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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Emetogenic Chemotherapy in Adolescent Patients

    Summary
    EudraCT number
    		 2014-004603-78
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    19 Feb 2007

    Results information
    Results version number
    		 v2(current)
    This version publication date
    12 May 2016
    First version publication date
    01 Aug 2015
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    0869-097
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00080444
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Merck protocol number: MK-0869-097
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000144-PIP01-07
    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
    19 Feb 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Feb 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to estimate the difference for the percentage of adolescent participants treated with aprepitant triple therapy or standard therapy who have one or more clinical or laboratory drug-related adverse experience(s) during the Cycle 1 study-drug therapy period plus 14 days post-therapy. The duration of treatment was the first 4 days of one 28-day cycle (Cycle 1). In the double-blind Part 1 of this study, enrolled participants were to be randomized to receive either aprepitant triple therapy or standard therapy. Participants who successfully completed Cycle 1 may have been eligible to participate for 9 subsequent optional, open-label, 28-day cycles. In Part 2 of this study, all enrolled participants were to receive open-label aprepitant.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research. The following additional measure defined for this individual study was in place for the protection of trial subjects: Participants may have been provided with a prescription for rescue therapy to relieve symptoms of nausea or vomiting according to investigator selection. Permitted rescue therapies were: 5-hydroxytryptamine (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron), benzodiazepines or benzamides (e.g., metoclopramide or alizapride). In addition, participants receiving multi-day chemotherapy regimens were permitted to receive preventative antiemetic treatment with a 5-HT3 antagonist if clinically indicated.
    Background therapy
    		 All participants received intravenous (IV) ondansetron on treatment Days 1 and 2 and oral (PO) dexamethasone on Day 1 and Days 2 to 4.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Apr 2004
    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
    Australia: 1
    Country: Number of subjects enrolled
    United States: 28
    Country: Number of subjects enrolled
    Brazil: 21
    Worldwide total number of subjects
    50
    EEA total number of subjects
    0
    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)
    1
    Adolescents (12-17 years)
    47
    Adults (18-64 years)
    2
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants aged 12 to 17 years who had confirmed malignancies and were to be treated with an emetogenic chemotherapy regimen were enrolled into this study.

    Period 1
    Period 1 title
    Cycle 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Aprepitant Triple Therapy: Cycle 1
    Arm description
    		 Cycle 1: Participants received one aprepitant 125 mg capsule PO on Day 1 and one aprepitant 80 mg capsule PO on Days 2 and 3 plus ondansetron solution (0.15 mg/kg x 3 doses) IV on Days 1 and 2 plus one dexamethasone 8 mg tablet PO on Day 1 and one dexamethasone 4 mg tablet PO on Days 2 to 4. After completion of Cycle 1, participants had the option to continue in the study for up to 9 additional cycles, for a total of 10 cycles of treatment. Cycles 2-10: Participants received open-label aprepitant triple therapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aprepitant
    Investigational medicinal product code
    Other name
    EMEND®, MK-0869
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Aprepitant 125 mg capsule PO on Day 1 and aprepitant 80 mg capsule PO on Days 2 and 3

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    DECADRON®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dexamethasone 8 mg tablet PO on Day 1 and dexamethasone 4 mg tablet PO on Days 2 to 4 for the Aprepitant Triple Therapy group OR Dexamethsone 16 mg tablet PO on Day 1 and dexamethasone 8 mg tablet PO on Days 2 to 4 for the Standard Therapy group

    Investigational medicinal product name
    Ondansetron
    Investigational medicinal product code
    Other name
    ZOFRAN®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ondansetron solution (0.15 mg/kg x 3 doses) IV on Days 1 and 2

    Arm title
    		 Standard Therapy: Cycle 1
    Arm description
    		 Cycle 1: Participants received placebo to aprepitant 125 mg PO on Day 1 and placebo to aprepitant 80 mg PO on Days 2 and 3 plus ondansetron solution (0.15 mg/kg x 3 doses) IV on Days 1 and 2 plus one dexamethasone 16 mg tablet PO on Day 1 and one dexamethasone 8 mg tablet PO on Days 2 to 4. After completion of Cycle 1, participants had the option to continue in the study for up to 9 additional cycles, for a total of 10 cycles of treatment. Cycles 2-10: Participants received open-label aprepitant triple therapy.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ondansetron
    Investigational medicinal product code
    Other name
    ZOFRAN®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    Ondansetron solution (0.15 mg/kg x 3 doses) IV on Days 1 and 2

    Investigational medicinal product name
    Placebo to aprepitant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to aprepitant 125 mg PO on Day 1 and Placebo to aprepitant 80 mg PO on Days 2 and 3

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    DECADRON®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dexamethasone 8 mg tablet PO on Day 1 and dexamethasone 4 mg tablet PO on Days 2 to 4 for the Aprepitant Triple Therapy group OR Dexamethsone 16 mg tablet PO on Day 1 and dexamethasone 8 mg tablet PO on Days 2 to 4 for the Standard Therapy group

    Number of subjects in period 1
    		Aprepitant Triple Therapy: Cycle 1 Standard Therapy: Cycle 1
    Started
    32
    18
    Completed
    31
    18
    Not completed
    1
    0
         Not specified
    1
    -
    Period 2
    Period 2 title
    Cycles 2-10
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    All study drug was open label; no blinding was needed. All participants received open-label aprepitant.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Aprepitant Triple Therapy: Cycles 2-10
    Arm description
    		 Cycle 1: Participants received one aprepitant 125 mg capsule PO on Day 1 and one aprepitant 80 mg capsule PO on Days 2 and 3 plus ondansetron solution (0.15 mg/kg x 3 doses) IV on Days 1 and 2 plus one dexamethasone 8 mg tablet PO on Day 1 and one dexamethasone 4 mg tablet PO on Days 2 to 4. After completion of Cycle 1, participants had the option to continue in the study for up to 9 additional cycles, for a total of 10 cycles of treatment. Cycles 2-10: Participants received open-label aprepitant triple therapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aprepitant
    Investigational medicinal product code
    Other name
    EMEND®, MK-0869
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Aprepitant 125 mg capsule PO on Day 1 and aprepitant 80 mg capsule PO on Days 2 and 3

    Investigational medicinal product name
    Ondansetron
    Investigational medicinal product code
    Other name
    ZOFRAN®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ondansetron solution (0.15 mg/kg x 3 doses) IV on Days 1 and 2

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    DECADRON®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dexamethasone 8 mg tablet PO on Day 1 and dexamethasone 4 mg tablet PO on Days 2 to 4 for the Aprepitant Triple Therapy group OR Dexamethsone 16 mg tablet PO on Day 1 and dexamethasone 8 mg tablet PO on Days 2 to 4 for the Standard Therapy group

    Arm title
    		 Standard Therapy: Cycles 2-10
    Arm description
    		 Cycle 1: Participants received placebo to aprepitant 125 mg PO on Day 1 and placebo to aprepitant 80 mg PO on Days 2 and 3 plus ondansetron solution (0.15 mg/kg x 3 doses) IV on Days 1 and 2 plus one dexamethasone 16 mg tablet PO on Day 1 and one dexamethasone 8 mg tablet PO on Days 2 to 4. After completion of Cycle 1, participants had the option to continue in the study for up to 9 additional cycles, for a total of 10 cycles of treatment. Cycles 2-10: Participants received open-label aprepitant triple therapy.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Aprepitant Triple Therapy: Cycles 2-10 Standard Therapy: Cycles 2-10
    Started
    29
    16
    Completed
    36
    0
    Not completed
    9
    16
         Consent withdrawn by subject
    2
    -
         Not specified
    5
    -
         Transferred to other arm/group
    -
    16
         Protocol deviation
    2
    -
    Joined
    16
    0
         Transferred in from other group/arm
    16
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Aprepitant Triple Therapy: Cycle 1
    Reporting group description
    		 Cycle 1: Participants received one aprepitant 125 mg capsule PO on Day 1 and one aprepitant 80 mg capsule PO on Days 2 and 3 plus ondansetron solution (0.15 mg/kg x 3 doses) IV on Days 1 and 2 plus one dexamethasone 8 mg tablet PO on Day 1 and one dexamethasone 4 mg tablet PO on Days 2 to 4. After completion of Cycle 1, participants had the option to continue in the study for up to 9 additional cycles, for a total of 10 cycles of treatment. Cycles 2-10: Participants received open-label aprepitant triple therapy.

    Reporting group title
    Standard Therapy: Cycle 1
    Reporting group description
    		 Cycle 1: Participants received placebo to aprepitant 125 mg PO on Day 1 and placebo to aprepitant 80 mg PO on Days 2 and 3 plus ondansetron solution (0.15 mg/kg x 3 doses) IV on Days 1 and 2 plus one dexamethasone 16 mg tablet PO on Day 1 and one dexamethasone 8 mg tablet PO on Days 2 to 4. After completion of Cycle 1, participants had the option to continue in the study for up to 9 additional cycles, for a total of 10 cycles of treatment. Cycles 2-10: Participants received open-label aprepitant triple therapy.

    Reporting group values
    		 Aprepitant Triple Therapy: Cycle 1 Standard Therapy: Cycle 1 Total
    Number of subjects
    		 32 18 50
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 0 1 1
        Adolescents (12-17 years)
    		 30 17 47
        Adults (18-64 years)
    		 2 0 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 15 ( 1.7 ) 14.6 ( 1.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 6 14
        Male
    		 24 12 36

    End points

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    End points reporting groups
    Reporting group title
    Aprepitant Triple Therapy: Cycle 1
    Reporting group description
    		 Cycle 1: Participants received one aprepitant 125 mg capsule PO on Day 1 and one aprepitant 80 mg capsule PO on Days 2 and 3 plus ondansetron solution (0.15 mg/kg x 3 doses) IV on Days 1 and 2 plus one dexamethasone 8 mg tablet PO on Day 1 and one dexamethasone 4 mg tablet PO on Days 2 to 4. After completion of Cycle 1, participants had the option to continue in the study for up to 9 additional cycles, for a total of 10 cycles of treatment. Cycles 2-10: Participants received open-label aprepitant triple therapy.

    Reporting group title
    Standard Therapy: Cycle 1
    Reporting group description
    		 Cycle 1: Participants received placebo to aprepitant 125 mg PO on Day 1 and placebo to aprepitant 80 mg PO on Days 2 and 3 plus ondansetron solution (0.15 mg/kg x 3 doses) IV on Days 1 and 2 plus one dexamethasone 16 mg tablet PO on Day 1 and one dexamethasone 8 mg tablet PO on Days 2 to 4. After completion of Cycle 1, participants had the option to continue in the study for up to 9 additional cycles, for a total of 10 cycles of treatment. Cycles 2-10: Participants received open-label aprepitant triple therapy.
    Reporting group title
    Aprepitant Triple Therapy: Cycles 2-10
    Reporting group description
    		 Cycle 1: Participants received one aprepitant 125 mg capsule PO on Day 1 and one aprepitant 80 mg capsule PO on Days 2 and 3 plus ondansetron solution (0.15 mg/kg x 3 doses) IV on Days 1 and 2 plus one dexamethasone 8 mg tablet PO on Day 1 and one dexamethasone 4 mg tablet PO on Days 2 to 4. After completion of Cycle 1, participants had the option to continue in the study for up to 9 additional cycles, for a total of 10 cycles of treatment. Cycles 2-10: Participants received open-label aprepitant triple therapy.

    Reporting group title
    Standard Therapy: Cycles 2-10
    Reporting group description
    		 Cycle 1: Participants received placebo to aprepitant 125 mg PO on Day 1 and placebo to aprepitant 80 mg PO on Days 2 and 3 plus ondansetron solution (0.15 mg/kg x 3 doses) IV on Days 1 and 2 plus one dexamethasone 16 mg tablet PO on Day 1 and one dexamethasone 8 mg tablet PO on Days 2 to 4. After completion of Cycle 1, participants had the option to continue in the study for up to 9 additional cycles, for a total of 10 cycles of treatment. Cycles 2-10: Participants received open-label aprepitant triple therapy.

    Primary: Percentage of Participants Who Experience At Least One Drug-related Adverse Event (AE) in Cycle 1

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    End point title
    		 Percentage of Participants Who Experience At Least One Drug-related Adverse Event (AE) in Cycle 1 [1]
    End point description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of study drug, is also an AE. Drug-related AEs were those AEs judged by the investigator to be definitely, probably or possibly related to study drug. Drug-related clinical and laboratory AEs are combined.
    End point type
    Primary
    End point timeframe
    Up to 14 days after last dose of study drug in Cycle 1 (Up to 17 days)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this end point.
    End point values
    		 Aprepitant Triple Therapy: Cycle 1 Standard Therapy: Cycle 1
    Number of subjects analysed
    32 [2]
    18 [3]
    Units: Percentage of participants
        number (not applicable)
    21.9
    5.6
    Notes
    [2] - All randomized participants who received ≥1 dose of study drug.
    [3] - All randomized participants who received ≥1 dose of study drug.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Experience At Least One Serious AE in Cycle 1

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    End point title
    		 Percentage of Participants Who Experience At Least One Serious AE in Cycle 1
    End point description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of study drug, is also an AE. A serious AE (SAE) is any adverse experience occurring at any dose that: Results in death, Is life threatening, Results in a persistent or significant disability/incapacity, Results in or prolongs an existing inpatient hospitalization, Is a congenital anomaly/birth defect, Is a cancer. Clinical and laboratory SAEs are combined.
    End point type
    Secondary
    End point timeframe
    Up to 14 days after last dose of study drug in Cycle 1 (Up to 17 days)
    End point values
    		 Aprepitant Triple Therapy: Cycle 1 Standard Therapy: Cycle 1
    Number of subjects analysed
    32 [4]
    18 [5]
    Units: Percentage of participants
        number (not applicable)
    31.3
    11.1
    Notes
    [4] - All randomized participants who received ≥1 dose of study drug.
    [5] - All randomized participants who received ≥1 dose of study drug.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Experience At Least One Serious Drug-related AE

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    End point title
    		 Percentage of Participants Who Experience At Least One Serious Drug-related AE
    End point description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of study drug, is also an AE. A serious AE (SAE) is any adverse experience occurring at any dose that: Results in death, Is life threatening, Results in a persistent or significant disability/incapacity, Results in or prolongs an existing inpatient hospitalization, Is a congenital anomaly/birth defect, Is a cancer. Drug-related AEs were those AEs judged by the investigator to be definitely, probably or possibly related to study drug. Drug-related clinical and laboratory SAEs are combined.
    End point type
    Secondary
    End point timeframe
    Up to 14 days after last dose of study drug (Up to 10.5 months)
    End point values
    		 Aprepitant Triple Therapy: Cycle 1 Aprepitant Triple Therapy: Cycles 2-10 Standard Therapy: Cycle 1
    Number of subjects analysed
    32 [6]
    45 [7]
    18 [8]
    Units: Percentage of participants
        number (not applicable)
    0
    0
    0
    Notes
    [6] - All randomized participants who received ≥1 dose of study drug.
    [7] - All randomized participants who received ≥1 dose of study drug.
    [8] - All randomized participants who received ≥1 dose of study drug.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Discontinue Study Drug Due to an AE

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    End point title
    		 Percentage of Participants Who Discontinue Study Drug Due to an AE
    End point description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of study drug, is also an AE.
    End point type
    Secondary
    End point timeframe
    Up to 10 cycles (Up to 10 months)
    End point values
    		 Aprepitant Triple Therapy: Cycle 1 Aprepitant Triple Therapy: Cycles 2-10 Standard Therapy: Cycle 1
    Number of subjects analysed
    32 [9]
    45 [10]
    18 [11]
    Units: Percentage of participants
        number (not applicable)
    0
    0
    0
    Notes
    [9] - All randomized participants who received ≥1 dose of study drug.
    [10] - All randomized participants who received ≥1 dose of study drug.
    [11] - All randomized participants who received ≥1 dose of study drug.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a Complete Response in Cycle 1

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    End point title
    		 Percentage of Participants With a Complete Response in Cycle 1
    End point description
    A complete response was defined as no vomiting and no use of rescue medication. Overall Phase = 0 to 120 hours following initiation of chemotherapy. Acute Phase = 0 to 24 hours following initiation of chemotherapy. Delayed Phase = 25 to 120 hours following initiation of chemotherapy.
    End point type
    Secondary
    End point timeframe
    Up to 120 hours following initiation of chemotherapy in Cycle 1
    End point values
    		 Aprepitant Triple Therapy: Cycle 1 Standard Therapy: Cycle 1
    Number of subjects analysed
    28 [12]
    18 [13]
    Units: Percentage of particpants
    number (not applicable)
        Overall Phase
    28.6
    5.6
        Acute Phase
    60.7
    38.9
        Delayed Phase
    35.7
    5.6
    Notes
    [12] - Participants received chemotherapy & ≥1 study drug regimen & had ≥1 post-treatment efficacy value.
    [13] - Participants received chemotherapy & ≥1 study drug regimen & had ≥1 post-treatment efficacy value.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Experienced No Vomiting in Cycle 1

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    End point title
    		 Percentage of Participants Who Experienced No Vomiting in Cycle 1
    End point description
    The percentage of participants who experienced no vomiting episodes during Cycle 1 is presented. Overall Phase = 0 to 120 hours following initiation of chemotherapy. Acute Phase = 0 to 24 hours following initiation of chemotherapy. Delayed Phase = 25 to 120 hours following initiation of chemotherapy.
    End point type
    Secondary
    End point timeframe
    Up to 120 hours after initiation of chemotherapy in Cycle 1
    End point values
    		 Aprepitant Triple Therapy: Cycle 1 Standard Therapy: Cycle 1
    Number of subjects analysed
    28 [14]
    18 [15]
    Units: Percentage of participants
    number (not applicable)
        Overall Phase
    32.1
    5.6
        Acute Phase
    64.3
    44.4
        Delayed Phase
    39.3
    5.6
    Notes
    [14] - Participants received chemotherapy & ≥1 study drug regimen & had ≥1 post-treatment efficacy value.
    [15] - Participants received chemotherapy & ≥1 study drug regimen & had ≥1 post-treatment efficacy value.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Experienced No Nausea in Cycle 1

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    End point title
    		 Percentage of Participants Who Experienced No Nausea in Cycle 1
    End point description
    The percentage of participants who experienced no nausea during Cycle 1 is presented. Nausea was defined as having nausea such that it interfered with a participant's usual daily activities. Overall Phase = 0 to 120 hours following initiation of chemotherapy.
    End point type
    Secondary
    End point timeframe
    Up to 120 hours following initiation of chemotherapy in Cycle 1
    End point values
    		 Aprepitant Triple Therapy: Cycle 1 Standard Therapy: Cycle 1
    Number of subjects analysed
    27 [16]
    17 [17]
    Units: Percentage of participants
        number (not applicable)
    44.4
    17.6
    Notes
    [16] - Participants received chemotherapy & ≥1 study drug regimen & had ≥1 post-treatment efficacy value.
    [17] - Participants received chemotherapy & ≥1 study drug regimen & had ≥1 post-treatment efficacy value.
    No statistical analyses for this end point

    Secondary: Aprepitant Area Under the Time-concentration Curve From 0 to 24 Hours (AUC0-24hr)

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    End point title
    		 Aprepitant Area Under the Time-concentration Curve From 0 to 24 Hours (AUC0-24hr)
    End point description
    Three (3) mL of blood were to be collected to measure aprepitant pharmacokinetics at predose (-2 hours), 1 (prior to chemotherapy infusion) 2, 3, 4, 8, 12, and 24 hours post aprepitant dose on Day 1. No participants in the Standard Therapy group received aprepitant during Cycle 1.
    End point type
    Secondary
    End point timeframe
    Up to 24 hours following aprepitant administration
    End point values
    		 Aprepitant Triple Therapy: Cycle 1 Standard Therapy: Cycle 1
    Number of subjects analysed
    18 [18]
    0 [19]
    Units: ng*hr/mL
        geometric mean (confidence interval 95%)
    14318.4 (11106.7 to 18458.9)
    ( to )
    Notes
    [18] - Participants who received chemotherapy & aprepitant regimen & had pharmacokinetic data.
    [19] - No participants in the Standard Therapy group received aprepitant during Cycle 1.
    No statistical analyses for this end point

    Secondary: Aprepitant Maximum Plasma Concentration (Cmax)

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    End point title
    		 Aprepitant Maximum Plasma Concentration (Cmax)
    End point description
    Three (3) mL of blood were to be collected to measure aprepitant pharmacokinetics at predose (-2 hours), 1 (prior to chemotherapy infusion) 2, 3, 4, 8, 12, and 24 hours post aprepitant dose on Day 1 and at 24 hours post aprepitant dose on Days 2 (i.e., Day 3) and 3 (i.e., Day 4). No participants in the Standard Therapy group received aprepitant during Cycle 1.
    End point type
    Secondary
    End point timeframe
    Up to 4 days following aprepitant administration
    End point values
    		 Aprepitant Triple Therapy: Cycle 1 Standard Therapy: Cycle 1
    Number of subjects analysed
    18 [20]
    0 [21]
    Units: ng/mL
        geometric mean (confidence interval 95%)
    1070.1 (828 to 1383)
    ( to )
    Notes
    [20] - Participants who received chemotherapy & aprepitant regimen & had pharmacokinetic data.
    [21] - No participants in the Standard Therapy group received aprepitant during Cycle 1.
    No statistical analyses for this end point

    Secondary: Aprepitant Plasma Concentration at 24 Hours Post-dose (C24hr)

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    End point title
    		 Aprepitant Plasma Concentration at 24 Hours Post-dose (C24hr)
    End point description
    Three (3) mL of blood were to be collected to measure aprepitant pharmacokinetics at 24 hours post aprepitant dose on Day 1. No participants in the Standard Therapy group received aprepitant during Cycle 1.
    End point type
    Secondary
    End point timeframe
    24 hours following aprepitant administration
    End point values
    		 Aprepitant Triple Therapy: Cycle 1 Standard Therapy: Cycle 1
    Number of subjects analysed
    9 [22]
    0 [23]
    Units: ng/mL
        geometric mean (confidence interval 95%)
    449.7 (327 to 618.6)
    ( to )
    Notes
    [22] - Participants who received chemotherapy & aprepitant regimen & had pharmacokinetic data.
    [23] - No participants in the Standard Therapy group received aprepitant during Cycle 1.
    No statistical analyses for this end point

    Secondary: Aprepitant Plasma Concentration at 48 Hours Post-dose (C48hr)

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    End point title
    		 Aprepitant Plasma Concentration at 48 Hours Post-dose (C48hr)
    End point description
    Three (3) mL of blood were to be collected to measure aprepitant pharmacokinetics at 24 hours post aprepitant dose on Day 2 (i.e., Day 3). No participants in the Standard Therapy group received aprepitant during Cycle 1.
    End point type
    Secondary
    End point timeframe
    48 hours following aprepitant administration
    End point values
    		 Aprepitant Triple Therapy: Cycle 1 Standard Therapy: Cycle 1
    Number of subjects analysed
    8 [24]
    0 [25]
    Units: ng/mL
        geometric mean (confidence interval 95%)
    460.5 (260.1 to 815.4)
    ( to )
    Notes
    [24] - Participants who received chemotherapy & aprepitant regimen & had pharmacokinetic data.
    [25] - No participants in the Standard Therapy group received aprepitant during Cycle 1.
    No statistical analyses for this end point

    Secondary: Aprepitant Plasma Concentration at 72 Hours Post-dose (C72hr)

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    End point title
    		 Aprepitant Plasma Concentration at 72 Hours Post-dose (C72hr)
    End point description
    Three (3) mL of blood were to be collected to measure aprepitant pharmacokinetics at 24 hours post aprepitant dose on Day 3 (i.e., Day 4). No participants in the Standard Therapy group received aprepitant during Cycle 1.
    End point type
    Secondary
    End point timeframe
    72 hours following aprepitant administration
    End point values
    		 Aprepitant Triple Therapy: Cycle 1 Standard Therapy: Cycle 1
    Number of subjects analysed
    16 [26]
    0 [27]
    Units: ng/mL
        geometric mean (confidence interval 95%)
    367 (223.4 to 602.9)
    ( to )
    Notes
    [26] - Participants who received chemotherapy & aprepitant regimen & had pharmacokinetic data.
    [27] - No participants in the Standard Therapy group received aprepitant during Cycle 1.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 10.5 months (Up to 2 weeks after last dose of study drug)
    Adverse event reporting additional description
    The safety population consisted of all randomized participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    Aprepitant Triple Therapy: Cycle 1
    Reporting group description
    		 Cycle 1: Participants received one aprepitant 125 mg capsule PO on Day 1 and one aprepitant 80 mg capsule PO on Days 2 and 3 plus ondansetron solution (0.15 mg/kg x 3 doses) IV on Days 1 and 2 plus one dexamethasone 8 mg tablet PO on Day 1 and one dexamethasone 4 mg tablet PO on Days 2 to 4. After completion of Cycle 1, participants had the option to continue in the study for up to 9 additional cycles, for a total of 10 cycles of treatment. Cycles 2-10: Participants received open-label aprepitant triple therapy.

    Reporting group title
    Aprepitant Triple Therapy: Cycles 2-10
    Reporting group description
    		 Cycles 2-10: All participants received one aprepitant 125 mg capsule PO on Day 1 and one aprepitant 80 mg capsule PO on Days 2 and 3 plus ondansetron solution (0.15 mg/kg x 3 doses) IV on Days 1 and 2 plus one dexamethasone 8 mg tablet PO on Day 1 and one dexamethasone 4 mg tablet PO on Days 2 to 4.

    Reporting group title
    Standard Therapy: Cycle 1
    Reporting group description
    		 Cycle 1: Participants received placebo to aprepitant 125 mg PO on Day 1 and placebo to aprepitant 80 mg PO on Days 2 and 3 plus ondansetron solution (0.15 mg/kg x 3 doses) IV on Days 1 and 2 plus one dexamethasone 16 mg tablet PO on Day 1 and one dexamethasone 8 mg tablet PO on Days 2 to 4. After completion of Cycle 1, participants had the option to continue in the study for up to 9 additional cycles, for a total of 10 cycles of treatment. Cycles 2-10: Participants received open-label aprepitant triple therapy.

    Serious adverse events
    		 Aprepitant Triple Therapy: Cycle 1 Aprepitant Triple Therapy: Cycles 2-10 Standard Therapy: Cycle 1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 32 (31.25%)
    19 / 45 (42.22%)
    2 / 18 (11.11%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Investigations
    Blood magnesium increased
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 45 (2.22%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 45 (2.22%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 45 (2.22%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 45 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 45 (2.22%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 45 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 45 (2.22%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    8 / 32 (25.00%)
    12 / 45 (26.67%)
    2 / 18 (11.11%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 17
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Granulocytopenia
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 45 (2.22%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 45 (2.22%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 45 (2.22%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Caecitis
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 45 (2.22%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 45 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Cystitis haemorrhagic
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 45 (2.22%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 45 (2.22%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Catheter site infection
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 45 (2.22%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 45 (2.22%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 45 (2.22%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 45 (4.44%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 45 (2.22%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 45 (4.44%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative infection
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 45 (2.22%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 45 (2.22%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 45 (2.22%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 45 (2.22%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Aprepitant Triple Therapy: Cycle 1 Aprepitant Triple Therapy: Cycles 2-10 Standard Therapy: Cycle 1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 32 (71.88%)
    1 / 45 (2.22%)
    14 / 18 (77.78%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    2
    0
    1
    Blood potassium decreased
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 45 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    1
    0
    2
    Blood sodium decreased
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Haemoglobin decreased
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    1
    Neutrophil count decreased
         subjects affected / exposed
    3 / 32 (9.38%)
    0 / 45 (0.00%)
    4 / 18 (22.22%)
         occurrences all number
    3
    0
    5
    Platelet count decreased
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    2
    0
    1
    Red blood cell count decreased
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Weight decreased
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 45 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    White blood cell count decreased
         subjects affected / exposed
    3 / 32 (9.38%)
    0 / 45 (0.00%)
    3 / 18 (16.67%)
         occurrences all number
    3
    0
    3
    White blood cells urine positive
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    1
    Vascular disorders
    Flushing
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 45 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    Hypotension
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 45 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    Pallor
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 32 (15.63%)
    0 / 45 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    6
    0
    0
    Headache
         subjects affected / exposed
    6 / 32 (18.75%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    7
    0
    2
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    3 / 32 (9.38%)
    1 / 45 (2.22%)
    0 / 18 (0.00%)
         occurrences all number
    3
    1
    0
    Granulocytopenia
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Fatigue
         subjects affected / exposed
    5 / 32 (15.63%)
    1 / 45 (2.22%)
    0 / 18 (0.00%)
         occurrences all number
    5
    1
    0
    Mucosal inflammation
         subjects affected / exposed
    4 / 32 (12.50%)
    0 / 45 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    4
    0
    0
    Pain
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    4 / 32 (12.50%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    4
    0
    1
    Eye disorders
    Conjunctival hyperaemia
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    5 / 32 (15.63%)
    0 / 45 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    6
    0
    0
    Constipation
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 45 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    Diarrhoea
         subjects affected / exposed
    3 / 32 (9.38%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    3
    0
    1
    Dyspepsia
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 45 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    Glossitis
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    7 / 32 (21.88%)
    0 / 45 (0.00%)
    3 / 18 (16.67%)
         occurrences all number
    9
    0
    3
    Oral soft tissue disorder
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    1
    Stomatitis
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Vomiting
         subjects affected / exposed
    7 / 32 (21.88%)
    0 / 45 (0.00%)
    3 / 18 (16.67%)
         occurrences all number
    11
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Hiccups
         subjects affected / exposed
    6 / 32 (18.75%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    6
    0
    1
    Sneezing
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Dysphoria
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Influenza
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Subcutaneous abscess
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    3 / 32 (9.38%)
    0 / 45 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    3
    0
    2
    Dehydration
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 45 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    2
    0
    2
    Decreased appetite
         subjects affected / exposed
    3 / 32 (9.38%)
    0 / 45 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    3
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Apr 2005
    Amendment 01: The protocol was revised to include changes to the Protocol title, Background and Rationale, Patient Inclusion and Exclusion Criteria, and Pharmacokinetic Measurements sections. In addition, there were some minor editorial changes. These changes affected the participation of the participant and the risk/benefit profile. Therefore, modifications to the consent form were required. All new participants and ongoing participants in the study were required to sign the revised consent form.
    19 Apr 2006
    Amendment 02: Due to slow enrollment, the protocol was amended. The major changes were: 1) the blinded standard therapy arm was discontinued (referred to as Part One), and all future participants were enrolled into the open-label aprepitant triple therapy arm (referred to as Part Two); 2) the study population was revised to include participants with any confirmed malignancies; rather than only participants with confirmed solid malignancies.

    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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