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    Clinical Trial Results:
    A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled,Dose Ranging Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A (AGN-151607) Injections into the Epicardial Fat Pads to Prevent Post-Operative Atrial Fibrillation in Patients Undergoing Open-Chest Cardiac Surgery

    Summary
    EudraCT number
    		 2017-004399-68
    Trial protocol
    		 GB   DE   ES   AT   SE   NL   IT  
    Global end of trial date
    06 Mar 2023

    Results information
    Results version number
    		 v2(current)
    This version publication date
    16 Jun 2024
    First version publication date
    20 Mar 2024
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Edits made to clarify text and clarify data table in 1 secondary endpoint.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    1925-201-008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03779841
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4UB
    Public contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.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
    06 Mar 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Mar 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This was a multi-center, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study to evaluate the efficacy and safety of botulinum toxin type A (AGN-151607) injections into the epicardial fat pads, foci of ganglionic plexi, to prevent Post-Operative Atrial Fibrillation (POAF) in patients undergoing open-chest cardiac surgery.
    Protection of trial subjects
    Prior to the initiation of any screening or study-specific procedures, the investigator or his or her representative explained the nature of the study to the subject or his or her representative and answered all questions regarding this study. The informed consent statement was reviewed and signed and dated by the subject and the person who administered the informed consent. A copy of the signed informed consent was to be given to the subject and the original was to be placed in the subject's medical record.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2019
    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
    United Kingdom: 5
    Country: Number of subjects enrolled
    United States: 186
    Country: Number of subjects enrolled
    Austria: 4
    Country: Number of subjects enrolled
    Canada: 97
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Italy: 12
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    Sweden: 3
    Worldwide total number of subjects
    319
    EEA total number of subjects
    31
    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)
    130
    From 65 to 84 years
    189
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 323 subjects were randomized, of which 319 received study drug (Safety Population).

    Period 1
    Period 1 title
    Overall Study Period (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
    		 Placebo
    Arm description
    		 Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1mL. One-time treatment.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Other use
    Dosage and administration details
    The placebo solution for injection contained only the excipients of AGN-151607. Subjects received a single dose divided into five equal injections to be administered into five epicardial fat pads during the open-chest surgery.

    Arm title
    		 AGN-151607 (125 U)
    Arm description
    		 Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clostridium botulinum toxin type A
    Investigational medicinal product code
    AGN-151607
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Other use
    Dosage and administration details
    A lyophilized formulation consisting of AGN-151607 was reconstituted. Subjects received a single dose divided into five equal injections to be administered into five epicardial fat pads during the open-chest surgery for total dose of 125 U.

    Arm title
    		 AGN-151607 (250 U)
    Arm description
    		 Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clostridium botulinum toxin type A
    Investigational medicinal product code
    AGN-151607
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Other use
    Dosage and administration details
    A lyophilized formulation consisting of AGN-151607 was reconstituted. Subjects received a single dose divided into five equal injections to be administered into five epicardial fat pads during the open-chest surgery for total dose of 250 U.

    Number of subjects in period 1
    		Placebo AGN-151607 (125 U) AGN-151607 (250 U)
    Started
    105
    105
    109
    Completed
    94
    87
    93
    Not completed
    11
    18
    16
         Adverse event, serious fatal
    1
    -
    2
         Consent withdrawn by subject
    4
    8
    6
         Adverse event, non-fatal
    1
    1
    -
         Lost to follow-up
    5
    9
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1mL. One-time treatment.

    Reporting group title
    AGN-151607 (125 U)
    Reporting group description
    		 Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.

    Reporting group title
    AGN-151607 (250 U)
    Reporting group description
    		 Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.

    Reporting group values
    		 Placebo AGN-151607 (125 U) AGN-151607 (250 U) Total
    Number of subjects
    		 105 105 109 319
    Age categorical
    Units: Subjects
        Between 18 and 64 years
    		 43 42 45 130
        ≥ 65 years
    		 62 63 64 189
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.8 ( 6.76 ) 66.8 ( 6.54 ) 67.2 ( 7.01 ) -
    Gender categorical
    Units: Subjects
        Female
    		 14 17 22 53
        Male
    		 91 88 87 266
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 6 8 6 20
        Not Hispanic or Latino
    		 99 97 103 299
    Race (NIH/OMB)
    Units: Subjects
        Asian
    		 1 0 2 3
        Black or African American
    		 2 2 2 6
        White
    		 102 102 105 309
        Unknown or Not Reported
    		 0 1 0 1
    Type of Surgery
    CABG = Coronary Artery Bypass Graft
    Units: Subjects
        Isolated CABG Surgery
    		 65 68 70 203
        Valve only Surgery
    		 27 24 27 78
        CABG and Valve Surgery
    		 13 13 12 38

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1mL. One-time treatment.

    Reporting group title
    AGN-151607 (125 U)
    Reporting group description
    		 Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.

    Reporting group title
    AGN-151607 (250 U)
    Reporting group description
    		 Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.

    Primary: Percentage of participants with at least 1 continuous AF (atrial fibrillation or atrial flutter) episode ≥ 30 seconds during the first 30 days post-surgery

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    End point title
    		 Percentage of participants with at least 1 continuous AF (atrial fibrillation or atrial flutter) episode ≥ 30 seconds during the first 30 days post-surgery
    End point description
    At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant’s chest. All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
    End point type
    Primary
    End point timeframe
    First 30 days following the initial intensive care unit (ICU) admission date after open-chest cardiac surgery.
    End point values
    		 Placebo AGN-151607 (125 U) AGN-151607 (250 U)
    Number of subjects analysed
    102
    104
    106
    Units: percentage of participants
        number (not applicable)
    46.1
    36.5
    47.2
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (125 U) v Placebo
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1612
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 1.1
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (250 U) v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7789
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.37

    Secondary: Percentage of Time Spent in Atrial Fibrillation or Atrial Flutter (AF Burden) During the First 30 Days Post-surgery

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    End point title
    		 Percentage of Time Spent in Atrial Fibrillation or Atrial Flutter (AF Burden) During the First 30 Days Post-surgery
    End point description
    The proportion of time an individual is in AF (atrial fibrillation or atrial flutter) during a monitoring period (expressed as a percentage) calculated as (the total time spent in AF during the first 30 days post-surgery divided by the total time of analyzable data obtained from the ECG patch during the first 30 days post-surgery) multiplied by 100. The calculation excludes continuous AF episodes < 30 seconds in duration. All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
    End point type
    Secondary
    End point timeframe
    First 30 days following the initial ICU admission date after open-chest cardiac surgery.
    End point values
    		 Placebo AGN-151607 (125 U) AGN-151607 (250 U)
    Number of subjects analysed
    102
    104
    106
    Units: units on a scale
        arithmetic mean (standard deviation)
    4.84 ( 14.898 )
    4.41 ( 14.976 )
    5.45 ( 15.821 )
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    P-value is obtained from stratified Wilcoxon (Van Elteren) test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years) as stratification factors.
    Comparison groups
    AGN-151607 (250 U) v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8722
    Method
    		 stratified Wilcoxon (Van Elteren)
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-value is obtained from stratified Wilcoxon (Van Elteren) test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years) as stratification factors.
    Comparison groups
    AGN-151607 (125 U) v Placebo
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2972
    Method
    		 stratified Wilcoxon (Van Elteren)
    Confidence interval

    Secondary: Percentage of Participants With at Least 1 Event of Symptomatic AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery

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    End point title
    		 Percentage of Participants With at Least 1 Event of Symptomatic AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery
    End point description
    At least 1 event of symptomatic AF (atrial fibrillation or atrial flutter) (symptoms occurring within 2 hours of an AF episode). For symptomatic AF, symptoms that occur in the interval that starts two hours prior to the onset of the AF episode and ends two hours after the conclusion of the AF episode will meet the definition of "within 2 hours of an AF episode". AF episode ≥ 30 seconds. All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
    End point type
    Secondary
    End point timeframe
    First 30 days following the initial ICU admission date after open-chest cardiac surgery.
    End point values
    		 Placebo AGN-151607 (125 U) AGN-151607 (250 U)
    Number of subjects analysed
    102
    104
    106
    Units: percentage of participants
        number (not applicable)
    13.7
    13.5
    13.2
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (125 U) v Placebo
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9814
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 1.96
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (250 U) v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9715
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 1.97

    Secondary: Time to First Occurrence of AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery

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    End point title
    		 Time to First Occurrence of AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery
    End point description
    Amount of time (days) to first AF (atrial fibrillation or atrial flutter) occurrence defined by first episode of AF lasting for ≥ 30 seconds. 99999 = Insufficient number of participants with events
    End point type
    Secondary
    End point timeframe
    First 30 days following the initial ICU admission date after open-chest cardiac surgery.
    End point values
    		 Placebo AGN-151607 (125 U) AGN-151607 (250 U)
    Number of subjects analysed
    102
    104
    106
    Units: days
        median (confidence interval 95%)
    99999 (9.1 to 99999)
    99999 (99999 to 99999)
    99999 (13.2 to 99999)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-value is from stratified log-rank test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years) as stratification factors.
    Comparison groups
    AGN-151607 (125 U) v Placebo
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1281
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    P-value is from stratified log-rank test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years) as stratification factors.
    Comparison groups
    AGN-151607 (250 U) v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.882
    Method
    		 Logrank
    Confidence interval

    Secondary: Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 2 Minutes During the First 30 Days Post-surgery

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    End point title
    		 Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 2 Minutes During the First 30 Days Post-surgery
    End point description
    At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 2 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
    End point type
    Secondary
    End point timeframe
    First 30 days following the initial ICU admission date after open-chest cardiac surgery.
    End point values
    		 Placebo AGN-151607 (125 U) AGN-151607 (250 U)
    Number of subjects analysed
    102
    104
    106
    Units: percentage of participants
        number (not applicable)
    45.1
    35.6
    46.2
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (250 U) v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7776
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.39
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (125 U) v Placebo
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1623
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 1.1

    Secondary: Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 5 Minutes During the First 30 Days Post-surgery

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    End point title
    		 Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 5 Minutes During the First 30 Days Post-surgery
    End point description
    At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 5 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
    End point type
    Secondary
    End point timeframe
    First 30 days following the initial ICU admission date after open-chest cardiac surgery.
    End point values
    		 Placebo AGN-151607 (125 U) AGN-151607 (250 U)
    Number of subjects analysed
    102
    104
    106
    Units: percentage of participants
        number (not applicable)
    44.1
    34.6
    46.2
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (125 U) v Placebo
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1603
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.1
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (250 U) v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6706
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.42

    Secondary: Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Minutes During the First 30 Days Post-surgery

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    End point title
    		 Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Minutes During the First 30 Days Post-surgery
    End point description
    At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 6 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
    End point type
    Secondary
    End point timeframe
    First 30 days following the initial ICU admission date after open-chest cardiac surgery.
    End point values
    		 Placebo AGN-151607 (125 U) AGN-151607 (250 U)
    Number of subjects analysed
    102
    104
    106
    Units: percentage of participants
        number (not applicable)
    43.1
    33.7
    45.3
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (125 U) v Placebo
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1583
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 1.1
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (250 U) v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6694
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.43

    Secondary: Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Minutes During the First 30 Days Post-surgery

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    End point title
    		 Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Minutes During the First 30 Days Post-surgery
    End point description
    At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 30 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
    End point type
    Secondary
    End point timeframe
    First 30 days following the initial ICU admission date after open-chest cardiac surgery.
    End point values
    		 Placebo AGN-151607 (125 U) AGN-151607 (250 U)
    Number of subjects analysed
    102
    104
    106
    Units: percentage of participants
        number (not applicable)
    38.2
    30.8
    39.6
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (125 U) v Placebo
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2578
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 1.18
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (250 U) v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7526
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.47

    Secondary: Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 1 Hour During the First 30 Days Post-surgery

    		 Close Top of page
    End point title
    		 Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 1 Hour During the First 30 Days Post-surgery
    End point description
    At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 1 hour documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
    End point type
    Secondary
    End point timeframe
    First 30 days following the initial ICU admission date after open-chest cardiac surgery.
    End point values
    		 Placebo AGN-151607 (125 U) AGN-151607 (250 U)
    Number of subjects analysed
    102
    104
    106
    Units: percentage of participants
        number (not applicable)
    37.3
    29.8
    37.7
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (250 U) v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8544
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.45
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (125 U) v Placebo
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2549
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 1.18

    Secondary: Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 4 Hours During the First 30 Days Post-surgery

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    End point title
    		 Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 4 Hours During the First 30 Days Post-surgery
    End point description
    At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 4 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
    End point type
    Secondary
    End point timeframe
    First 30 days following the initial ICU admission date after open-chest cardiac surgery.
    End point values
    		 Placebo AGN-151607 (125 U) AGN-151607 (250 U)
    Number of subjects analysed
    102
    104
    106
    Units: percentage of participants
        number (not applicable)
    32.4
    24.0
    26.4
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (125 U) v Placebo
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1718
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 1.14
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (250 U) v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3801
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.27

    Secondary: Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Hours During the First 30 Days Post-surgery

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    End point title
    		 Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Hours During the First 30 Days Post-surgery
    End point description
    At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 6 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
    End point type
    Secondary
    End point timeframe
    First 30 days following the initial ICU admission date after open-chest cardiac surgery.
    End point values
    		 Placebo AGN-151607 (125 U) AGN-151607 (250 U)
    Number of subjects analysed
    102
    104
    106
    Units: percentage of participants
        number (not applicable)
    25.5
    22.1
    20.8
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (125 U) v Placebo
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5531
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.39
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (250 U) v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4213
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 1.33

    Secondary: Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 12 Hours During the First 30 Days Post-surgery

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    End point title
    		 Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 12 Hours During the First 30 Days Post-surgery
    End point description
    At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 12 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
    End point type
    Secondary
    End point timeframe
    First 30 days following the initial ICU admission date after open-chest cardiac surgery.
    End point values
    		 Placebo AGN-151607 (125 U) AGN-151607 (250 U)
    Number of subjects analysed
    102
    104
    106
    Units: percentage of participants
        number (not applicable)
    15.7
    14.4
    17.0
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (125 U) v Placebo
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.804
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 1.73
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (250 U) v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7573
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 1.98

    Secondary: Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 24 Hours During the First 30 Days Post-surgery

    		 Close Top of page
    End point title
    		 Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 24 Hours During the First 30 Days Post-surgery
    End point description
    At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 24 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
    End point type
    Secondary
    End point timeframe
    First 30 days following the initial ICU admission date after open-chest cardiac surgery.
    End point values
    		 Placebo AGN-151607 (125 U) AGN-151607 (250 U)
    Number of subjects analysed
    102
    104
    106
    Units: percentage of participants
        number (not applicable)
    9.8
    6.7
    12.3
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (250 U) v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5257
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 2.7
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (125 U) v Placebo
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4065
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.28
         upper limit
    		 1.67

    Secondary: Percentage of Participants With at Least 1 Continuous Atrial Fibrillation (Excluding Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery

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    End point title
    		 Percentage of Participants With at Least 1 Continuous Atrial Fibrillation (Excluding Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery
    End point description
    At least one episode of continuous atrial fibrillation (excluding atrial flutter) sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
    End point type
    Secondary
    End point timeframe
    First 30 days following the initial ICU admission date after open-chest cardiac surgery.
    End point values
    		 Placebo AGN-151607 (125 U) AGN-151607 (250 U)
    Number of subjects analysed
    102
    104
    106
    Units: percentage of participants
        number (not applicable)
    43.1
    33.7
    42.5
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (250 U) v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9966
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.35
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (125 U) v Placebo
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1612
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 1.11

    Secondary: Percentage of Participants With at Least 1 Continuous Atrial Flutter Episode ≥ 30 Seconds During the First 30 Days Post-surgery

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    End point title
    		 Percentage of Participants With at Least 1 Continuous Atrial Flutter Episode ≥ 30 Seconds During the First 30 Days Post-surgery
    End point description
    At least one episode of continuous atrial flutter sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
    End point type
    Secondary
    End point timeframe
    First 30 days following the initial ICU admission date after open-chest cardiac surgery.
    End point values
    		 Placebo AGN-151607 (125 U) AGN-151607 (250 U)
    Number of subjects analysed
    102
    104
    106
    Units: percentage of participants
        number (not applicable)
    12.7
    8.7
    15.1
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (125 U) v Placebo
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3374
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 1.52
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (250 U) v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5403
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 2.45

    Secondary: Percentage of Participants With at Least 1 Continuous Atrial Tachycardia Episode (Defined as the Duration of the Longest Supraventricular Tachycardia [SVT] Run) ≥ 30 Seconds During the First 30 Days Post-surgery

    		 Close Top of page
    End point title
    		 Percentage of Participants With at Least 1 Continuous Atrial Tachycardia Episode (Defined as the Duration of the Longest Supraventricular Tachycardia [SVT] Run) ≥ 30 Seconds During the First 30 Days Post-surgery
    End point description
    At least one episode of continuous atrial tachycardia sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
    End point type
    Secondary
    End point timeframe
    First 30 days following the initial ICU admission date after open-chest cardiac surgery.
    End point values
    		 Placebo AGN-151607 (125 U) AGN-151607 (250 U)
    Number of subjects analysed
    102
    104
    106
    Units: percentage of participants
        number (not applicable)
    2.9
    11.5
    7.5
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (125 U) v Placebo
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0163
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    3.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.16
         upper limit
    		 13.42
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (250 U) v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1101
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 9.64

    Secondary: Percentage of Participants With at Least 1 Continuous Episode of Either Atrial Fibrillation or Atrial Flutter or Atrial Tachycardia ≥ 30 Seconds During the First 30 Days Post-surgery

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    End point title
    		 Percentage of Participants With at Least 1 Continuous Episode of Either Atrial Fibrillation or Atrial Flutter or Atrial Tachycardia ≥ 30 Seconds During the First 30 Days Post-surgery
    End point description
    At least one episode of continuous atrial fibrillation or atrial flutter or atrial tachycardia sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
    End point type
    Secondary
    End point timeframe
    First 30 days following the initial ICU admission date after open-chest cardiac surgery.
    End point values
    		 Placebo AGN-151607 (125 U) AGN-151607 (250 U)
    Number of subjects analysed
    102
    104
    106
    Units: percentage of participants
        number (not applicable)
    48.0
    41.3
    51.9
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (125 U) v Placebo
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3339
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.16
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years).
    Comparison groups
    AGN-151607 (250 U) v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4614
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.42

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1).
    Adverse event reporting additional description
    Of the 323 subjects enrolled and included in the All-cause mortality data table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time that the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607250 Units was 371.0, 372.0 and 371.0 days, respectively.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    PLACEBO
    Reporting group description
    		 -

    Reporting group title
    AGN-151607_250_U
    Reporting group description
    		 -

    Reporting group title
    AGN-151607_125_U
    Reporting group description
    		 -

    Serious adverse events
    		 PLACEBO AGN-151607_250_U AGN-151607_125_U
    Total subjects affected by serious adverse events
         subjects affected / exposed
    36 / 105 (34.29%)
    28 / 109 (25.69%)
    38 / 105 (36.19%)
         number of deaths (all causes)
    1
    2
    0
         number of deaths resulting from adverse events
    1
    2
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    LUNG NEOPLASM
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    NON-SMALL CELL LUNG CANCER
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    LUNG ADENOCARCINOMA
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RENAL CANCER
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    SHOCK HAEMORRHAGIC
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    AORTIC PERFORATION
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    DEEP VEIN THROMBOSIS
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    THROMBOSIS
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HAEMORRHAGE
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HYPERTENSION
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    INTERMITTENT CLAUDICATION
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ORTHOSTATIC HYPOTENSION
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HAEMATOMA
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PYREXIA
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    PNEUMOTHORAX
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    3 / 105 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PULMONARY EMBOLISM
         subjects affected / exposed
    5 / 105 (4.76%)
    2 / 109 (1.83%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PLEURAL EFFUSION
         subjects affected / exposed
    3 / 105 (2.86%)
    1 / 109 (0.92%)
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HAEMOTHORAX
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    DYSPNOEA EXERTIONAL
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    DYSPNOEA
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    DIAPHRAGMATIC PARALYSIS
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CHRONIC OBSTRUCTIVE PULMONARY DISEASE
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ASPIRATION
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ACUTE RESPIRATORY FAILURE
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PULMONARY OEDEMA
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RESPIRATORY FAILURE
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    MENTAL STATUS CHANGES
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    BLOOD CREATINE PHOSPHOKINASE INCREASED
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HAEMOGLOBIN DECREASED
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    INTERNATIONAL NORMALISED RATIO INCREASED
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ELECTROENCEPHALOGRAM ABNORMAL
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    CORONARY SINUS INJURY
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    FALL
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PERIPROCEDURAL MYOCARDIAL INFARCTION
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    POST PROCEDURAL HAEMORRHAGE
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    POSTOPERATIVE ILEUS
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PROCEDURAL HAEMORRHAGE
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    TRANSFUSION-RELATED ACUTE LUNG INJURY
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SUBDURAL HAEMATOMA
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    VASCULAR GRAFT OCCLUSION
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    VASCULAR PROCEDURE COMPLICATION
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    AORTIC VALVE INCOMPETENCE
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ATRIAL FIBRILLATION
         subjects affected / exposed
    6 / 105 (5.71%)
    4 / 109 (3.67%)
    6 / 105 (5.71%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ATRIAL FLUTTER
         subjects affected / exposed
    5 / 105 (4.76%)
    5 / 109 (4.59%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ATRIOVENTRICULAR BLOCK
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ATRIOVENTRICULAR BLOCK COMPLETE
         subjects affected / exposed
    1 / 105 (0.95%)
    2 / 109 (1.83%)
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    BRADYCARDIA
         subjects affected / exposed
    0 / 105 (0.00%)
    2 / 109 (1.83%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CARDIAC ARREST
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    CARDIAC FAILURE
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CARDIAC FAILURE ACUTE
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ACUTE MYOCARDIAL INFARCTION
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CARDIOGENIC SHOCK
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ACUTE LEFT VENTRICULAR FAILURE
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PERICARDIAL EFFUSION
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    NODAL RHYTHM
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    MYOCARDIAL ISCHAEMIA
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CORONARY ARTERY PERFORATION
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CORONARY ARTERY DISEASE
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PERICARDITIS
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SUPRAVENTRICULAR TACHYCARDIA
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    FACIAL PARALYSIS
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    LOSS OF CONSCIOUSNESS
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    TRANSIENT ISCHAEMIC ATTACK
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 109 (0.92%)
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SYNCOPE
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 109 (0.92%)
    3 / 105 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    MYASTHENIA GRAVIS
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ENCEPHALOPATHY
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    DIZZINESS
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CEREBROVASCULAR ACCIDENT
         subjects affected / exposed
    3 / 105 (2.86%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CEREBRAL ISCHAEMIA
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    BELL'S PALSY
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    AMYOTROPHIC LATERAL SCLEROSIS
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    BLOOD LOSS ANAEMIA
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ANAEMIA
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COAGULOPATHY
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    THROMBOCYTOSIS
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    DIPLOPIA
         subjects affected / exposed
    0 / 105 (0.00%)
    2 / 109 (1.83%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    MELAENA
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ILEUS
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    GASTROINTESTINAL HAEMORRHAGE
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    DYSPHAGIA
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    DIARRHOEA
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    AORTO-OESOPHAGEAL FISTULA
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Hepatobiliary disorders
    CHOLECYSTITIS ACUTE
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    ACUTE KIDNEY INJURY
         subjects affected / exposed
    2 / 105 (1.90%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HAEMATURIA
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    NEPHROLITHIASIS
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    URINARY RETENTION
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    MUSCULAR WEAKNESS
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ROTATOR CUFF SYNDROME
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    APPENDICITIS
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ENDOCARDITIS
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    DIVERTICULITIS
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    MEDIASTINITIS
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COLONIC ABSCESS
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CELLULITIS
         subjects affected / exposed
    2 / 105 (1.90%)
    1 / 109 (0.92%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    BRONCHITIS
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    BACTERAEMIA
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19 PNEUMONIA
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    OSTEOMYELITIS
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 109 (0.92%)
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SEPSIS
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 109 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 109 (0.92%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    WOUND INFECTION
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    LACTIC ACIDOSIS
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 109 (0.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PLACEBO AGN-151607_250_U AGN-151607_125_U
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    86 / 105 (81.90%)
    94 / 109 (86.24%)
    84 / 105 (80.00%)
    Vascular disorders
    HYPOTENSION
         subjects affected / exposed
    15 / 105 (14.29%)
    17 / 109 (15.60%)
    10 / 105 (9.52%)
         occurrences all number
    18
    20
    10
    HYPERTENSION
         subjects affected / exposed
    8 / 105 (7.62%)
    6 / 109 (5.50%)
    7 / 105 (6.67%)
         occurrences all number
    9
    6
    7
    General disorders and administration site conditions
    PYREXIA
         subjects affected / exposed
    2 / 105 (1.90%)
    5 / 109 (4.59%)
    8 / 105 (7.62%)
         occurrences all number
    2
    6
    8
    OEDEMA PERIPHERAL
         subjects affected / exposed
    13 / 105 (12.38%)
    10 / 109 (9.17%)
    10 / 105 (9.52%)
         occurrences all number
    15
    10
    11
    FATIGUE
         subjects affected / exposed
    7 / 105 (6.67%)
    5 / 109 (4.59%)
    3 / 105 (2.86%)
         occurrences all number
    8
    5
    3
    Respiratory, thoracic and mediastinal disorders
    PNEUMOTHORAX
         subjects affected / exposed
    1 / 105 (0.95%)
    6 / 109 (5.50%)
    7 / 105 (6.67%)
         occurrences all number
    1
    6
    7
    PLEURAL EFFUSION
         subjects affected / exposed
    14 / 105 (13.33%)
    22 / 109 (20.18%)
    10 / 105 (9.52%)
         occurrences all number
    15
    24
    11
    DYSPNOEA
         subjects affected / exposed
    13 / 105 (12.38%)
    13 / 109 (11.93%)
    3 / 105 (2.86%)
         occurrences all number
    19
    13
    4
    COUGH
         subjects affected / exposed
    6 / 105 (5.71%)
    7 / 109 (6.42%)
    3 / 105 (2.86%)
         occurrences all number
    7
    7
    3
    ATELECTASIS
         subjects affected / exposed
    12 / 105 (11.43%)
    18 / 109 (16.51%)
    11 / 105 (10.48%)
         occurrences all number
    12
    20
    11
    Psychiatric disorders
    INSOMNIA
         subjects affected / exposed
    16 / 105 (15.24%)
    12 / 109 (11.01%)
    17 / 105 (16.19%)
         occurrences all number
    16
    12
    17
    ANXIETY
         subjects affected / exposed
    6 / 105 (5.71%)
    5 / 109 (4.59%)
    3 / 105 (2.86%)
         occurrences all number
    6
    5
    4
    DELIRIUM
         subjects affected / exposed
    2 / 105 (1.90%)
    6 / 109 (5.50%)
    2 / 105 (1.90%)
         occurrences all number
    2
    6
    2
    Injury, poisoning and procedural complications
    VASOPLEGIA SYNDROME
         subjects affected / exposed
    3 / 105 (2.86%)
    13 / 109 (11.93%)
    5 / 105 (4.76%)
         occurrences all number
    3
    13
    5
    PROCEDURAL PAIN
         subjects affected / exposed
    20 / 105 (19.05%)
    21 / 109 (19.27%)
    20 / 105 (19.05%)
         occurrences all number
    20
    21
    21
    Cardiac disorders
    SINUS TACHYCARDIA
         subjects affected / exposed
    7 / 105 (6.67%)
    2 / 109 (1.83%)
    1 / 105 (0.95%)
         occurrences all number
    8
    2
    1
    PALPITATIONS
         subjects affected / exposed
    7 / 105 (6.67%)
    6 / 109 (5.50%)
    4 / 105 (3.81%)
         occurrences all number
    10
    6
    6
    BRADYCARDIA
         subjects affected / exposed
    4 / 105 (3.81%)
    4 / 109 (3.67%)
    7 / 105 (6.67%)
         occurrences all number
    4
    4
    8
    ATRIAL FLUTTER
         subjects affected / exposed
    6 / 105 (5.71%)
    7 / 109 (6.42%)
    5 / 105 (4.76%)
         occurrences all number
    6
    7
    6
    ATRIAL FIBRILLATION
         subjects affected / exposed
    32 / 105 (30.48%)
    35 / 109 (32.11%)
    31 / 105 (29.52%)
         occurrences all number
    38
    40
    37
    TACHYCARDIA
         subjects affected / exposed
    4 / 105 (3.81%)
    12 / 109 (11.01%)
    4 / 105 (3.81%)
         occurrences all number
    4
    12
    6
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    8 / 105 (7.62%)
    5 / 109 (4.59%)
    4 / 105 (3.81%)
         occurrences all number
    10
    5
    4
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    27 / 105 (25.71%)
    30 / 109 (27.52%)
    19 / 105 (18.10%)
         occurrences all number
    28
    30
    20
    Gastrointestinal disorders
    VOMITING
         subjects affected / exposed
    4 / 105 (3.81%)
    7 / 109 (6.42%)
    2 / 105 (1.90%)
         occurrences all number
    4
    7
    2
    NAUSEA
         subjects affected / exposed
    25 / 105 (23.81%)
    29 / 109 (26.61%)
    25 / 105 (23.81%)
         occurrences all number
    25
    30
    27
    CONSTIPATION
         subjects affected / exposed
    10 / 105 (9.52%)
    6 / 109 (5.50%)
    7 / 105 (6.67%)
         occurrences all number
    10
    6
    9
    Skin and subcutaneous tissue disorders
    DERMATITIS CONTACT
         subjects affected / exposed
    5 / 105 (4.76%)
    6 / 109 (5.50%)
    2 / 105 (1.90%)
         occurrences all number
    5
    6
    2
    Musculoskeletal and connective tissue disorders
    MUSCULOSKELETAL CHEST PAIN
         subjects affected / exposed
    12 / 105 (11.43%)
    9 / 109 (8.26%)
    11 / 105 (10.48%)
         occurrences all number
    12
    9
    12
    Infections and infestations
    URINARY TRACT INFECTION
         subjects affected / exposed
    4 / 105 (3.81%)
    6 / 109 (5.50%)
    6 / 105 (5.71%)
         occurrences all number
    4
    6
    7
    COVID-19
         subjects affected / exposed
    5 / 105 (4.76%)
    6 / 109 (5.50%)
    10 / 105 (9.52%)
         occurrences all number
    5
    6
    12
    Metabolism and nutrition disorders
    HYPOPHOSPHATAEMIA
         subjects affected / exposed
    5 / 105 (4.76%)
    7 / 109 (6.42%)
    6 / 105 (5.71%)
         occurrences all number
    5
    7
    6
    HYPOKALAEMIA
         subjects affected / exposed
    3 / 105 (2.86%)
    9 / 109 (8.26%)
    3 / 105 (2.86%)
         occurrences all number
    3
    9
    3
    HYPERVOLAEMIA
         subjects affected / exposed
    18 / 105 (17.14%)
    23 / 109 (21.10%)
    24 / 105 (22.86%)
         occurrences all number
    19
    23
    24
    HYPERGLYCAEMIA
         subjects affected / exposed
    14 / 105 (13.33%)
    17 / 109 (15.60%)
    17 / 105 (16.19%)
         occurrences all number
    16
    17
    19

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Sep 2020
    The purpose of this protocol amendment was to clarify specific points within the protocol based on clinical experience to date. These changes did not impact the safety assessment of botulinum toxin type A or alter the risk-benefit ratio for study participants. Administrative edits were also made, but not specifically noted (eg, corrected spelling, punctuation, grammar, abbreviations, and style errors) including global edits required for consistency (eg, “study drug”, “participants”, abbreviation use).

    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
    For support, Contact us.
    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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