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    Clinical Trial Results:
    A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 (PF-07265803) in Patients with Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation (REALM-DCM)

    Summary
    EudraCT number
    		 2017-004310-25
    Trial protocol
    		 GB   NO   BE   ES   NL   IT   DK  
    Global end of trial date
    13 Oct 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Oct 2023
    First version publication date
    19 Oct 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C4411002 (Array-797-301)
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03439514
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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
    12 Jun 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Oct 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the effect of ARRY-371797 (PF-07265803) on functional capacity as measured by the 6-minute walk test (6MWT) compared to placebo in subjects with symptomatic dilated cardiomyopathy (DCM) due to a Lamin A/C protein (LMNA) gene mutation.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Apr 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
    Belgium: 2
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Italy: 11
    Country: Number of subjects enrolled
    Spain: 33
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    United States: 27
    Worldwide total number of subjects
    77
    EEA total number of subjects
    46
    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)
    66
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total

    Pre-assignment
    Screening details
    		 A total of 77 subjects with Lamin A/C protein (LMNA)-related dilated cardiomyopathy (DCM) in New York heart association (NYHA) functional Class II and III were enrolled in the study. All subjects enrolled received at least 1 dose of study intervention.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PF-07265803 (ARRY-371797)
    Arm description
    		 Subjects were randomised to receive PF-07265803 400 mg (4*100 mg tablets) twice daily (BID).
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-07265803
    Investigational medicinal product code
    Other name
    ARRY-371797
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subject received 400 mg (4*100 mg) twice daily (BID).

    Arm title
    		 Placebo
    Arm description
    		 Subjects were randomised to receive placebo matched to PF-07265803 BID.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo matched to PF-07265803.

    Number of subjects in period 1
    		PF-07265803 (ARRY-371797) Placebo
    Started
    40
    37
    Completed
    0
    0
    Not completed
    40
    37
         Adverse event, serious fatal
    1
    2
         Consent withdrawn by subject
    4
    2
         Not specified
    4
    1
         Study Termination by Sponsor
    29
    32
         Lost to follow-up
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PF-07265803 (ARRY-371797)
    Reporting group description
    		 Subjects were randomised to receive PF-07265803 400 mg (4*100 mg tablets) twice daily (BID).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomised to receive placebo matched to PF-07265803 BID.

    Reporting group values
    		 PF-07265803 (ARRY-371797) Placebo Total
    Number of subjects
    		 40 37 77
    Age Categorical
    Units: Subjects
        18-34 years
    		 4 1 5
        35-49 years
    		 15 10 25
        50-64 years
    		 17 19 36
        >= 65 years
    		 4 7 11
    Sex: Female, Male
    Units: Subjects
        Female
    		 18 15 33
        Male
    		 22 22 44
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 2 0 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 1 1
        White
    		 38 36 74
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 3 4 7
        Not Hispanic or Latino
    		 37 33 70
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    PF-07265803 (ARRY-371797)
    Reporting group description
    		 Subjects were randomised to receive PF-07265803 400 mg (4*100 mg tablets) twice daily (BID).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomised to receive placebo matched to PF-07265803 BID.

    Primary: Change From Baseline in Six-Minute Walk Test (6 MWT) at Week 24

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    End point title
    		 Change From Baseline in Six-Minute Walk Test (6 MWT) at Week 24
    End point description
    The 6 MWT was an assessment where the distance that a subject could walk on a flat and hard surface in 6 minutes was measured. Subjects were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed, and under supervision of a qualified professional. Study discontinuation & death were incorporated into endpoint definition through ranking in hypothesis testing of treatment difference. Missing data resulting from study discontinuation were imputed using control-based multiple imputation method to estimate treatment effect. Efficacy analysis set (EAS): functional Class II/III randomised subjects. 'Number of Subjects Analyzed' : subjects evaluable for endpoint & contributed data to table but may not have evaluable data for every row. Five subjects (ARRY-371797 [n=3], placebo [n=2]) discontinued study before week 24 due to sponsor’s decision to terminate & were excluded from primary analysis. “n”: subjects evaluable for each specified rows.
    End point type
    Primary
    End point timeframe
    Baseline, Week 24
    End point values
    		 PF-07265803 (ARRY-371797) Placebo
    Number of subjects analysed
    37
    35
    Units: Meter
    median (inter-quartile range (Q1-Q3))
        Baseline median (n=35,33)
    402.500 (348.195 to 444.000)
    393.935 (360.000 to 425.500)
        Week 24 median (n=35,33)
    420.234 (358.902 to 459.117)
    393.455 (347.409 to 450.826)
        Week 24 median change from baseline (n=35,33)
    20.996 (-22.757 to 51.477)
    2.679 (-11.530 to 33.698)
    Statistical analysis title
    		 PF-07265803 vs Placebo
    Comparison groups
    PF-07265803 (ARRY-371797) v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.818 [1]
    Method
    		 Van Elteren test
    Parameter type
    		 Median difference (net)
    Point estimate
    4.936
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.246
         upper limit
    		 34.118
    Notes
    [1] - Two-sided p-value

    Secondary: Change From Baseline in 6 MWT at Weeks 4 and 12

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    End point title
    		 Change From Baseline in 6 MWT at Weeks 4 and 12
    End point description
    The 6 MWT was an assessment where the distance that a subject could walk on a flat and hard surface in 6 minutes was measured. Subjects were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed, and under supervision of a qualified professional. EAS included all NYHA functional Class II or III randomised subjects. All subjects reported under 'Number of Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. n= number of subjects evaluable for specified rows of respective arms.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 12
    End point values
    		 PF-07265803 (ARRY-371797) Placebo
    Number of subjects analysed
    40
    37
    Units: Meter
    median (full range (min-max))
        Change at Week 4 (n=35, 32)
    15.40 (-72.0 to 71.8)
    -2.60 (-85.0 to 34.5)
        Change at Week 12 (n=33, 33)
    21.47 (-70.2 to 69.3)
    10.00 (-100.9 to 89.5)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Physical Limitation (PL) and Total Symptom Score (TSS) Domain Scores at Weeks 12 and 24

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    End point title
    		 Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Physical Limitation (PL) and Total Symptom Score (TSS) Domain Scores at Weeks 12 and 24
    End point description
    The KCCQ measured the effects of symptoms, functional (physical) limitations, and psychological distress on an individual’s health-related quality of life. It contains 23 items, which assessed the ability to perform activities of daily living, frequency and severity of symptoms, the impact of these symptoms, and health-related quality of life. PL was a single questionnaire with score range of 0 to 100, where higher scores reflected better physical functioning status. TSS included frequency and severity of symptoms, and the impact of these symptoms. TSS scores were transformed to a range of 0 to 100, where higher scores reflected better health status. EAS included all NYHA functional Class II or III randomised subjects. All subjects reported under 'Number of Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. n= number of subjects evaluable for specified rows of respective arms.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 24
    End point values
    		 PF-07265803 (ARRY-371797) Placebo
    Number of subjects analysed
    40
    37
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 12 Physical Limitation (n=33, 32)
    4.48 ( 11.373 )
    -1.17 ( 15.326 )
        Week 24 Physical Limitation (n=28, 31)
    2.98 ( 17.510 )
    1.21 ( 14.104 )
        Week 12 Total Symptom Score (n=33, 32)
    3.66 ( 12.487 )
    1.04 ( 16.491 )
        Week 24 Total Symptom Score (n=28, 31)
    4.02 ( 19.171 )
    -0.94 ( 14.981 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With Improvement From Baseline in Patient Global Impression of Severity (PGI-S) Score at Weeks 12 and 24

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    End point title
    		 Number of Subjects With Improvement From Baseline in Patient Global Impression of Severity (PGI-S) Score at Weeks 12 and 24
    End point description
    PGI-S is a global index that rate the severity of the disease using a 5-point scale. In this endpoint, the number of subjects with improvements in PGI-S the severity of their heart failure (HF) symptoms and in the severity of their PL were reported. Measured by the scale of: none, mild, moderate, severe or very severe (listed from better to worse). EAS included all NYHA functional Class II or III randomised subjects. All subjects reported under 'Number of Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. n= number of subjects evaluable for specified rows of respective arms.
    End point type
    Secondary
    End point timeframe
    Week 12, Week 24
    End point values
    		 PF-07265803 (ARRY-371797) Placebo
    Number of subjects analysed
    40
    37
    Units: Subjects
        Week 12: HF symptoms|None (n=33, 32)
    4
    5
        Week 24: HF symptoms|None (n=28, 31)
    4
    6
        Week 12: Physical limitation|None (n=33, 32)
    6
    7
        Week 24: Physical limitation|None (n=28, 31)
    6
    6
        Week 12: HF symptoms|Mild (n=33, 32)
    16
    14
        Week 24: HF symptoms|Mild (n=28, 31)
    11
    10
        Week 12: Physical limitation|Mild (n=33, 32)
    11
    5
        Week 24: Physical limitation|Mild (n=28, 31)
    5
    7
        Week 12: HF symptoms|Moderate (n=33, 32)
    8
    10
        Week 24: HF symptoms|Moderate (n=28, 31)
    10
    12
        Week 12: Physical limitation|Moderate (n=33, 32)
    12
    15
        Week 24: Physical limitation|Moderate (n=28, 31)
    13
    15
        Week 12: HF symptoms|Severe (n=33, 32)
    4
    2
        Week 24: HF symptoms|Severe (n=28, 31)
    3
    3
        Week 12: Physical limitation|Severe (n=33, 32)
    3
    4
        Week 24: Physical limitation|Severe (n=28, 31)
    4
    3
        Week 12: HF symptoms|Very Severe (n=33, 32)
    1
    1
        Week 24: HF symptoms|Very Severe (n=28, 31)
    0
    0
        Week 12:Physical limitation|Very Severe (n=33, 32)
    1
    1
        Week 24:Physical limitation|Very Severe (n=28, 31)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Improvement From Baseline in Patient Global Impression of Change (PGI-C) Score at Weeks 12 and 24

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    End point title
    		 Number of Subjects With Improvement From Baseline in Patient Global Impression of Change (PGI-C) Score at Weeks 12 and 24
    End point description
    PGI-C is a global index that rate the severity of the disease using a 7-point scale. In this endpoint, the number subjects with improvements in their heart failure symptoms (HFS) and “in their physical activity limitations (PL)?”, were reported. Measured by the scale of: very much better, moderately better, a little better, no change, a little worse, moderately worse, very much worse (listed from better to worse). EAS included all NYHA functional Class II or III randomised subjects. All subjects reported under 'Number of Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. n= number of subjects evaluable for specified rows of respective arms.
    End point type
    Secondary
    End point timeframe
    Week 12, Week 24
    End point values
    		 PF-07265803 (ARRY-371797) Placebo
    Number of subjects analysed
    40
    37
    Units: Subjects
        Week 12: Change in HFS|Very Much Better (n=33,32)
    0
    2
        Week 24: Change in HFS|Very Much Better (n=28,29)
    1
    1
        Week 12: Change in PL|Very Much Better (n=33,32)
    0
    1
        Week 24: Change in PL|Very Much Better (n=28,29)
    1
    1
        Week 12: Change in HFS|Moderately Better (n=33,32)
    3
    1
        Week 24: Change in HFS|Moderately Better (n=28,29)
    3
    2
        Week 12: Change in PL|Moderately Better (n=33,32)
    3
    2
        Week 24: Change in PL|Moderately Better (n=28,29)
    3
    0
        Week 12: Change in HFS|A Little Better (n=33,32)
    7
    9
        Week 24: Change in HFS|A Little Better (n=28,29)
    7
    6
        Week 12: Change in PL|A Little Better (n=33,32)
    3
    5
        Week 24: Change in PL|A Little Better (n=28,29)
    3
    4
        Week 12: Change in HFS|No Change (n=33,32)
    18
    17
        Week 24: Change in HFS|No Change (n=28,29)
    16
    16
        Week 12: Change in PL|No Change (n=33,32)
    24
    21
        Week 24: Change in PL|No Change (n=28,29)
    19
    20
        Week 12: Change in HFS|A Little Worse (n=33,32)
    3
    1
        Week 24: Change in HFS|A Little Worse (n=28,29)
    0
    2
        Week 12: Change in PL|A Little Worse (n=33,32)
    0
    1
        Week 24: Change in PL|A Little Worse (n=28,29)
    1
    3
        Week 12: Change in HFS|Moderately Worse (n=33,32)
    1
    0
        Week 24: Change in HFS|Moderately Worse (n=28,29)
    1
    1
        Week 12: Change in PL|Moderately Worse (n=33,32)
    3
    1
        Week 24: Change in PL|Moderately Worse (n=28,29)
    1
    1
        Week 12: Change in HFS|Very Much Worse (n=33,32)
    1
    2
        Week 24: Change in HFS|Very Much Worse (n=28,29)
    0
    1
        Week 12: Change in PL|Very Much Worse (n=33,32)
    0
    1
        Week 24: Change in PL|Very Much Worse (n=28,29)
    0
    0
    No statistical analyses for this end point

    Secondary: Change From Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT‑proBNP) at Weeks 4, 12, and 24

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    End point title
    		 Change From Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT‑proBNP) at Weeks 4, 12, and 24
    End point description
    NT pro-BNP is a cardiac biomarker that is released in the blood in response to changes in the pressure inside of the heart. Levels go up when heart failure develops or gets worse, and levels go down when heart failure is stable or improves. This biomarker helps to measure the changes in the severity of heart failure over time in response to therapy. EAS included all NYHA functional Class II or III randomised subjects. All subjects reported under 'Number of Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. n= signifies number of subjects evaluable for specified rows of respective arms.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 12, Week 24
    End point values
    		 PF-07265803 (ARRY-371797) Placebo
    Number of subjects analysed
    40
    37
    Units: picomoles per liter
    arithmetic mean (standard deviation)
        Change at Week 4 (n=33,33)
    -43.89 ( 65.465 )
    -3.07 ( 62.745 )
        Change at Week 12 (n=31,32)
    -36.40 ( 69.228 )
    -0.70 ( 54.870 )
        Change at Week 24 (n=23,28)
    5.00 ( 236.643 )
    24.37 ( 134.225 )
    No statistical analyses for this end point

    Secondary: Composite Time to First Occurrence of All-Cause Mortality or Worsening Heart Failure (WHF)

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    End point title
    		 Composite Time to First Occurrence of All-Cause Mortality or Worsening Heart Failure (WHF)
    End point description
    Defined as the time from randomisation to the first occurrence of any event of death due to any cause, or worsening heart failure (HF-related hospitalisation or HF-related urgent care visit). Kaplan-Meier method and cox regression model were used for analysis. The safety analysis set (SAS) included all subjects who received at least 1 dose of study intervention regardless of NYHA functional class. Number of events analysed (PF-07265803: 3, Placebo: 7). Here “99999” suggests that data could not be evaluated as there were less subjects with events.
    End point type
    Secondary
    End point timeframe
    Maximum up to 212.28 weeks (maximum exposure was 208 weeks)
    End point values
    		 PF-07265803 (ARRY-371797) Placebo
    Number of subjects analysed
    40
    37
    Units: Weeks
        median (confidence interval 95%)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    Statistical analysis title
    		 PF-07265803 (ARRY-371797) vs Placebo
    Comparison groups
    PF-07265803 (ARRY-371797) v Placebo
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2257
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.13
         upper limit
    		 1.39

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS was defined as time from randomisation to death due to any cause. Subjects who did not have a death date were censored for OS at their last contact date. Kaplan-Meier method and cox regression model were used for analysis. The SAS included all subjects who received at least 1 dose of study intervention regardless of NYHA functional class. Number of events analysed (PF-07265803: 3, Placebo: 3). Here “99999” suggests that data could not be evaluated as there were less subjects with events.
    End point type
    Secondary
    End point timeframe
    From randomisation up to death due to any cause or censored date, maximum up to 212.28 weeks (maximum exposure was of 208 weeks)
    End point values
    		 PF-07265803 (ARRY-371797) Placebo
    Number of subjects analysed
    40
    37
    Units: Weeks
        median (confidence interval 95%)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    Statistical analysis title
    		 PF-07265803 (ARRY-371797) vs Placebo
    Comparison groups
    PF-07265803 (ARRY-371797) v Placebo
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.837
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 4.63

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (AEs) and by Severity

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    End point title
    		 Number of Subjects With Treatment Emergent Adverse Events (AEs) and by Severity
    End point description
    An AE was any untoward medical occurrence in a subject who received investigational product without regard to possibility of causal relationship. Treatment-emergent AEs were events that occurred between first dose of study drug and up to 30 days after last dose. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalisation; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all Non-SAEs. Grade >=3 AEs meant severe AEs. The SAS included all subjects who received at least 1 dose of study intervention regardless of NYHA functional class.
    End point type
    Secondary
    End point timeframe
    Maximum up to 212.28 weeks (maximum exposure was of 208 weeks)
    End point values
    		 PF-07265803 (ARRY-371797) Placebo
    Number of subjects analysed
    40
    37
    Units: Subjects
        Subjects with TEAEs
    35
    34
        Subjects with serious TEAEs
    10
    21
        Subjects with severe (Grades >=3) TEAEs
    16
    20
    No statistical analyses for this end point

    Secondary: Number of Subjects With Laboratory Test Abnormalities

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    End point title
    		 Number of Subjects With Laboratory Test Abnormalities
    End point description
    Following parameters were analysed for laboratory examination: hematology (eosinophils, erythrocytes mean corpuscular hemoglobin/mean corpuscular volume [MCH/MCV], hemoglobin [Hb], hematocrit [HCT], granulocytes, leukocytes, lymphocytes, monocytes, platelets, neutrophils, nucleated erythrocytes); blood chemistry (alanine aminotransferase [ALT], albumin, alkaline phosphatase [ALP], aspartate aminotransferase [AST], bicarbonate, bilirubin, blood urea nitrogen, C-reactive protein, calcium, chloride, creatinine [Cr], creatine kinase [CK], epidermal growth factor receptor [EGFR], follicle stimulating hormone [FSH], gamma glutamyl transferase [GGT], glucose, magnesium, N-Terminal ProB-type natriuretic peptide [NT-proBNP], phosphate, potassium, protein, sodium, potassium, thyrotropin, troponin I, troponin T, urate). The SAS included all subjects who received at least 1 dose of study intervention regardless of NYHA functional class.
    End point type
    Secondary
    End point timeframe
    Maximum up to 212.28 weeks (maximum exposure was of 208 weeks)
    End point values
    		 PF-07265803 (ARRY-371797) Placebo
    Number of subjects analysed
    40
    37
    Units: Subjects
        Eosinophils: High (>0.8) 10^9/L
    1
    0
        Eosinophils/Leukocytes: High (>7) %
    1
    1
        Erythrocyte MCH Concentration: Low (<310) g/L
    30
    29
        Erythrocyte MCH: Low (<27) pg
    6
    3
        Erythrocyte MCH: High (>34) pg
    0
    1
        Erythrocyte MCV: Low (Males <78, Females <82)
    2
    2
        Erythrocyte MCV: High (Males >100, Females >102)
    10
    15
        Erythrocytes:Low(Males:<4.63, Females:<3.7)10^12/L
    14
    16
        Erythrocyte:High(Males:>6.08, Females:>5.2)10^12/L
    4
    4
        Erythrocytes Distribution Width: High (>14.5) %
    22
    20
        HCT: Low(Males:<0.37, Females:<0.33) L/L
    1
    3
        HCT: High(Males:>0.51, Females:>0.47) L/L
    12
    15
        Hb: Low (Males: < 125; Females: <110) g/L
    7
    5
        Hb: High (Males: > 170; Females: > 155) g/L
    5
    4
        Immature Granulocytes: High (> 0.07) 10^9/L
    9
    7
        Immature Granulocytes/Leukocytes: High (> 1) %
    6
    6
        Leukocytes: Low (< 3.7) 10^9/L
    1
    0
        Leukocytes: High (> 11) 10^9/L
    9
    8
        Lymphocytes: Low (< 0.9) 10^9/L
    3
    4
        Lymphocytes: Low (> 3.6) 10^9/L
    4
    2
        Lymphocytes/Leukocytes: Low (< 12) %
    3
    3
        Lymphocytes/Leukocytes: High (> 46) %
    2
    1
        Mean Platelet Volume: Low (< 9.6) fL
    5
    0
        Mean Platelet Volume: High (> 13.8) fL
    3
    3
        Monocytes: High (> 1.2) 10^9/L
    1
    1
        Monocytes/Leukocytes: High (>11) %
    11
    10
        Neutrophils: Low (< 1.7) 10^9/L
    1
    1
        Neutrophils: High (> 7.9) 10^9/L
    8
    5
        Neutrophils/Leukocytes: High (>71) %
    16
    17
        Nucleated Erythrocytes: High (>0.01) 10^9/L
    6
    1
        Nucleated Erythrocytes/Leukocytes: High (>0.2) %
    6
    1
        Platelets: Low (< 163) 10^9/L
    13
    11
        Platelets: High (> 375) 10^9/L
    2
    1
        ALT: Low (< 10) U/L
    4
    5
        ALT: High (Males: > 40; Females: > 33) U/L
    18
    17
        Albumin: Low (< 35) g/L
    1
    0
        ALP: Low (Males: < 43; Females: <30) U/L
    3
    5
        ALP: High (> 115) U/L
    4
    5
        AST: High (Males: > 43; Females: > 36) U/L
    11
    8
        Bicarbonate: Low (< 21) mmol/L
    9
    12
        Bicarbonate: High (> 33) mmol/L
    0
    1
        Bilirubin: High (> 18.8) mcmol/L
    4
    12
        Blood Urea Nitrogen: High (> 7.14) mmol/L
    28
    27
        C Reactive Protein: High (> 47.6) nmol/L
    20
    19
        Calcium: Low (< 2.12) mmol/L
    0
    1
        Calcium: High (> 2.62) mmol/L
    0
    1
        Chloride: Low (< 95) mmol/L
    2
    1
        CK: Low (< 24) U/L
    0
    2
        CK: High (Males: > 207; Females: > 169) U/L
    20
    12
        Creatinine: Low (< 62) mcmol/L
    14
    13
        Creatinine: High (> 124) mcmol/L
    4
    6
        Cr Clearance: Low (Males:<85; Females:<75) mL/min
    9
    8
        Cr Clearance: High(Males:>125; Females:>115)mL/min
    16
    14
        Direct Bilirubin: High (> 6.8) mcmol/L
    4
    8
        EGFR: Low (Males: < 60) mL/min/1.73m2
    1
    0
        FSH: High (Males: > 12.4; Females: > 21.5) IU/L
    2
    4
        GGT: Low (Males: < 10; Females: <5) U/L
    1
    0
        GGT: High (Males: > 49; Females: > 32) U/L
    15
    27
        Glucose: Low(Males<3.94, Females <3.33) mmol/L
    4
    4
        Glucose: High (Males >7.66, Females >6.38) mmol/L
    10
    10
        Magnesium: High (> 1.05) mmol/L
    1
    1
        NT-proBNP: High (> 14.63) pmol/L
    40
    37
        Phosphate: Low (< 0.81) mmol/L
    6
    6
        Phosphate: High (> 1.45) mmol/L
    8
    4
        Potassium: Low (< 3.5) mmol/L
    1
    0
        Potassium: High (> 5) mmol/L
    7
    16
        Protein: Low (< 60) g/L
    2
    3
        Protein: High (> 80) g/L
    2
    3
        Sodium: High (> 145) mmol/L
    1
    1
        Thyrotropin: Low (< 0.27) mIU/L
    1
    1
        Thyrotropin: High (> 4.2) mIU/L
    5
    5
        Troponin I: High (> 0.3) mcg/L
    4
    6
        Troponin T: High (> 14) ng/L
    36
    34
        Urate: Low (Males:<0.238; Females:<0.119) mmol/L
    3
    2
        Urate: High (Males:>0.476; Females:>0.357) mmol/L
    9
    17
    No statistical analyses for this end point

    Secondary: Number of Subjects According to Categorisation of Abnormal Vital Signs

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    End point title
    		 Number of Subjects According to Categorisation of Abnormal Vital Signs
    End point description
    Following vital sign parameters were assessed: diastolic blood pressure (BP), systolic BP, heart rate, and body weight. Vital sign abnormalities criteria included: a) systolic blood pressure (mmHg): decrease (change <= -20, or value <90) and increase (change >=20, or value >140); b) diastolic blood pressure (mmHg): decrease (change <= -15, or value <60) and increase (change >=15, or value >90); c) heart Rate (bpm) decrease: (change <= -15, or value <50) and increase (change >=15, or value >100); d) weight: (kg) decrease (Change <= -7%) and increase (Change > =7%). The SAS included all subjects who received at least 1 dose of study intervention regardless of NYHA functional class. “n” =subjects evaluable for specified rows of respective arms.
    End point type
    Secondary
    End point timeframe
    Maximum up to 212.28 weeks (maximum exposure was of 208 weeks)
    End point values
    		 PF-07265803 (ARRY-371797) Placebo
    Number of subjects analysed
    40
    37
    Units: Subjects
        Systolic BP (mmHg): Decrease (n=37,37)
    22
    17
        Systolic BP (mmHg): Increase (n=37,37)
    6
    14
        Diastolic BP (mmHg): Decrease (n=37,37)
    28
    22
        Diastolic BP (mmHg): Increase (n=37,37)
    7
    18
        Heart Rate (bpm): Decrease (n=37,37)
    7
    9
        Heart Rate (bpm): Increase (n=37,37)
    15
    10
        Weight (kg): Decrease (n=36,35)
    10
    7
        Weight (kg): Increase (n=36,35)
    5
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects According to Categorisation of Electrocardiogram (ECG) Data

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    End point title
    		 Number of Subjects According to Categorisation of Electrocardiogram (ECG) Data
    End point description
    Following parameters were analysed: heart rate, QT interval, corrected QT (QTc) interval, Bazett's correction QT (QTcB) interval, and Fridericia's correction (QTcF) interval. Criteria for notable ECG values were as follows: QT interval (in millisecond [msec]) new (newly occurring post-baseline value) greater than (>) 450, 480, 500, increase from baseline >30, increase from baseline >60; corrected QT interval by Fredericia formula (QTcF) in msec new (newly occurring post-baseline value) > 450, 480, 500, increase from baseline >30, increase from baseline >60; corrected QT interval by Bazett's formula (QTcB) in msec new (newly occurring post-baseline value) > 450, 480, 500, increase from baseline >30, increase from baseline >60; heart rate in bpm new (newly occurring post-baseline value) <60 and >100. The SAS included all subjects who received at least 1 dose of study intervention regardless of NYHA functional class. “n” =subjects evaluable for specified rows of respective arms.
    End point type
    Secondary
    End point timeframe
    Maximum up to 212.28 weeks (maximum exposure was of 208 weeks)
    End point values
    		 PF-07265803 (ARRY-371797) Placebo
    Number of subjects analysed
    28
    26
    Units: Subjects
        QTcB (msec): New >450 (n=10, 6)
    5
    4
        QTcB (msec): New >480 (n=17, 15)
    10
    4
        QTcB (msec): New >500 (n=23, 18)
    11
    2
        QTcB (msec): Increase from baseline >30 (n=28, 26)
    12
    4
        QTcB (msec): Increase from baseline >60 (n=28, 26)
    5
    1
        QTcF (msec): New >450 (n=10,6)
    7
    2
        QTcF (msec): New >480 (n=18,17)
    9
    3
        QTcF (msec): New >500 (n=24,20)
    8
    4
        QTcF (msec): Increase from baseline >30 (n=28,26)
    11
    4
        QTcF (msec): Increase from baseline >60 (n=28,26)
    3
    0
        QT (msec): New >450 (n=9,10)
    5
    4
        QT (msec): New >480 (n=21,18)
    11
    1
        QT (msec): New >500 (n=24,22)
    2
    1
        QT (msec): Increase from baseline >30 (n=28,26)
    8
    3
        QT (msec): Increase from baseline >60 (n=28,26)
    2
    0
        Heart rate (bpm): New <60 (n=18,19)
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With a new Clinically Significant Ventricular or Atrial Arrhythmias

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    End point title
    		 Number of Subjects With a new Clinically Significant Ventricular or Atrial Arrhythmias
    End point description
    Arrhythmia assessment: incidence of new and clinically significant ventricular or atrial arrhythmias was assessed by an implantable cardioverter defibrillator (ICD) or CRT defibrillator (CRT-D) applicable device interrogations. The SAS included all subjects who received at least 1 dose of study intervention regardless of NYHA functional class. “n” =subjects evaluable for specified rows of respective arms.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 24
    End point values
    		 PF-07265803 (ARRY-371797) Placebo
    Number of subjects analysed
    40
    37
    Units: Subjects
        Baseline: Atrial arrhythmia (n=29, 25)
    0
    0
        Week 12: Atrial arrhythmia (n=20, 20)
    0
    2
        Week 24: Atrial arrhythmia (n=14, 15)
    0
    0
        Baseline: Ventricular arrhythmia (n=24, 24)
    0
    0
        Week 12: Ventricular arrhythmia (n=18, 18)
    0
    3
        Week 24: Ventricular arrhythmia (n=14, 15)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline (Day1) up to a maximum of 208 weeks
    Adverse event reporting additional description
    Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorised as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study. All subjects who receive any of the study intervention.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomised to receive placebo matched to PF-07265803 BID.

    Reporting group title
    PF-07265803 (ARRY-371797)
    Reporting group description
    		 Subjects were randomised to receive PF-07265803 400 mg (4*100 mg tablets) twice daily (BID).

    Serious adverse events
    		 Placebo PF-07265803 (ARRY-371797)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 37 (56.76%)
    10 / 40 (25.00%)
         number of deaths (all causes)
    3
    3
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary thyroid cancer
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal cavity cancer
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Prostatitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Ejection fraction decreased
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Thoracic vertebral fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 37 (5.41%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 37 (2.70%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    5 / 37 (13.51%)
    5 / 40 (12.50%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    3 / 37 (8.11%)
    2 / 40 (5.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    2 / 37 (5.41%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    3 / 37 (8.11%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal haemorrhage
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary obstruction
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 37 (2.70%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Gouty arthritis
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia bacterial
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complicated appendicitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo PF-07265803 (ARRY-371797)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 37 (72.97%)
    31 / 40 (77.50%)
    Investigations
    Blood creatine phosphokinase increased
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 37 (5.41%)
    3 / 40 (7.50%)
         occurrences all number
    2
    3
    SARS-CoV-2 test positive
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 37 (18.92%)
    11 / 40 (27.50%)
         occurrences all number
    7
    14
    Vascular disorders
    Hypotension
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 37 (10.81%)
    4 / 40 (10.00%)
         occurrences all number
    5
    4
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    2 / 37 (5.41%)
    3 / 40 (7.50%)
         occurrences all number
    5
    4
    Atrial fibrillation
         subjects affected / exposed
    5 / 37 (13.51%)
    6 / 40 (15.00%)
         occurrences all number
    10
    7
    Angina pectoris
         subjects affected / exposed
    1 / 37 (2.70%)
    3 / 40 (7.50%)
         occurrences all number
    1
    3
    Cardiac failure acute
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 40 (5.00%)
         occurrences all number
    2
    2
    Ventricular tachycardia
         subjects affected / exposed
    8 / 37 (21.62%)
    7 / 40 (17.50%)
         occurrences all number
    12
    10
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 37 (10.81%)
    9 / 40 (22.50%)
         occurrences all number
    4
    13
    Headache
         subjects affected / exposed
    6 / 37 (16.22%)
    4 / 40 (10.00%)
         occurrences all number
    12
    6
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 37 (8.11%)
    4 / 40 (10.00%)
         occurrences all number
    6
    5
    Gastrointestinal disorders
    Nausea
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 37 (13.51%)
    7 / 40 (17.50%)
         occurrences all number
    7
    9
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 37 (8.11%)
    2 / 40 (5.00%)
         occurrences all number
    4
    4
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 37 (10.81%)
    12 / 40 (30.00%)
         occurrences all number
    7
    19
    Constipation
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 37 (8.11%)
    2 / 40 (5.00%)
         occurrences all number
    3
    3
    Abdominal pain upper
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 37 (10.81%)
    3 / 40 (7.50%)
         occurrences all number
    6
    3
    Stomatitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 37 (0.00%)
    5 / 40 (12.50%)
         occurrences all number
    0
    7
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    6 / 37 (16.22%)
    1 / 40 (2.50%)
         occurrences all number
    8
    2
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 37 (2.70%)
    5 / 40 (12.50%)
         occurrences all number
    1
    7
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 37 (5.41%)
    3 / 40 (7.50%)
         occurrences all number
    2
    3

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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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