<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01732458</url>
  </required_header>
  <id_info>
    <org_study_id>0869-219</org_study_id>
    <secondary_id>2011-006006-27</secondary_id>
    <nct_id>NCT01732458</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Aprepitant for the Prevention of Post-Operative Nausea and Vomiting in Children (MK-0869-219)</brief_title>
  <official_title>A Phase IIb, Partially-Blinded, Randomized, Active Comparator-Controlled Study to Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Aprepitant in Pediatric Patients for the Prevention of Post Operative Nausea and Vomiting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability&#xD;
      of aprepitant for the prevention of post-operative nausea and vomiting (PONV) in pediatric&#xD;
      participants.&#xD;
&#xD;
      Post-operative aprepitant plasma concentrations will be evaluated with a non-compartmental&#xD;
      analysis (NCA) at each dose and for each age cohort. Full PK profiles analyzed using&#xD;
      population PK modeling and simulation will be described in a separate report.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Because the opportunity to collect specimens for PK analyses in children will be limited, a&#xD;
      flexible sparse sampling scheme using ranges of collection times will be utilized which will&#xD;
      limit the burden to participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2013</start_date>
  <completion_date type="Actual">September 26, 2016</completion_date>
  <primary_completion_date type="Actual">September 26, 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>This study will be conducted as a partially blinded study. PK samples will not be collected from participants in the control group. To maintain a partial blind, approximately 3 participants randomly selected from each age group in each of the aprepitant treatment groups will not have PK sampling. All participants will remain blinded to the study treatment. The investigator and Sponsor will be blinded to the study medication in participants not providing PK samples. The investigator and Sponsor will remain blinded to the aprepitant dose given to participants from whom PK samples will be collected.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Concentration-time Curve of Aprepitant From Time 0 to the Last Measurable Concentration (AUC0-last) Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using a noncompartmental analysis (NCA). The limit of quantitation (LOQ) value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Concentration (Cmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Maximum Concentration (Tmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to &lt;12 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to &lt;12 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to &lt;12 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to &lt;6 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to &lt;6 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to &lt;6 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to &lt;2 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to &lt;2 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to &lt;2 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-last Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to &lt;12 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to &lt;12 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to &lt;12 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to &lt;6 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to &lt;6 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to &lt;6 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to &lt;2 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to &lt;2 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to &lt;2 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-last Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to &lt;12 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to &lt;12 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to &lt;12 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to &lt;6 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to &lt;6 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to &lt;6 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to &lt;2 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to &lt;2 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to &lt;2 Year Age Group</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC0-inf) Following Administration of Single Dose</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Plasma for aprepitant AUC0-inf assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. AUC0-inf data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Total Clearance (CL/F) of Aprepitant From Plasma Following Administration of Single Dose</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Plasma for aprepitant CL/F assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. CL/F data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Terminal Half-life (t ½) of Aprepitant Following Administration of Single Dose</measure>
    <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
    <description>Plasma for aprepitant t ½ assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. t ½ data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Experiencing at Least One Adverse Event (AE)</measure>
    <time_frame>From pre-operative phase up to Follow-up (Day 1 to Day 15)</time_frame>
    <description>An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants experiencing ≥1 AE was reported by dose group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Discontinuing Study Due to an AE</measure>
    <time_frame>From pre-operative phase up to Follow-up (Day 1 to Day 15)</time_frame>
    <description>An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants discontinuing study due to an AE was reported by dose group.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">229</enrollment>
  <condition>Post-operative Nausea</condition>
  <condition>Post-operative Vomiting</condition>
  <arm_group>
    <arm_group_label>Aprepitant Dose 1: Equivalent to 125 mg in Adults</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pediatric participants receive a single dose of apprepitant that is equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered intravenously (IV) immediately prior to anesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aprepitant Dose 2: Equivalent to 40 mg in Adults</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pediatric participants receive a single dose of apprepitant that is equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aprepitant Dose 3: Equivalent to 10 mg in Adults</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pediatric participants receive a single dose of apprepitant that is equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ondansetron</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pediatric participants in the control regimen are administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aprepitant</intervention_name>
    <description>Administered as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia. Aprepitant was supplied in a sachet containing a powder for suspension (PFS) that was reconstituted up to total volume of 5 mL using potable water.</description>
    <arm_group_label>Aprepitant Dose 1: Equivalent to 125 mg in Adults</arm_group_label>
    <arm_group_label>Aprepitant Dose 2: Equivalent to 40 mg in Adults</arm_group_label>
    <arm_group_label>Aprepitant Dose 3: Equivalent to 10 mg in Adults</arm_group_label>
    <other_name>MK-0869</other_name>
    <other_name>EMEND™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to Aprepitant</intervention_name>
    <arm_group_label>Ondansetron</arm_group_label>
    <other_name>Matching placebo to aprepritant was administered as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ondansetron</intervention_name>
    <description>Administered IV at a dose of 4 mg for participants &gt;40 kg in weight and 0.1 mg/kg for participants ≤40 kg in weight. In participants &lt;1 month of age, the dose of ondansetron was administered per the product label or based on local standard of care. Ondansetron was supplied by the Sponsor as vials or ampules, depending on the country.</description>
    <arm_group_label>Ondansetron</arm_group_label>
    <other_name>Zofran</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to match ondansetron</intervention_name>
    <description>Participants in the aprepitant regimen received normal saline IV (provided by the site) as the placebo for ondansetron on Day 1, immediately prior to induction of anesthesia.</description>
    <arm_group_label>Aprepitant Dose 1: Equivalent to 125 mg in Adults</arm_group_label>
    <arm_group_label>Aprepitant Dose 2: Equivalent to 40 mg in Adults</arm_group_label>
    <arm_group_label>Aprepitant Dose 3: Equivalent to 10 mg in Adults</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant enrolled at birth should be at least 37 weeks gestation and ≥3 kg of&#xD;
             weight&#xD;
&#xD;
          -  Scheduled to receive general anesthesia AND must have at least one of the following&#xD;
             risk factors for post-operative nausea and vomiting (PONV) in addition to receiving&#xD;
             general anesthesia:&#xD;
&#xD;
               1. scheduled to have a surgery with an associated risk of PONV: tonsillectomy,&#xD;
                  adenoidectomy, strabismus surgery, dental surgery, hydrocelectomy, orchidopexy or&#xD;
                  herniorraphy; OR&#xD;
&#xD;
               2. scheduled to have an operative procedure associated with PONV: intraoperative&#xD;
                  opioid use or anticipated opioid administration within the first 24 hours&#xD;
                  following surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency surgery for a life-threatening condition&#xD;
&#xD;
          -  Scheduled to receive propofol for maintenance of anesthesia (Note: propofol is&#xD;
             permitted for induction of anesthesia).&#xD;
&#xD;
          -  Expected to receive opioid antagonists (e.g., naloxone, naltrexone) or&#xD;
&#xD;
        benzodiazepine antagonists (e.g., flumazenil)&#xD;
&#xD;
          -  Scheduled to undergo cardiac or neurosurgery&#xD;
&#xD;
          -  Vomiting caused by any organic etiology (such as gastric outlet&#xD;
&#xD;
        obstruction or small bowel obstruction)&#xD;
&#xD;
          -  Vomiting within 24 hours prior to surgery&#xD;
&#xD;
          -  Participant had a nasogastric or oral gastric tube intra- or post-operatively for&#xD;
             suctioning gastric contents (note: nasogastric or oral gastric tube intra- or&#xD;
             post-operatively could only be used for feeding. Participants were to be excluded if a&#xD;
             nasogastric or oral gastric tube for suctioning was routinely used for the type of&#xD;
             surgery being performed)&#xD;
&#xD;
          -  Active infection (e.g., pneumonia), congestive heart failure, bradyarrythmia, any&#xD;
             uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction)&#xD;
             except for malignancy, or a history of any illness which in the opinion of the&#xD;
             investigator, might confound the results of the study or pose unwarranted risk to the&#xD;
             participant&#xD;
&#xD;
          -  Use of any illicit drugs, including marijuana or has current evidence of alcohol abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <removed_countries>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Czech Republic</country>
    <country>Guatemala</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Mexico</country>
    <country>Peru</country>
    <country>Puerto Rico</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United States</country>
  </removed_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <results_first_submitted>August 4, 2017</results_first_submitted>
  <results_first_submitted_qc>August 4, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">September 6, 2017</results_first_posted>
  <last_update_submitted>August 27, 2018</last_update_submitted>
  <last_update_submitted_qc>August 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ondansetron</mesh_term>
    <mesh_term>Aprepitant</mesh_term>
    <mesh_term>Fosaprepitant</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Of 262 screened for inclusion, 229 were randomized to treatment. 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose arm that was not evaluated in this study; therefore the participant was not included in any analyses. Of remaining 228 randomized participants, 8 did not receive treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Aprepitant Dose 1: Equivalent to 125 mg in Adults</title>
          <description>Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered intravenously (IV) immediately prior to anesthesia.</description>
        </group>
        <group group_id="P2">
          <title>Aprepitant Dose 2: Equivalent to 40 mg in Adults</title>
          <description>Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
        </group>
        <group group_id="P3">
          <title>Aprepitant Dose 3: Equivalent to 10 mg in Adults</title>
          <description>Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
        </group>
        <group group_id="P4">
          <title>Ondansetron</title>
          <description>Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="58"/>
                <participants group_id="P3" count="58"/>
                <participants group_id="P4" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="55"/>
                <participants group_id="P3" count="56"/>
                <participants group_id="P4" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="53"/>
                <participants group_id="P3" count="55"/>
                <participants group_id="P4" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-Compliance With Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Screen Failure</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All Participants as Treated (APaT) population; all randomized participants who received at least 1 dose of study treatment.</population>
      <group_list>
        <group group_id="B1">
          <title>Aprepitant Dose 1: Equivalent to 125 mg in Adults</title>
          <description>Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered intravenously (IV) immediately prior to anesthesia.</description>
        </group>
        <group group_id="B2">
          <title>Aprepitant Dose 2: Equivalent to 40 mg in Adults</title>
          <description>Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
        </group>
        <group group_id="B3">
          <title>Aprepitant Dose 3: Equivalent to 10 mg in Adults</title>
          <description>Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
        </group>
        <group group_id="B4">
          <title>Ondansetron</title>
          <description>Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="57"/>
            <count group_id="B2" value="55"/>
            <count group_id="B3" value="56"/>
            <count group_id="B4" value="52"/>
            <count group_id="B5" value="220"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="90.4" spread="64.3"/>
                    <measurement group_id="B2" value="87.5" spread="64.6"/>
                    <measurement group_id="B3" value="85.1" spread="59.7"/>
                    <measurement group_id="B4" value="86.0" spread="65.0"/>
                    <measurement group_id="B5" value="87.3" spread="63.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Birth to &lt;2 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 years to &lt;6 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 years to &lt;12 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 years to 17 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="36"/>
                    <measurement group_id="B5" value="134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration-time Curve of Aprepitant From Time 0 to the Last Measurable Concentration (AUC0-last) Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group</title>
        <description>AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using a noncompartmental analysis (NCA). The limit of quantitation (LOQ) value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve of Aprepitant From Time 0 to the Last Measurable Concentration (AUC0-last) Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group</title>
          <description>AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using a noncompartmental analysis (NCA). The limit of quantitation (LOQ) value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hr*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7120" spread="33.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Concentration (Cmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group</title>
        <description>Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Concentration (Cmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group</title>
          <description>Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1340" spread="43.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time to Maximum Concentration (Tmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group</title>
        <description>Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Maximum Concentration (Tmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group</title>
          <description>Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hour (hr)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.86" spread="56.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to &lt;12 Year Age Group</title>
        <description>AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 6 to &lt;12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 1: Equivalent to 125 mg in Adults; 6 to &lt;12</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to &lt;12 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to &lt;12 Year Age Group</title>
          <description>AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 6 to &lt;12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hr*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10300" spread="39.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to &lt;12 Year Age Group</title>
        <description>Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 6 to &lt;12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 1: Equivalent to 125 mg in Adults; 6 to &lt;12</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to &lt;12 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to &lt;12 Year Age Group</title>
          <description>Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 6 to &lt;12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1870" spread="53.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to &lt;12 Year Age Group</title>
        <description>Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 6 to &lt;12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 1: Equivalent to 125 mg in Adults; 6 to &lt;12</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to &lt;12 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to &lt;12 Year Age Group</title>
          <description>Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 6 to &lt;12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.82" spread="26.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to &lt;6 Year Age Group</title>
        <description>AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 2 to &lt;6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 1: Equivalent to 125 mg in Adults; 2 to &lt;6</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to &lt;6 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to &lt;6 Year Age Group</title>
          <description>AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 2 to &lt;6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hr*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12000" spread="39.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to &lt;6 Year Age Group</title>
        <description>Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 2 to &lt;6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 1: Equivalent to 125 mg in Adults; 2 to &lt;6</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to &lt;6 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to &lt;6 Year Age Group</title>
          <description>Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 2 to &lt;6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2260" spread="35.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to &lt;6 Year Age Group</title>
        <description>Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 2 to &lt;6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 1: Equivalent to 125 mg in Adults; 2 to &lt;6</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to &lt;6 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to &lt;6 Year Age Group</title>
          <description>Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 2 to &lt;6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.91" spread="51.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to &lt;2 Year Age Group</title>
        <description>AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged birth to &lt;2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. Two participants were excluded from the analysis, due to a missing 8-hour post-dose sample and aprepitant concentration in the pre-dose sample, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 1: Equivalent to 125 mg in Adults; Birth to &lt;2</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to &lt;2 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to &lt;2 Year Age Group</title>
          <description>AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged birth to &lt;2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. Two participants were excluded from the analysis, due to a missing 8-hour post-dose sample and aprepitant concentration in the pre-dose sample, respectively.</population>
          <units>hr*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6410" spread="67.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to &lt;2 Year Age Group</title>
        <description>Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged birth to &lt;2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. One participant was excluded from the analysis due to aprepitant concentration in the pre-dose sample.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 1: Equivalent to 125 mg in Adults; Birth to &lt;2</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to &lt;2 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to &lt;2 Year Age Group</title>
          <description>Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged birth to &lt;2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. One participant was excluded from the analysis due to aprepitant concentration in the pre-dose sample.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1280" spread="78.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to &lt;2 Year Age Group</title>
        <description>Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged birth to &lt;2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 1: Equivalent to 125 mg in Adults; Birth to &lt;2</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to &lt;2 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to &lt;2 Year Age Group</title>
          <description>Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged birth to &lt;2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.71" spread="51.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC0-last Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group</title>
        <description>AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 2: Equivalent to 40 mg in Adults; 12 to 17</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-last Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group</title>
          <description>AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hr*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2570" spread="41.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group</title>
        <description>Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 2: Equivalent to 40 mg in Adults; 12 to 17</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group</title>
          <description>Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="513" spread="41.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group</title>
        <description>Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 2: Equivalent to 40 mg in Adults; 12 to 17</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group</title>
          <description>Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.17" spread="69.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to &lt;12 Year Age Group</title>
        <description>AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 6 to &lt;12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 2: Equivalent to 40 mg in Adults; 6 to &lt;12</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to &lt;12 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to &lt;12 Year Age Group</title>
          <description>AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 6 to &lt;12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hr*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4730" spread="60.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to &lt;12 Year Age Group</title>
        <description>Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 6 to &lt;12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 2: Equivalent to 40 mg in Adults; 6 to &lt;12</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to &lt;12 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to &lt;12 Year Age Group</title>
          <description>Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 6 to &lt;12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="930" spread="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to &lt;12 Year Age Group</title>
        <description>Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 6 to &lt;12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 2: Equivalent to 40 mg in Adults; 6 to &lt;12</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to &lt;12 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to &lt;12 Year Age Group</title>
          <description>Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 6 to &lt;12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.22" spread="53.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to &lt;6 Year Age Group</title>
        <description>AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 2 to &lt;6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 2: Equivalent to 40 mg in Adults; 2 to &lt;6</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to &lt;6 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to &lt;6 Year Age Group</title>
          <description>AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 2 to &lt;6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hr*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6320" spread="78.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to &lt;6 Year Age Group</title>
        <description>Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 2 to &lt;6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 2: Equivalent to 40 mg in Adults; 2 to &lt;6</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to &lt;6 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to &lt;6 Year Age Group</title>
          <description>Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 2 to &lt;6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1290" spread="81.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to &lt;6 Year Age Group</title>
        <description>Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 2 to &lt;6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 2: Equivalent to 40 mg in Adults; 2 to &lt;6</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to &lt;6 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to &lt;6 Year Age Group</title>
          <description>Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 2 to &lt;6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.35" spread="43.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to &lt;2 Year Age Group</title>
        <description>AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged birth to &lt;2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. One participant was excluded from the analysis due aprepitant concentration in the pre-dose sample.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 2: Equivalent to 40 mg in Adults; Birth to &lt;2</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to &lt;2 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to &lt;2 Year Age Group</title>
          <description>AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged birth to &lt;2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. One participant was excluded from the analysis due aprepitant concentration in the pre-dose sample.</population>
          <units>hr*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7910" spread="153.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to &lt;2 Year Age Group</title>
        <description>Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged birth to &lt;2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. One participant was excluded from the analysis due aprepitant concentration in the pre-dose sample.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 2: Equivalent to 40 mg in Adults; Birth to &lt;2</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to &lt;2 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to &lt;2 Year Age Group</title>
          <description>Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged birth to &lt;2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. One participant was excluded from the analysis due aprepitant concentration in the pre-dose sample.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1570" spread="146.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to &lt;2 Year Age Group</title>
        <description>Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged birth to &lt;2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 2: Equivalent to 40 mg in Adults; Birth to &lt;2</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to &lt;2 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to &lt;2 Year Age Group</title>
          <description>Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged birth to &lt;2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.94" spread="38.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC0-last Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group</title>
        <description>AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 3: Equivalent to 10 mg in Adults; 12 to 17</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-last Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group</title>
          <description>AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hr*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="806" spread="51.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group</title>
        <description>Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 3: Equivalent to 10 mg in Adults; 12 to 17</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group</title>
          <description>Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131" spread="50.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group</title>
        <description>Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 3: Equivalent to 10 mg in Adults; 12 to 17</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group</title>
          <description>Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.53" spread="54.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to &lt;12 Year Age Group</title>
        <description>AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 6 to &lt;12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 3: Equivalent to 10 mg in Adults; 6 to &lt;12</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to &lt;12 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to &lt;12 Year Age Group</title>
          <description>AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 6 to &lt;12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hr*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1390" spread="77.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to &lt;12 Year Age Group</title>
        <description>Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 6 to &lt;12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 3: Equivalent to 10 mg in Adults; 6 to &lt;12</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to &lt;12 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to &lt;12 Year Age Group</title>
          <description>Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 6 to &lt;12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="289" spread="128.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to &lt;12 Year Age Group</title>
        <description>Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 6 to &lt;12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 3: Equivalent to 10 mg in Adults; 6 to &lt;12</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to &lt;12 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to &lt;12 Year Age Group</title>
          <description>Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to &lt;12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 6 to &lt;12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.75" spread="57.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to &lt;6 Year Age Group</title>
        <description>AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 2 to &lt;6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 3: Equivalent to 10 mg in Adults; 2 to &lt;6</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to &lt;6 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to &lt;6 Year Age Group</title>
          <description>AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 2 to &lt;6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hr*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1580" spread="45.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to &lt;6 Year Age Group</title>
        <description>Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 2 to &lt;6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 3: Equivalent to 10 mg in Adults; 2 to &lt;6</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to &lt;6 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to &lt;6 Year Age Group</title>
          <description>Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 2 to &lt;6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="300" spread="49.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to &lt;6 Year Age Group</title>
        <description>Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged 2 to &lt;6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 3: Equivalent to 10 mg in Adults; 2 to &lt;6</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to &lt;6 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to &lt;6 Year Age Group</title>
          <description>Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to &lt;6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged 2 to &lt;6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.36" spread="45.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to &lt;2 Year Age Group</title>
        <description>AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged birth to &lt;2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 3: Equivalent to 10 mg in Adults; Birth to &lt;2</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to &lt;2 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to &lt;2 Year Age Group</title>
          <description>AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged birth to &lt;2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hr*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1800" spread="107.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to &lt;2 Year Age Group</title>
        <description>Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged birth to &lt;2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 3: Equivalent to 10 mg in Adults; Birth to &lt;2</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to &lt;2 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to &lt;2 Year Age Group</title>
          <description>Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged birth to &lt;2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="336" spread="112.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to &lt;2 Year Age Group</title>
        <description>Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Participants aged birth to &lt;2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 3: Equivalent to 10 mg in Adults; Birth to &lt;2</title>
            <description>Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to &lt;2 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to &lt;2 Year Age Group</title>
          <description>Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to &lt;2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.</description>
          <population>Participants aged birth to &lt;2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.</population>
          <units>hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.11" spread="48.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC0-inf) Following Administration of Single Dose</title>
        <description>Plasma for aprepitant AUC0-inf assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. AUC0-inf data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. AUC0-inf) was not possible.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 1: Equivalent to 125 mg in Adults</title>
            <description>Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
          </group>
          <group group_id="O2">
            <title>Aprepitant Dose 2: Equivalent to 40 mg in Adults</title>
            <description>Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
          </group>
          <group group_id="O3">
            <title>Aprepitant Dose 3: Equivalent to 10 mg in Adults</title>
            <description>Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
          </group>
          <group group_id="O4">
            <title>Ondansetron</title>
            <description>Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC0-inf) Following Administration of Single Dose</title>
          <description>Plasma for aprepitant AUC0-inf assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. AUC0-inf data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.</description>
          <population>Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. AUC0-inf) was not possible.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Apparent Total Clearance (CL/F) of Aprepitant From Plasma Following Administration of Single Dose</title>
        <description>Plasma for aprepitant CL/F assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. CL/F data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. CL/F) was not possible.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 1: Equivalent to 125 mg in Adults</title>
            <description>Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
          </group>
          <group group_id="O2">
            <title>Aprepitant Dose 2: Equivalent to 40 mg in Adults</title>
            <description>Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
          </group>
          <group group_id="O3">
            <title>Aprepitant Dose 3: Equivalent to 10 mg in Adults</title>
            <description>Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
          </group>
          <group group_id="O4">
            <title>Ondansetron</title>
            <description>Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Total Clearance (CL/F) of Aprepitant From Plasma Following Administration of Single Dose</title>
          <description>Plasma for aprepitant CL/F assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. CL/F data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.</description>
          <population>Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. CL/F) was not possible.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Apparent Terminal Half-life (t ½) of Aprepitant Following Administration of Single Dose</title>
        <description>Plasma for aprepitant t ½ assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. t ½ data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.</description>
        <time_frame>30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration</time_frame>
        <population>Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. t ½) was not possible.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 1: Equivalent to 125 mg in Adults</title>
            <description>Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
          </group>
          <group group_id="O2">
            <title>Aprepitant Dose 2: Equivalent to 40 mg in Adults</title>
            <description>Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
          </group>
          <group group_id="O3">
            <title>Aprepitant Dose 3: Equivalent to 10 mg in Adults</title>
            <description>Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
          </group>
          <group group_id="O4">
            <title>Ondansetron</title>
            <description>Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Terminal Half-life (t ½) of Aprepitant Following Administration of Single Dose</title>
          <description>Plasma for aprepitant t ½ assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. t ½ data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.</description>
          <population>Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. t ½) was not possible.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Experiencing at Least One Adverse Event (AE)</title>
        <description>An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants experiencing ≥1 AE was reported by dose group.</description>
        <time_frame>From pre-operative phase up to Follow-up (Day 1 to Day 15)</time_frame>
        <population>All randomized participants who received at least one dose of study treatment were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 1: Equivalent to 125 mg in Adults</title>
            <description>Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
          </group>
          <group group_id="O2">
            <title>Aprepitant Dose 2: Equivalent to 40 mg in Adults</title>
            <description>Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
          </group>
          <group group_id="O3">
            <title>Aprepitant Dose 3: Equivalent to 10 mg in Adults</title>
            <description>Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
          </group>
          <group group_id="O4">
            <title>Ondansetron</title>
            <description>Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Experiencing at Least One Adverse Event (AE)</title>
          <description>An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants experiencing ≥1 AE was reported by dose group.</description>
          <population>All randomized participants who received at least one dose of study treatment were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.6"/>
                    <measurement group_id="O2" value="43.6"/>
                    <measurement group_id="O3" value="35.7"/>
                    <measurement group_id="O4" value="48.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in Percentage vs. Ondansetron</param_type>
            <param_value>-16.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-34.0</ci_lower_limit>
            <ci_upper_limit>2.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in Percentage vs. Ondansetron</param_type>
            <param_value>-4.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-22.9</ci_lower_limit>
            <ci_upper_limit>14.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in Percentage vs. Ondansetron</param_type>
            <param_value>-12.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-30.3</ci_lower_limit>
            <ci_upper_limit>6.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Discontinuing Study Due to an AE</title>
        <description>An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants discontinuing study due to an AE was reported by dose group.</description>
        <time_frame>From pre-operative phase up to Follow-up (Day 1 to Day 15)</time_frame>
        <population>All randomized participants who received at least one dose of study treatment were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant Dose 1: Equivalent to 125 mg in Adults</title>
            <description>Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
          </group>
          <group group_id="O2">
            <title>Aprepitant Dose 2: Equivalent to 40 mg in Adults</title>
            <description>Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
          </group>
          <group group_id="O3">
            <title>Aprepitant Dose 3: Equivalent to 10 mg in Adults</title>
            <description>Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
          </group>
          <group group_id="O4">
            <title>Ondansetron</title>
            <description>Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Discontinuing Study Due to an AE</title>
          <description>An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants discontinuing study due to an AE was reported by dose group.</description>
          <population>All randomized participants who received at least one dose of study treatment were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From pre-operative phase up to Follow-up (up to 17 days)</time_frame>
      <desc>All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.</desc>
      <group_list>
        <group group_id="E1">
          <title>Aprepitant 125 mg Adult Equivalent (Dose 1)</title>
          <description>Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
        </group>
        <group group_id="E2">
          <title>Aprepitant 40 mg Adult Equivalent (Dose 2)</title>
          <description>Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
        </group>
        <group group_id="E3">
          <title>Aprepitant 10 mg Adult Equivalent (Dose 3)</title>
          <description>Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.</description>
        </group>
        <group group_id="E4">
          <title>Ondansetron</title>
          <description>Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Procedural complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Bladder perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Male genital tract fistula</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="56"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E4" events="6" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E4" events="6" subjects_affected="4" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="8" subjects_affected="4" subjects_at_risk="57"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="55"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication timelines.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01732458
org study id: 0869-219
secondary id: 2011-006006-27
nct id: NCT01732458
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability
      of aprepitant for the prevention of post-operative nausea and vomiting (PONV) in pediatric
      participants.

      Post-operative aprepitant plasma concentrations will be evaluated with a non-compartmental
      analysis (NCA) at each dose and for each age cohort. Full PK profiles analyzed using
      population PK modeling and simulation will be described in a separate report.
Because the opportunity to collect specimens for PK analyses in children will be limited, a
      flexible sparse sampling scheme using ranges of collection times will be utilized which will
      limit the burden to participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: This study will be conducted as a partially blinded study. PK samples will not be collected from participants in the control group. To maintain a partial blind, approximately 3 participants randomly selected from each age group in each of the aprepitant treatment groups will not have PK sampling. All participants will remain blinded to the study treatment. The investigator and Sponsor will be blinded to the study medication in participants not providing PK samples. The investigator and Sponsor will remain blinded to the aprepitant dose given to participants from whom PK samples will be collected.
measure: Area Under the Concentration-time Curve of Aprepitant From Time 0 to the Last Measurable Concentration (AUC0-last) Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using a noncompartmental analysis (NCA). The limit of quantitation (LOQ) value for this analysis was 10 ng/mL.
measure: Maximum Concentration (Cmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Time to Maximum Concentration (Tmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: AUC0-last Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Cmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Tmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: AUC0-last Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.
measure: Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC0-inf) Following Administration of Single Dose
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Plasma for aprepitant AUC0-inf assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. AUC0-inf data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.
measure: Apparent Total Clearance (CL/F) of Aprepitant From Plasma Following Administration of Single Dose
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Plasma for aprepitant CL/F assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. CL/F data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.
measure: Apparent Terminal Half-life (t ½) of Aprepitant Following Administration of Single Dose
time frame: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
description: Plasma for aprepitant t ½ assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. t ½ data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.
measure: Percentage of Participants Experiencing at Least One Adverse Event (AE)
time frame: From pre-operative phase up to Follow-up (Day 1 to Day 15)
description: An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants experiencing ≥1 AE was reported by dose group.
measure: Percentage of Participants Discontinuing Study Due to an AE
time frame: From pre-operative phase up to Follow-up (Day 1 to Day 15)
description: An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants discontinuing study due to an AE was reported by dose group.
arm group label: Aprepitant Dose 1: Equivalent to 125 mg in Adults
arm group type: Experimental
description: Pediatric participants receive a single dose of apprepitant that is equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered intravenously (IV) immediately prior to anesthesia.
arm group label: Aprepitant Dose 2: Equivalent to 40 mg in Adults
arm group type: Experimental
description: Pediatric participants receive a single dose of apprepitant that is equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
arm group label: Aprepitant Dose 3: Equivalent to 10 mg in Adults
arm group type: Experimental
description: Pediatric participants receive a single dose of apprepitant that is equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
arm group label: Ondansetron
arm group type: Active Comparator
description: Pediatric participants in the control regimen are administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.
intervention type: Drug
intervention name: Aprepitant
description: Administered as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia. Aprepitant was supplied in a sachet containing a powder for suspension (PFS) that was reconstituted up to total volume of 5 mL using potable water.
arm group label: Aprepitant Dose 1: Equivalent to 125 mg in Adults
arm group label: Aprepitant Dose 2: Equivalent to 40 mg in Adults
arm group label: Aprepitant Dose 3: Equivalent to 10 mg in Adults
other name: MK-0869
other name: EMEND™
intervention type: Drug
intervention name: Placebo to Aprepitant
arm group label: Ondansetron
other name: Matching placebo to aprepritant was administered as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.
intervention type: Drug
intervention name: Ondansetron
description: Administered IV at a dose of 4 mg for participants >40 kg in weight and 0.1 mg/kg for participants ≤40 kg in weight. In participants <1 month of age, the dose of ondansetron was administered per the product label or based on local standard of care. Ondansetron was supplied by the Sponsor as vials or ampules, depending on the country.
arm group label: Ondansetron
other name: Zofran
intervention type: Drug
intervention name: Placebo to match ondansetron
description: Participants in the aprepitant regimen received normal saline IV (provided by the site) as the placebo for ondansetron on Day 1, immediately prior to induction of anesthesia.
arm group label: Aprepitant Dose 1: Equivalent to 125 mg in Adults
arm group label: Aprepitant Dose 2: Equivalent to 40 mg in Adults
arm group label: Aprepitant Dose 3: Equivalent to 10 mg in Adults
criteria: 
gender: All
minimum age: N/A
maximum age: 17 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Brazil
country: Canada
country: Chile
country: Czech Republic
country: Guatemala
country: Hungary
country: Italy
country: Mexico
country: Peru
country: Puerto Rico
country: Russian Federation
country: South Africa
country: Spain
country: Turkey
country: Ukraine
country: United States
responsible party type: Sponsor
mesh term: Nausea
mesh term: Vomiting
mesh term: Postoperative Nausea and Vomiting
mesh term: Ondansetron
mesh term: Aprepitant
mesh term: Fosaprepitant
sharing ipd: Yes
ipd description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 