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    Clinical Trial Results:
    A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of a Single 150 mg Dose of Intravenous Fosaprepitant Dimeglumine for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated with Moderately Emetogenic Chemotherapy

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2012-001718-41
    Trial protocol
    		 FI   NL   ES   CZ   SE   HU   IT   PT   LV   PL   BG   GR   NO   HR  
    Global end of trial date
    03 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Feb 2016
    First version publication date
    06 Feb 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MK-0517-031
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01594749
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Merck Protocol Number: MK-0517-031
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Nov 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study aims to demonstrate that, when given concomitantly with a 5-hydroxytryptamine 3 (5-HT3) antagonist and a corticosteroid, a single 150 mg intravenous (IV) dose of fosaprepitant given on Day 1 is superior to the control regimen of 5-HT3 antagonist and corticosteroid only, in preventing chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC).
    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: Rescue medication was allowed for established cases of nausea or vomiting.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Sep 2012
    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: 48
    Country: Number of subjects enrolled
    Bulgaria: 9
    Country: Number of subjects enrolled
    Canada: 9
    Country: Number of subjects enrolled
    Chile: 2
    Country: Number of subjects enrolled
    Colombia: 21
    Country: Number of subjects enrolled
    Croatia: 13
    Country: Number of subjects enrolled
    Czech Republic: 42
    Country: Number of subjects enrolled
    Finland: 10
    Country: Number of subjects enrolled
    Germany: 46
    Country: Number of subjects enrolled
    Greece: 60
    Country: Number of subjects enrolled
    Hungary: 70
    Country: Number of subjects enrolled
    Italy: 36
    Country: Number of subjects enrolled
    Latvia: 25
    Country: Number of subjects enrolled
    Mexico: 9
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    Norway: 12
    Country: Number of subjects enrolled
    Peru: 55
    Country: Number of subjects enrolled
    Philippines: 26
    Country: Number of subjects enrolled
    Poland: 36
    Country: Number of subjects enrolled
    Portugal: 16
    Country: Number of subjects enrolled
    Puerto Rico: 16
    Country: Number of subjects enrolled
    Romania: 51
    Country: Number of subjects enrolled
    Russian Federation: 52
    Country: Number of subjects enrolled
    South Africa: 19
    Country: Number of subjects enrolled
    Spain: 64
    Country: Number of subjects enrolled
    Sweden: 31
    Country: Number of subjects enrolled
    Thailand: 3
    Country: Number of subjects enrolled
    Turkey: 32
    Country: Number of subjects enrolled
    Ukraine: 14
    Country: Number of subjects enrolled
    United States: 182
    Worldwide total number of subjects
    1015
    EEA total number of subjects
    527
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    634
    From 65 to 84 years
    376
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 Males and females who were ≥18 years old and were scheduled to receive MEC were enrolled into this study. Additional inclusion and exclusion criteria applied.

    Pre-assignment
    Screening details
    		 A total of 14 participants were randomized but did not receive study drug. The source documents for one additional participant were lost. One participant was randomized to receive Control Regimen, but actually received Fosaprepitant Regimen. Disposition is by actual treatment group and not by randomized treatment group.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fosaprepitant Regimen
    Arm description
    		 On Day 1, participants received fosaprepitant, 150 mg intravenous (IV) infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, orally (PO) ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-hydroxytryptamine 3 (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
    Arm type
    		 Experimental

    Investigational medicinal product name
    fosaprepitant
    Investigational medicinal product code
    MK-0517
    Other name
    EMEND®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    fosaprepitant 150 mg IV infusion

    Investigational medicinal product name
    ondansetron
    Investigational medicinal product code
    Other name
    ZOFRAN®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Day 1: ondansetron 8 mg PO + 8 mg PO 8 hours later; Days 2-3: placebo to ondansetron PO every 12 hours

    Investigational medicinal product name
    dexamethasone
    Investigational medicinal product code
    Other name
    DECADRON®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Day 1: dexamethasone 12 mg PO (3 capsules of dexamethasone 4 mg + 2 capsules of placebo)

    Arm title
    		 Control Regimen
    Arm description
    		 On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    placebo for fosaprepitant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    150 mL IV infusion

    Investigational medicinal product name
    ondansetron
    Investigational medicinal product code
    Other name
    ZOFRAN®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Day 1: ondansetron 8 mg PO and 8 mg PO 8 hrs later; Days 2-3: ondansetron 8 mg PO every 12 hours

    Investigational medicinal product name
    dexamethasone
    Investigational medicinal product code
    Other name
    DECADRON®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Day 1: dexamethasone 20 mg PO (5 capsules of dexamethasone 4 mg)

    Number of subjects in period 1
    		Fosaprepitant Regimen Control Regimen
    Started
    508
    507
    Treated
    504
    497
    Completed
    487
    489
    Not completed
    21
    18
         Adverse event, serious fatal
    9
    3
         Consent withdrawn by subject
    2
    2
         Physician decision
    1
    1
         Adverse event, non-fatal
    2
    1
         Lost to follow-up
    1
    -
         Non-compliance with Protocol
    -
    1
         Protocol deviation
    2
    -
         Not treated
    4
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fosaprepitant Regimen
    Reporting group description
    		 On Day 1, participants received fosaprepitant, 150 mg intravenous (IV) infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, orally (PO) ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-hydroxytryptamine 3 (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.

    Reporting group title
    Control Regimen
    Reporting group description
    		 On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.

    Reporting group values
    		 Fosaprepitant Regimen Control Regimen Total
    Number of subjects
    		 508 507 1015
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 311 323 634
        From 65-84 years
    		 193 183 376
        85 years and over
    		 4 1 5
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 60.1 ( 11.8 ) 59.2 ( 12.3 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 299 301 600
        Male
    		 209 206 415

    End points

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    End points reporting groups
    Reporting group title
    Fosaprepitant Regimen
    Reporting group description
    		 On Day 1, participants received fosaprepitant, 150 mg intravenous (IV) infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, orally (PO) ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-hydroxytryptamine 3 (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.

    Reporting group title
    Control Regimen
    Reporting group description
    		 On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.

    Subject analysis set title
    Fosaprepitant Regimen - ITT Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intent-to-Treat (ITT) efficacy population consisted of all participants in the group to which they were randomized and who received at least one dose of study drug. One participant with missing source documents was excluded from the efficacy analyses.

    Subject analysis set title
    Fosaprepitant Regimen - Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population consisted of All Participants as Treated (APaT) which includes all randomized participants who received at least one dose of study medication.

    Subject analysis set title
    Control Regimen - ITT Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT efficacy population consisted of all participants in the group to which they were randomized and who received at least one dose of study drug.

    Subject analysis set title
    Control Regimen - Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population consisted of APaT which includes all randomized participants who received at least one dose of study medication.

    Primary: Percentage of participants with Complete Response from 25 to 120 hours after initiation of moderately emetogenic chemotherapy (MEC)

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    End point title
    		 Percentage of participants with Complete Response from 25 to 120 hours after initiation of moderately emetogenic chemotherapy (MEC)
    End point description
    A Complete Response was defined as no vomiting and no use of rescue medication.
    End point type
    Primary
    End point timeframe
    25 to 120 hours after initiation of MEC
    End point values
    		 Fosaprepitant Regimen - ITT Set Control Regimen - ITT Set
    Number of subjects analysed
    502
    498
    Units: Percentage of Participants
        number (not applicable)
    78.9
    68.5
    Statistical analysis title
    		 Percentage difference: Fosaprepitant vs. Control
    Comparison groups
    Fosaprepitant Regimen - ITT Set v Control Regimen - ITT Set
    Number of subjects included in analysis
    1000
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [1] - P-value based on Cochran-Mantel-Haenszel (CMH) method with stratification of gender

    Primary: Percentage of participants with infusion-site thrombophlebitis

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    End point title
    		 Percentage of participants with infusion-site thrombophlebitis
    End point description
    The percentages of participants with infusion-site thrombophlebitis are presented. Thrombophlebitis was defined as a condition affecting a superficial vein used for an IV infusion, associated with red color, hardness upon palpation, and the presence of a tender cord and possible fever.
    End point type
    Primary
    End point timeframe
    Day 1 through Day 17, inclusive
    End point values
    		 Fosaprepitant Regimen - Safety Set Control Regimen - Safety Set
    Number of subjects analysed
    504
    497
    Units: Percentage of Participants
        number (not applicable)
    0.6
    0
    Statistical analysis title
    		 Percentage Difference: Fosaprepitant vs. Control
    Comparison groups
    Fosaprepitant Regimen - Safety Set v Control Regimen - Safety Set
    Number of subjects included in analysis
    1001
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.085 [2]
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in percentage vs. Control
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 1.7
    Notes
    [2] - P-value based on Miettinen & Nurminen method

    Primary: Percentage of participants with severe infusion-site reactions

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    End point title
    		 Percentage of participants with severe infusion-site reactions [3]
    End point description
    The percentages of participants with severe infusion-site reactions, including severe site pain, or severe site redness (erythema) or severe site hardness (induration) are presented.
    End point type
    Primary
    End point timeframe
    Day 1 through Day 17, inclusive
    Notes
    [3] - 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 participants experienced a severe infusion-site reaction, so no statistical analyses were performed.
    End point values
    		 Fosaprepitant Regimen - Safety Set Control Regimen - Safety Set
    Number of subjects analysed
    504
    497
    Units: Percentage of Participants
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants with Complete Response from 0 to 120 hours after initiation of MEC

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    End point title
    		 Percentage of participants with Complete Response from 0 to 120 hours after initiation of MEC
    End point description
    A Complete Response was defined as no vomiting and no use of rescue medication.
    End point type
    Secondary
    End point timeframe
    0 to 120 hours after initiation of MEC
    End point values
    		 Fosaprepitant Regimen - ITT Set Control Regimen - ITT Set
    Number of subjects analysed
    502
    498
    Units: Percentage of Participants
        number (not applicable)
    77.1
    66.9
    Statistical analysis title
    		 Percentage Difference: Fosaprepitant vs. Control
    Comparison groups
    Fosaprepitant Regimen - ITT Set v Control Regimen - ITT Set
    Number of subjects included in analysis
    1000
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [4] - P-value based on CMH method with stratification of gender

    Secondary: Percentage of participants with Complete Response from 0 to 24 hours after initiation of MEC

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    End point title
    		 Percentage of participants with Complete Response from 0 to 24 hours after initiation of MEC
    End point description
    A Complete Response was defined as no vomiting and no use of rescue medication.
    End point type
    Secondary
    End point timeframe
    0 to 24 hours after initiation of MEC
    End point values
    		 Fosaprepitant Regimen - ITT Set Control Regimen - ITT Set
    Number of subjects analysed
    502
    498
    Units: Percentage of Participants
        number (not applicable)
    93.2
    91
    Statistical analysis title
    		 Percentage difference: Fosaprepitant vs. Control
    Comparison groups
    Fosaprepitant Regimen - ITT Set v Control Regimen - ITT Set
    Number of subjects included in analysis
    1000
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.184 [5]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [5] - P-value based on CMH method with stratification of gender

    Secondary: Percentage of participants with No Vomiting from 0 to 120 hours after initiation of MEC

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    End point title
    		 Percentage of participants with No Vomiting from 0 to 120 hours after initiation of MEC
    End point description
    No Vomiting was defined as no emetic (vomiting) episodes, including no vomiting and no retching or dry heaves (attempts to vomit that are not productive of stomach contents), regardless of use of rescue medication.
    End point type
    Secondary
    End point timeframe
    0 to 120 hours after initiation of MEC
    End point values
    		 Fosaprepitant Regimen - ITT Set Control Regimen - ITT Set
    Number of subjects analysed
    502
    498
    Units: Percentage of participants
        number (not applicable)
    82.7
    72.9
    Statistical analysis title
    		 Percentage difference: Fosaprepitant vs. Control
    Comparison groups
    Fosaprepitant Regimen - ITT Set v Control Regimen - ITT Set
    Number of subjects included in analysis
    1000
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [6] - P-value based on CMH method with stratification of gender

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
    Adverse event reporting additional description
    The Safety population consisted of all participants who received study drug. Participants are included in the treatment group based on the study drug they actually received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Control Regimen
    Reporting group description
    		 On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.

    Reporting group title
    Fosaprepitant Regimen
    Reporting group description
    		 On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.

    Serious adverse events
    		 Control Regimen Fosaprepitant Regimen
    Total subjects affected by serious adverse events
         subjects affected / exposed
    35 / 497 (7.04%)
    39 / 504 (7.74%)
         number of deaths (all causes)
    2
    8
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases to bone
         subjects affected / exposed
    1 / 497 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular disorders
    Thrombosis
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 497 (0.40%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 497 (0.00%)
    2 / 504 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Disease progression
         subjects affected / exposed
    1 / 497 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 497 (0.20%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 497 (0.20%)
    2 / 504 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 497 (0.20%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Haemoptysis
         subjects affected / exposed
    1 / 497 (0.20%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 497 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 497 (0.00%)
    2 / 504 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood glucose increased
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 497 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fracture
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 497 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 497 (0.20%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac disorder
         subjects affected / exposed
    1 / 497 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 497 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 497 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 497 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Abdominal lymphadenopathy
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    1 / 497 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    5 / 497 (1.01%)
    8 / 504 (1.59%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 497 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    4 / 497 (0.80%)
    3 / 504 (0.60%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 497 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 497 (0.20%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 497 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic colitis
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatitis
         subjects affected / exposed
    1 / 497 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 497 (0.20%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatorenal failure
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 497 (0.40%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    2 / 497 (0.40%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 497 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 497 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 497 (0.60%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 497 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 497 (0.00%)
    2 / 504 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 497 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 497 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Control Regimen Fosaprepitant Regimen
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    193 / 497 (38.83%)
    190 / 504 (37.70%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    35 / 497 (7.04%)
    30 / 504 (5.95%)
         occurrences all number
    37
    32
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    33 / 497 (6.64%)
    38 / 504 (7.54%)
         occurrences all number
    33
    38
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    64 / 497 (12.88%)
    75 / 504 (14.88%)
         occurrences all number
    64
    78
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    51 / 497 (10.26%)
    47 / 504 (9.33%)
         occurrences all number
    53
    48
    Diarrhoea
         subjects affected / exposed
    55 / 497 (11.07%)
    63 / 504 (12.50%)
         occurrences all number
    57
    66
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    26 / 497 (5.23%)
    11 / 504 (2.18%)
         occurrences all number
    26
    11
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    32 / 497 (6.44%)
    26 / 504 (5.16%)
         occurrences all number
    32
    27

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Mar 2013
    Amendment 04: This amendment provided important clarifications related to the targeted participant population and study procedures, including use of multiday chemotherapy, concomitant radiotherapy, contraception, and overdose. Several other operational clarifications were included such as dosing and administration details and specifying the documenting investigator review of laboratory tests and electrocardiograms prior to randomization.

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

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

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