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    Clinical Trial Results:
    IOCYTE AMI-3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intravenous FDY-5301 in Patients with an Anterior ST-Elevation Myocardial Infarction

    Summary
    EudraCT number
    		 2021-001924-16
    Trial protocol
    		 HU   SK   ES   PL   PT   CZ   NL   IT  
    Global end of trial date
    03 Sep 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jan 2026
    First version publication date
    15 Jan 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FDY-5301-302
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04837001
    WHO universal trial number (UTN)
    		 U1111-1308-0435
    Sponsors
    Sponsor organisation name
    Faraday Pharmaceuticals, Inc.
    Sponsor organisation address
    1616 Eastlake Ave E, Suite 560, Seattle, United States, 98102
    Public contact
    Stephen Hill, MD, CEO, Stephen Hill, MD, CEO, 1 (706) 621-6504, faradaypharma@gmail.com
    Scientific contact
    Stephen Hill, MD, CEO, Stephen Hill, MD, CEO, 1 (706) 621-6504, faradaypharma@gmail.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
    27 Oct 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Sep 2025
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Sep 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of FDY-5301 on cardiovascular mortality and heart failure events in subjects with an anterior STEMI undergoing pPCI.
    Protection of trial subjects
    This trial complied with the International Conference on Harmonization Tripartite Guideline on Good Clinical Practice, the ethical principles stated in the latest version of the Declaration of Helsinki, and the applicable local and international regulations, whichever provided the greater protection of the individual.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 May 2022
    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
    Netherlands: 226
    Country: Number of subjects enrolled
    Poland: 203
    Country: Number of subjects enrolled
    Portugal: 69
    Country: Number of subjects enrolled
    Slovakia: 98
    Country: Number of subjects enrolled
    Spain: 621
    Country: Number of subjects enrolled
    Czechia: 159
    Country: Number of subjects enrolled
    Germany: 25
    Country: Number of subjects enrolled
    Hungary: 247
    Country: Number of subjects enrolled
    Italy: 169
    Country: Number of subjects enrolled
    Canada: 38
    Country: Number of subjects enrolled
    United States: 37
    Country: Number of subjects enrolled
    Israel: 193
    Country: Number of subjects enrolled
    United Kingdom: 266
    Worldwide total number of subjects
    2351
    EEA total number of subjects
    1817
    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)
    1440
    From 65 to 84 years
    855
    85 years and over
    56

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first participant enrolled on May 02, 2022. Study centers were located in 13 countries which were Canada, Czechia, Germany, Hungary, Israel, Italy, Netherlands, Poland, Portugal, Slovakia, Spain, United Kingdom, and United States. The study ended on Sept 03, 2025.

    Pre-assignment
    Screening details
    		 A total of 2,351 subjects were randomized 1:1 to receive either the study drug or placebo, of which 2,317 received study treatment. The Full Analysis Set (FAS) and safety population included intent-to-treat (ITT) subjects who received study treatment.

    Pre-assignment period milestones
    Number of subjects started
    		 2351
    Number of subjects completed
    		 2317

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Physician decision: 19
    Reason: Number of subjects
    		 Other: 14
    Reason: Number of subjects
    		 Consent withdrawn by subject: 1
    Period 1
    Period 1 title
    Administration of Study Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FDY-5301
    Arm description
    		 FDY-5301 (2mg/kg) was administered as a single IV bolus injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FDY-5301
    Investigational medicinal product code
    20377
    Other name
    Sodium Iodide
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Following an anterior STEMI diagnosis, based on clinical and electrocardiogram (ECG) findings and the receipt of informed consent, randomized subjects were dosed with a single bolus intravenous administration of FDY-5301 ≤ 6 hours of myocardial ischemia symptom onset. The full dose of investigational product was administered at any time between 60 minutes and 5 minutes prior to pPCI.

    Arm title
    		 Placebo
    Arm description
    		 Placebo (normal saline) was administered as a single IV bolus injection.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Following an anterior STEMI diagnosis, based on clinical and electrocardiogram (ECG) findings and the receipt of informed consent, randomized subjects were dosed with a single bolus intravenous administration of volume matched placebo ≤ 6 hours of myocardial ischemia symptom onset. The full dose of investigational product was administered at any time between 60 minutes and 5 minutes prior to pPCI.

    Number of subjects in period 1 [1]
    		FDY-5301 Placebo
    Started
    1164
    1153
    Completed
    1088
    1077
    Not completed
    76
    76
         Adverse event, serious fatal
    60
    51
         Consent withdrawn by subject
    9
    14
         Lost to follow-up
    7
    11
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The ITT population includes all randomized subjects (2,351). The Full Analysis Set (FAS) population (2,317) includes all intent-to-treat (ITT) subjects who received investigational product.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FDY-5301
    Reporting group description
    		 FDY-5301 (2mg/kg) was administered as a single IV bolus injection.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (normal saline) was administered as a single IV bolus injection.

    Reporting group values
    		 FDY-5301 Placebo Total
    Number of subjects
    		 1164 1153 2317
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 717 709 1426
        From 65-84 years
    		 411 424 835
        85 years and over
    		 36 20 56
    Gender categorical
    Units: Subjects
        Female
    		 183 176 359
        Male
    		 981 977 1958
    Race
    Units: Subjects
        Asian
    		 30 32 62
        Native Hawaiian or Other Pacific Islander
    		 1 0 1
        Black or African American
    		 10 14 24
        White
    		 1091 1071 2162
        More than one race
    		 2 2 4
        Unknown or Not Reported
    		 30 34 64
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 72 76 148
        Not Hispanic or Latino
    		 1051 1029 2080
        Unknown or Not Reported
    		 41 48 89
    Weight
    The FAS included subjects who received study treatment and totaled 2,317 subjects.
    Units: kg
        arithmetic mean (standard deviation)
    		 82.78 ( 15.74 ) 83.00 ( 15.56 ) -
    Height
    This subject set included 1,159 subjects in the FDY-5301 arm and 1,147 subjects in the Placebo arm. There are 11 subjects with a missing height in the database (5 FDY-5301 and 6 placebo).
    Units: cm
        arithmetic mean (standard deviation)
    		 172.8 ( 8.64 ) 172.9 ( 8.50 ) -
    Body Mass Index
    This subject set included 1,159 subjects in the FDY-5301 arm and 1,147 subjects in the Placebo arm. There are 11 subjects with a missing height in the database (5 FDY-5301 and 6 placebo).
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 27.65 ( 4.50 ) 27.72 ( 4.55 ) -
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes all randomized subjects who received study treatment.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Includes all randomized subjects who received study treatment. Subjects were analyzed by the actual study treatment received.

    Subject analysis sets values
    		 Full Analysis Set Safety Analysis Set
    Number of subjects
    2317
    2317
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    1426
    1426
        From 65-84 years
    835
    835
        85 years and over
    56
    56
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    359
    359
        Male
    1958
    1958
    Race
    Units: Subjects
        Asian
    62
    62
        Native Hawaiian or Other Pacific Islander
    1
    1
        Black or African American
    24
    24
        White
    2162
    2162
        More than one race
    4
    4
        Unknown or Not Reported
    64
    64
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    148
    148
        Not Hispanic or Latino
    2080
    2080
        Unknown or Not Reported
    89
    89
    Weight
    The FAS included subjects who received study treatment and totaled 2,317 subjects.
    Units: kg
        arithmetic mean (standard deviation)
    82.89 ( 15.65 )
    82.89 ( 15.65 )
    Height
    This subject set included 1,159 subjects in the FDY-5301 arm and 1,147 subjects in the Placebo arm. There are 11 subjects with a missing height in the database (5 FDY-5301 and 6 placebo).
    Units: cm
        arithmetic mean (standard deviation)
    172.8 ( 8.57 )
    172.8 ( 8.57 )
    Body Mass Index
    This subject set included 1,159 subjects in the FDY-5301 arm and 1,147 subjects in the Placebo arm. There are 11 subjects with a missing height in the database (5 FDY-5301 and 6 placebo).
    Units: kg/m2
        arithmetic mean (standard deviation)
    27.68 ( 4.52 )
    27.68 ( 4.52 )

    End points

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    End points reporting groups
    Reporting group title
    FDY-5301
    Reporting group description
    		 FDY-5301 (2mg/kg) was administered as a single IV bolus injection.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (normal saline) was administered as a single IV bolus injection.

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes all randomized subjects who received study treatment.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Includes all randomized subjects who received study treatment. Subjects were analyzed by the actual study treatment received.

    Primary: Cardiovascular Mortality or Heart Failure

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    End point title
    		 Cardiovascular Mortality or Heart Failure
    End point description
    The proportion of subjects who experience either cardiovascular mortality or a heart failure event.
    End point type
    Primary
    End point timeframe
    Through Month 12
    End point values
    		 FDY-5301 Placebo Full Analysis Set
    Number of subjects analysed
    1164 [1]
    1153 [2]
    2317 [3]
    Units: Number of events
    1164
    1153
    2317
    Notes
    [1] - Excludes subjects who did not receive study treatment.
    [2] - Excludes subjects who did not receive study treatment.
    [3] - All subjects who received study treatment.
    Statistical analysis title
    		 Analysis of the Primary Efficacy Endpoint
    Statistical analysis description
    The proportion of the events were estimated using the Kaplan-Meier Method.
    Comparison groups
    FDY-5301 v Placebo
    Number of subjects included in analysis
    2317
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3589 [4]
    Method
    		 z-test
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.38
         upper limit
    		 2.33
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.458
    Notes
    [4] - one-sided

    Secondary: All-cause Mortality or Heart Failure

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    End point title
    		 All-cause Mortality or Heart Failure
    End point description
    The proportion of subjects who experience either all-cause mortality or a heart failure event.
    End point type
    Secondary
    End point timeframe
    Through Month 12
    End point values
    		 FDY-5301 Placebo Full Analysis Set
    Number of subjects analysed
    1164 [5]
    1153 [6]
    2317 [7]
    Units: Number of events
    1164
    1153
    2317
    Notes
    [5] - Excluded subjects who did not receive study treatment.
    [6] - Excluded subjects who did not receive study treatment.
    [7] - All subjects who received study treatment.
    Statistical analysis title
    		 Analysis of First Secondary Endpoint
    Comparison groups
    FDY-5301 v Placebo
    Number of subjects included in analysis
    2317
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2983 [8]
    Method
    		 z-test
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.71
         upper limit
    		 2.13
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.491
    Notes
    [8] - one-sided

    Secondary: Cardiovascular Events

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    End point title
    		 Cardiovascular Events
    End point description
    The total number of cardiovascular events defined as cardiovascular mortality and heart failure events.
    End point type
    Secondary
    End point timeframe
    Through Month 12
    End point values
    		 FDY-5301 Placebo Full Analysis Set
    Number of subjects analysed
    1164 [9]
    1153 [10]
    2317 [11]
    Units: Number of events
    1164
    1153
    2317
    Notes
    [9] - All subjects who received study treatment.
    [10] - All subjects who received study treatment.
    [11] - All subjects who received study treatment.
    Statistical analysis title
    		 Analysis of Second Secondary Endpoint
    Comparison groups
    FDY-5301 v Placebo
    Number of subjects included in analysis
    2317
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4226 [12]
    Method
    		 Regression, Cox
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.004
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.044
         upper limit
    		 0.036
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.02
    Notes
    [12] - one-sided

    Secondary: Other Non-Fatal Cardiovascular Morbidity

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    End point title
    		 Other Non-Fatal Cardiovascular Morbidity
    End point description
    The proportion of subjects who experience a composite of the following specified non-fatal cardiovascular events: thromboembolic cerebral vascular accident (CVA), ventricular aneurysm/hemorrhage, recurrent myocardial infarction (e.g., remote or stent thrombosis), or persistent arrhythmia requiring intervention (e.g., ventricular fibrillation, sustained ventricular tachycardia, or bradyarrhythmia).
    End point type
    Secondary
    End point timeframe
    Through Month 12
    End point values
    		 FDY-5301 Placebo Full Analysis Set
    Number of subjects analysed
    1164 [13]
    1153 [14]
    2317 [15]
    Units: Number of events
    1164
    1153
    2317
    Notes
    [13] - All subjects who received study treatment.
    [14] - All subjects who received study treatment.
    [15] - All subjects who received study treatment.
    Statistical analysis title
    		 Analysis of Third Secondary Endpoint
    Comparison groups
    FDY-5301 v Placebo
    Number of subjects included in analysis
    2317
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2953 [16]
    Method
    		 z-test
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.46
         upper limit
    		 1.97
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.385
    Notes
    [16] - one-sided

    Secondary: Serum Troponin T

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    End point title
    		 Serum Troponin T
    End point description
    Serum high-sensitivity troponin T levels from approximately 500 subjects were collected at sponsor designated sites and countries only. For the Subject analysis set 1, the percent relative difference in the geometric least-square means.
    End point type
    Secondary
    End point timeframe
    Day 3
    End point values
    		 FDY-5301 Placebo Full Analysis Set
    Number of subjects analysed
    235 [17]
    276 [18]
    511 [19]
    Units: ug/L
        geometric mean (standard error)
    1.936 ( 0.401 )
    1.880 ( 0.393 )
    2.949 ( 11.284 )
    Notes
    [17] - Subjects who received study treatment and had Troponin T measured on Day 3.
    [18] - Subjects who received study treatment and had Troponin T measured on Day 3.
    [19] - Subjects who received study treatment and had Troponin T measured on Day 3.
    Statistical analysis title
    		 Analysis of Fourth Secondary Endpoint
    Comparison groups
    FDY-5301 v Placebo
    Number of subjects included in analysis
    511
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3945 [20]
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of Geometric Means
    Point estimate
    1.029
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.115
    Notes
    [20] - one-sided

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From study treatment until Day 28
    Adverse event reporting additional description
    The ‘non-serious adverse events’ section includes both serious and non-serious events. Prespecified cardiovascular endpoints (refer to protocol) were excluded from AE reporting, recorded only on endpoint CRFs, and not reported as AEs within 24 hours. After adjudication, events not meeting endpoint criteria were reported as AEs/SAEs through Day 28.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    FDY-5301
    Reporting group description
    		 FDY-5301 was administered as a single IV bolus injection. During the first 28 days after receiving the study treatment, 6 subjects died who got the study drug and these early deaths are reported as adverse events, separate from the topline results on subjects who either experienced heart failure or dying from heart-related causes (cardiovascular mortality).

    Reporting group title
    Placebo
    Reporting group description
    		 During the first 28 days after receiving the study treatment, 9 subjects died and these early deaths are reported here as adverse events, separate from the topline results on subjects who either experienced heart failure or dying from heart‑related causes (cardiovascular mortality).

    Serious adverse events
    		 FDY-5301 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    92 / 1164 (7.90%)
    116 / 1153 (10.06%)
         number of deaths (all causes)
    6
    9
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac neoplasm unspecified
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    7 / 1164 (0.60%)
    5 / 1153 (0.43%)
         occurrences causally related to treatment / all
    1 / 7
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    1 / 1164 (0.09%)
    2 / 1153 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Aortic stenosis
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic thrombosis
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jugular vein thrombosis
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superficial vein thrombosis
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 1164 (0.09%)
    3 / 1153 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 1164 (0.09%)
    2 / 1153 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 1164 (0.09%)
    2 / 1153 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter site haemorrhage
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pyrexia
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Immune system disorders
    Contrast media reaction
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 1164 (0.00%)
    2 / 1153 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 1164 (0.00%)
    2 / 1153 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 1164 (0.00%)
    2 / 1153 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrothorax
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    3 / 1164 (0.26%)
    4 / 1153 (0.35%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Ejection fraction decreased
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         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
    Cardiac procedure complication
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural hypotension
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular access site pseudoaneurysm
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular procedure complication
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac ventricular thrombosis
         subjects affected / exposed
    6 / 1164 (0.52%)
    12 / 1153 (1.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    3 / 1164 (0.26%)
    9 / 1153 (0.78%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Angina pectoris
         subjects affected / exposed
    5 / 1164 (0.43%)
    3 / 1153 (0.26%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    4 / 1164 (0.34%)
    4 / 1153 (0.35%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systolic dysfunction
         subjects affected / exposed
    4 / 1164 (0.34%)
    3 / 1153 (0.26%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    5 / 1164 (0.43%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    1 / 1164 (0.09%)
    3 / 1153 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coronary artery perforation
         subjects affected / exposed
    1 / 1164 (0.09%)
    3 / 1153 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary no-reflow phenomenon
         subjects affected / exposed
    1 / 1164 (0.09%)
    3 / 1153 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dressler's syndrome
         subjects affected / exposed
    2 / 1164 (0.17%)
    2 / 1153 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    2 / 1164 (0.17%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 1164 (0.09%)
    2 / 1153 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 1164 (0.09%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 1164 (0.09%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery dissection
         subjects affected / exposed
    0 / 1164 (0.00%)
    2 / 1153 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery embolism
         subjects affected / exposed
    0 / 1164 (0.00%)
    2 / 1153 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriospasm coronary
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery thrombosis
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary slow flow phenomenon
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nodal rhythm
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prinzmetal angina
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 1164 (0.00%)
    3 / 1153 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 1164 (0.09%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haematoma
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Middle cerebral artery stroke
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar stroke
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Blood loss anaemia
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 1164 (0.09%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 1164 (0.09%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Melaena
         subjects affected / exposed
    0 / 1164 (0.00%)
    2 / 1153 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         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 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal pseudo-obstruction
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric vein thrombosis
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    2 / 1164 (0.17%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 1164 (0.17%)
    5 / 1153 (0.43%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal failure
         subjects affected / exposed
    2 / 1164 (0.17%)
    4 / 1153 (0.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 1164 (0.00%)
    2 / 1153 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal haemorrhage
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    11 / 1164 (0.95%)
    8 / 1153 (0.69%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    2 / 1164 (0.17%)
    2 / 1153 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 1164 (0.09%)
    3 / 1153 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 1164 (0.00%)
    3 / 1153 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 1164 (0.09%)
    2 / 1153 (0.17%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    3 / 1164 (0.26%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 1164 (0.09%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 1164 (0.09%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 1164 (0.09%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Endocarditis
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 1164 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 1164 (0.00%)
    1 / 1153 (0.09%)
         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: 1%
    Non-serious adverse events
    		 FDY-5301 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    657 / 1164 (56.44%)
    620 / 1153 (53.77%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    44 / 1164 (3.78%)
    47 / 1153 (4.08%)
         occurrences all number
    46
    51
    Hypertension
         subjects affected / exposed
    31 / 1164 (2.66%)
    23 / 1153 (1.99%)
         occurrences all number
    41
    26
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    16 / 1164 (1.37%)
    27 / 1153 (2.34%)
         occurrences all number
    18
    28
    Non-cardiac chest pain
         subjects affected / exposed
    19 / 1164 (1.63%)
    19 / 1153 (1.65%)
         occurrences all number
    20
    19
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    13 / 1164 (1.12%)
    17 / 1153 (1.47%)
         occurrences all number
    13
    17
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    5 / 1164 (0.43%)
    13 / 1153 (1.13%)
         occurrences all number
    5
    13
    Investigations
    Ejection fraction decreased
         subjects affected / exposed
    27 / 1164 (2.32%)
    22 / 1153 (1.91%)
         occurrences all number
    27
    22
    Aspartate aminotransferase increased
         subjects affected / exposed
    10 / 1164 (0.86%)
    12 / 1153 (1.04%)
         occurrences all number
    11
    13
    Cardiac disorders
    Cardiac ventricular thrombosis
         subjects affected / exposed
    41 / 1164 (3.52%)
    48 / 1153 (4.16%)
         occurrences all number
    41
    48
    Ventricular tachycardia
         subjects affected / exposed
    49 / 1164 (4.21%)
    37 / 1153 (3.21%)
         occurrences all number
    53
    37
    Cardiac failure
         subjects affected / exposed
    31 / 1164 (2.66%)
    32 / 1153 (2.78%)
         occurrences all number
    33
    33
    Pericarditis
         subjects affected / exposed
    36 / 1164 (3.09%)
    27 / 1153 (2.34%)
         occurrences all number
    36
    27
    Angina pectoris
         subjects affected / exposed
    23 / 1164 (1.98%)
    26 / 1153 (2.25%)
         occurrences all number
    28
    27
    Coronary artery embolism
         subjects affected / exposed
    21 / 1164 (1.80%)
    26 / 1153 (2.25%)
         occurrences all number
    26
    27
    Left ventricular dysfunction
         subjects affected / exposed
    24 / 1164 (2.06%)
    23 / 1153 (1.99%)
         occurrences all number
    25
    23
    Atrial fibrillation
         subjects affected / exposed
    17 / 1164 (1.46%)
    21 / 1153 (1.82%)
         occurrences all number
    18
    21
    Coronary artery dissection
         subjects affected / exposed
    15 / 1164 (1.29%)
    21 / 1153 (1.82%)
         occurrences all number
    19
    23
    Coronary no-reflow phenomenon
         subjects affected / exposed
    15 / 1164 (1.29%)
    17 / 1153 (1.47%)
         occurrences all number
    17
    17
    Pericardial effusion
         subjects affected / exposed
    13 / 1164 (1.12%)
    15 / 1153 (1.30%)
         occurrences all number
    13
    15
    Bradycardia
         subjects affected / exposed
    5 / 1164 (0.43%)
    11 / 1153 (0.95%)
         occurrences all number
    5
    12
    Coronary slow flow phenomenon
         subjects affected / exposed
    15 / 1164 (1.29%)
    8 / 1153 (0.69%)
         occurrences all number
    16
    8
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    15 / 1164 (1.29%)
    12 / 1153 (1.04%)
         occurrences all number
    15
    13
    Headache
         subjects affected / exposed
    12 / 1164 (1.03%)
    11 / 1153 (0.95%)
         occurrences all number
    12
    11
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    16 / 1164 (1.37%)
    16 / 1153 (1.39%)
         occurrences all number
    19
    17
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    34 / 1164 (2.92%)
    20 / 1153 (1.73%)
         occurrences all number
    35
    24
    Vomiting
         subjects affected / exposed
    21 / 1164 (1.80%)
    18 / 1153 (1.56%)
         occurrences all number
    21
    21
    Diarrhoea
         subjects affected / exposed
    22 / 1164 (1.89%)
    8 / 1153 (0.69%)
         occurrences all number
    22
    9
    Constipation
         subjects affected / exposed
    13 / 1164 (1.12%)
    11 / 1153 (0.95%)
         occurrences all number
    13
    11
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    17 / 1164 (1.46%)
    19 / 1153 (1.65%)
         occurrences all number
    19
    20
    Haematuria
         subjects affected / exposed
    8 / 1164 (0.69%)
    13 / 1153 (1.13%)
         occurrences all number
    8
    13
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    11 / 1164 (0.95%)
    15 / 1153 (1.30%)
         occurrences all number
    11
    15
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    23 / 1164 (1.98%)
    16 / 1153 (1.39%)
         occurrences all number
    23
    16
    Urinary tract infection
         subjects affected / exposed
    15 / 1164 (1.29%)
    13 / 1153 (1.13%)
         occurrences all number
    15
    13
    COVID-19
         subjects affected / exposed
    16 / 1164 (1.37%)
    7 / 1153 (0.61%)
         occurrences all number
    16
    7
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    34 / 1164 (2.92%)
    20 / 1153 (1.73%)
         occurrences all number
    47
    27
    Hypercholesterolaemia
         subjects affected / exposed
    15 / 1164 (1.29%)
    17 / 1153 (1.47%)
         occurrences all number
    17
    20
    Diabetes mellitus
         subjects affected / exposed
    10 / 1164 (0.86%)
    15 / 1153 (1.30%)
         occurrences all number
    10
    17
    Hyperlipidaemia
         subjects affected / exposed
    12 / 1164 (1.03%)
    9 / 1153 (0.78%)
         occurrences all number
    23
    13

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Oct 2023
    The modifications to the protocol were as follows: • Modification of the interim analysis to allow the inclusion of subjects that have completed at least 28 days of the 12-month follow-up for the primary endpoint. • Corresponding modifications to the statistical analysis methodology by utilizing the Kaplan-Meier method for both interim and final analysis. • Clarification of the heart failure definition and to allow for the use of clinical judgement in the setting of insufficient documentation. • Clarification of inclusion and exclusion criteria. • Broadening of inpatient study visit windows to accommodate physician workflow. • General clarification statements and incorporation of updates due to requests from global regulatory agencies and ethic committees.

    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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