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    Clinical Trial Results:
    A randomized parallel-group, placebo-controlled, double-blind, multi-center trial to evaluate the efficacy and safety of the oral sGC stimulator vericiguat to improve physical functioning in activities of daily living in patients with heart failure and preserved ejection fraction (VITALITY-HFpEF)

    Summary
    EudraCT number
    		 2018-000298-65
    Trial protocol
    		 BE   PT   AT   ES   HU   BG   GR   PL   IT  
    Global end of trial date
    04 Nov 2019

    Results information
    Results version number
    		 v2(current)
    This version publication date
    08 Jan 2021
    First version publication date
    15 Oct 2020
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY1021189/19334
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03547583
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser-Wilhelm-Allee, D-51368 Leverkusen, Germany,
    Public contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Nov 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Patients suffering from Heart failure with preserved ejection fraction (HFpEF) are a large and growing population and HFpEF patients also have substantially reduced functional capacity and quality of life. Since patients with HFpEF are highly symptomatic with a poor quality of life, it is important to find new therapies that can alleviate symptoms and improve patient well-being. Primary objectives: • To evaluate the efficacy of vericiguat 10 mg in comparison to placebo on improving physical functioning from baseline to week 24. • To evaluate the efficacy of vericiguat 15 mg in comparison to placebo on improving physical functioning from baseline to week 24. • To evaluate the safety and tolerability of vericiguat.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jun 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 44
    Country: Number of subjects enrolled
    Austria: 35
    Country: Number of subjects enrolled
    Belgium: 11
    Country: Number of subjects enrolled
    Bulgaria: 96
    Country: Number of subjects enrolled
    Canada: 23
    Country: Number of subjects enrolled
    Colombia: 12
    Country: Number of subjects enrolled
    Germany: 19
    Country: Number of subjects enrolled
    Greece: 48
    Country: Number of subjects enrolled
    Hungary: 43
    Country: Number of subjects enrolled
    Israel: 61
    Country: Number of subjects enrolled
    Italy: 44
    Country: Number of subjects enrolled
    Japan: 41
    Country: Number of subjects enrolled
    Malaysia: 5
    Country: Number of subjects enrolled
    Poland: 70
    Country: Number of subjects enrolled
    Portugal: 25
    Country: Number of subjects enrolled
    Russian Federation: 63
    Country: Number of subjects enrolled
    Singapore: 5
    Country: Number of subjects enrolled
    South Africa: 18
    Country: Number of subjects enrolled
    Spain: 29
    Country: Number of subjects enrolled
    Taiwan: 21
    Country: Number of subjects enrolled
    United States: 76
    Worldwide total number of subjects
    789
    EEA total number of subjects
    420
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    155
    From 65 to 84 years
    558
    85 years and over
    76

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study was conducted at 178 study centers worldwide, between 15-Jun-2018 (first subject first visit) and 04-Nov-2019 (last subject last visit).

    Pre-assignment
    Screening details
    		 Overall, 979 subjects were screened, of whom 789 patients were randomized in the study. 788 of the randomized subjects were allocated to study treatment, of whom 672 subjects completed the study.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Vericiguat up to 10 mg
    Arm description
    		 Subjects received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    vericiguat
    Investigational medicinal product code
    BAY1021189
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    vericiguat, which was started at 2.5 mg at randomization and up-titrated to 5 mg at week 2, and to 10 mg at week 4, with sham titration to 15 mg at week 6.

    Arm title
    		 Vericiguat up to 15 mg
    Arm description
    		 Subjects received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    vericiguat
    Investigational medicinal product code
    BAY1021189
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    vericiguat, which was started at 2.5 mg at randomization and up-titrated to 5 mg at week 2, and to 10 mg at week 4, with up-titration to 15 mg at week 6.

    Arm title
    		 Placebo
    Arm description
    		 Subject received placebo once daily and sham up-titration at weeks 2, 4, and 6.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    placebo and sham up-titration at weeks 2, 4, and 6

    Number of subjects in period 1
    		Vericiguat up to 10 mg Vericiguat up to 15 mg Placebo
    Started
    263
    264
    262
    Treated
    262
    264
    262
    Completed
    218
    224
    230
    Not completed
    45
    40
    32
         Physician decision
    1
    -
    3
         Consent withdrawn by subject
    12
    19
    10
         Death
    11
    7
    4
         Adverse event
    16
    11
    10
         Non-compliance with study drug
    -
    -
    1
         Lost to follow-up
    1
    -
    -
         unspecified
    2
    2
    3
         Protocol deviation
    2
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Vericiguat up to 10 mg
    Reporting group description
    		 Subjects received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6.

    Reporting group title
    Vericiguat up to 15 mg
    Reporting group description
    		 Subjects received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6.

    Reporting group title
    Placebo
    Reporting group description
    		 Subject received placebo once daily and sham up-titration at weeks 2, 4, and 6.

    Reporting group values
    		 Vericiguat up to 10 mg Vericiguat up to 15 mg Placebo Total
    Number of subjects
    		 263 264 262 789
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 72.2 ( 9.7 ) 73.1 ( 9.1 ) 72.8 ( 9.4 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 124 140 121 385
        Male
    		 139 124 141 404
    Race
    Units: Subjects
        White
    		 228 224 222 674
        Black or African American
    		 5 7 9 21
        Asian
    		 24 26 25 75
        American Indian or Alaska Native
    		 3 4 4 11
        Not reported
    		 1 1 0 2
        Multiple
    		 2 2 2 6
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 235 242 238 715
        Hispanic or Latino
    		 28 21 23 72
        Not reported
    		 0 1 1 2
    Kansas City Cardiopathy Questionnaire Physical limitation score (KCCQ PLS)
    The KCCQ measures the impact of patients’ heart failure, or its treatment, on 6 domains; Physical Limitation, Symptom (with subscores for frequency and burden), Quality of Life, Social Limitations, Symptom Stability and Self-Efficacy. Scores are calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status. FAS KCCQ: All patients randomized and treated (at least one dose of the study treatment), and had at least one observed KCCQ PLS assessment at both baseline and during post-baseline (excluding safety follow-up).
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    		 57.30 ( 24.77 ) 60.03 ( 24.64 ) 59.03 ( 24.00 ) -
    Six-minute walk test
    Six-minute walk test (6MWT) was conducted to test the physical limitations of the patient by assessing the patient’s exercise capacity. The distance walked by the patient in 6 minutes was measured. FAS 6MWT: All patients randomized and treated (at least one dose of the study treatment), and who were able to perform at least one 6MWT assessment at both baseline and post-baseline (excluding safety follow-up).
    Units: Meters
        arithmetic mean (standard deviation)
    		 292.13 ( 107.75 ) 294.99 ( 118.00 ) 295.80 ( 106.27 ) -

    End points

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    End points reporting groups
    Reporting group title
    Vericiguat up to 10 mg
    Reporting group description
    		 Subjects received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6.

    Reporting group title
    Vericiguat up to 15 mg
    Reporting group description
    		 Subjects received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6.

    Reporting group title
    Placebo
    Reporting group description
    		 Subject received placebo once daily and sham up-titration at weeks 2, 4, and 6.

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects randomized were valid for the FAS.

    Subject analysis set title
    FAS KCCQ
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All patients randomized and treated (at least one dose of the study treatment), and had at least one observed KCCQ PLS assessment at both baseline and during post-baseline (excluding safety follow-up).

    Subject analysis set title
    FAS 6MWT
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All patients randomized and treated (at least one dose of the study treatment), and who were able to perform at least one 6MWT assessment at both baseline and post-baseline (excluding safety follow-up).

    Primary: Change in KCCQ physical limitation score from baseline to week 24

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    End point title
    		 Change in KCCQ physical limitation score from baseline to week 24
    End point description
    The City Cardiomyopathy Questionnaire (KCCQ) measures the impact of patients’ heart failure, or its treatment, on 6 domains; Physical Limitation, Symptom (with subscores for frequency and burden), Quality of Life, Social Limitations, Symptom Stability and Self-Efficacy. Scores are calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.
    End point type
    Primary
    End point timeframe
    From baseline to Week 24
    End point values
    		 Vericiguat up to 10 mg Vericiguat up to 15 mg Placebo
    Number of subjects analysed
    254 [1]
    255 [2]
    252 [3]
    Units: Scores on a scale
        least squares mean (standard error)
    6.41 ( 1.592 )
    5.47 ( 1.538 )
    6.93 ( 1.535 )
    Notes
    [1] - FAS KCCQ
    [2] - FAS KCCQ
    [3] - FAS KCCQ
    Statistical analysis title
    		 Vericiguat 10 mg vs Placebo
    Statistical analysis description
    The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline PLS values as covariates.
    Comparison groups
    Placebo v Vericiguat up to 10 mg
    Number of subjects included in analysis
    506
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8008
    Method
    		 Mixed model repeated-measures
    Parameter type
    		 Difference of LS-means
    Point estimate
    -0.52
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -5.17
         upper limit
    		 4.13
    Statistical analysis title
    		 Vericiguat 15mg vs Placebo
    Statistical analysis description
    The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline PLS values as covariates.
    Comparison groups
    Vericiguat up to 15 mg v Placebo
    Number of subjects included in analysis
    507
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4722
    Method
    		 Mixed model repeated-measures
    Parameter type
    		 Difference of LS-means
    Point estimate
    -1.46
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -6.02
         upper limit
    		 3.1

    Secondary: Change in the Six-minute walk test (6MWT) from baseline to Week 24

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    End point title
    		 Change in the Six-minute walk test (6MWT) from baseline to Week 24
    End point description
    6MWT was conducted to test the physical limitations of the patient by assessing the patient's exercise capacity. The distance walked by the patient in 6 minutes was measured.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 24
    End point values
    		 Vericiguat up to 10 mg Vericiguat up to 15 mg Placebo
    Number of subjects analysed
    236 [4]
    245 [5]
    240 [6]
    Units: Meters
        least squares mean (standard error)
    8.68 ( 5.841 )
    5.00 ( 5.718 )
    10.49 ( 5.512 )
    Notes
    [4] - FAS 6MWT
    [5] - FAS 6MWT
    [6] - FAS 6MWT
    Statistical analysis title
    		 Vericiguat 10 mg vs Placebo
    Statistical analysis description
    The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline 6MWT values as covariates.
    Comparison groups
    Vericiguat up to 10 mg v Placebo
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8054
    Method
    		 Mixed model repeated-measures
    Parameter type
    		 Difference of LS-means
    Point estimate
    -1.81
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -18.3
         upper limit
    		 14.67
    Statistical analysis title
    		 Vericiguat 15 mg vs Placebo
    Statistical analysis description
    The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline 6MWT values as covariates.
    Comparison groups
    Vericiguat up to 15 mg v Placebo
    Number of subjects included in analysis
    485
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4502
    Method
    		 mixed model repeated measures
    Parameter type
    		 Difference of LS-means
    Point estimate
    -5.49
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -21.77
         upper limit
    		 10.8

    Other pre-specified: Number of participants with treatment emergent adverse events

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    End point title
    		 Number of participants with treatment emergent adverse events
    End point description
    An AE is any untoward medical occurrence (i.e. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a patient or clinical investigation patient after providing written informed consent for participation in the study. Adverse events are considered to be treatment-emergent if they have started or worsened after first application of study medication up to 5 calendar days after end of treatment with study medication.
    End point type
    Other pre-specified
    End point timeframe
    From first application of study drug up to 5 calendar days after end of treatment with study drug
    End point values
    		 Vericiguat up to 10 mg Vericiguat up to 15 mg Placebo
    Number of subjects analysed
    262
    264
    262
    Units: Subjects
        Any TEAE
    163
    172
    172
        Any study drug related TEAE
    38
    42
    24
        Any TESAE
    46
    54
    48
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for reporting adverse events: From the first application of study medication up to 5 calendar days after end of treatment with study medication Timeframe for number of death (all causes): After study medication start until last contact date.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Vericiguat up to 10 mg
    Reporting group description
    		 Subjects received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo for 24 weeks, once daily, starting sham up-titration at weeks 2, 4, and 6.

    Reporting group title
    Vericiguat up to 15 mg
    Reporting group description
    		 Subjects received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6.

    Serious adverse events
    		 Vericiguat up to 10 mg Placebo Vericiguat up to 15 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    46 / 262 (17.56%)
    48 / 262 (18.32%)
    54 / 264 (20.45%)
         number of deaths (all causes)
    15
    7
    10
         number of deaths resulting from adverse events
    8
    4
    5
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Laryngeal cancer
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Phaeochromocytoma
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Aortic stenosis
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Hypertension
         subjects affected / exposed
    0 / 262 (0.00%)
    2 / 262 (0.76%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    2 / 262 (0.76%)
    4 / 262 (1.53%)
    3 / 264 (1.14%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 4
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Inguinal hernia repair
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leg amputation
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac pacemaker replacement
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 262 (0.00%)
    2 / 262 (0.76%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Pelvic mass
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Sudden death
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    2 / 264 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 262 (0.38%)
    1 / 262 (0.38%)
    4 / 264 (1.52%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract inflammation
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device malfunction
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angiocardiogram
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 262 (0.00%)
    2 / 262 (0.76%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Scrotal haematoma
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    2 / 262 (0.76%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vulvovaginal injury
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    4 / 262 (1.53%)
    1 / 262 (0.38%)
    4 / 264 (1.52%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiovascular disorder
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 262 (0.38%)
    2 / 262 (0.76%)
    2 / 264 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    0 / 262 (0.00%)
    2 / 262 (0.76%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery insufficiency
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Diabetic neuropathy
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    2 / 264 (0.76%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thalamus haemorrhage
         subjects affected / exposed
    1 / 262 (0.38%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 262 (1.15%)
    1 / 262 (0.38%)
    2 / 264 (0.76%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Diplopia
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Macular oedema
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Dysphagia
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    2 / 264 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Odynophagia
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Proctitis
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal incarcerated hernia
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Stevens-Johnson syndrome
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    0 / 262 (0.00%)
    2 / 262 (0.76%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    0 / 262 (0.00%)
    2 / 262 (0.76%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    3 / 262 (1.15%)
    4 / 262 (1.53%)
    3 / 264 (1.14%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 4
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    2 / 262 (0.76%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 262 (0.38%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psoriatic arthropathy
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 262 (0.76%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    3 / 264 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis staphylococcal
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endophthalmitis
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    2 / 264 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 262 (1.15%)
    4 / 262 (1.53%)
    7 / 264 (2.65%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Pyelonephritis chronic
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 262 (0.00%)
    3 / 262 (1.15%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Implant site infection
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia pyelonephritis
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Medical device site joint infection
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 262 (0.38%)
    0 / 262 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 262 (0.38%)
    1 / 262 (0.38%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Hyponatraemia
         subjects affected / exposed
    0 / 262 (0.00%)
    0 / 262 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Vericiguat up to 10 mg Placebo Vericiguat up to 15 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    121 / 262 (46.18%)
    131 / 262 (50.00%)
    134 / 264 (50.76%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 262 (1.91%)
    10 / 262 (3.82%)
    11 / 264 (4.17%)
         occurrences all number
    5
    12
    12
    Hypotension
         subjects affected / exposed
    16 / 262 (6.11%)
    12 / 262 (4.58%)
    22 / 264 (8.33%)
         occurrences all number
    18
    14
    31
    Surgical and medical procedures
    Cataract operation
         subjects affected / exposed
    1 / 262 (0.38%)
    3 / 262 (1.15%)
    2 / 264 (0.76%)
         occurrences all number
    2
    4
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 262 (1.15%)
    3 / 262 (1.15%)
    1 / 264 (0.38%)
         occurrences all number
    3
    4
    1
    Chest pain
         subjects affected / exposed
    2 / 262 (0.76%)
    3 / 262 (1.15%)
    4 / 264 (1.52%)
         occurrences all number
    3
    4
    4
    Fatigue
         subjects affected / exposed
    3 / 262 (1.15%)
    3 / 262 (1.15%)
    7 / 264 (2.65%)
         occurrences all number
    4
    3
    8
    Oedema
         subjects affected / exposed
    2 / 262 (0.76%)
    0 / 262 (0.00%)
    3 / 264 (1.14%)
         occurrences all number
    2
    0
    3
    Oedema peripheral
         subjects affected / exposed
    16 / 262 (6.11%)
    8 / 262 (3.05%)
    10 / 264 (3.79%)
         occurrences all number
    17
    10
    13
    Pyrexia
         subjects affected / exposed
    2 / 262 (0.76%)
    5 / 262 (1.91%)
    4 / 264 (1.52%)
         occurrences all number
    2
    5
    4
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    3 / 262 (1.15%)
    3 / 262 (1.15%)
    3 / 264 (1.14%)
         occurrences all number
    3
    3
    4
    Cough
         subjects affected / exposed
    5 / 262 (1.91%)
    6 / 262 (2.29%)
    5 / 264 (1.89%)
         occurrences all number
    5
    6
    6
    Dyspnoea
         subjects affected / exposed
    7 / 262 (2.67%)
    14 / 262 (5.34%)
    5 / 264 (1.89%)
         occurrences all number
    8
    15
    5
    Epistaxis
         subjects affected / exposed
    3 / 262 (1.15%)
    3 / 262 (1.15%)
    5 / 264 (1.89%)
         occurrences all number
    5
    3
    5
    Rhinorrhoea
         subjects affected / exposed
    2 / 262 (0.76%)
    0 / 262 (0.00%)
    3 / 264 (1.14%)
         occurrences all number
    2
    0
    3
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    3 / 262 (1.15%)
    3 / 262 (1.15%)
    2 / 264 (0.76%)
         occurrences all number
    4
    4
    2
    Insomnia
         subjects affected / exposed
    1 / 262 (0.38%)
    1 / 262 (0.38%)
    3 / 264 (1.14%)
         occurrences all number
    1
    1
    3
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    3 / 262 (1.15%)
    0 / 262 (0.00%)
    3 / 264 (1.14%)
         occurrences all number
    3
    0
    4
    Blood uric acid increased
         subjects affected / exposed
    3 / 262 (1.15%)
    2 / 262 (0.76%)
    4 / 264 (1.52%)
         occurrences all number
    3
    2
    4
    Weight decreased
         subjects affected / exposed
    3 / 262 (1.15%)
    2 / 262 (0.76%)
    3 / 264 (1.14%)
         occurrences all number
    3
    2
    3
    N-terminal prohormone brain natriuretic peptide increased
         subjects affected / exposed
    2 / 262 (0.76%)
    4 / 262 (1.53%)
    1 / 264 (0.38%)
         occurrences all number
    2
    5
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    4 / 262 (1.53%)
    3 / 262 (1.15%)
    3 / 264 (1.14%)
         occurrences all number
    4
    3
    4
    Contusion
         subjects affected / exposed
    2 / 262 (0.76%)
    1 / 262 (0.38%)
    3 / 264 (1.14%)
         occurrences all number
    2
    1
    5
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    7 / 262 (2.67%)
    6 / 262 (2.29%)
    7 / 264 (2.65%)
         occurrences all number
    8
    6
    9
    Coronary artery disease
         subjects affected / exposed
    0 / 262 (0.00%)
    3 / 262 (1.15%)
    0 / 264 (0.00%)
         occurrences all number
    0
    3
    0
    Palpitations
         subjects affected / exposed
    4 / 262 (1.53%)
    3 / 262 (1.15%)
    0 / 264 (0.00%)
         occurrences all number
    5
    3
    0
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 262 (0.38%)
    1 / 262 (0.38%)
    4 / 264 (1.52%)
         occurrences all number
    1
    1
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    8 / 262 (3.05%)
    11 / 262 (4.20%)
    7 / 264 (2.65%)
         occurrences all number
    9
    14
    9
    Headache
         subjects affected / exposed
    5 / 262 (1.91%)
    11 / 262 (4.20%)
    6 / 264 (2.27%)
         occurrences all number
    6
    16
    7
    Tremor
         subjects affected / exposed
    0 / 262 (0.00%)
    3 / 262 (1.15%)
    0 / 264 (0.00%)
         occurrences all number
    0
    3
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 262 (2.29%)
    9 / 262 (3.44%)
    13 / 264 (4.92%)
         occurrences all number
    6
    9
    13
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 262 (0.38%)
    4 / 262 (1.53%)
    3 / 264 (1.14%)
         occurrences all number
    1
    4
    3
    Abdominal pain upper
         subjects affected / exposed
    5 / 262 (1.91%)
    6 / 262 (2.29%)
    1 / 264 (0.38%)
         occurrences all number
    5
    6
    1
    Constipation
         subjects affected / exposed
    2 / 262 (0.76%)
    4 / 262 (1.53%)
    8 / 264 (3.03%)
         occurrences all number
    2
    6
    9
    Diarrhoea
         subjects affected / exposed
    3 / 262 (1.15%)
    5 / 262 (1.91%)
    5 / 264 (1.89%)
         occurrences all number
    3
    5
    5
    Dyspepsia
         subjects affected / exposed
    4 / 262 (1.53%)
    3 / 262 (1.15%)
    6 / 264 (2.27%)
         occurrences all number
    4
    3
    7
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 262 (1.15%)
    1 / 262 (0.38%)
    4 / 264 (1.52%)
         occurrences all number
    3
    1
    4
    Nausea
         subjects affected / exposed
    8 / 262 (3.05%)
    2 / 262 (0.76%)
    4 / 264 (1.52%)
         occurrences all number
    10
    2
    4
    Vomiting
         subjects affected / exposed
    3 / 262 (1.15%)
    0 / 262 (0.00%)
    4 / 264 (1.52%)
         occurrences all number
    4
    0
    5
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    3 / 262 (1.15%)
    6 / 262 (2.29%)
    3 / 264 (1.14%)
         occurrences all number
    4
    8
    5
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    3 / 262 (1.15%)
    2 / 262 (0.76%)
    4 / 264 (1.52%)
         occurrences all number
    3
    2
    4
    Renal impairment
         subjects affected / exposed
    5 / 262 (1.91%)
    5 / 262 (1.91%)
    4 / 264 (1.52%)
         occurrences all number
    6
    7
    7
    Chronic kidney disease
         subjects affected / exposed
    1 / 262 (0.38%)
    3 / 262 (1.15%)
    1 / 264 (0.38%)
         occurrences all number
    1
    3
    1
    Acute kidney injury
         subjects affected / exposed
    3 / 262 (1.15%)
    7 / 262 (2.67%)
    3 / 264 (1.14%)
         occurrences all number
    3
    9
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 262 (0.38%)
    8 / 262 (3.05%)
    5 / 264 (1.89%)
         occurrences all number
    1
    10
    6
    Back pain
         subjects affected / exposed
    5 / 262 (1.91%)
    5 / 262 (1.91%)
    3 / 264 (1.14%)
         occurrences all number
    6
    6
    3
    Muscle spasms
         subjects affected / exposed
    1 / 262 (0.38%)
    3 / 262 (1.15%)
    1 / 264 (0.38%)
         occurrences all number
    1
    3
    1
    Myalgia
         subjects affected / exposed
    2 / 262 (0.76%)
    2 / 262 (0.76%)
    3 / 264 (1.14%)
         occurrences all number
    2
    2
    3
    Osteoarthritis
         subjects affected / exposed
    2 / 262 (0.76%)
    4 / 262 (1.53%)
    2 / 264 (0.76%)
         occurrences all number
    2
    4
    2
    Pain in extremity
         subjects affected / exposed
    1 / 262 (0.38%)
    3 / 262 (1.15%)
    4 / 264 (1.52%)
         occurrences all number
    2
    4
    4
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 262 (1.15%)
    7 / 262 (2.67%)
    5 / 264 (1.89%)
         occurrences all number
    3
    7
    6
    Gastroenteritis
         subjects affected / exposed
    4 / 262 (1.53%)
    2 / 262 (0.76%)
    5 / 264 (1.89%)
         occurrences all number
    5
    2
    5
    Influenza
         subjects affected / exposed
    3 / 262 (1.15%)
    3 / 262 (1.15%)
    4 / 264 (1.52%)
         occurrences all number
    3
    4
    4
    Nasopharyngitis
         subjects affected / exposed
    8 / 262 (3.05%)
    7 / 262 (2.67%)
    7 / 264 (2.65%)
         occurrences all number
    9
    7
    7
    Pneumonia
         subjects affected / exposed
    2 / 262 (0.76%)
    5 / 262 (1.91%)
    2 / 264 (0.76%)
         occurrences all number
    2
    5
    2
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 262 (0.76%)
    6 / 262 (2.29%)
    4 / 264 (1.52%)
         occurrences all number
    2
    6
    4
    Urinary tract infection
         subjects affected / exposed
    1 / 262 (0.38%)
    4 / 262 (1.53%)
    6 / 264 (2.27%)
         occurrences all number
    1
    4
    6
    Respiratory tract infection viral
         subjects affected / exposed
    3 / 262 (1.15%)
    2 / 262 (0.76%)
    1 / 264 (0.38%)
         occurrences all number
    3
    2
    1
    Respiratory tract infection
         subjects affected / exposed
    5 / 262 (1.91%)
    4 / 262 (1.53%)
    7 / 264 (2.65%)
         occurrences all number
    5
    6
    7
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    5 / 262 (1.91%)
    12 / 262 (4.58%)
    7 / 264 (2.65%)
         occurrences all number
    5
    13
    7
    Hyperuricaemia
         subjects affected / exposed
    7 / 262 (2.67%)
    3 / 262 (1.15%)
    8 / 264 (3.03%)
         occurrences all number
    7
    3
    9
    Hypoglycaemia
         subjects affected / exposed
    0 / 262 (0.00%)
    3 / 262 (1.15%)
    2 / 264 (0.76%)
         occurrences all number
    0
    3
    2
    Hypokalaemia
         subjects affected / exposed
    5 / 262 (1.91%)
    8 / 262 (3.05%)
    7 / 264 (2.65%)
         occurrences all number
    7
    8
    8
    Decreased appetite
         subjects affected / exposed
    0 / 262 (0.00%)
    1 / 262 (0.38%)
    4 / 264 (1.52%)
         occurrences all number
    0
    1
    5

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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