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    Clinical Trial Results:
    Effects of postoperative palonosetron in ambulatory patients identified with high risk for postdischarge nausea and vomiting (PDNV) – a randomized controlled trial with comparison to placebo.

    Summary
    EudraCT number
    		 2015-003956-32
    Trial protocol
    		 SE  
    Global end of trial date
    10 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jun 2023
    First version publication date
    15 Jun 2023
    Other versions
    Summary report(s)
    		 Delayed results

    Trial information

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    Trial identification
    Sponsor protocol code
    POSTPAL
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Umeå University
    Sponsor organisation address
    x, Umeå, Sweden,
    Public contact
    Jakob Wallden, Umeå University, jakob.wallden@umu.se
    Scientific contact
    Jakob Wallden, Umeå University, +46 703644392, jakob.wallden@umu.se
    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
    15 Nov 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Apr 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate if palonosetron (compared to placebo) could reduce the incidence of postdischarge nausea and vomiting (PDNV) in patients with high risk for PDNV in ambulatory surgery. In the high-risk group incidences of 40-50% are reported and a reduction in PDNV of 50% during the first 48 hours is clinically relevant.
    Protection of trial subjects
    The study was conducted in compliance with the declarations of Helsinki and ICH guidelines, as well as regulations and laws in Sweden. The study was approved by the Ethical review board in Sweden and patients gave informed and written consent to participate.
    Background therapy
    		 Standard postoperative care including multimodal analgesia.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 May 2016
    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
    Sweden: 524
    Worldwide total number of subjects
    524
    EEA total number of subjects
    524
    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)
    412
    From 65 to 84 years
    112
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited at two study sites in Sweden, Sundsvall Hospital, Sundvall and Sunderby Hospital, Luleå. Inclusion period was 2017/03/13 to 2020/04/10

    Pre-assignment
    Screening details
    		 Patients were first screened for inclusion BEFORE the surgical procedure/anesthesia. Patients needed to be included before surgery/anaesthesia as information and consent not can be provided in an immediate postoperative setting. Final inclusion in the interventional randomized part of the study depended on the PDNV-score post.

    Pre-assignment period milestones
    Number of subjects started
    		 524
    Number of subjects completed
    		 170

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 No resources to randomize (if PDNV3-5): 8
    Reason: Number of subjects
    		 Wrong PDNV-classification: 2
    Reason: Number of subjects
    		 Low risk for PDNV: 344
    Period 1
    Period 1 title
    Randomisation of patients with high risk (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Palonosetron
    Arm description
    		 Singel dose of Palonosetron 75µg intravenous before discharge to home
    Arm type
    		 Experimental

    Investigational medicinal product name
    Palonosetron
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Palonosetron 75µg intravenous

    Arm title
    		 Placebo
    Arm description
    		 Placebo Sodium Cloride 9mg/mL, 1,5 mL
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Injection
    Dosage and administration details
    1.5 ML SodiumCloride 9mg/mL

    Number of subjects in period 1 [1]
    		Palonosetron Placebo
    Started
    84
    86
    Completed
    66
    70
    Not completed
    18
    16
         Lost to follow-up
    18
    16
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The inclusion in the RCT-part was a two-step procedure. Preopertively, a broad range of patients were included and gave consent to be included in the RCT, if the PNDV score was >3 at the evaluation before discharge. Of 559 patients included, 170 was randomized.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Palonosetron
    Reporting group description
    		 Singel dose of Palonosetron 75µg intravenous before discharge to home

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo Sodium Cloride 9mg/mL, 1,5 mL

    Reporting group values
    		 Palonosetron Placebo Total
    Number of subjects
    		 84 86 170
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 42.0 (18.3 to 79.1) 39.8 (18.5 to 82.1) -
    Gender categorical
    Units: Subjects
        Female
    		 74 76 150
        Male
    		 10 10 20
    Smokers
    Smokers
    Units: Subjects
        Yes
    		 11 6 17
        No
    		 73 80 153
    ASA
    ASA physical status classification
    Units: Subjects
        Class 1
    		 48 44 92
        Class 2 or 3
    		 36 42 78
    History of motion sickness
    Units: Subjects
        Yes
    		 43 46 89
        No
    		 41 40 81
    Type of procedure
    Units: Subjects
        General Surgery
    		 44 39 83
        Orthopaedics
    		 16 17 33
        Urology
    		 2 2 4
        Gynaecology
    		 15 18 33
        ENT
    		 6 10 16
        Ophtalmic
    		 1 0 1
    History of PONV
    Units: Subjects
        Yes
    		 40 48 88
        No
    		 44 38 82
    Maintenance of anaesthesia
    Units: Subjects
        Volatile
    		 52 55 107
        Intravenous
    		 32 30 62
        Missing
    		 0 1 1
    Number of antiemetic prophylaxis
    Units: Subjects
        One
    		 13 13 26
        Two
    		 53 48 101
        Three
    		 18 25 43
    Nausea in PACU
    Units: Subjects
        yes
    		 33 39 72
        no
    		 51 47 98
    Rescue opioids at PACU
    Units: Subjects
        Yes
    		 65 57 122
        No
    		 19 29 48
    PDNV-score before discharge
    Units: Subjects
        PDNV 3
    		 55 65 120
        PDNV 4
    		 25 17 42
        PDNV 5
    		 4 4 8
    Trial site
    Units: Subjects
        Sundsvall
    		 77 80 157
        Sunderbyn
    		 7 6 13
    BMI
    Body Mass Index
    Units: kg m-1
        median (full range (min-max))
    		 25.9 (19.5 to 42.8) 26.6 (15.6 to 41.2) -
    Duration procedure
    Surgical duration "knife to last suture"
    Units: minutes
        median (full range (min-max))
    		 58 (7 to 161) 48 (4 to 201) -
    Subject analysis sets

    Subject analysis set title
    Analysed Palonosetron
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects included in analysis randomized to Palonosetron

    Subject analysis set title
    Analysed Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Analysed patients in the placebo group

    Subject analysis sets values
    		 Analysed Palonosetron Analysed Placebo
    Number of subjects
    66
    70
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (full range (min-max))
    42.1 (18.5 to 82.1)
    45.3 (18.3 to 79.1)
    Gender categorical
    Units: Subjects
        Female
    59
    64
        Male
    7
    6
    Smokers
    Smokers
    Units: Subjects
        Yes
    7
    5
        No
    59
    65
    ASA
    ASA physical status classification
    Units: Subjects
        Class 1
    39
    35
        Class 2 or 3
    27
    35
    History of motion sickness
    Units: Subjects
        Yes
    35
    38
        No
    31
    32
    Type of procedure
    Units: Subjects
        General Surgery
    36
    30
        Orthopaedics
    13
    15
        Urology
    1
    2
        Gynaecology
    11
    15
        ENT
    4
    8
        Ophtalmic
    1
    0
    History of PONV
    Units: Subjects
        Yes
    35
    38
        No
    31
    32
    Maintenance of anaesthesia
    Units: Subjects
        Volatile
    26
    26
        Intravenous
    40
    43
        Missing
    0
    1
    Number of antiemetic prophylaxis
    Units: Subjects
        One
    9
    9
        Two
    43
    41
        Three
    14
    20
    Nausea in PACU
    Units: Subjects
        yes
    24
    29
        no
    44
    41
    Rescue opioids at PACU
    Units: Subjects
        Yes
    50
    49
        No
    16
    21
    PDNV-score before discharge
    Units: Subjects
        PDNV 3
    46
    54
        PDNV 4
    18
    13
        PDNV 5
    2
    3
    Trial site
    Units: Subjects
        Sundsvall
    60
    65
        Sunderbyn
    6
    5
    BMI
    Body Mass Index
    Units: kg m-1
        median (full range (min-max))
    25.6 (19.5 to 42.8)
    26.5 (15.6 to 41.2)
    Duration procedure
    Surgical duration "knife to last suture"
    Units: minutes
        median (full range (min-max))
    50 (7 to 161)
    49 (4 to 201)

    End points

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    End points reporting groups
    Reporting group title
    Palonosetron
    Reporting group description
    		 Singel dose of Palonosetron 75µg intravenous before discharge to home

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo Sodium Cloride 9mg/mL, 1,5 mL

    Subject analysis set title
    Analysed Palonosetron
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects included in analysis randomized to Palonosetron

    Subject analysis set title
    Analysed Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Analysed patients in the placebo group

    Primary: Complete response

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    End point title
    		 Complete response
    End point description
    Number of patients with no events of nausea, no events of vomit and not taking any rescue antiemetics
    End point type
    Primary
    End point timeframe
    Discharge from ambulatory surgery until the second postoperative day (POD2)
    End point values
    		 Analysed Palonosetron Analysed Placebo
    Number of subjects analysed
    66
    70
    Units: Number of patients
        Yes
    32
    25
    Statistical analysis title
    		 Complete response
    Statistical analysis description
    Primary analysis
    Comparison groups
    Analysed Palonosetron v Analysed Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.131
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 3.37

    Secondary: PDNV POD0

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    End point title
    		 PDNV POD0
    End point description
    Patients reporting nausea or vomit
    End point type
    Secondary
    End point timeframe
    On the day of procedure, after discharge
    End point values
    		 Analysed Palonosetron Analysed Placebo
    Number of subjects analysed
    66
    70
    Units: Number of patients
        Yes
    31
    39
    Statistical analysis title
    		 PNDV POD0
    Comparison groups
    Analysed Palonosetron v Analysed Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.181
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.36
         upper limit
    		 1.38

    Secondary: PDNV POD1

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    End point title
    		 PDNV POD1
    End point description
    Patients reporting nausea or vomit
    End point type
    Secondary
    End point timeframe
    On postoperative day 1 (POD1)
    End point values
    		 Analysed Palonosetron Analysed Placebo
    Number of subjects analysed
    66
    70
    Units: Number of patients
        Yes
    12
    24
    Statistical analysis title
    		 PDNV POD1
    Comparison groups
    Analysed Palonosetron v Analysed Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.033
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.19
         upper limit
    		 0.94

    Secondary: PDNV POD2

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    End point title
    		 PDNV POD2
    End point description
    Patients reporting nausea or vomit
    End point type
    Secondary
    End point timeframe
    On postoperative day 2 (POD2)
    End point values
    		 Analysed Palonosetron Analysed Placebo
    Number of subjects analysed
    66
    70
    Units: Number of patients
        Yes
    6
    19
    Statistical analysis title
    		 PDNV POD2
    Comparison groups
    Analysed Palonosetron v Analysed Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.007
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 0.94

    Secondary: PDNV POD3

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    End point title
    		 PDNV POD3
    End point description
    Patients reporting nausea or vomit
    End point type
    Secondary
    End point timeframe
    On postoperative day 3 (POD3)
    End point values
    		 Analysed Palonosetron Analysed Placebo
    Number of subjects analysed
    66
    70
    Units: Numer of patients
        Yes
    10
    9
    Statistical analysis title
    		 PDNV POD3
    Comparison groups
    Analysed Palonosetron v Analysed Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 1.21
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 3.2

    Secondary: PDNV POD1-POD2

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    End point title
    		 PDNV POD1-POD2
    End point description
    Patients reporting nausea or vomit
    End point type
    Secondary
    End point timeframe
    On the first and second postoperative days
    End point values
    		 Analysed Palonosetron Analysed Placebo
    Number of subjects analysed
    66
    70
    Units: Number of patients
        Yes
    12
    27
    Statistical analysis title
    		 PDNV POD1-2
    Comparison groups
    Analysed Palonosetron v Analysed Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.009
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.16
         upper limit
    		 0.78

    Secondary: Rescue Antiemetics POD0

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    End point title
    		 Rescue Antiemetics POD0
    End point description
    Patients taken rescue antiemetics
    End point type
    Secondary
    End point timeframe
    Day of surgery, after discharge
    End point values
    		 Analysed Palonosetron Analysed Placebo
    Number of subjects analysed
    66
    70
    Units: Number of patients
        Yes
    17
    21
    Statistical analysis title
    		 Rescue POD0
    Comparison groups
    Analysed Palonosetron v Analysed Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.582
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 1.72

    Secondary: Rescue Antiemetics POD1

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    End point title
    		 Rescue Antiemetics POD1
    End point description
    Patients taken rescue antiemetics
    End point type
    Secondary
    End point timeframe
    Postoperative day 1 (POD1)
    End point values
    		 Analysed Palonosetron Analysed Placebo
    Number of subjects analysed
    66
    70
    Units: Number of patients
        yes
    7
    15
    Statistical analysis title
    		 Rescue POD1
    Comparison groups
    Analysed Palonosetron v Analysed Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.087
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.16
         upper limit
    		 1.15

    Secondary: Rescue Antiemetics POD2

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    End point title
    		 Rescue Antiemetics POD2
    End point description
    End point type
    Secondary
    End point timeframe
    On the second postoperative day (POD2)
    End point values
    		 Analysed Palonosetron Analysed Placebo
    Number of subjects analysed
    66
    70
    Units: Number of patients
        yes
    2
    10
    Statistical analysis title
    		 Rescue POD2
    Comparison groups
    Analysed Palonosetron v Analysed Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.021
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.04
         upper limit
    		 0.89

    Secondary: Rescue antiemetics POD3

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    End point title
    		 Rescue antiemetics POD3
    End point description
    End point type
    Secondary
    End point timeframe
    On the third postoperative day (POD3)
    End point values
    		 Analysed Palonosetron Analysed Placebo
    Number of subjects analysed
    66
    70
    Units: Member of patients
        yes
    2
    5
    Statistical analysis title
    		 REscue POD3
    Comparison groups
    Analysed Palonosetron v Analysed Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.278
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.08
         upper limit
    		 2.17

    Secondary: Rescue antiemetics POD1-POD2

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    End point title
    		 Rescue antiemetics POD1-POD2
    End point description
    End point type
    Secondary
    End point timeframe
    On postoperative day 1 and 2 (POD1-POD2)
    End point values
    		 Analysed Palonosetron Analysed Placebo
    Number of subjects analysed
    66
    70
    Units: Number of patients
        yes
    8
    17
    Statistical analysis title
    		 Rescue POD1-2
    Comparison groups
    Analysed Placebo v Analysed Palonosetron
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.067
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.17
         upper limit
    		 1.08

    Other pre-specified: Headache

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    End point title
    		 Headache
    End point description
    Patients reporting headache
    End point type
    Other pre-specified
    End point timeframe
    From discharge to postoperative day 3
    End point values
    		 Analysed Palonosetron Analysed Placebo
    Number of subjects analysed
    66
    70
    Units: Number of patients
        yes
    25
    24
    Statistical analysis title
    		 Headache
    Comparison groups
    Analysed Palonosetron v Analysed Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.66
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 5.36

    Other pre-specified: Visual disturbances POD0-POD3

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    End point title
    		 Visual disturbances POD0-POD3
    End point description
    Patients reporting visual disturbances
    End point type
    Other pre-specified
    End point timeframe
    Discharge to postoperative day 3
    End point values
    		 Analysed Palonosetron Analysed Placebo
    Number of subjects analysed
    66
    70
    Units: Number of patients
        yes
    14
    8
    Statistical analysis title
    		 Visual dist
    Comparison groups
    Analysed Palonosetron v Analysed Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.12
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 5.36

    Other pre-specified: Sleeping difficulties POD0-POD1

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    End point title
    		 Sleeping difficulties POD0-POD1
    End point description
    Patients reporting sleeping difficulties
    End point type
    Other pre-specified
    End point timeframe
    From discharge until postoperative day 3
    End point values
    		 Analysed Palonosetron Analysed Placebo
    Number of subjects analysed
    66
    70
    Units: Number of patients
        yes
    32
    31
    Statistical analysis title
    		 Sleepingdiff
    Comparison groups
    Analysed Palonosetron v Analysed Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.62
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 2.33

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Until postoperative day 30
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    SWE 221130
    Reporting groups
    Reporting group title
    Palonosetron
    Reporting group description
    		 The groups that received the intervention in the trial

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Palonosetron Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 86 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Palonosetron Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 84 (3.57%)
    3 / 86 (3.49%)
    Surgical and medical procedures
    Postoperative bleeding
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 86 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Bradycardia
    Additional description: transient bradycardia (lowest heart rate 38 beats/min) immediately after administration of the study drug in a subject with a baseline heart rate of 50 beats min/m
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    Immune system disorders
    Allergic reaction
    Additional description: Allergic reaction that required a visit to the emergency department on POD1
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    hiccoughs
    Additional description: on POD6
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 86 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Postoperative retention of urine
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 86 (1.16%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Backache
    Additional description: Back pain on POD5
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 86 (0.00%)
         occurrences all number
    1
    0

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/37246062
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