia 934 01
    273 Novartis Investigative Site Lucenec Slovakia 984 39
    274 Novartis Investigative Site Martin Slovakia 036 59
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    276 Novartis Investigative Site Trnava Slovakia 917 75
    277 Novartis Investigative Site Sanlúcar de Barrameda Andalucia Spain 11540
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    288 Novartis Investigative Site Göteborg Sweden 416 85
    289 Novartis Investigative Site Stockholm Sweden 118 83
    290 Novartis Investigative Site Stockholm Sweden 141 86
    291 Novartis Investigative Site Stockholm Sweden 182 88
    292 Novartis Investigative Site Kaohsiung Taiwan 807
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    295 Novartis Investigative Site Taichung Taiwan 40447
    296 Novartis Investigative Site Taipei Taiwan 112
    297 Novartis Investigative Site Taipei Taiwan
    298 Novartis Investigative Site Ankara Turkey 06500
    299 Novartis Investigative Site Atakum / Samsun Turkey 55139
    300 Novartis Investigative Site Etlik / Ankara Turkey 06018
    301 Novartis Investigative Site Istanbul Turkey 34303
    302 Novartis Investigative Site Istanbul Turkey 34304
    303 Novartis Investigative Site Izmir Turkey 35040
    304 Novartis Investigative Site Izmir Turkey 35340
    305 Novartis Investigative Site Kirikkale Turkey 71100
    306 Novartis Investigative Site Kocaeli Turkey 41380
    307 Novartis Investigative Site Sivas Turkey 58140
    308 Novartis Investigative Site Talas / Kayseri Turkey 38039

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
    • Study Director: Novartis, Novartis

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00894387
    Other Study ID Numbers:
    • CSPP100A2368
    • 2009-010236-18
    First Posted:
    May 7, 2009
    Last Update Posted:
    Nov 7, 2013
    Last Verified:
    Oct 1, 2013
    Keywords provided by Novartis Pharmaceuticals
    elevated BNP
    reduced LVEF
    Acute Heart Failure
    Cardiovascular death
    CHF
    hospitalization
    morbi-mortality trial
    outcome study
    endpoint driven
    plasma renin activity
    renin angiotensin
    aldosterone system
    direct renin inhibitors
    BNP
    KCCQ
    eGFR
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Of the 2134 screened patients (including 1 patient who was screened twice), 1639 patients were randomized.
    Arm/Group Title Aliskiren Placebo
    Arm/Group Description Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy. Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
    Period Title: Overall Study
    STARTED 821 818
    Safety Set 808 810
    Full Analysis Set 808 807
    Completed Primary Efficacy Phase (6 m) 717 707
    Completed Secondary Efficacy Phase (12m) 654 640
    COMPLETED 646 643
    NOT COMPLETED 175 175

    Baseline Characteristics

    Arm/Group Title Aliskiren Placebo Total
    Arm/Group Description Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy. Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren. Total of all reporting groups
    Overall Participants 808 807 1615
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    64.7
    (12.44)
    64.5
    (11.88)
    64.6
    (12.16)
    Sex: Female, Male (Count of Participants)
    Female
    171
    21.2%
    197
    24.4%
    368
    22.8%
    Male
    637
    78.8%
    610
    75.6%
    1247
    77.2%

    Outcome Measures

    1. Secondary Outcome
    Title Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months
    Description Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 12 months of randomization was the key secondary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 395 (394 days from randomization). The secondary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 12 months.
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    Full analysis set (FAS) consisted of randomized patients who had received at least one dose of study drug.
    Arm/Group Title Aliskiren Placebo
    Arm/Group Description Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy. Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
    Measure Participants 808 807
    Secondary Composite Endpoint
    283
    35%
    301
    37.3%
    Cardiovascular death
    126
    15.6%
    137
    17%
    Heart faliure re-hospitalization
    212
    26.2%
    224
    27.8%
    2. Secondary Outcome
    Title Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months
    Description Symptom reduction and reduction in physical limitations was assessed using the clinical summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a self-administered questionnaire and contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Health-Related Quality of Life (QoL), including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Each scale score was calculated as the mean of its item scores and transformed to a 0-100 scale, with higher score indicating higher level of functioning. A score of 100 represents perfect health whereas a score of 0 represents death. A positive change in score from baseline indicates an improvement.
    Time Frame Baseline, 1 months, 6 months and 12 months

    Outcome Measure Data

    Analysis Population Description
    Full analysis set included all randomized patients who had taken at least one dose of drug. 'n' in each category indicates patients with assessable data both at baseline and corresponding time points.
    Arm/Group Title Aliskiren Placebo
    Arm/Group Description Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy. Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
    Measure Participants 808 807
    1 Month (n= 574, 571)
    24.13
    (0.903)
    23.58
    (0.908)
    6 Months (n= 485, 474)
    26.54
    (1.004)
    24.51
    (1.016)
    12 Months (n= 241, 230)
    24.82
    (1.268)
    24.70
    (1.291)
    3. Secondary Outcome
    Title Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months
    Description A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    Full analysis set included all randomized patients who had taken at least one dose of drug.
    Arm/Group Title Aliskiren Placebo
    Arm/Group Description Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy. Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
    Measure Participants 808 807
    Cardiovascular event
    209
    25.9%
    233
    28.9%
    Cardiovascular death
    77
    9.5%
    85
    10.5%
    Heart faliure re-hospitalization
    153
    18.9%
    166
    20.6%
    All-cause myocardial infarction
    14
    1.7%
    23
    2.9%
    Fatal myocardial infarction
    2
    0.2%
    6
    0.7%
    Non-fatal myocardial infarction
    12
    1.5%
    22
    2.7%
    All-cause stroke
    13
    1.6%
    22
    2.7%
    Fatal stroke
    6
    0.7%
    4
    0.5%
    Non-fatal stroke
    13
    1.6%
    22
    2.7%
    Resuscitated sudden death
    3
    0.4%
    8
    1%
    4. Secondary Outcome
    Title Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months
    Description
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    Full ananlysis set included all randomized patients who had at least one dose of study drug.
    Arm/Group Title Aliskiren Placebo
    Arm/Group Description Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy. Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
    Measure Participants 808 807
    Number [Participants]
    144
    17.8%
    148
    18.3%
    5. Primary Outcome
    Title Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 6 Months
    Description Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months of randomization was the primary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 190 (189 days from randomization). The primary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 6 months.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    Full analysis set (FAS) consisted of randomized patients who had received at least one dose of study drug.
    Arm/Group Title Aliskiren Placebo
    Arm/Group Description Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy. Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
    Measure Participants 808 807
    Primary Composite Endpoint
    201
    24.9%
    214
    26.5%
    Cardiovascular death
    77
    9.5%
    85
    10.5%
    Heart faliure re-hospitalization
    153
    18.9%
    166
    20.6%
    6. Secondary Outcome
    Title Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months
    Description The reported Least square means, and Confidential Interval were from a repeated measures model on log transformed NT-proBNP data containing treatment, visit, and region as factors, log baseline NT-proBNP as a continuous covariate and treatment by visit and visit by log baseline NT-proBNP as interaction terms.
    Time Frame Baseline, 1 month, 6 months and 12 months

    Outcome Measure Data

    Analysis Population Description
    Full analysis set included all randomized patients who had taken at least one dose of study drug. 'n' in each category indicates patients with assessable date at baseline and each corresponding time point.
    Arm/Group Title Aliskiren Placebo
    Arm/Group Description Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy. Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
    Measure Participants 808 807
    Month 1 (n= 669, 675)
    0.86
    0.95
    Month 6 (n= 569, 556)
    0.64
    0.76
    Month 12 (n=447, 425)
    0.62
    0.74
    7. Secondary Outcome
    Title Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months
    Description A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    Full analysis set included all randomized patients who had taken at least one dose of study drug.
    Arm/Group Title Aliskiren Placebo
    Arm/Group Description Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy. Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
    Measure Participants 808 807
    Cardiovascular event
    293
    36.3%
    321
    39.8%
    Cardiovascular death
    126
    15.6%
    137
    17%
    Heart faliure re-hospitalization
    212
    26.2%
    224
    27.8%
    All-cause myocardial infarction
    18
    2.2%
    38
    4.7%
    Fatal myocardial infarction
    4
    0.5%
    12
    1.5%
    Non-fatal myocardial infarction
    16
    2%
    36
    4.5%
    All-cause stroke
    18
    2.2%
    27
    3.3%
    Fatal stroke
    6
    0.7%
    7
    0.9%
    Non-fatal stroke
    18
    2.2%
    27
    3.3%
    Resuscitated sudden death
    5
    0.6%
    10
    1.2%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Aliskiren Placebo
    Arm/Group Description Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy. Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
    All Cause Mortality
    Aliskiren Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Aliskiren Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 421/808 (52.1%) 435/810 (53.7%)
    Blood and lymphatic system disorders
    Anaemia 6/808 (0.7%) 5/810 (0.6%)
    Haemorrhagic disorder 1/808 (0.1%) 0/810 (0%)
    Hilar lymphadenopathy 1/808 (0.1%) 0/810 (0%)
    Jaundice acholuric 0/808 (0%) 1/810 (0.1%)
    Leukocytosis 0/808 (0%) 1/810 (0.1%)
    Lymphadenopathy 1/808 (0.1%) 0/810 (0%)
    Splenic infarction 1/808 (0.1%) 0/810 (0%)
    Thrombocytopenia 0/808 (0%) 1/810 (0.1%)
    Cardiac disorders
    Acute coronary syndrome 3/808 (0.4%) 3/810 (0.4%)
    Acute left ventricular failure 1/808 (0.1%) 1/810 (0.1%)
    Acute myocardial infarction 9/808 (1.1%) 15/810 (1.9%)
    Angina pectoris 9/808 (1.1%) 10/810 (1.2%)
    Angina unstable 7/808 (0.9%) 6/810 (0.7%)
    Aortic valve incompetence 1/808 (0.1%) 0/810 (0%)
    Arrhythmia 3/808 (0.4%) 3/810 (0.4%)
    Arrhythmia supraventricular 0/808 (0%) 1/810 (0.1%)
    Arteriospasm coronary 1/808 (0.1%) 0/810 (0%)
    Atrial fibrillation 14/808 (1.7%) 16/810 (2%)
    Atrial flutter 3/808 (0.4%) 2/810 (0.2%)
    Atrial tachycardia 1/808 (0.1%) 1/810 (0.1%)
    Atrioventricular block complete 2/808 (0.2%) 1/810 (0.1%)
    Bradyarrhythmia 0/808 (0%) 1/810 (0.1%)
    Bradycardia 1/808 (0.1%) 2/810 (0.2%)
    Cardiac arrest 11/808 (1.4%) 14/810 (1.7%)
    Cardiac failure 147/808 (18.2%) 155/810 (19.1%)
    Cardiac failure acute 58/808 (7.2%) 60/810 (7.4%)
    Cardiac failure chronic 50/808 (6.2%) 62/810 (7.7%)
    Cardiac failure congestive 21/808 (2.6%) 31/810 (3.8%)
    Cardiac tamponade 0/808 (0%) 1/810 (0.1%)
    Cardio-respiratory arrest 7/808 (0.9%) 3/810 (0.4%)
    Cardiogenic shock 7/808 (0.9%) 6/810 (0.7%)
    Cardiomyopathy 1/808 (0.1%) 0/810 (0%)
    Cardiopulmonary failure 2/808 (0.2%) 1/810 (0.1%)
    Cardiorenal syndrome 0/808 (0%) 1/810 (0.1%)
    Congestive cardiomyopathy 2/808 (0.2%) 2/810 (0.2%)
    Coronary artery disease 4/808 (0.5%) 2/810 (0.2%)
    Heart valve incompetence 0/808 (0%) 1/810 (0.1%)
    Ischaemic cardiomyopathy 0/808 (0%) 1/810 (0.1%)
    Left ventricular dysfunction 1/808 (0.1%) 0/810 (0%)
    Low cardiac output syndrome 1/808 (0.1%) 0/810 (0%)
    Myocardial fibrosis 1/808 (0.1%) 0/810 (0%)
    Myocardial infarction 11/808 (1.4%) 11/810 (1.4%)
    Myocardial ischaemia 3/808 (0.4%) 3/810 (0.4%)
    Palpitations 2/808 (0.2%) 2/810 (0.2%)
    Pericardial effusion 0/808 (0%) 1/810 (0.1%)
    Pulseless electrical activity 0/808 (0%) 2/810 (0.2%)
    Sick sinus syndrome 0/808 (0%) 1/810 (0.1%)
    Supraventricular tachycardia 0/808 (0%) 2/810 (0.2%)
    Tachyarrhythmia 1/808 (0.1%) 0/810 (0%)
    Tachycardia 3/808 (0.4%) 1/810 (0.1%)
    Ventricular arrhythmia 2/808 (0.2%) 4/810 (0.5%)
    Ventricular dysfunction 0/808 (0%) 1/810 (0.1%)
    Ventricular extrasystoles 1/808 (0.1%) 0/810 (0%)
    Ventricular fibrillation 4/808 (0.5%) 5/810 (0.6%)
    Ventricular tachycardia 10/808 (1.2%) 6/810 (0.7%)
    Ear and labyrinth disorders
    Vertigo 4/808 (0.5%) 2/810 (0.2%)
    Eye disorders
    Cataract 3/808 (0.4%) 0/810 (0%)
    Eye haemorrhage 0/808 (0%) 1/810 (0.1%)
    Glaucoma 1/808 (0.1%) 1/810 (0.1%)
    Retinal detachment 1/808 (0.1%) 0/810 (0%)
    Retinal haemorrhage 0/808 (0%) 1/810 (0.1%)
    Retinal vein occlusion 0/808 (0%) 1/810 (0.1%)
    Gastrointestinal disorders
    Abdominal pain 3/808 (0.4%) 4/810 (0.5%)
    Abdominal pain upper 0/808 (0%) 1/810 (0.1%)
    Ascites 0/808 (0%) 4/810 (0.5%)
    Colonic polyp 0/808 (0%) 1/810 (0.1%)
    Constipation 2/808 (0.2%) 0/810 (0%)
    Diarrhoea 2/808 (0.2%) 3/810 (0.4%)
    Diverticular perforation 0/808 (0%) 1/810 (0.1%)
    Diverticulum intestinal 0/808 (0%) 1/810 (0.1%)
    Duodenal ulcer haemorrhage 1/808 (0.1%) 0/810 (0%)
    Dyspepsia 2/808 (0.2%) 2/810 (0.2%)
    Enteritis 0/808 (0%) 1/810 (0.1%)
    Enterocolitis 1/808 (0.1%) 0/810 (0%)
    Gastritis 1/808 (0.1%) 0/810 (0%)
    Gastrointestinal haemorrhage 1/808 (0.1%) 5/810 (0.6%)
    Gingival bleeding 0/808 (0%) 1/810 (0.1%)
    Haemorrhoidal haemorrhage 0/808 (0%) 1/810 (0.1%)
    Haemorrhoids 0/808 (0%) 1/810 (0.1%)
    Hiatus hernia 1/808 (0.1%) 0/810 (0%)
    Inguinal hernia 1/808 (0.1%) 1/810 (0.1%)
    Intestinal obstruction 1/808 (0.1%) 0/810 (0%)
    Intestinal polyp 1/808 (0.1%) 0/810 (0%)
    Lower gastrointestinal haemorrhage 0/808 (0%) 2/810 (0.2%)
    Nausea 8/808 (1%) 3/810 (0.4%)
    Pancreatitis acute 0/808 (0%) 1/810 (0.1%)
    Rectal haemorrhage 0/808 (0%) 2/810 (0.2%)
    Small intestinal haemorrhage 0/808 (0%) 2/810 (0.2%)
    Small intestinal obstruction 1/808 (0.1%) 0/810 (0%)
    Tongue oedema 0/808 (0%) 1/810 (0.1%)
    Umbilical hernia, obstructive 1/808 (0.1%) 0/810 (0%)
    Upper gastrointestinal haemorrhage 1/808 (0.1%) 0/810 (0%)
    Vomiting 5/808 (0.6%) 2/810 (0.2%)
    General disorders
    Asthenia 1/808 (0.1%) 3/810 (0.4%)
    Cardiac death 3/808 (0.4%) 3/810 (0.4%)
    Chest discomfort 1/808 (0.1%) 0/810 (0%)
    Chest pain 6/808 (0.7%) 0/810 (0%)
    Death 21/808 (2.6%) 25/810 (3.1%)
    Device breakage 0/808 (0%) 1/810 (0.1%)
    Device lead issue 1/808 (0.1%) 0/810 (0%)
    Device malfunction 1/808 (0.1%) 4/810 (0.5%)
    Drug intolerance 1/808 (0.1%) 0/810 (0%)
    Fatigue 2/808 (0.2%) 4/810 (0.5%)
    General physical health deterioration 2/808 (0.2%) 3/810 (0.4%)
    Generalised oedema 2/808 (0.2%) 2/810 (0.2%)
    Implant site haematoma 0/808 (0%) 1/810 (0.1%)
    Medical device complication 0/808 (0%) 1/810 (0.1%)
    Metaplasia 0/808 (0%) 1/810 (0.1%)
    Multi-organ failure 1/808 (0.1%) 3/810 (0.4%)
    Necrosis 1/808 (0.1%) 0/810 (0%)
    Non-cardiac chest pain 7/808 (0.9%) 1/810 (0.1%)
    Oedema peripheral 3/808 (0.4%) 6/810 (0.7%)
    Pain 0/808 (0%) 1/810 (0.1%)
    Pyrexia 2/808 (0.2%) 2/810 (0.2%)
    Soft tissue inflammation 1/808 (0.1%) 0/810 (0%)
    Stent malfunction 0/808 (0%) 1/810 (0.1%)
    Sudden cardiac death 5/808 (0.6%) 7/810 (0.9%)
    Sudden death 9/808 (1.1%) 5/810 (0.6%)
    Hepatobiliary disorders
    Acute hepatic failure 0/808 (0%) 1/810 (0.1%)
    Cholecystitis 2/808 (0.2%) 1/810 (0.1%)
    Cholelithiasis 1/808 (0.1%) 2/810 (0.2%)
    Hepatic cirrhosis 1/808 (0.1%) 0/810 (0%)
    Hepatic cyst 1/808 (0.1%) 0/810 (0%)
    Hepatitis 0/808 (0%) 1/810 (0.1%)
    Hepatitis cholestatic 0/808 (0%) 1/810 (0.1%)
    Hepatomegaly 1/808 (0.1%) 1/810 (0.1%)
    Hepatorenal syndrome 1/808 (0.1%) 0/810 (0%)
    Ischaemic hepatitis 0/808 (0%) 1/810 (0.1%)
    Immune system disorders
    Heart transplant rejection 1/808 (0.1%) 0/810 (0%)
    Infections and infestations
    Abscess limb 0/808 (0%) 1/810 (0.1%)
    Anal abscess 1/808 (0.1%) 0/810 (0%)
    Appendicitis 2/808 (0.2%) 0/810 (0%)
    Arthritis infective 0/808 (0%) 1/810 (0.1%)
    Bacteraemia 1/808 (0.1%) 1/810 (0.1%)
    Bronchiolitis 0/808 (0%) 1/810 (0.1%)
    Bronchitis 6/808 (0.7%) 6/810 (0.7%)
    Bronchitis bacterial 1/808 (0.1%) 0/810 (0%)
    Bronchopneumonia 3/808 (0.4%) 4/810 (0.5%)
    Cellulitis 1/808 (0.1%) 3/810 (0.4%)
    Citrobacter sepsis 0/808 (0%) 1/810 (0.1%)
    Clostridium difficile colitis 0/808 (0%) 1/810 (0.1%)
    Device related infection 1/808 (0.1%) 4/810 (0.5%)
    Endocarditis 0/808 (0%) 3/810 (0.4%)
    Erysipelas 2/808 (0.2%) 1/810 (0.1%)
    Gangrene 2/808 (0.2%) 3/810 (0.4%)
    Gastroenteritis 2/808 (0.2%) 3/810 (0.4%)
    Gastroenteritis norovirus 1/808 (0.1%) 1/810 (0.1%)
    Gastrointestinal viral infection 1/808 (0.1%) 0/810 (0%)
    Hepatitis B 1/808 (0.1%) 0/810 (0%)
    Infective exacerbation of chronic obstructive airways disease 1/808 (0.1%) 1/810 (0.1%)
    Influenza 0/808 (0%) 1/810 (0.1%)
    Liver abscess 1/808 (0.1%) 0/810 (0%)
    Lobar pneumonia 1/808 (0.1%) 2/810 (0.2%)
    Localised infection 1/808 (0.1%) 0/810 (0%)
    Lower respiratory tract infection 3/808 (0.4%) 2/810 (0.2%)
    Lung infection pseudomonal 0/808 (0%) 1/810 (0.1%)
    Orchitis 1/808 (0.1%) 0/810 (0%)
    Osteomyelitis 1/808 (0.1%) 2/810 (0.2%)
    Osteomyelitis acute 1/808 (0.1%) 0/810 (0%)
    Paronychia 1/808 (0.1%) 0/810 (0%)
    Peritonitis 0/808 (0%) 1/810 (0.1%)
    Pneumonia 25/808 (3.1%) 27/810 (3.3%)
    Pneumonia legionella 0/808 (0%) 1/810 (0.1%)
    Postoperative wound infection 1/808 (0.1%) 2/810 (0.2%)
    Pseudomembranous colitis 2/808 (0.2%) 0/810 (0%)
    Pseudomonas bronchitis 0/808 (0%) 1/810 (0.1%)
    Pulmonary sepsis 1/808 (0.1%) 1/810 (0.1%)
    Respiratory tract infection 3/808 (0.4%) 2/810 (0.2%)
    Sepsis 8/808 (1%) 5/810 (0.6%)
    Septic shock 5/808 (0.6%) 5/810 (0.6%)
    Skin infection 0/808 (0%) 2/810 (0.2%)
    Staphylococcal sepsis 1/808 (0.1%) 1/810 (0.1%)
    Subacute endocarditis 0/808 (0%) 1/810 (0.1%)
    Upper respiratory tract infection 1/808 (0.1%) 4/810 (0.5%)
    Urinary tract infection 4/808 (0.5%) 5/810 (0.6%)
    Urosepsis 0/808 (0%) 1/810 (0.1%)
    Viral infection 1/808 (0.1%) 0/810 (0%)
    Wound infection pseudomonas 1/808 (0.1%) 0/810 (0%)
    Injury, poisoning and procedural complications
    Accidental overdose 1/808 (0.1%) 0/810 (0%)
    Ankle fracture 1/808 (0.1%) 0/810 (0%)
    Brain herniation 0/808 (0%) 1/810 (0.1%)
    Contusion 1/808 (0.1%) 0/810 (0%)
    Dermatitis artefacta 1/808 (0.1%) 0/810 (0%)
    Electric shock 1/808 (0.1%) 0/810 (0%)
    Extradural haematoma 1/808 (0.1%) 0/810 (0%)
    Facial bones fracture 0/808 (0%) 1/810 (0.1%)
    Fall 0/808 (0%) 3/810 (0.4%)
    Femoral neck fracture 1/808 (0.1%) 0/810 (0%)
    Femur fracture 4/808 (0.5%) 1/810 (0.1%)
    Foot fracture 0/808 (0%) 1/810 (0.1%)
    Hand fracture 0/808 (0%) 1/810 (0.1%)
    Head injury 1/808 (0.1%) 0/810 (0%)
    Hip fracture 1/808 (0.1%) 2/810 (0.2%)
    Humerus fracture 2/808 (0.2%) 1/810 (0.1%)
    In-stent arterial restenosis 0/808 (0%) 1/810 (0.1%)
    Laceration 1/808 (0.1%) 0/810 (0%)
    Lower limb fracture 0/808 (0%) 1/810 (0.1%)
    Optic nerve injury 0/808 (0%) 1/810 (0.1%)
    Pelvic fracture 1/808 (0.1%) 1/810 (0.1%)
    Pneumothorax traumatic 0/808 (0%) 1/810 (0.1%)
    Post procedural haematoma 1/808 (0.1%) 0/810 (0%)
    Procedural haemorrhage 1/808 (0.1%) 0/810 (0%)
    Pubis fracture 1/808 (0.1%) 0/810 (0%)
    Rib fracture 0/808 (0%) 1/810 (0.1%)
    Road traffic accident 0/808 (0%) 1/810 (0.1%)
    Spinal compression fracture 1/808 (0.1%) 0/810 (0%)
    Splenic rupture 1/808 (0.1%) 0/810 (0%)
    Subcutaneous haematoma 1/808 (0.1%) 1/810 (0.1%)
    Subdural haematoma 2/808 (0.2%) 0/810 (0%)
    Thermal burn 1/808 (0.1%) 0/810 (0%)
    Tongue injury 0/808 (0%) 1/810 (0.1%)
    Toxicity to various agents 2/808 (0.2%) 1/810 (0.1%)
    Traumatic haematoma 0/808 (0%) 1/810 (0.1%)
    Vascular graft occlusion 0/808 (0%) 2/810 (0.2%)
    Vascular graft thrombosis 0/808 (0%) 1/810 (0.1%)
    Wound necrosis 0/808 (0%) 1/810 (0.1%)
    Investigations
    Activated partial thromboplastin time prolonged 0/808 (0%) 1/810 (0.1%)
    Anticoagulation drug level above therapeutic 1/808 (0.1%) 1/810 (0.1%)
    Blood creatinine increased 3/808 (0.4%) 1/810 (0.1%)
    Blood osmolarity decreased 0/808 (0%) 1/810 (0.1%)
    Blood potassium increased 0/808 (0%) 1/810 (0.1%)
    Coagulation test abnormal 0/808 (0%) 1/810 (0.1%)
    Ejection fraction decreased 0/808 (0%) 1/810 (0.1%)
    Haemoglobin decreased 1/808 (0.1%) 0/810 (0%)
    International normalised ratio increased 2/808 (0.2%) 1/810 (0.1%)
    Renal function test abnormal 1/808 (0.1%) 0/810 (0%)
    Transaminases increased 0/808 (0%) 1/810 (0.1%)
    Urine output decreased 0/808 (0%) 3/810 (0.4%)
    Weight increased 1/808 (0.1%) 3/810 (0.4%)
    Metabolism and nutrition disorders
    Decreased appetite 1/808 (0.1%) 0/810 (0%)
    Dehydration 3/808 (0.4%) 4/810 (0.5%)
    Diabetes mellitus 1/808 (0.1%) 3/810 (0.4%)
    Diabetes mellitus inadequate control 3/808 (0.4%) 3/810 (0.4%)
    Diabetic ketoacidosis 1/808 (0.1%) 0/810 (0%)
    Electrolyte imbalance 0/808 (0%) 1/810 (0.1%)
    Failure to thrive 1/808 (0.1%) 0/810 (0%)
    Fluid intake reduced 1/808 (0.1%) 0/810 (0%)
    Fluid overload 1/808 (0.1%) 1/810 (0.1%)
    Gout 2/808 (0.2%) 3/810 (0.4%)
    Hyperglycaemia 2/808 (0.2%) 3/810 (0.4%)
    Hyperkalaemia 12/808 (1.5%) 12/810 (1.5%)
    Hyperosmolar state 0/808 (0%) 1/810 (0.1%)
    Hypervolaemia 0/808 (0%) 1/810 (0.1%)
    Hypocholesterolaemia 0/808 (0%) 1/810 (0.1%)
    Hypoglycaemia 7/808 (0.9%) 2/810 (0.2%)
    Hypokalaemia 6/808 (0.7%) 6/810 (0.7%)
    Hyponatraemia 4/808 (0.5%) 5/810 (0.6%)
    Hypovolaemia 0/808 (0%) 1/810 (0.1%)
    Type 2 diabetes mellitus 0/808 (0%) 1/810 (0.1%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/808 (0.1%) 0/810 (0%)
    Arthritis 1/808 (0.1%) 0/810 (0%)
    Back pain 1/808 (0.1%) 2/810 (0.2%)
    Bursitis 1/808 (0.1%) 0/810 (0%)
    Costochondritis 1/808 (0.1%) 0/810 (0%)
    Fasciitis 0/808 (0%) 1/810 (0.1%)
    Flank pain 1/808 (0.1%) 1/810 (0.1%)
    Intervertebral disc protrusion 0/808 (0%) 1/810 (0.1%)
    Joint effusion 1/808 (0.1%) 0/810 (0%)
    Muscle haemorrhage 0/808 (0%) 1/810 (0.1%)
    Muscular weakness 1/808 (0.1%) 0/810 (0%)
    Musculoskeletal chest pain 2/808 (0.2%) 2/810 (0.2%)
    Pain in extremity 2/808 (0.2%) 1/810 (0.1%)
    Rotator cuff syndrome 0/808 (0%) 1/810 (0.1%)
    Soft tissue necrosis 1/808 (0.1%) 1/810 (0.1%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign bone neoplasm 0/808 (0%) 1/810 (0.1%)
    Bladder neoplasm 1/808 (0.1%) 0/810 (0%)
    Bronchial carcinoma 0/808 (0%) 1/810 (0.1%)
    Choroid melanoma 0/808 (0%) 1/810 (0.1%)
    Chronic lymphocytic leukaemia 1/808 (0.1%) 1/810 (0.1%)
    Colon cancer 2/808 (0.2%) 1/810 (0.1%)
    Colorectal cancer 1/808 (0.1%) 0/810 (0%)
    Hepatic neoplasm 1/808 (0.1%) 0/810 (0%)
    Hepatobiliary neoplasm 1/808 (0.1%) 0/810 (0%)
    Lipoma 0/808 (0%) 1/810 (0.1%)
    Liposarcoma 0/808 (0%) 1/810 (0.1%)
    Lung adenocarcinoma 1/808 (0.1%) 0/810 (0%)
    Lung neoplasm malignant 1/808 (0.1%) 0/810 (0%)
    Lung squamous cell carcinoma stage unspecified 1/808 (0.1%) 0/810 (0%)
    Multiple myeloma 1/808 (0.1%) 0/810 (0%)
    Non-small cell lung cancer metastatic 0/808 (0%) 1/810 (0.1%)
    Oesophageal neoplasm 0/808 (0%) 1/810 (0.1%)
    Ovarian cancer 0/808 (0%) 1/810 (0.1%)
    Prostate cancer 1/808 (0.1%) 3/810 (0.4%)
    Prostate cancer metastatic 1/808 (0.1%) 0/810 (0%)
    Renal cancer 1/808 (0.1%) 1/810 (0.1%)
    Uterine leiomyoma 1/808 (0.1%) 0/810 (0%)
    Nervous system disorders
    Anterior spinal artery syndrome 1/808 (0.1%) 0/810 (0%)
    Aphasia 0/808 (0%) 1/810 (0.1%)
    Burning sensation 1/808 (0.1%) 0/810 (0%)
    Cerebellar infarction 1/808 (0.1%) 1/810 (0.1%)
    Cerebral haematoma 1/808 (0.1%) 0/810 (0%)
    Cerebral infarction 1/808 (0.1%) 1/810 (0.1%)
    Cerebral ischaemia 0/808 (0%) 1/810 (0.1%)
    Cerebrovascular accident 9/808 (1.1%) 15/810 (1.9%)
    Coma 1/808 (0.1%) 0/810 (0%)
    Convulsion 0/808 (0%) 1/810 (0.1%)
    Diabetic hyperglycaemic coma 0/808 (0%) 1/810 (0.1%)
    Diabetic neuropathy 1/808 (0.1%) 0/810 (0%)
    Dizziness 4/808 (0.5%) 0/810 (0%)
    Dysarthria 1/808 (0.1%) 0/810 (0%)
    Embolic stroke 2/808 (0.2%) 0/810 (0%)
    Epilepsy 2/808 (0.2%) 0/810 (0%)
    Haemorrhagic stroke 1/808 (0.1%) 0/810 (0%)
    Hemiparesis 0/808 (0%) 3/810 (0.4%)
    Hypokinesia 1/808 (0.1%) 1/810 (0.1%)
    Intracranial haematoma 1/808 (0.1%) 0/810 (0%)
    Ischaemic stroke 5/808 (0.6%) 9/810 (1.1%)
    Loss of consciousness 1/808 (0.1%) 0/810 (0%)
    Metabolic encephalopathy 1/808 (0.1%) 0/810 (0%)
    Myasthenia gravis 1/808 (0.1%) 0/810 (0%)
    Myasthenia gravis crisis 1/808 (0.1%) 0/810 (0%)
    Neuropathy peripheral 1/808 (0.1%) 0/810 (0%)
    Presyncope 3/808 (0.4%) 4/810 (0.5%)
    Sensory disturbance 1/808 (0.1%) 1/810 (0.1%)
    Somnolence 2/808 (0.2%) 1/810 (0.1%)
    Subarachnoid haemorrhage 0/808 (0%) 2/810 (0.2%)
    Syncope 11/808 (1.4%) 13/810 (1.6%)
    Transient ischaemic attack 0/808 (0%) 3/810 (0.4%)
    Trigeminal neuralgia 1/808 (0.1%) 0/810 (0%)
    Unresponsive to stimuli 1/808 (0.1%) 0/810 (0%)
    Uraemic encephalopathy 1/808 (0.1%) 0/810 (0%)
    Vertebrobasilar insufficiency 0/808 (0%) 1/810 (0.1%)
    Psychiatric disorders
    Abnormal behaviour 1/808 (0.1%) 0/810 (0%)
    Alcohol abuse 1/808 (0.1%) 0/810 (0%)
    Anxiety 1/808 (0.1%) 0/810 (0%)
    Confusional state 2/808 (0.2%) 0/810 (0%)
    Depression 1/808 (0.1%) 1/810 (0.1%)
    Depression suicidal 1/808 (0.1%) 0/810 (0%)
    Disorientation 0/808 (0%) 1/810 (0.1%)
    Insomnia 0/808 (0%) 1/810 (0.1%)
    Mental status changes 0/808 (0%) 1/810 (0.1%)
    Restlessness 1/808 (0.1%) 1/810 (0.1%)
    Screaming 1/808 (0.1%) 0/810 (0%)
    Suicidal ideation 0/808 (0%) 1/810 (0.1%)
    Renal and urinary disorders
    Acute prerenal failure 1/808 (0.1%) 1/810 (0.1%)
    Anuria 0/808 (0%) 1/810 (0.1%)
    Bladder tamponade 1/808 (0.1%) 0/810 (0%)
    Haematuria 1/808 (0.1%) 0/810 (0%)
    Nephropathy 1/808 (0.1%) 0/810 (0%)
    Obstructive uropathy 0/808 (0%) 1/810 (0.1%)
    Polyuria 1/808 (0.1%) 0/810 (0%)
    Renal artery stenosis 1/808 (0.1%) 0/810 (0%)
    Renal artery thrombosis 0/808 (0%) 1/810 (0.1%)
    Renal failure 6/808 (0.7%) 8/810 (1%)
    Renal failure acute 20/808 (2.5%) 12/810 (1.5%)
    Renal failure chronic 1/808 (0.1%) 3/810 (0.4%)
    Renal impairment 5/808 (0.6%) 4/810 (0.5%)
    Urinary retention 0/808 (0%) 1/810 (0.1%)
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 2/808 (0.2%) 0/810 (0%)
    Menorrhagia 1/808 (0.1%) 0/810 (0%)
    Ovarian cyst 0/808 (0%) 1/810 (0.1%)
    Scrotal oedema 0/808 (0%) 1/810 (0.1%)
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema 7/808 (0.9%) 4/810 (0.5%)
    Acute respiratory distress syndrome 1/808 (0.1%) 0/810 (0%)
    Acute respiratory failure 2/808 (0.2%) 1/810 (0.1%)
    Asthma 1/808 (0.1%) 0/810 (0%)
    Atelectasis 1/808 (0.1%) 0/810 (0%)
    Bronchiectasis 1/808 (0.1%) 0/810 (0%)
    Bronchitis chronic 0/808 (0%) 1/810 (0.1%)
    Bronchospasm 0/808 (0%) 1/810 (0.1%)
    Chronic obstructive pulmonary disease 13/808 (1.6%) 5/810 (0.6%)
    Cough 2/808 (0.2%) 2/810 (0.2%)
    Dyspnoea 20/808 (2.5%) 18/810 (2.2%)
    Dyspnoea at rest 0/808 (0%) 1/810 (0.1%)
    Dyspnoea paroxysmal nocturnal 0/808 (0%) 1/810 (0.1%)
    Epistaxis 0/808 (0%) 2/810 (0.2%)
    Haemoptysis 1/808 (0.1%) 3/810 (0.4%)
    Interstitial lung disease 0/808 (0%) 1/810 (0.1%)
    Lung disorder 0/808 (0%) 1/810 (0.1%)
    Obstructive airways disorder 0/808 (0%) 1/810 (0.1%)
    Pleural effusion 2/808 (0.2%) 2/810 (0.2%)
    Pleurisy 0/808 (0%) 1/810 (0.1%)
    Pneumonitis 1/808 (0.1%) 0/810 (0%)
    Pneumothorax 1/808 (0.1%) 0/810 (0%)
    Productive cough 1/808 (0.1%) 0/810 (0%)
    Pulmonary artery thrombosis 1/808 (0.1%) 0/810 (0%)
    Pulmonary congestion 1/808 (0.1%) 2/810 (0.2%)
    Pulmonary embolism 5/808 (0.6%) 5/810 (0.6%)
    Pulmonary oedema 4/808 (0.5%) 8/810 (1%)
    Rales 0/808 (0%) 1/810 (0.1%)
    Respiratory arrest 0/808 (0%) 1/810 (0.1%)
    Respiratory distress 0/808 (0%) 1/810 (0.1%)
    Respiratory failure 6/808 (0.7%) 5/810 (0.6%)
    Wheezing 1/808 (0.1%) 0/810 (0%)
    Skin and subcutaneous tissue disorders
    Dermatitis 0/808 (0%) 1/810 (0.1%)
    Diabetic foot 1/808 (0.1%) 2/810 (0.2%)
    Hyperhidrosis 2/808 (0.2%) 0/810 (0%)
    Skin exfoliation 0/808 (0%) 1/810 (0.1%)
    Skin necrosis 1/808 (0.1%) 1/810 (0.1%)
    Skin ulcer 1/808 (0.1%) 0/810 (0%)
    Skin ulcer haemorrhage 1/808 (0.1%) 0/810 (0%)
    Swelling face 0/808 (0%) 1/810 (0.1%)
    Surgical and medical procedures
    Gastric bypass 0/808 (0%) 1/810 (0.1%)
    Vascular disorders
    Circulatory collapse 0/808 (0%) 2/810 (0.2%)
    Deep vein thrombosis 1/808 (0.1%) 1/810 (0.1%)
    Extremity necrosis 1/808 (0.1%) 0/810 (0%)
    Haematoma 1/808 (0.1%) 1/810 (0.1%)
    Hypertension 2/808 (0.2%) 3/810 (0.4%)
    Hypertensive crisis 1/808 (0.1%) 3/810 (0.4%)
    Hypertensive emergency 0/808 (0%) 2/810 (0.2%)
    Hypotension 24/808 (3%) 16/810 (2%)
    Intra-abdominal haematoma 0/808 (0%) 1/810 (0.1%)
    Orthostatic hypotension 0/808 (0%) 2/810 (0.2%)
    Peripheral arterial occlusive disease 4/808 (0.5%) 2/810 (0.2%)
    Peripheral ischaemia 1/808 (0.1%) 0/810 (0%)
    Peripheral vascular disorder 2/808 (0.2%) 1/810 (0.1%)
    Phlebitis 1/808 (0.1%) 0/810 (0%)
    Venous haemorrhage 0/808 (0%) 1/810 (0.1%)
    Other (Not Including Serious) Adverse Events
    Aliskiren Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 367/808 (45.4%) 333/810 (41.1%)
    Gastrointestinal disorders
    Diarrhoea 49/808 (6.1%) 36/810 (4.4%)
    Metabolism and nutrition disorders
    Hyperkalaemia 155/808 (19.2%) 128/810 (15.8%)
    Hypokalaemia 42/808 (5.2%) 53/810 (6.5%)
    Nervous system disorders
    Dizziness 35/808 (4.3%) 43/810 (5.3%)
    Renal and urinary disorders
    Renal impairment 47/808 (5.8%) 33/810 (4.1%)
    Respiratory, thoracic and mediastinal disorders
    Cough 59/808 (7.3%) 53/810 (6.5%)
    Vascular disorders
    Hypotension 117/808 (14.5%) 83/810 (10.2%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.

    Results Point of Contact

    Name/Title Study Director
    Organization Novartis Pharmaceuticals
    Phone 862-778-8300
    Email trialandresults.registries@novartis.com
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00894387
    Other Study ID Numbers:
    • CSPP100A2368
    • 2009-010236-18
    First Posted:
    May 7, 2009
    Last Update Posted:
    Nov 7, 2013
    Last Verified:
    Oct 1, 2013