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    Clinical Trial Results:
    Time to transit Recovery After treatment with Naloxegol in cardiac Surgery Intensive care Trial

    Summary
    EudraCT number
    		 2020-000087-26
    Trial protocol
    		 FR  
    Global end of trial date
    03 Mar 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Jun 2023
    First version publication date
    17 Jun 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    2019/09
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04433390
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CMC Ambroise Pare
    Sponsor organisation address
    25-27 boulevard Victor Hugo, Neuilly-sur-Seine, France, 92200
    Public contact
    Service de recherche clinique, CMC Ambroise Pare, +33 10146415079, recherche@clinique-a-pare.fr
    Scientific contact
    Service de recherche clinique, CMC Ambroise Pare, +33 10146415079, recherche@clinique-a-pare.fr
    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
    24 Feb 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Mar 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Mar 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Prove that the administration of Naloxegol in the perioperative period of cardiac surgery reduces the duration of the postoperative ileus.
    Protection of trial subjects
    This clinical trial was approved by a Committee for Protection of Human Subjects (CPP OUEST III - CPP 20.03.22/SI CNRIPH 20.02.25.46201) and the french national agency for medicines and health products safety (ANSM MEDAECNAT-2020-02-00024). The trial was conducted in accordance with the Declaration of Helsinki and the Good Clinical Practice. Prior to inclusion, written informed consent was obtained from all subjects after a thorough oral and written participant information had been given.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Oct 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 305
    Worldwide total number of subjects
    305
    EEA total number of subjects
    305
    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)
    181
    From 65 to 84 years
    123
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were included from October 2020 to January 2022. Patients scheduled for cardiac surgery with cardiopulmonary bypass were informed of the study protocol during the cardiology visit. They were included before the surgery after signing informed consent. We enrolled patient over 18 years-old with social security.

    Pre-assignment
    Screening details
    		 Exclusion criteria : Allergy to Naloxegol or opioid antagonist; Severe hepatic failure; GFR<60ml/min; Treatment with cytochrome P450 3A4 inhibitor, laxative or methadone; History of gastro-intestinal obstruction or digestive arteritis; Alteration of the blood-brain-barrier or gastrointestinal lining; Cancer with risk of gastroduodenal perforation.

    Pre-assignment period milestones
    Number of subjects started
    		 305
    Number of subjects completed
    		 304

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Cancelled surgery: 1
    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 No
    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
    		 Naloxegol
    Arm description
    		 One naloxegol 12.5 mg tablet will be administrated 2 hours before surgery. One 25 mg naloxegol tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Naloxegol 12,5 mg and 25mg
    Investigational medicinal product code
    Other name
    Moventig
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One naloxegol 12.5 mg tablet will be administrated 2hours before surgery. One 25 mg naloxegol tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.

    Arm title
    		 Placebo
    Arm description
    		 One inert tablet will be administrated 2 hours before surgery. One inert tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Inert Tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One inert tablet will be administrated 2 hours before surgery. One inert tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.

    Number of subjects in period 1
    		Naloxegol Placebo
    Started
    153
    151
    Treated
    151
    150
    Completed
    151
    150
    Not completed
    2
    1
         Consent withdrawn by subject
    1
    1
         Cancelled surgery
    1
    -
    Period 2
    Period 2 title
    Treated
    Is this the baseline period?
    		 No
    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
    		 Naloxegol
    Arm description
    		 One naloxegol 12.5 mg tablet will be administrated 2 hours before surgery. One 25 mg naloxegol tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Naloxegol 12,5 mg and 25mg
    Investigational medicinal product code
    Other name
    Moventig
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One naloxegol 12.5 mg tablet will be administrated 2hours before surgery. One 25 mg naloxegol tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.

    Arm title
    		 Placebo
    Arm description
    		 One inert tablet will be administrated 2 hours before surgery. One inert tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Inert Tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One inert tablet will be administrated 2 hours before surgery. One inert tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.

    Number of subjects in period 2
    		Naloxegol Placebo
    Started
    151
    150
    Transit recovery
    151
    148
    Completed
    151
    148
    Not completed
    0
    2
         Adverse event, serious fatal
    -
    2
    Period 3
    Period 3 title
    Transit recovery
    Is this the baseline period?
    		 Yes [1]
    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
    		 Naloxegol
    Arm description
    		 One naloxegol 12.5 mg tablet will be administrated 2 hours before surgery. One 25 mg naloxegol tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Naloxegol 12,5 mg and 25mg
    Investigational medicinal product code
    Other name
    Moventig
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One naloxegol 12.5 mg tablet will be administrated 2hours before surgery. One 25 mg naloxegol tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.

    Arm title
    		 Placebo
    Arm description
    		 One inert tablet will be administrated 2 hours before surgery. One inert tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Inert Tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One inert tablet will be administrated 2 hours before surgery. One inert tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: As defined in the clinical trial protocol, we analyze the baseline characteristics and the end points for the patients treated and recovering transit. The number of subjects treated and recovering transit are the number of subjects reported to be in the baseline period. So the baseline period is the period 3 « Transit Recovery » and not the period 1 « Overall Period ».
    Number of subjects in period 3 [2]
    		Naloxegol Placebo
    Started
    151
    148
    Completed
    151
    148
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: As defined in the clinical trial protocol, we analyze the baseline characteristics and the end points for the patients treated and recovering transit. The number of subjects treated and recovering transit are the number of subjects reported to be in the baseline period. So the number of subjects reported to be in the baseline period are not the same as the worlwide enrolled in the trial.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Naloxegol
    Reporting group description
    		 One naloxegol 12.5 mg tablet will be administrated 2 hours before surgery. One 25 mg naloxegol tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.

    Reporting group title
    Placebo
    Reporting group description
    		 One inert tablet will be administrated 2 hours before surgery. One inert tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.

    Reporting group values
    		 Naloxegol Placebo Total
    Number of subjects
    		 151 148 299
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 81 96 177
        From 65-84 years
    		 69 52 121
        85 years and over
    		 1 0 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.0 ( 10.6 ) 61.7 ( 10.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 27 28 55
        Male
    		 124 120 244
    Hypertension
    Units: Subjects
        Yes
    		 76 85 161
        No
    		 75 63 138
    Dyslipidemia
    Units: Subjects
        Yes
    		 78 95 173
        No
    		 73 53 126
    Diabetes
    Units: Subjects
        Yes
    		 33 29 62
        No
    		 118 119 237
    Peripheral arterial disease
    Units: Subjects
        Yes
    		 14 16 30
        No
    		 137 132 269
    Smoker status
    Units: Subjects
        Current and former <3years
    		 51 59 110
        Never or former > 3years
    		 100 89 189
    Chronic obstructive pulmonary disease - COPD
    Units: Subjects
        Yes
    		 9 17 26
        No
    		 142 131 273
    Sleep apnea syndrome
    Units: Subjects
        Yes
    		 14 13 27
        No
    		 137 135 272
    Prior or under treatment cancer
    Units: Subjects
        Yes
    		 15 17 32
        No
    		 136 131 267
    Prior ischemic cardiopathy
    Units: Subjects
        Yes
    		 33 40 73
        No
    		 118 108 226
    Prior abdominal surgery
    Units: Subjects
        Yes
    		 26 29 55
        No
    		 125 119 244
    Prior urologic surgery
    Units: Subjects
        Yes
    		 7 9 16
        No
    		 144 139 283
    Prior cardiac surgery
    Units: Subjects
        Yes
    		 4 4 8
        No
    		 147 144 291
    Aortic regurgitation
    Units: Subjects
        Yes
    		 10 9 19
        No
    		 141 139 280
    Aortic stenosis
    Units: Subjects
        Yes
    		 52 40 92
        No
    		 99 108 207
    Mitral regurgitation
    Units: Subjects
        Yes
    		 36 28 64
        No
    		 115 120 235
    Mitral stenosis
    Units: Subjects
        Yes
    		 3 4 7
        No
    		 148 144 292
    Ischemic cardiopathy
    Units: Subjects
        Yes
    		 63 74 137
        No
    		 88 74 162
    Type of surgery - Coronary bypass grafting
    Units: Subjects
        Yes
    		 63 74 137
        No
    		 88 74 162
    Type of surgery - Aortic valve replacement
    Units: Subjects
        Yes
    		 60 45 105
        No
    		 91 103 194
    Type of surgery - Mitral valve replacement
    Units: Subjects
        Yes
    		 6 8 14
        No
    		 145 140 285
    Type of surgery - Mitral valvuloplasty
    Units: Subjects
        Yes
    		 32 22 54
        No
    		 119 126 245
    Type of surgery - Ascendant aorta surgery
    Units: Subjects
        Yes
    		 15 8 23
        No
    		 136 140 276
    Type of surgery - Tricuspid valvuloplasty
    Units: Subjects
        Yes
    		 9 1 10
        No
    		 142 147 289
    Body mass index (BMI)
    Units: kilogram(s)/square metre
        median (inter-quartile range (Q1-Q3))
    		 25.6 (23.6 to 29.4) 25.9 (23.8 to 29.3) -
    Preoperative Left Ventricular Ejection Fraction (LVEF)
    Units: percent
        arithmetic mean (standard deviation)
    		 64.9 ( 7.5 ) 64.1 ( 7.8 ) -
    Euroscore 2
    Units: percent
        arithmetic mean (standard deviation)
    		 1.5 ( 1.2 ) 1.26 ( 0.9 ) -
    Aortic-cross clamping time
    Units: minute
        median (inter-quartile range (Q1-Q3))
    		 61 (48 to 72) 60.5 (46 to 71) -
    Cardiopulmonary bypass time
    Units: minute
        median (inter-quartile range (Q1-Q3))
    		 77 (60 to 101) 73.5 (58 to 87) -

    End points

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    End points reporting groups
    Reporting group title
    Naloxegol
    Reporting group description
    		 One naloxegol 12.5 mg tablet will be administrated 2 hours before surgery. One 25 mg naloxegol tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.

    Reporting group title
    Placebo
    Reporting group description
    		 One inert tablet will be administrated 2 hours before surgery. One inert tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.
    Reporting group title
    Naloxegol
    Reporting group description
    		 One naloxegol 12.5 mg tablet will be administrated 2 hours before surgery. One 25 mg naloxegol tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.

    Reporting group title
    Placebo
    Reporting group description
    		 One inert tablet will be administrated 2 hours before surgery. One inert tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.
    Reporting group title
    Naloxegol
    Reporting group description
    		 One naloxegol 12.5 mg tablet will be administrated 2 hours before surgery. One 25 mg naloxegol tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.

    Reporting group title
    Placebo
    Reporting group description
    		 One inert tablet will be administrated 2 hours before surgery. One inert tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.

    Primary: Transit recovery

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    End point title
    		 Transit recovery
    End point description
    The primary endpoint was the time of postoperative gastrointestinal transit recovery after the cardiac surgery defined as the time interval in hours between the anesthetic induction and the emission of the first significant stool.
    End point type
    Primary
    End point timeframe
    30 days
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: Hours
        median (inter-quartile range (Q1-Q3))
    76 (69.3 to 93.5)
    78.3 (70.0 to 95.8)
    Statistical analysis title
    		 Primary outcome - Mann - Whitney U test
    Comparison groups
    Naloxegol v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Evaluation of pain with post operative opioid consumption

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    End point title
    		 Evaluation of pain with post operative opioid consumption
    End point description
    Evaluation of pain with post operative opioid consumption in equivalent morphine in milligram.
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: milligram(s)
        median (inter-quartile range (Q1-Q3))
    778 (596 to 941)
    758 (618 to 945)
    Statistical analysis title
    		 Opioid consumption - Mann - Whitney U test
    Comparison groups
    Naloxegol v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.69
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Evaluation of pain with EVA at day 1

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    End point title
    		 Evaluation of pain with EVA at day 1
    End point description
    Evaluation of pain with visual analogue scale (VAS) at day 1. Pain VAS visual analogue scale ranging from 0 to 10 (0=no pain, 10=worst possible pain).
    End point type
    Secondary
    End point timeframe
    1 days post-surgery
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: No unit
        median (inter-quartile range (Q1-Q3))
    2 (1 to 3)
    2 (1 to 3)
    Statistical analysis title
    		 Pain score D1 - Mann Whitney test
    Comparison groups
    Naloxegol v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.83
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Evaluation of pain with EVA at day 2

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    End point title
    		 Evaluation of pain with EVA at day 2
    End point description
    Evaluation of pain with visual analogue scale (VAS) at day 2. Pain VAS visual analogue scale ranging from 0 to 10 (0=no pain, 10=worst possible pain).
    End point type
    Secondary
    End point timeframe
    2 days post surgery
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: No unit
        median (inter-quartile range (Q1-Q3))
    1 (0 to 1)
    1 (0 to 2)
    Statistical analysis title
    		 Pain score D2 - Mann Whitney test
    Comparison groups
    Naloxegol v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.08
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Evaluation of pain with EVA at day 3

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    End point title
    		 Evaluation of pain with EVA at day 3
    End point description
    Evaluation of pain with visual analogue scale (VAS) at day 3. Pain VAS visual analogue scale ranging from 0 to 10 (0=no pain, 10=worst possible pain).
    End point type
    Secondary
    End point timeframe
    3 days post surgery
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: No unit
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 1)
    Statistical analysis title
    		 Pain score D3 - Mann Whitney test
    Comparison groups
    Naloxegol v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.48
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Duration of hospital stay

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    End point title
    		 Duration of hospital stay
    End point description
    Duration of hospital stay.
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: day
        median (inter-quartile range (Q1-Q3))
    12 (11 to 15)
    12 (10 to 14)
    Statistical analysis title
    		 Duration of hospital stay -Mann-Whitney test
    Comparison groups
    Naloxegol v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.42
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Duration of ICU stay

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    End point title
    		 Duration of ICU stay
    End point description
    Duration of ICU stay.
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: day
        median (inter-quartile range (Q1-Q3))
    4 (2 to 6)
    3 (2 to 5)
    Statistical analysis title
    		 Duration of ICU stay - Mann - Whitney test
    Comparison groups
    Naloxegol v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.17
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Digestive complications - PIA day 1

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    End point title
    		 Digestive complications - PIA day 1
    End point description
    Digestive complications defined as intra-abdominal pressure at day 1.
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: centimetreH20
        median (inter-quartile range (Q1-Q3))
    5 (4 to 7)
    6 (4 to 8)
    Statistical analysis title
    		 Digestive complications - PIA Day 1 - Mann Whitney
    Comparison groups
    Naloxegol v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.41
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Digestive complications - PIA day 2

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    End point title
    		 Digestive complications - PIA day 2
    End point description
    Digestive complications defined as intra-abdominal pressure at day 2.
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: centimetreH2O
        median (inter-quartile range (Q1-Q3))
    7 (5 to 9)
    7 (5 to 10)
    Statistical analysis title
    		 Digestive complication - PIA Day 2 - Mann Whitney
    Comparison groups
    Naloxegol v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.65
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Digestive complications - Post operative gastric tube

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    End point title
    		 Digestive complications - Post operative gastric tube
    End point description
    Digestive complications defined as number of patients who require temporary nasogastric tube.
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: Number of patients
    18
    14
    Statistical analysis title
    		 Digestive complications - Gastric tube - Fisher
    Comparison groups
    Naloxegol v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.58
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Digestive complications - Vomiting

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    End point title
    		 Digestive complications - Vomiting
    End point description
    Digestive complications defined as number of patients with episode of vomiting.
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: Number of patients
    5
    12
    Statistical analysis title
    		 Digestive complication - Vomiting - Fisher
    Comparison groups
    Naloxegol v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.08
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Digestive complications - Ogilvie syndrome

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    End point title
    		 Digestive complications - Ogilvie syndrome
    End point description
    Digestive complications defined as number of patients with Ogilvie syndrome.
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: Number of patients
    0
    0
    No statistical analyses for this end point

    Secondary: Digestive complications - Mesenteric ischemia

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    End point title
    		 Digestive complications - Mesenteric ischemia
    End point description
    Digestive complications defined as number of patients with mesenteric ischemia.
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: Number of patients
    0
    0
    No statistical analyses for this end point

    Secondary: Digestive complications - Need of colonoscopy

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    End point title
    		 Digestive complications - Need of colonoscopy
    End point description
    Digestive complications defined as number of patients with need of colonoscopy.
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: Number of patients
    0
    2
    Statistical analysis title
    		 Digestive complication - Colonoscopy - Fisher
    Comparison groups
    Naloxegol v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.24
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Digestive complications - Solid food intolerance at day 2

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    End point title
    		 Digestive complications - Solid food intolerance at day 2
    End point description
    Digestive complications defined as number of patients with solid food intolerance at day 2.
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: Number of patients
    21
    24
    Statistical analysis title
    		 Digestive complication - Food intolerance - Fisher
    Comparison groups
    Placebo v Naloxegol
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.28
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Respiratory complications - Pneumonia

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    End point title
    		 Respiratory complications - Pneumonia
    End point description
    Respiratory complications defined as number of patients with pneumonia.
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: Number of patients
    7
    9
    Statistical analysis title
    		 Respiratory complications - Pneumonia - Fisher
    Comparison groups
    Naloxegol v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.62
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Respiratory complications - Reintubation

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    End point title
    		 Respiratory complications - Reintubation
    End point description
    Respiratory complications defined as number of patients with reintubation for respiratory failure.
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: Number of patients
    3
    4
    Statistical analysis title
    		 Respiratory complications - Reintubation - Fisher
    Comparison groups
    Naloxegol v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.72
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Respiratory complications - Invasive or not invasive ventilation at day 2

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    End point title
    		 Respiratory complications - Invasive or not invasive ventilation at day 2
    End point description
    Respiratory complications defined as number of patients with invasive or not invasive ventilation at day 2.
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: Number of patients
    3
    1
    Statistical analysis title
    		 Respiratory complications-Ventilation D2-Fisher
    Comparison groups
    Naloxegol v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.62
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Respiratory complications -Invasive ventilation

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    End point title
    		 Respiratory complications -Invasive ventilation
    End point description
    Respiratory complications defined as duration of invasive ventilation.
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: Hours
        median (inter-quartile range (Q1-Q3))
    3 (2 to 4)
    2.5 (2 to 4)
    Statistical analysis title
    		 Invasive ventilation - Mann Whitney
    Comparison groups
    Naloxegol v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.34
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Respiratory complications - Non invasive ventilation

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    End point title
    		 Respiratory complications - Non invasive ventilation
    End point description
    Respiratory complications defined as duration of non invasive ventilation.
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: Hours
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Infection complications - Sepsis

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    End point title
    		 Infection complications - Sepsis
    End point description
    Infection complications defined as number of patients with sepsis.
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: Number of patients
    0
    0
    No statistical analyses for this end point

    Secondary: Infection complications-Wound infection

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    End point title
    		 Infection complications-Wound infection
    End point description
    Infection complications defined as number of patients with sternal wound infection.
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Naloxegol Placebo
    Number of subjects analysed
    151
    148
    Units: Number of patients
    1
    2
    Statistical analysis title
    		 Infection complication - Sternal wound infection
    Comparison groups
    Naloxegol v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.62
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From time of inclusion to 30 days after surgery.
    Adverse event reporting additional description
    All adverse events were evaluated and followed-up by all the investigator for all patients treated (number of patients 301).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Naloxegol
    Reporting group description
    		 One naloxegol 12.5 mg tablet will be administrated 2 hours before surgery. One 25 mg naloxegol tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.

    Reporting group title
    Placebo
    Reporting group description
    		 One inert tablet will be administrated 2 hours before surgery. One inert tablet per day will be administrated from 24h post-surgery until bowel movement; formaximum 5 days.

    Serious adverse events
    		 Naloxegol Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    66 / 151 (43.71%)
    56 / 150 (37.33%)
         number of deaths (all causes)
    1
    2
         number of deaths resulting from adverse events
    1
    2
    Vascular disorders
    Haemorrhage
         subjects affected / exposed
    9 / 151 (5.96%)
    3 / 150 (2.00%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    9 / 151 (5.96%)
    5 / 150 (3.33%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    0 / 151 (0.00%)
    2 / 150 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cardiac pacemaker insertion
         subjects affected / exposed
    2 / 151 (1.32%)
    2 / 150 (1.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardioversion
         subjects affected / exposed
    3 / 151 (1.99%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac ablation
         subjects affected / exposed
    1 / 151 (0.66%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial drainage
         subjects affected / exposed
    2 / 151 (1.32%)
    6 / 150 (4.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial septal defect repair
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheostomy
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interventional procedure
         subjects affected / exposed
    3 / 151 (1.99%)
    5 / 150 (3.33%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hospitalisation
         subjects affected / exposed
    1 / 151 (0.66%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Organ failure
         subjects affected / exposed
    21 / 151 (13.91%)
    14 / 150 (9.33%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 151 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    2 / 151 (1.32%)
    2 / 150 (1.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 151 (0.00%)
    3 / 150 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diaphragmatic disorder
         subjects affected / exposed
    1 / 151 (0.66%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinal effusion
         subjects affected / exposed
    0 / 151 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    2 / 151 (1.32%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Anaemia
         subjects affected / exposed
    1 / 151 (0.66%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International normalised ratio abnormal
         subjects affected / exposed
    0 / 151 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    2 / 151 (1.32%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasoplegia syndrome
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Ventricular arrhythmia
         subjects affected / exposed
    4 / 151 (2.65%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 151 (1.32%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    7 / 151 (4.64%)
    3 / 150 (2.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 151 (0.66%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infarction
         subjects affected / exposed
    0 / 151 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    0 / 151 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 151 (0.66%)
    3 / 150 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    1 / 151 (0.66%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral perforation
         subjects affected / exposed
    0 / 151 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ventricular fibrillation
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    3 / 151 (1.99%)
    2 / 150 (1.33%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 151 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium tremens
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Speech disorder
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonic clonic movements
         subjects affected / exposed
    0 / 151 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    2 / 151 (1.32%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Faecaloma
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 151 (0.66%)
    2 / 150 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    2 / 151 (1.32%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis haemorrhagic
         subjects affected / exposed
    1 / 151 (0.66%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecal vomiting
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal polyp
         subjects affected / exposed
    0 / 151 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 151 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    1 / 151 (0.66%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 151 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 151 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cytolysis
         subjects affected / exposed
    6 / 151 (3.97%)
    8 / 150 (5.33%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    3 / 151 (1.99%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    8 / 151 (5.30%)
    13 / 150 (8.67%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 151 (0.66%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 151 (1.32%)
    2 / 150 (1.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 151 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asymptomatic COVID-19
         subjects affected / exposed
    4 / 151 (2.65%)
    2 / 150 (1.33%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    2 / 151 (1.32%)
    2 / 150 (1.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 151 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Naloxegol Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    94 / 151 (62.25%)
    75 / 150 (50.00%)
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    32 / 151 (21.19%)
    32 / 150 (21.33%)
         occurrences all number
    32
    32
    Pericardial effusion
         subjects affected / exposed
    30 / 151 (19.87%)
    10 / 150 (6.67%)
         occurrences all number
    30
    10
    Bundle branch block right
         subjects affected / exposed
    2 / 151 (1.32%)
    1 / 150 (0.67%)
         occurrences all number
    2
    1
    Bradycardia
         subjects affected / exposed
    1 / 151 (0.66%)
    3 / 150 (2.00%)
         occurrences all number
    1
    3
    Atrioventricular block first degree
         subjects affected / exposed
    5 / 151 (3.31%)
    1 / 150 (0.67%)
         occurrences all number
    5
    1
    Atrial flutter
         subjects affected / exposed
    0 / 151 (0.00%)
    3 / 150 (2.00%)
         occurrences all number
    0
    3
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    5 / 151 (3.31%)
    5 / 150 (3.33%)
         occurrences all number
    5
    5
    Gastrointestinal disorders
    Impaired gastric emptying
         subjects affected / exposed
    4 / 151 (2.65%)
    0 / 150 (0.00%)
         occurrences all number
    4
    0
    Constipation
         subjects affected / exposed
    4 / 151 (2.65%)
    1 / 150 (0.67%)
         occurrences all number
    4
    1
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    3 / 151 (1.99%)
    1 / 150 (0.67%)
         occurrences all number
    3
    1
    Diaphragmatic disorder
         subjects affected / exposed
    7 / 151 (4.64%)
    4 / 150 (2.67%)
         occurrences all number
    7
    4
    Bronchial disorder
         subjects affected / exposed
    1 / 151 (0.66%)
    2 / 150 (1.33%)
         occurrences all number
    1
    2
    Hepatobiliary disorders
    Hepatic cytolysis
         subjects affected / exposed
    2 / 151 (1.32%)
    1 / 150 (0.67%)
         occurrences all number
    2
    1
    Cholestasis
         subjects affected / exposed
    1 / 151 (0.66%)
    4 / 150 (2.67%)
         occurrences all number
    1
    4
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    3 / 151 (1.99%)
    1 / 150 (0.67%)
         occurrences all number
    3
    1
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    10 / 151 (6.62%)
    6 / 150 (4.00%)
         occurrences all number
    10
    6
    Renal failure
         subjects affected / exposed
    2 / 151 (1.32%)
    2 / 150 (1.33%)
         occurrences all number
    2
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 151 (1.99%)
    1 / 150 (0.67%)
         occurrences all number
    3
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 151 (1.32%)
    1 / 150 (0.67%)
         occurrences all number
    2
    1
    Enterobacter infection
         subjects affected / exposed
    2 / 151 (1.32%)
    3 / 150 (2.00%)
         occurrences all number
    2
    3
    Metabolism and nutrition disorders
    Oedema peripheral
         subjects affected / exposed
    4 / 151 (2.65%)
    1 / 150 (0.67%)
         occurrences all number
    4
    1

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    We performed a modified intention-to-treat analysis on the baseline characteristics and on primary/secondary endpoints for all patients treated and patients with primary endpoint. Adverse event was analyzed for all patients treated.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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