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    Clinical Trial Results:
    A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Patients

    Summary
    EudraCT number
    2011-000651-16
    Trial protocol
    SE   PT   LT   ES   NL   DK   HU   SI   GR   GB   IT   Outside EU/EEA  
    Global end of trial date
    16 Aug 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Apr 2016
    First version publication date
    25 Feb 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    0869-208
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01362530
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    MK-0869: Aprepitant
    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)
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Aug 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will compare the safety and efficacy of a three-day oral aprepitant regimen (aprepitant plus ondansetron) to ondansetron alone in the prevention of chemotherapy-induced nausea and vomiting (CINV) in the 120 hours following the initiation of chemotherapy in pediatric participants. Those who complete this first cycle of treatment and meet certain eligibility criteria will have the option of continuing for 5 additional cycles of 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: Subjects were permitted to take "rescue medication" for established (not anticipated) nausea and vomiting throughout the study. Recommended rescue medications included: 5-HT3 antagonists, phenothiazines, butyrophenones, benzamides, corticosteroids, benzodiazepines, and domperidone. In all cases, rescue medication was administered consistent with local regulations and standards of practice.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    13 Sep 2011
    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
    Argentina: 3
    Country: Number of subjects enrolled
    Chile: 18
    Country: Number of subjects enrolled
    Colombia: 11
    Country: Number of subjects enrolled
    Croatia: 9
    Country: Number of subjects enrolled
    Netherlands: 17
    Country: Number of subjects enrolled
    Israel: 19
    Country: Number of subjects enrolled
    Mexico: 4
    Country: Number of subjects enrolled
    Peru: 10
    Country: Number of subjects enrolled
    Poland: 18
    Country: Number of subjects enrolled
    Russian Federation: 15
    Country: Number of subjects enrolled
    Slovenia: 5
    Country: Number of subjects enrolled
    Sweden: 8
    Country: Number of subjects enrolled
    Ecuador: 13
    Country: Number of subjects enrolled
    Denmark: 6
    Country: Number of subjects enrolled
    Greece: 17
    Country: Number of subjects enrolled
    Italy: 16
    Country: Number of subjects enrolled
    Dominican Republic: 6
    Country: Number of subjects enrolled
    Hungary: 16
    Country: Number of subjects enrolled
    Korea, Republic of: 25
    Country: Number of subjects enrolled
    Lithuania: 11
    Country: Number of subjects enrolled
    Spain: 20
    Country: Number of subjects enrolled
    Turkey: 19
    Country: Number of subjects enrolled
    United Kingdom: 13
    Country: Number of subjects enrolled
    United States: 8
    Worldwide total number of subjects
    307
    EEA total number of subjects
    156
    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)
    35
    Children (2-11 years)
    177
    Adolescents (12-17 years)
    95
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The base study consisted of one cycle of treatment (Cycle 1). Participants in either treatment group who met the eligibility criteria were eligible to participate in optional open-label aprepitant treatment for an additional 5 cycles (Cycles 2-6).

    Period 1
    Period 1 title
    Base Study (Cycle 1)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Aprepitant Regimen
    Arm description
    Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) +ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg).
    Arm type
    Experimental

    Investigational medicinal product name
    Aprepitant 125 mg
    Investigational medicinal product code
    A04AD12
    Other name
    MK-0869, Emend
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    On the morning of Day 1: one 125 mg capsule PO 60 minutes prior to chemotherapy for participants 12 to 17 years of age

    Investigational medicinal product name
    Aprepitant 80 mg
    Investigational medicinal product code
    A04AD12
    Other name
    MK-0869, Emend
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    On the morning of Days 2 and 3: one 80 mg capsule PO for participants 12 to 17 years of age

    Investigational medicinal product name
    Aprepitant powder for suspension (PFS)
    Investigational medicinal product code
    A04AD12
    Other name
    MK-0869, Emend
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    On the morning of Day 1: 3.0 mg/kg (up to 125 mg) PO 60 minutes prior to chemotherapy for participants 6 months to <12 years of age. On the morning of Days 2 and 3: 2.0 mg/kg (up to 80 mg) PO 60 minutes prior to chemotherapy (if applicable) for participants 6 months to <12 years of age

    Investigational medicinal product name
    Ondansetron
    Investigational medicinal product code
    Other name
    Zofran
    Pharmaceutical forms
    Capsule, Solution for injection
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Day 1: Administered according to product label for pediatric usage or local standard of care.

    Investigational medicinal product name
    Emetogenic chemotherapy
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Any moderately emetic, highly emetic, or very highly emetic chemotherapeutic agent such as cyclophosphamide, doxorubicin, methotrexate, carboplatin, cisplatin, irinotecan, carmustine, ifosfamide, and streptozocin, or chemotherapeutics of a lower emetogenicity that were not previously tolerated. No chemotherapeutic agents were specified by the protocol, and many could potentially have been used.

    Arm title
    Control Regimen
    Arm description
    Cycle 1: Participants 12 to 17 years of age, Day 1: dose-matched placebo for aprepitant 125 mg capsule oral (PO) + ondansetron. Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: dose-matched placebo for PFS (3.0 mg/kg, up to 125 mg) + ondansetron. Days 2 to 3: dose-matched placebo for PFS (2.0 mg/kg, up to 80 mg).
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo for Aprepitant 125 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    On the morning of Day 1: one dose-matched (125 mg) capsule PO 60 minutes prior to chemotherapy for participants 12 to 17 years of age

    Investigational medicinal product name
    Placebo for Aprepitant 80 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    On the morning of Days 2 and 3: one dose-matched (80 mg) capsule PO for participants 12 to 17 years of age

    Investigational medicinal product name
    Placebo for Aprepitant PFS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    On the morning of Day 1: dose-matched suspension (3.0 mg/kg, up to 125 mg) PO 60 minutes prior to chemotherapy for participants 6 months to <12 years of age. On the morning of Days 2 and 3: dosematched suspension (2.0 mg/kg, up to 80 mg) PO 60 minutes prior to chemotherapy (if applicable) for participants 6 months to <12 years of age.

    Investigational medicinal product name
    Ondansetron
    Investigational medicinal product code
    Other name
    Zofran
    Pharmaceutical forms
    Capsule, Solution for injection
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Day 1: Administered according to product label for pediatric usage or local standard of care.

    Investigational medicinal product name
    Emetogenic chemotherapy
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Any moderately emetic, highly emetic, or very highly emetic chemotherapeutic agent such as cyclophosphamide, doxorubicin, methotrexate, carboplatin, cisplatin, irinotecan, carmustine, ifosfamide, and streptozocin, or chemotherapeutics of a lower emetogenicity that were not previously tolerated. No chemotherapeutic agents were specified by the protocol, and many could potentially have been used.

    Number of subjects in period 1
    Aprepitant Regimen Control Regimen
    Started
    155
    152
    Treated (Intent To Treat Population)
    152
    150
    Completed
    150
    149
    Not completed
    5
    3
         Protocol deviation
    2
    -
         Physician decision
    -
    1
         Adverse event, non-fatal
    2
    -
         Consent withdrawn by subject
    1
    2
    Period 2
    Period 2 title
    Optional Extension (Cycles 2-6)
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Open Label Aprepitant (Cycles 2-6)
    Arm description
    Participants completing Cycle 1 from either the aprepitant or the control regimen who met eligibility criteria received open-label aprepitant administered in the same manner as in Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule PO + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant PFS, 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg).
    Arm type
    Experimental

    Investigational medicinal product name
    Aprepitant 125 mg
    Investigational medicinal product code
    A04AD12
    Other name
    MK-0869, Emend
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    On the morning of Day 1: one 125 mg capsule PO 60 minutes prior to chemotherapy for participants 12 to 17 years of age

    Investigational medicinal product name
    Aprepitant 80 mg
    Investigational medicinal product code
    A04AD12
    Other name
    MK-0869, Emend
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    On the morning of Days 2 and 3: one 80 mg capsule PO for participants 12 to 17 years of age

    Investigational medicinal product name
    Aprepitant powder for suspension (PFS)
    Investigational medicinal product code
    A04AD12
    Other name
    MK-0869, Emend
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    On the morning of Day 1: 3.0 mg/kg (up to 125 mg) PO 60 minutes prior to chemotherapy for participants 6 months to <12 years of age. On the morning of Days 2 and 3: 2.0 mg/kg (up to 80 mg) PO 60 minutes prior to chemotherapy (if applicable) for participants 6 months to <12 years of age

    Investigational medicinal product name
    Ondansetron
    Investigational medicinal product code
    Other name
    Zofran
    Pharmaceutical forms
    Capsule, Solution for injection
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Day 1: Administered according to product label for pediatric usage or local standard of care.

    Investigational medicinal product name
    Emetogenic chemotherapy
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Any moderately emetic, highly emetic, or very highly emetic chemotherapeutic agent such as cyclophosphamide, doxorubicin, methotrexate, carboplatin, cisplatin, irinotecan, carmustine, ifosfamide, and streptozocin, or chemotherapeutics of a lower emetogenicity that were not previously tolerated. No chemotherapeutic agents were specified by the protocol, and many could potentially have been used.

    Number of subjects in period 2 [1]
    Open Label Aprepitant (Cycles 2-6)
    Started
    171
    Treated
    170
    Completed
    46
    Not completed
    125
         Protocol deviation
    4
         Physician decision
    19
         Lack of efficacy
    1
         Completed Chemotherapy Regimen
    51
         Did Not Respond To Chemotherapy Regimen
    4
         Adverse event, non-fatal
    2
         Did Not Meet Additional Criteria
    25
         Consent withdrawn by subject
    18
         Lost to follow-up
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Cycles 2-6 were optional and not required for the study. Following Cycle 1, 171 subjects elected to participate in the optional cycles (Cycles 2-6).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Aprepitant Regimen
    Reporting group description
    Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) +ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg).

    Reporting group title
    Control Regimen
    Reporting group description
    Cycle 1: Participants 12 to 17 years of age, Day 1: dose-matched placebo for aprepitant 125 mg capsule oral (PO) + ondansetron. Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: dose-matched placebo for PFS (3.0 mg/kg, up to 125 mg) + ondansetron. Days 2 to 3: dose-matched placebo for PFS (2.0 mg/kg, up to 80 mg).

    Reporting group values
    Aprepitant Regimen Control Regimen Total
    Number of subjects
    155 152 307
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    97.4 ± 62.8 99.2 ± 60.8 -
    Gender categorical
    Units: Subjects
        Female
    69 71 140
        Male
    86 81 167
        Not recorded
    0 0 0
    Subject analysis sets

    Subject analysis set title
    Aprepitant Regimen-Intent-to-treat (ITT) Population
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Aprepitant Regimen ITT population; consisting of all randomized patients who received at least one dose of Aprepitant.

    Subject analysis set title
    Control Regimen-ITT Population
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Control Regimen ITT population; consisting of all randomized patients who received at least one dose of control.

    Subject analysis sets values
    Aprepitant Regimen-Intent-to-treat (ITT) Population Control Regimen-ITT Population
    Number of subjects
    152
    150
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    97.7 ± 63.2
    99.4 ± 60.9
    Gender categorical
    Units: Subjects
        Female
    68
    71
        Male
    84
    79
        Not recorded
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Aprepitant Regimen
    Reporting group description
    Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) +ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg).

    Reporting group title
    Control Regimen
    Reporting group description
    Cycle 1: Participants 12 to 17 years of age, Day 1: dose-matched placebo for aprepitant 125 mg capsule oral (PO) + ondansetron. Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: dose-matched placebo for PFS (3.0 mg/kg, up to 125 mg) + ondansetron. Days 2 to 3: dose-matched placebo for PFS (2.0 mg/kg, up to 80 mg).
    Reporting group title
    Open Label Aprepitant (Cycles 2-6)
    Reporting group description
    Participants completing Cycle 1 from either the aprepitant or the control regimen who met eligibility criteria received open-label aprepitant administered in the same manner as in Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule PO + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant PFS, 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg).

    Subject analysis set title
    Aprepitant Regimen-Intent-to-treat (ITT) Population
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Aprepitant Regimen ITT population; consisting of all randomized patients who received at least one dose of Aprepitant.

    Subject analysis set title
    Control Regimen-ITT Population
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Control Regimen ITT population; consisting of all randomized patients who received at least one dose of control.

    Primary: Percentage of Participants with a Complete Response in the Delayed Phase of Cycle 1

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    End point title
    Percentage of Participants with a Complete Response in the Delayed Phase of Cycle 1
    End point description
    The Delayed Phase was defined as 25-120 hours after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the delayed phase of Cycle 1.
    End point type
    Primary
    End point timeframe
    25 to 120 hours after the start of chemotherapy (Day 1)
    End point values
    Aprepitant Regimen Control Regimen
    Number of subjects analysed
    152
    150
    Units: P e r c e n t a g e of participants
        number (not applicable)
    50.7
    26
    Statistical analysis title
    Complete Response in the Delayed Phase of Cycle 1
    Statistical analysis description
    Cochran-Mantel-Haenszel Analysis: Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.
    Comparison groups
    Aprepitant Regimen v Control Regimen
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    < 0.01
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [1] - The superiority hypotheses was evaluated by comparing the 1-tailed p-value to 0.025 and significance declared if this p-value was ≤0.025.

    Secondary: Percentage of Participants with a Complete Response in the Acute Phase of Cycle 1

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    End point title
    Percentage of Participants with a Complete Response in the Acute Phase of Cycle 1
    End point description
    The Acute phase was defined as 0 to 24 hours after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the Acute Phase of Cycle 1.
    End point type
    Secondary
    End point timeframe
    0 to 24 hours after initiation of chemotherapy (Day 1)
    End point values
    Aprepitant Regimen Control Regimen
    Number of subjects analysed
    152
    150
    Units: percentage of participants
        number (not applicable)
    66.4
    52
    Statistical analysis title
    Complete Response in the Acute Phase of Cycle 1
    Statistical analysis description
    Cochran-Mantel-Haenszel analysis was stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.
    Comparison groups
    Control Regimen v Aprepitant Regimen
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    superiority [2]
    P-value
    < 0.05
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [2] - The superiority hypotheses was evaluated by comparing the 1-tailed p-value to 0.025 and significance declared if this p-value was ≤0.025.

    Secondary: Percentage of Participants with a Complete Response in the Overall Phase of Cycle 1

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    End point title
    Percentage of Participants with a Complete Response in the Overall Phase of Cycle 1
    End point description
    The Overall Phase was defined as 0 to 120 hours after the start of chemotherapy. Complete Response was defined as no vomiting or retching and no use of rescue medication in the Overall Phase of Cycle 1.
    End point type
    Secondary
    End point timeframe
    0 to 120 hours after initiation of chemotherapy (Day 1)
    End point values
    Aprepitant Regimen Control Regimen
    Number of subjects analysed
    152
    150
    Units: percentage of participants
        number (not applicable)
    40.1
    20
    Statistical analysis title
    Complete Response in the Overall Phase of Cycle 1
    Statistical analysis description
    Cochran-Mantel-Haenszel Analysis: Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.
    Comparison groups
    Aprepitant Regimen v Control Regimen
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    P-value
    < 0.01
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [3] - The superiority hypotheses was evaluated by comparing the 1-tailed p-value to 0.025 and significance declared if this p-value was ≤0.025.

    Secondary: Percentage of Participants with No Vomiting in the Overall Phase of Cycle 1

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    End point title
    Percentage of Participants with No Vomiting in the Overall Phase of Cycle 1
    End point description
    The Overall Phase was defined as 0 to 120 hours after the start of chemotherapy. No vomiting was defined as no emesis or retching or dry heaves in the Overall Phase of Cycle 1.
    End point type
    Secondary
    End point timeframe
    0 to 120 hours after initiation of chemotherapy (Day 1)
    End point values
    Aprepitant Regimen Control Regimen
    Number of subjects analysed
    152
    150
    Units: percentage of participants
        number (not applicable)
    46.7
    21.3
    Statistical analysis title
    No Vomiting in the Overall Phase of Cycle 1
    Statistical analysis description
    Cochran-Mantel-Haenszel Analysis: Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.
    Comparison groups
    Aprepitant Regimen v Control Regimen
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    superiority [4]
    P-value
    < 0.01
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [4] - The superiority hypotheses was evaluated by comparing the 1-tailed p-value to 0.025 and significance declared if this p-value was ≤0.025.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    14 days after the last dose of study drug (for maximum of 6 cycles, up to 6 months)
    Adverse event reporting additional description
    Intent-to-treat (ITT) population: all randomized participants who received study medication.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Aprepitant Regimen Cycle 1
    Reporting group description
    Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg).

    Reporting group title
    Aprepitant Regimen Cycles 2-6
    Reporting group description
    Participants completing Cycle 1 from either the aprepitant or the control regimen who met eligibility criteria received open-label aprepitant administered in the same manner as in Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg).

    Reporting group title
    Control Regimen Cycle 1
    Reporting group description
    Cycle 1: Participants 12 to 17 years of age, Day 1: dose-matched placebo for aprepitant 125 mg capsule oral (PO) + ondansetron. Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: dose-matched placebo for PFS (3.0 mg/kg, up to 125 mg) + ondansetron. Days 2 to 3: dose-matched placebo for PFS (2.0 mg/kg, up to 80 mg).

    Serious adverse events
    Aprepitant Regimen Cycle 1 Aprepitant Regimen Cycles 2-6 Control Regimen Cycle 1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    46 / 152 (30.26%)
    84 / 170 (49.41%)
    41 / 150 (27.33%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Epithelioid sarcoma
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Neuroblastoma
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 170 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Osteosarcoma recurrent
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Tumour haemorrhage
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    1 / 152 (0.66%)
    1 / 170 (0.59%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 170 (0.00%)
    0 / 150 (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
    Drug hypersensitivity
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 170 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Catheter site pain
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Chills
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Mucosal inflammation
         subjects affected / exposed
    2 / 152 (1.32%)
    3 / 170 (1.76%)
    2 / 150 (1.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Thrombosis in device
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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 / 152 (0.00%)
    8 / 170 (4.71%)
    2 / 150 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Toxicity to various agents
         subjects affected / exposed
    0 / 152 (0.00%)
    2 / 170 (1.18%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound complication
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Wound dehiscence
         subjects affected / exposed
    0 / 152 (0.00%)
    2 / 170 (1.18%)
    0 / 150 (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
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Drug clearance decreased
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 170 (0.00%)
    0 / 150 (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
    Neutrophil count decreased
         subjects affected / exposed
    1 / 152 (0.66%)
    4 / 170 (2.35%)
    2 / 150 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Electrocardiogram T wave inversion
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 170 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    2 / 152 (1.32%)
    1 / 170 (0.59%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 170 (0.00%)
    0 / 150 (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
    Respiratory, thoracic and mediastinal disorders
    Pulmonary oedema
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Tracheal inflammation
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Agranulocytosis
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Anaemia
         subjects affected / exposed
    2 / 152 (1.32%)
    9 / 170 (5.29%)
    3 / 150 (2.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 11
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone marrow failure
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    23 / 152 (15.13%)
    53 / 170 (31.18%)
    22 / 150 (14.67%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 88
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 152 (0.00%)
    2 / 170 (1.18%)
    0 / 150 (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
    Neutropenia
         subjects affected / exposed
    4 / 152 (2.63%)
    4 / 170 (2.35%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    3 / 152 (1.97%)
    4 / 170 (2.35%)
    6 / 150 (4.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 152 (0.00%)
    3 / 170 (1.76%)
    2 / 150 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Presyncope
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 170 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Abdominal pain
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 170 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Caecitis
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 170 (0.00%)
    0 / 150 (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
    Duodenitis
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Gastritis erosive
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Haematochezia
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Intestinal obstruction
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Oesophagitis
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Stomatitis
         subjects affected / exposed
    1 / 152 (0.66%)
    1 / 170 (0.59%)
    0 / 150 (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
    Vomiting
         subjects affected / exposed
    2 / 152 (1.32%)
    8 / 170 (4.71%)
    3 / 150 (2.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatotoxicity
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 170 (0.00%)
    0 / 150 (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
    Renal failure acute
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Haematuria
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Renal tubular disorder
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 152 (0.00%)
    4 / 170 (2.35%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    0 / 152 (0.00%)
    3 / 170 (1.76%)
    0 / 150 (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
    Hypokalaemia
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 170 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Bacillus infection
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 170 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Balanoposthitis infective
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Bronchitis
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 170 (0.00%)
    1 / 150 (0.67%)
         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 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Clostridium difficile infection
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 170 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    2 / 152 (1.32%)
    0 / 170 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Enterobiasis
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Enterococcal sepsis
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Gastroenteritis clostridial
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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 infection
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Otitis media acute
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 170 (0.00%)
    0 / 150 (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
    Pneumonia
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 170 (0.00%)
    0 / 150 (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
    Postoperative wound infection
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    1 / 152 (0.66%)
    1 / 170 (0.59%)
    0 / 150 (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
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Varicella
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 170 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 152 (0.00%)
    3 / 170 (1.76%)
    2 / 150 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 170 (0.59%)
    0 / 150 (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
    Wound infection
         subjects affected / exposed
    0 / 152 (0.00%)
    2 / 170 (1.18%)
    0 / 150 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Aprepitant Regimen Cycle 1 Aprepitant Regimen Cycles 2-6 Control Regimen Cycle 1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    106 / 152 (69.74%)
    86 / 170 (50.59%)
    109 / 150 (72.67%)
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    8 / 152 (5.26%)
    14 / 170 (8.24%)
    6 / 150 (4.00%)
         occurrences all number
    9
    27
    7
    Platelet count decreased
         subjects affected / exposed
    10 / 152 (6.58%)
    26 / 170 (15.29%)
    15 / 150 (10.00%)
         occurrences all number
    10
    58
    16
    Neutrophil count decreased
         subjects affected / exposed
    12 / 152 (7.89%)
    32 / 170 (18.82%)
    17 / 150 (11.33%)
         occurrences all number
    12
    83
    19
    White blood cell count decreased
         subjects affected / exposed
    5 / 152 (3.29%)
    12 / 170 (7.06%)
    6 / 150 (4.00%)
         occurrences all number
    5
    15
    6
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    9 / 152 (5.92%)
    18 / 170 (10.59%)
    5 / 150 (3.33%)
         occurrences all number
    9
    25
    6
    Epistaxis
         subjects affected / exposed
    3 / 152 (1.97%)
    10 / 170 (5.88%)
    3 / 150 (2.00%)
         occurrences all number
    3
    15
    3
    Rhinorrhoea
         subjects affected / exposed
    2 / 152 (1.32%)
    11 / 170 (6.47%)
    1 / 150 (0.67%)
         occurrences all number
    2
    11
    1
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    8 / 152 (5.26%)
    13 / 170 (7.65%)
    10 / 150 (6.67%)
         occurrences all number
    9
    22
    11
    Anaemia
         subjects affected / exposed
    24 / 152 (15.79%)
    62 / 170 (36.47%)
    35 / 150 (23.33%)
         occurrences all number
    25
    134
    38
    Thrombocytopenia
         subjects affected / exposed
    15 / 152 (9.87%)
    38 / 170 (22.35%)
    14 / 150 (9.33%)
         occurrences all number
    15
    80
    16
    Neutropenia
         subjects affected / exposed
    17 / 152 (11.18%)
    39 / 170 (22.94%)
    18 / 150 (12.00%)
         occurrences all number
    17
    74
    20
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 152 (7.24%)
    14 / 170 (8.24%)
    7 / 150 (4.67%)
         occurrences all number
    11
    15
    7
    General disorders and administration site conditions
    Mucosal inflammation
         subjects affected / exposed
    1 / 152 (0.66%)
    11 / 170 (6.47%)
    5 / 150 (3.33%)
         occurrences all number
    1
    13
    5
    Pyrexia
         subjects affected / exposed
    8 / 152 (5.26%)
    22 / 170 (12.94%)
    10 / 150 (6.67%)
         occurrences all number
    8
    27
    10
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    11 / 152 (7.24%)
    17 / 170 (10.00%)
    10 / 150 (6.67%)
         occurrences all number
    15
    26
    15
    Abdominal pain upper
         subjects affected / exposed
    0 / 152 (0.00%)
    10 / 170 (5.88%)
    1 / 150 (0.67%)
         occurrences all number
    0
    12
    1
    Constipation
         subjects affected / exposed
    3 / 152 (1.97%)
    12 / 170 (7.06%)
    6 / 150 (4.00%)
         occurrences all number
    3
    15
    6
    Diarrhoea
         subjects affected / exposed
    8 / 152 (5.26%)
    16 / 170 (9.41%)
    8 / 150 (5.33%)
         occurrences all number
    11
    23
    8
    Nausea
         subjects affected / exposed
    13 / 152 (8.55%)
    42 / 170 (24.71%)
    17 / 150 (11.33%)
         occurrences all number
    20
    78
    20
    Stomatitis
         subjects affected / exposed
    5 / 152 (3.29%)
    12 / 170 (7.06%)
    4 / 150 (2.67%)
         occurrences all number
    6
    16
    4
    Vomiting
         subjects affected / exposed
    21 / 152 (13.82%)
    59 / 170 (34.71%)
    20 / 150 (13.33%)
         occurrences all number
    31
    152
    21

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jul 2012
    AMENDMENT 02: The primary reason for this amendment is to satisfy requirements proposed by the Food and Drug Administration (FDA) Written Request and to address the aprepitant Chemotherapy-Induced Nausea and Vomiting (CINV) Pediatric Research Equity Act (PREA) requirements. The minimum age requirement for eligibility has been changed to 6 months of age. Patients will be stratified into 4 age groups as follows: 12-17 years; 6 years to < 12 years; 2 years to <6 years; and 6 months to <2 years.
    29 Aug 2012
    AMENDMENT 03: Amendment 02 was immediately replaced with Amendment 03 after an error was discovered in the Cycle 1 Flow Chart.

    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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