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    Clinical Trial Results:
    A phase 3, single-dose, multicenter, randomized, double-blind, parallel group study to assess the efficacy and safety of palonosetron 0.25 mg administered as a 30-minute IV infusion compared to palonosetron 0.25 mg administered as a 30-second IV bolus for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving highly emetogenic chemotherapy.

    Summary
    EudraCT number
    		 2015-001747-37
    Trial protocol
    		 HU   LT   GR  
    Global end of trial date
    09 Mar 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Dec 2017
    First version publication date
    02 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PALO-15-17
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02557035
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Helsinn Healthcare SA
    Sponsor organisation address
    Via Pian Scairolo 9, Lugano, Switzerland, 6912
    Public contact
    Clinical Operation, Helsinn Healthcare SA, +41 91 985 21 21, daniel.voisin@helsinn.com
    Scientific contact
    Clinical Operation, Helsinn Healthcare SA, +41 91 985 21 21, daniel.voisin@helsinn.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
    09 Mar 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Mar 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of a single intravenous dose of palonosetron 0.25 mg administered as a 30-minute infusion with oral dexamethasone versus a single intravenous dose of palonosetron 0.25 mg administered as a 30-second bolus with oral dexamethasone, in terms of proportion of patients with complete response in the acute phase (0-24 hour after start of reference HEC)
    Protection of trial subjects
    This study was in compliance with the ethical principles founded in the Declaration of Helsinki, the International Conference on Harmonisation (ICH) guidelines regarding Good Clinical Practices and the European Union Directives on Clinical Trials. The appropriateness of the clinical trial protocol, as well as the risks and benefits to study participants, were reviewed and approved by the Institutional Review Board (IRB).
    Background therapy
    		 Oral dexamethasone
    Evidence for comparator
    		 Palonosetron 0.25 mg administered as a 30-second IV bolus was approved in Europe in March 2005 for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy. Since 0.25 mg palonosetron efficacy has been demonstrated when administered as a 30-second bolus injection, the scope of the present study is to demonstrate efficacy (non-inferiority) of palonosetron 0.25 also when administered as a 30-minute infusion.
    Actual start date of recruitment
    30 Sep 2015
    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
    Romania: 91
    Country: Number of subjects enrolled
    Bulgaria: 38
    Country: Number of subjects enrolled
    Greece: 14
    Country: Number of subjects enrolled
    Hungary: 98
    Country: Number of subjects enrolled
    Lithuania: 4
    Country: Number of subjects enrolled
    Russian Federation: 134
    Country: Number of subjects enrolled
    Georgia: 42
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 5
    Country: Number of subjects enrolled
    Belarus: 15
    Worldwide total number of subjects
    441
    EEA total number of subjects
    245
    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)
    314
    From 65 to 84 years
    127
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study population consisted of adult (≥18 years of age) chemotherapy-naїve male and female patients with a diagnosis of malignant solid tumor requiring a first treatment with one of the protocol pre-defined reference highly emetogenic chemotherapy (HEC) regimens.

    Pre-assignment
    Screening details
    		 All patients who have met the inclusion and exclusion criteria were randomized into one of the two treatment groups. Of the 441 subjects randomized, 440 received a study drug.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Carer, Assessor, Subject
    Blinding implementation details
    The blinding of the study medications is guaranteed by the use of identical placebos to the respective active drugs (double-dummy technique). When palonosetron 0.25 mg will be administered as 30-minute IV infusion, a 30-second IV bolus of placebo will be administered (Group 1). Oppositely, when palonosetron 0.25 mg is administered as a 30-second IV bolus, a 30-minute infusion of placebo will be administered (Group 2). Therefore, each patient will receive both one of which contains the active IMP

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 30-min Infusion
    Arm description
    		 Subjects in this arm received a single-dose of palonosetron 0.25 mg administered as a 30-min IV infusion with oral dexamethasone prior to highly emetogenic chemotherapy. 20 mg/day single-dose of dexamethasone was received on Day 1 then 8 mg bid on Days 2 to 4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    palonosetron 0.25 mg (as 50 mL solution for IV infusion)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Palonosetron 0.25 mg administered as a 30-minute (+/- 5 min) IV infusion on Day 1. The IV infusion will start 30 minutes prior to, and will be completed, before the start of the reference HEC administration. The compound which is held in a 5 mL vial (with strength of 0.25 mg) is diluted in 50 mL sterile 5% glucose solution per vial.

    Arm title
    		 30-sec Bolus
    Arm description
    		 Subjects in this arm received a single-dose of palonosetron 0.25 mg administered as a 30-sec IV bolus with oral dexamethasone prior to highly emetogenic chemotherapy. 20 mg/day single-dose of dexamethasone was received on Day 1 then 8 mg bid on Days 2 to 4.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Palonosetron 0.25 mg bolus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Palonosetron 0.25 mg administered as a 30-second IV bolus on Day 1. The IV bolus will be administered 30 minutes before the start of the reference HEC administration.

    Number of subjects in period 1
    		30-min Infusion 30-sec Bolus
    Started
    225
    216
    Completed
    218
    206
    Not completed
    7
    10
         Consent withdrawn by subject
    -
    2
         Death
    6
    7
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    30-min Infusion
    Reporting group description
    		 Subjects in this arm received a single-dose of palonosetron 0.25 mg administered as a 30-min IV infusion with oral dexamethasone prior to highly emetogenic chemotherapy. 20 mg/day single-dose of dexamethasone was received on Day 1 then 8 mg bid on Days 2 to 4.

    Reporting group title
    30-sec Bolus
    Reporting group description
    		 Subjects in this arm received a single-dose of palonosetron 0.25 mg administered as a 30-sec IV bolus with oral dexamethasone prior to highly emetogenic chemotherapy. 20 mg/day single-dose of dexamethasone was received on Day 1 then 8 mg bid on Days 2 to 4.

    Reporting group values
    		 30-min Infusion 30-sec Bolus Total
    Number of subjects
    		 225 216 441
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 156 157 313
        From 65-84 years
    		 69 59 128
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.9 ± 8.7 58.9 ± 8.5 -
    Gender categorical
    Units: Subjects
        Female
    		 74 71 145
        Male
    		 151 145 296
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set: 30-min Infusion
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) was to include all patients who had been randomized to treatment and received HEC regimen and active study drug (including partial infusion). Following the intent-to-treat principle, patients were to be assigned to the study treatment group according to the treatment to which they had been randomized.

    Subject analysis set title
    Per Protocol Population: 30-min Infusion
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per-Protocol (PP) population was to include all patients from the FAS who had completed the 0-24 h study period with no major protocol violations, i.e., those affecting the primary efficacy endpoint. All protocol violations (e.g., wrong inclusion, poor compliance, missing diaries, forbidden concomitant medications, and mis-randomizations) were to be reviewed and discussed case by case during the BDRM and decisions were to be described in the blind data review document/minutes which were to be finalized prior to database lock.

    Subject analysis set title
    Full Analysis Set: 30-sec Bolus
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) was to include all patients who had been randomized to treatment and received HEC regimen and active study drug (including partial infusion). Following the intent-to-treat principle, patients were to be assigned to the study treatment group according to the treatment to which they had been randomized.

    Subject analysis set title
    Per Protocol Population: 30-sec Bolus
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per-Protocol (PP) population was to include all patients from the FAS who had completed the 0-24 h study period with no major protocol violations, i.e., those affecting the primary efficacy endpoint. All protocol violations (e.g., wrong inclusion, poor compliance, missing diaries, forbidden concomitant medications, and mis-randomizations) were to be reviewed and discussed case by case during the BDRM and decisions were to be described in the blind data review document/minutes which were to be finalized prior to database lock.

    Subject analysis set title
    Safety Population: 30-min Infusion
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population was to include all patients who had received active study drug (including partial infusion). Patients were to be assigned to study treatment groups according to the actual treatment received.

    Subject analysis set title
    Safety Population: 30-sec Bolus
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population was to include all patients who had received active study drug (including partial infusion). Patients were to be assigned to study treatment groups according to the actual treatment received.

    Subject analysis sets values
    		 Full Analysis Set: 30-min Infusion Per Protocol Population: 30-min Infusion Full Analysis Set: 30-sec Bolus Per Protocol Population: 30-sec Bolus Safety Population: 30-min Infusion Safety Population: 30-sec Bolus
    Number of subjects
    225
    214
    215
    211
    225
    215
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    156
    150
    157
    154
    156
    157
        From 65-84 years
    69
    64
    58
    57
    69
    58
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    59.9 ± 8.7
    59.8 ± 8.7
    58.9 ± 8.5
    58.8 ± 8.5
    59.9 ± 8.7
    58.9 ± 8.5
    Gender categorical
    Units: Subjects
        Female
    74
    71
    71
    69
    74
    71
        Male
    151
    143
    144
    142
    151
    144

    End points

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    End points reporting groups
    Reporting group title
    30-min Infusion
    Reporting group description
    		 Subjects in this arm received a single-dose of palonosetron 0.25 mg administered as a 30-min IV infusion with oral dexamethasone prior to highly emetogenic chemotherapy. 20 mg/day single-dose of dexamethasone was received on Day 1 then 8 mg bid on Days 2 to 4.

    Reporting group title
    30-sec Bolus
    Reporting group description
    		 Subjects in this arm received a single-dose of palonosetron 0.25 mg administered as a 30-sec IV bolus with oral dexamethasone prior to highly emetogenic chemotherapy. 20 mg/day single-dose of dexamethasone was received on Day 1 then 8 mg bid on Days 2 to 4.

    Subject analysis set title
    Full Analysis Set: 30-min Infusion
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) was to include all patients who had been randomized to treatment and received HEC regimen and active study drug (including partial infusion). Following the intent-to-treat principle, patients were to be assigned to the study treatment group according to the treatment to which they had been randomized.

    Subject analysis set title
    Per Protocol Population: 30-min Infusion
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per-Protocol (PP) population was to include all patients from the FAS who had completed the 0-24 h study period with no major protocol violations, i.e., those affecting the primary efficacy endpoint. All protocol violations (e.g., wrong inclusion, poor compliance, missing diaries, forbidden concomitant medications, and mis-randomizations) were to be reviewed and discussed case by case during the BDRM and decisions were to be described in the blind data review document/minutes which were to be finalized prior to database lock.

    Subject analysis set title
    Full Analysis Set: 30-sec Bolus
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) was to include all patients who had been randomized to treatment and received HEC regimen and active study drug (including partial infusion). Following the intent-to-treat principle, patients were to be assigned to the study treatment group according to the treatment to which they had been randomized.

    Subject analysis set title
    Per Protocol Population: 30-sec Bolus
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per-Protocol (PP) population was to include all patients from the FAS who had completed the 0-24 h study period with no major protocol violations, i.e., those affecting the primary efficacy endpoint. All protocol violations (e.g., wrong inclusion, poor compliance, missing diaries, forbidden concomitant medications, and mis-randomizations) were to be reviewed and discussed case by case during the BDRM and decisions were to be described in the blind data review document/minutes which were to be finalized prior to database lock.

    Subject analysis set title
    Safety Population: 30-min Infusion
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population was to include all patients who had received active study drug (including partial infusion). Patients were to be assigned to study treatment groups according to the actual treatment received.

    Subject analysis set title
    Safety Population: 30-sec Bolus
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population was to include all patients who had received active study drug (including partial infusion). Patients were to be assigned to study treatment groups according to the actual treatment received.

    Primary: Complete Response in acute phase

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    End point title
    		 Complete Response in acute phase
    End point description
    Complete response in the acute phase which is defined as the absence of chemotherapy induced nausea or vomiting 0-24 hour after start of reference highly emetogenic chemotherapy [HEC]. Confidence interval of proportions are obtained by using the Newcombe-Wilson method.
    End point type
    Primary
    End point timeframe
    Acute phase (0-24 hour)
    End point values
    		 30-min Infusion 30-sec Bolus Full Analysis Set: 30-min Infusion Per Protocol Population: 30-min Infusion Full Analysis Set: 30-sec Bolus Per Protocol Population: 30-sec Bolus
    Number of subjects analysed
    225
    215 [1]
    225
    214
    215
    211
    Units: Proportion
        number (confidence interval 95%)
    82.7 (77.2 to 87.1)
    86.5 (81.3 to 90.4)
    82.7 (77.2 to 87.1)
    82.7 (77.1 to 87.2)
    86.5 (81.3 to 90.4)
    86.3 (81 to 90.3)
    Notes
    [1] - One patient did not receive any treatment and was excluded from all analysis sets
    Statistical analysis title
    		 Primary statistical analysis (FAS)
    Statistical analysis description
    The Cochran-Mantel-Haenszel test stratified by gender and country was used to test the null hypothesis that the risk difference between 30-min Infusion and 30-sec Bolus is less than or equal to a pre-specified non-inferiority margin of -15%.
    Comparison groups
    Full Analysis Set: 30-sec Bolus v Full Analysis Set: 30-min Infusion
    Number of subjects included in analysis
    440
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -3.8
    Confidence interval
         level
    		 99%
         sides
    2-sided
         lower limit
    		 -12.2
         upper limit
    		 4.7
    Notes
    [2] - A non-inferiority margin of -15% was pre-specified. The null hypothesis was to be rejected and the non-inferiority of palonosetron 0.25 mg 30-min infusion versus palonosetron 0.25 mg 30-sec infusion demonstrated, if the lower limit of the 2-sided 99% CI for the difference in proportion of patients with CR was greater than -15%.
    Statistical analysis title
    		 Primary statistical analysis (PP Population)
    Statistical analysis description
    The Cochran-Mantel-Haenszel test stratified by gender and country was used to test the null hypothesis that the risk difference between 30-min Infusion and 30-sec Bolus is less than or equal to a pre-specified non-inferiority margin of -15%.
    Comparison groups
    Per Protocol Population: 30-min Infusion v Per Protocol Population: 30-sec Bolus
    Number of subjects included in analysis
    425
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -3.4
    Confidence interval
         level
    		 99%
         sides
    2-sided
         lower limit
    		 -12
         upper limit
    		 5.2
    Notes
    [3] - A non-inferiority margin of -15% was pre-specified. The null hypothesis was to be rejected and the non-inferiority of palonosetron 0.25 mg 30-min infusion versus palonosetron 0.25 mg 30-sec infusion demonstrated, if the lower limit of the 2-sided 99% CI for the difference in proportion of patients with CR was greater than -15%.

    Secondary: Complete Response in Delayed phase

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    End point title
    		 Complete Response in Delayed phase
    End point description
    Complete response in the delayed phase which is defined as the absence of chemotherapy induced nausea or vomiting and no rescue medication from >24 to 120 hour after start of reference highly emetogenic chemotherapy [HEC]. Confidence interval of proportions are obtained by using the Newcombe-Wilson method.
    End point type
    Secondary
    End point timeframe
    Delayed phase (>24 - 120 hour)
    End point values
    		 30-min Infusion 30-sec Bolus Full Analysis Set: 30-min Infusion Full Analysis Set: 30-sec Bolus
    Number of subjects analysed
    225
    215 [4]
    225
    215
    Units: Proportion
        number (confidence interval 95%)
    75.6 (69.5 to 80.7)
    76.7 (70.7 to 81.9)
    75.6 (69.5 to 80.7)
    76.7 (70.7 to 81.9)
    Notes
    [4] - One patient did not receive any treatment and was excluded from all analysis sets
    Statistical analysis title
    		 Complete Response Delayed phase- Analysis
    Statistical analysis description
    The Cochran-Mantel-Haenszel test stratified by gender and country was used to compare both treatment with a 2-sided 95% confidence interval. No test for non-inferiority was to be performed.
    Comparison groups
    Full Analysis Set: 30-min Infusion v Full Analysis Set: 30-sec Bolus
    Number of subjects included in analysis
    440
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.7
         upper limit
    		 6.3
    Notes
    [5] - No formal test was planned for this endpoint

    Secondary: Complete Response in Overall phase

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    End point title
    		 Complete Response in Overall phase
    End point description
    Complete response in the overall phase which is defined as the absence of chemotherapy induced nausea or vomiting and no rescue medication from 0 to 120 hour after start of reference highly emetogenic chemotherapy [HEC]. Confidence interval of proportions are obtained by using the Newcombe-Wilson method.
    End point type
    Secondary
    End point timeframe
    Overall phase (0 - 120 hour)
    End point values
    		 30-min Infusion 30-sec Bolus Full Analysis Set: 30-min Infusion Full Analysis Set: 30-sec Bolus
    Number of subjects analysed
    225
    215 [6]
    225
    215
    Units: Proportion
        number (confidence interval 95%)
    66.7 (60.3 to 72.5)
    72.6 (66.2 to 78.1)
    66.7 (60.3 to 72.5)
    72.6 (66.2 to 78.1)
    Notes
    [6] - One patient did not receive any treatment and was excluded from all analysis sets
    Statistical analysis title
    		 Complete Response Overall phase- Analysis
    Statistical analysis description
    The Cochran-Mantel-Haenszel test stratified by gender and country was used to compare both treatment with a 2-sided 95% confidence interval. No test for non-inferiority was to be performed.
    Comparison groups
    Full Analysis Set: 30-min Infusion v Full Analysis Set: 30-sec Bolus
    Number of subjects included in analysis
    440
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.1
         upper limit
    		 2.1
    Notes
    [7] - No formal test was planned for this endpoint

    Secondary: No emetic episode in acute phase

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    End point title
    		 No emetic episode in acute phase
    End point description
    No emetic episodes in the acute phase which is defined as the absence of emetic episodes in 0-24 hour after start of reference highly emetogenic chemotherapy [HEC]. Confidence interval of proportions are obtained by using the Newcombe-Wilson method.
    End point type
    Secondary
    End point timeframe
    Acute phase (0-24 hour)
    End point values
    		 30-min Infusion 30-sec Bolus Full Analysis Set: 30-min Infusion Full Analysis Set: 30-sec Bolus
    Number of subjects analysed
    225
    215 [8]
    225
    215
    Units: Proportion
        number (confidence interval 95%)
    82.7 (77.2 to 87.1)
    88.4 (83.4 to 92)
    82.7 (77.2 to 87.1)
    88.4 (83.4 to 92)
    Notes
    [8] - One patient did not receive any treatment and was excluded from all analysis sets
    Statistical analysis title
    		 No emetic episodes: Acute phase- Analysis
    Statistical analysis description
    The Cochran-Mantel-Haenszel test stratified by gender and country was used to compare both treatment with a 2-sided 95% confidence interval. No test for non-inferiority was to be performed.
    Comparison groups
    Full Analysis Set: 30-min Infusion v Full Analysis Set: 30-sec Bolus
    Number of subjects included in analysis
    440
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.9
         upper limit
    		 0.6
    Notes
    [9] - No formal test was planned for this endpoint

    Secondary: No emetic episodes delayed phase

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    End point title
    		 No emetic episodes delayed phase
    End point description
    No emetic episodes in the delayed phase which is defined as the absence of emetic episodes in >24-120 hour after start of reference highly emetogenic chemotherapy [HEC]. Confidence interval of proportions are obtained by using the Newcombe-Wilson method.
    End point type
    Secondary
    End point timeframe
    Delayed phase (>24 - 120 hour)
    End point values
    		 30-min Infusion 30-sec Bolus Full Analysis Set: 30-min Infusion Full Analysis Set: 30-sec Bolus
    Number of subjects analysed
    225
    215 [10]
    225
    215
    Units: Proportion
        number (confidence interval 95%)
    78.2 (72.4 to 83.1)
    78.1 (72.1 to 83.1)
    78.2 (72.4 to 83.1)
    78.1 (72.1 to 83.1)
    Notes
    [10] - One patient did not receive any treatment and was excluded from all analysis sets
    Statistical analysis title
    		 No emetic episodes: Delayed phase- Analysis
    Statistical analysis description
    The Cochran-Mantel-Haenszel test stratified by gender and country was used to compare both treatment with a 2-sided 95% confidence interval. No test for non-inferiority was to be performed.
    Comparison groups
    Full Analysis Set: 30-min Infusion v Full Analysis Set: 30-sec Bolus
    Number of subjects included in analysis
    440
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.2
         upper limit
    		 7.4
    Notes
    [11] - No formal test was planned for this endpoint

    Secondary: No emetic episode in overall phase

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    End point title
    		 No emetic episode in overall phase
    End point description
    No emetic episodes in the overallphase which is defined as the absence of emetic episodes in 0-120 hour after start of reference highly emetogenic chemotherapy [HEC]. Confidence interval of proportions are obtained by using the Newcombe-Wilson method.
    End point type
    Secondary
    End point timeframe
    Overall phase (0-120 hour)
    End point values
    		 30-min Infusion 30-sec Bolus Full Analysis Set: 30-min Infusion Full Analysis Set: 30-sec Bolus
    Number of subjects analysed
    225
    215 [12]
    225
    215
    Units: Proportion
        number (confidence interval 95%)
    68.9 (62.6 to 74.6)
    74.4 (68.2 to 79.8)
    68.9 (62.6 to 74.6)
    74.4 (68.2 to 79.8)
    Notes
    [12] - One patient did not receive any treatment and was excluded from all analysis sets
    Statistical analysis title
    		 No emetic episodes: Overall phase- Analysis
    Statistical analysis description
    The Cochran-Mantel-Haenszel test stratified by gender and country was used to compare both treatment with a 2-sided 95% confidence interval. No test for non-inferiority was to be performed.
    Comparison groups
    Full Analysis Set: 30-min Infusion v Full Analysis Set: 30-sec Bolus
    Number of subjects included in analysis
    440
    Analysis specification
    Pre-specified
    Analysis type
    		 other [13]
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.6
         upper limit
    		 2.4
    Notes
    [13] - No formal test was planned for this endpoint

    Secondary: No Rescue Medication in acute phase

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    End point title
    		 No Rescue Medication in acute phase
    End point description
    No rescue medication in the acute phase which is defined as the absence of rescue medication in 0-24 hour after start of reference highly emetogenic chemotherapy [HEC]. Confidence interval of proportions are obtained by using the Newcombe-Wilson method.
    End point type
    Secondary
    End point timeframe
    Acute Phase (0-24 hour)
    End point values
    		 30-min Infusion 30-sec Bolus Full Analysis Set: 30-min Infusion Full Analysis Set: 30-sec Bolus
    Number of subjects analysed
    225 [14]
    215
    225
    215
    Units: Proportion
        number (confidence interval 95%)
    88.9 (84.1 to 92.4)
    90.7 (86.1 to 93.9)
    88.9 (84.1 to 92.4)
    90.7 (86.1 to 93.9)
    Notes
    [14] - One patient did not receive any treatment and was excluded from all analysis sets
    Statistical analysis title
    		 No rescue medication: Acute phase- Analysis
    Statistical analysis description
    The Cochran-Mantel-Haenszel test stratified by gender and country was used to compare both treatment with a 2-sided 95% confidence interval. No test for non-inferiority was to be performed.
    Comparison groups
    Full Analysis Set: 30-min Infusion v Full Analysis Set: 30-sec Bolus
    Number of subjects included in analysis
    440
    Analysis specification
    Pre-specified
    Analysis type
    		 other [15]
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7
         upper limit
    		 3.7
    Notes
    [15] - No formal test was planned for this endpoint

    Secondary: No Rescue Medication in delayed phase

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    End point title
    		 No Rescue Medication in delayed phase
    End point description
    No rescue medication in the delayed phase which is defined as the absence of rescue medication in 0-24 hours after start of reference highly emetogenic chemotherapy [HEC]. Confidence interval of proportions are obtained by using the Newcombe-Wilson method.
    End point type
    Secondary
    End point timeframe
    Delayed phase (>24 - 120 hours)
    End point values
    		 30-min Infusion 30-sec Bolus Full Analysis Set: 30-min Infusion Full Analysis Set: 30-sec Bolus
    Number of subjects analysed
    225
    215 [16]
    225
    215
    Units: Proportion
        number (confidence interval 95%)
    81.3 (75.7 to 85.9)
    81.9 (76.2 to 86.4)
    81.3 (75.7 to 85.9)
    81.9 (76.2 to 86.4)
    Notes
    [16] - One patient did not receive any treatment and was excluded from all analysis sets
    Statistical analysis title
    		 No rescue medication: Delayed phase- Analysis
    Statistical analysis description
    The Cochran-Mantel-Haenszel test stratified by gender and country was used to compare both treatment with a 2-sided 95% confidence interval. No test for non-inferiority was to be performed.
    Comparison groups
    Full Analysis Set: 30-min Infusion v Full Analysis Set: 30-sec Bolus
    Number of subjects included in analysis
    440
    Analysis specification
    Pre-specified
    Analysis type
    		 other [17]
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.6
         upper limit
    		 6.3
    Notes
    [17] - No formal test was planned for this endpoint

    Secondary: No Rescue Medication in overall phase

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    End point title
    		 No Rescue Medication in overall phase
    End point description
    No emetic episodes in the overall phase which is defined as the absence of emetic episodes in 0-120 hour after start of reference highly emetogenic chemotherapy [HEC]. Confidence interval of proportions are obtained by using the Newcombe-Wilson method.
    End point type
    Secondary
    End point timeframe
    Overall phase (0-120 hour)
    End point values
    		 30-min Infusion 30-sec Bolus Full Analysis Set: 30-min Infusion Full Analysis Set: 30-sec Bolus
    Number of subjects analysed
    225
    215 [18]
    225
    215
    Units: Proportion
        number (confidence interval 95%)
    76.9 (71 to 81.9)
    78.6 (72.6 to 83.6)
    76.9 (71 to 81.9)
    78.6 (72.6 to 83.6)
    Notes
    [18] - One patient did not receive any treatment and was excluded from all analysis sets
    Statistical analysis title
    		 No rescue medication: Overall phase- Analysis
    Statistical analysis description
    The Cochran-Mantel-Haenszel test stratified by gender and country was used to test the null hypothesis that the risk difference between 30-min Infusion and 30-sec Bolus is less than or equal to a pre-specified non-inferiority margin of -15%.
    Comparison groups
    Full Analysis Set: 30-min Infusion v Full Analysis Set: 30-sec Bolus
    Number of subjects included in analysis
    440
    Analysis specification
    Pre-specified
    Analysis type
    		 other [19]
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.3
         upper limit
    		 5.4
    Notes
    [19] - No formal test was planned for this endpoint

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were collected from Informed consent signature up to the follow-up visit or last patient contact which is a maximum of 37 days.
    Adverse event reporting additional description
    Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    30-sec Bolus
    Reporting group description
    		 Subjects in this arm received a single-dose of palonosetron 0.25 mg administered as a 30-sec IV bolus with oral dexamethasone prior to highly emetogenic chemotherapy. 20 mg/day single-dose of dexamethasone was received on Day 1 then 8 mg bid on Days 2 to 4.

    Reporting group title
    30-min Infusion
    Reporting group description
    		 Subjects in this arm received a single-dose of palonosetron 0.25 mg administered as a 30-min IV infusion with oral dexamethasone prior to highly emetogenic chemotherapy. 20 mg/day single-dose of dexamethasone was received on Day 1 then 8 mg bid on Days 2 to 4.

    Serious adverse events
    		 30-sec Bolus 30-min Infusion
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         number of deaths (all causes)
    7
    6
         number of deaths resulting from adverse events
    0
    1
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 30-sec Bolus 30-min Infusion
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    72 / 215 (33.49%)
    80 / 225 (35.56%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bone cancer metastatic
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    2 / 215 (0.93%)
    8 / 225 (3.56%)
         occurrences all number
    2
    12
    Hypertensive crisis
         subjects affected / exposed
    3 / 215 (1.40%)
    1 / 225 (0.44%)
         occurrences all number
    3
    1
    Hypotension
         subjects affected / exposed
    1 / 215 (0.47%)
    3 / 225 (1.33%)
         occurrences all number
    2
    3
    Peripheral circulatory failure
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Phlebitis deep
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Superior vena cava syndrome
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    10 / 215 (4.65%)
    4 / 225 (1.78%)
         occurrences all number
    10
    4
    Chest pain
         subjects affected / exposed
    1 / 215 (0.47%)
    1 / 225 (0.44%)
         occurrences all number
    1
    1
    Fatigue
         subjects affected / exposed
    3 / 215 (1.40%)
    1 / 225 (0.44%)
         occurrences all number
    3
    1
    Hyperthermia
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    2
    Mucosal inflammation
         subjects affected / exposed
    0 / 215 (0.00%)
    2 / 225 (0.89%)
         occurrences all number
    0
    2
    Oedema peripheral
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 215 (0.00%)
    3 / 225 (1.33%)
         occurrences all number
    0
    3
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Bronchitis chronic
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Cough
         subjects affected / exposed
    1 / 215 (0.47%)
    2 / 225 (0.89%)
         occurrences all number
    1
    2
    Dyspnoea
         subjects affected / exposed
    0 / 215 (0.00%)
    3 / 225 (1.33%)
         occurrences all number
    0
    3
    Epistaxis
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Hiccups
         subjects affected / exposed
    3 / 215 (1.40%)
    6 / 225 (2.67%)
         occurrences all number
    4
    14
    Hypoxia
         subjects affected / exposed
    1 / 215 (0.47%)
    1 / 225 (0.44%)
         occurrences all number
    1
    1
    Productive cough
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 215 (0.47%)
    2 / 225 (0.89%)
         occurrences all number
    1
    2
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 215 (1.86%)
    1 / 225 (0.44%)
         occurrences all number
    4
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 215 (1.40%)
    0 / 225 (0.00%)
         occurrences all number
    3
    0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 215 (0.47%)
    1 / 225 (0.44%)
         occurrences all number
    1
    1
    Blood calcium decreased
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Blood chloride decreased
         subjects affected / exposed
    1 / 215 (0.47%)
    2 / 225 (0.89%)
         occurrences all number
    1
    2
    Blood creatine increased
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 215 (0.93%)
    0 / 225 (0.00%)
         occurrences all number
    2
    0
    Blood creatinine increased
         subjects affected / exposed
    6 / 215 (2.79%)
    2 / 225 (0.89%)
         occurrences all number
    7
    2
    Blood potassium decreased
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Blood urea increased
         subjects affected / exposed
    3 / 215 (1.40%)
    4 / 225 (1.78%)
         occurrences all number
    3
    4
    Breath sounds abnormal
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Creatinine renal clearance decreased
         subjects affected / exposed
    2 / 215 (0.93%)
    0 / 225 (0.00%)
         occurrences all number
    2
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    3 / 215 (1.40%)
    0 / 225 (0.00%)
         occurrences all number
    3
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Monocyte count decreased
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Neutrophil count increased
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Platelet count increased
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Transaminases increased
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Weight decreased
         subjects affected / exposed
    1 / 215 (0.47%)
    1 / 225 (0.44%)
         occurrences all number
    1
    1
    White blood cell count increased
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Radiation skin injury
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Cardiac disorders
    Arrhythmia supraventricular
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Atrial fibrillation
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Atrial flutter
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Atrial tachycardia
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Bundle branch block right
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Palpitations
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Sinus tachycardia
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 215 (0.00%)
    3 / 225 (1.33%)
         occurrences all number
    0
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 215 (1.40%)
    2 / 225 (0.89%)
         occurrences all number
    3
    2
    Headache
         subjects affected / exposed
    4 / 215 (1.86%)
    4 / 225 (1.78%)
         occurrences all number
    4
    4
    Paraesthesia
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Somnolence
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Syncope
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 215 (0.93%)
    2 / 225 (0.89%)
         occurrences all number
    2
    3
    Granulocytopenia
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Leukopenia
         subjects affected / exposed
    4 / 215 (1.86%)
    3 / 225 (1.33%)
         occurrences all number
    4
    4
    Lymphopenia
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Neutropenia
         subjects affected / exposed
    8 / 215 (3.72%)
    7 / 225 (3.11%)
         occurrences all number
    8
    9
    Neutrophilia
         subjects affected / exposed
    2 / 215 (0.93%)
    1 / 225 (0.44%)
         occurrences all number
    2
    1
    Pancytopenia
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    2 / 215 (0.93%)
    4 / 225 (1.78%)
         occurrences all number
    2
    7
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    2 / 215 (0.93%)
    1 / 225 (0.44%)
         occurrences all number
    2
    1
    Breath odour
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Chronic gastritis
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    3 / 215 (1.40%)
    5 / 225 (2.22%)
         occurrences all number
    5
    5
    Diarrhoea
         subjects affected / exposed
    6 / 215 (2.79%)
    11 / 225 (4.89%)
         occurrences all number
    7
    14
    Duodenal ulcer
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Duodenitis
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    5 / 215 (2.33%)
    5 / 225 (2.22%)
         occurrences all number
    5
    5
    Retching
         subjects affected / exposed
    1 / 215 (0.47%)
    1 / 225 (0.44%)
         occurrences all number
    1
    1
    Salivary hypersecretion
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Stomatitis
         subjects affected / exposed
    2 / 215 (0.93%)
    1 / 225 (0.44%)
         occurrences all number
    2
    1
    Vomiting
         subjects affected / exposed
    1 / 215 (0.47%)
    3 / 225 (1.33%)
         occurrences all number
    1
    3
    Hepatobiliary disorders
    Hepatocellular injury
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    8 / 215 (3.72%)
    5 / 225 (2.22%)
         occurrences all number
    8
    5
    Dermatitis
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Dermatitis allergic
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Erythema
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 215 (0.47%)
    2 / 225 (0.89%)
         occurrences all number
    1
    2
    Chronic kidney disease
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Glycosuria
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Pollakiuria
         subjects affected / exposed
    2 / 215 (0.93%)
    0 / 225 (0.00%)
         occurrences all number
    2
    0
    Proteinuria
         subjects affected / exposed
    3 / 215 (1.40%)
    2 / 225 (0.89%)
         occurrences all number
    3
    2
    Renal failure
         subjects affected / exposed
    2 / 215 (0.93%)
    3 / 225 (1.33%)
         occurrences all number
    2
    4
    Renal impairment
         subjects affected / exposed
    3 / 215 (1.40%)
    2 / 225 (0.89%)
         occurrences all number
    3
    3
    Urinary retention
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    0 / 215 (0.00%)
    2 / 225 (0.89%)
         occurrences all number
    0
    2
    Myalgia
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 225 (0.00%)
         occurrences all number
    1
    0
    Fungal infection
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 215 (0.47%)
    1 / 225 (0.44%)
         occurrences all number
    1
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 215 (0.93%)
    3 / 225 (1.33%)
         occurrences all number
    2
    3
    Dehydration
         subjects affected / exposed
    2 / 215 (0.93%)
    1 / 225 (0.44%)
         occurrences all number
    2
    1
    Diabetes mellitus
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    2 / 215 (0.93%)
    1 / 225 (0.44%)
         occurrences all number
    2
    1
    Hyperkalaemia
         subjects affected / exposed
    1 / 215 (0.47%)
    1 / 225 (0.44%)
         occurrences all number
    1
    1
    Hypocalcaemia
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    2
    Hypokalaemia
         subjects affected / exposed
    1 / 215 (0.47%)
    2 / 225 (0.89%)
         occurrences all number
    1
    6
    Hyponatraemia
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 225 (0.44%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jan 2016
    Time windows were specified in detail for study drug and additional non-investigational study drug administration (palonosetron IV bolus, palonosetron IV infusion, and dexamethasone tablets), for the reference chemotherapy administration, for the vital signs measurements at 24 h ±2 h and 120 h -6 h/+54 h and for 12-lead ECG measurement at 120 h -6 h/+54 h.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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