<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/NCT01697579</url>
  </required_header>
  <id_info>
    <org_study_id>0517-029</org_study_id>
    <secondary_id>2012-002340-24</secondary_id>
    <secondary_id>MK-0517-029</secondary_id>
    <nct_id>NCT01697579</nct_id>
  </id_info>
  <brief_title>Study of the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fosaprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Children (MK-0517-029)</brief_title>
  <official_title>A Phase IIb, Partially-Blinded, Randomized, Active Comparator-Controlled Study to Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Fosaprepitant in Pediatric Patients for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Emetogenic Chemotherapy Sub-title: Open-Label Cohort to Further Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Fosaprepitant in Pediatric Patients Birth to &lt;12 Years Old</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 was to determine the appropriate dosing regimen of fosaprepitant,&#xD;
      when administered with ondansetron (with or without dexamethasone), for the prevention of&#xD;
      CINV in children from birth to &lt;17 years of age. Fosaprepitant is a prodrug to aprepitant.&#xD;
      All participants who completed the randomized Cycle 1 could elect to receive open-label&#xD;
      fosaprepitant during optional Cycles 2-6.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Under Amendment 01, 0517-029 enrolled participants in the following age cohorts: 2-&lt;6, 6-&lt;12&#xD;
      and 12-17 years old. The study was randomized, partially-blinded, with parallel group&#xD;
      assignment. Participants were randomized to one of three fosaprepitant doses or the control&#xD;
      group. (Amendment 02 and Amendment 03 were country-specific amendments in Brazil that were&#xD;
      required as per local regulations with no change in study design.) Under Amendment 04, the&#xD;
      12-17 year-old cohort was closed since that cohort fully enrolled. An additional&#xD;
      fosaprepitant dose was added and all participants were allocated to this one treatment group.&#xD;
      Amendment 04 was open-label and enrolled participants in the following age cohorts: 0-&lt;2,&#xD;
      2-&lt;6 and 6-&lt;12 years old.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2012</start_date>
  <completion_date type="Actual">November 21, 2016</completion_date>
  <primary_completion_date type="Actual">November 21, 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>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Concentration (Cmax) of Aprepitant in Participants 0 to &lt;2 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Maximum Concentration (Tmax) of Aprepitant in Participants 0 to &lt;2 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC 0-∞) in Participants 0 to &lt;2 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Concentration-time Curve of Aprepitant From Time 0 to 24 Hours (AUC 0-24hr) in Participants 0 to &lt;2 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Terminal Half-life (t1/2) of Aprepitant in Participants 0 to &lt;2 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of Aprepitant After 24 Hours (C24hr) in Participants 0 to &lt;2 Years of Age</measure>
    <time_frame>Approximately 24 hours (from 23 to 25 hours) post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of Aprepitant After 48 Hours (C48hr) in Participants 0 to &lt;2 Years of Age</measure>
    <time_frame>Approximately 48 hours (from 46 to 50 hours) post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Total Body Clearance (CL/F) of Aprepitant in Participants 0 to &lt;2 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Aprepitant in Participants 2 to &lt;6 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax of Aprepitant in Participants 2 to &lt;6 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC 0-∞ of Aprepitant in Participants 2 to &lt;6 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC 0-24hr of Aprepitant in Participants 2 to &lt;6 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>t1/2 of Aprepitant in Participants 2 to &lt;6 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>C24hr of Aprepitant in Participants 2 to &lt;6 Years of Age</measure>
    <time_frame>Approximately 24 hours (from 23 to 25 hours) post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>C48hr of Aprepitant in Participants 2 to &lt;6 Years of Age</measure>
    <time_frame>Approximately 48 hours (from 46 to 50 hours) post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CL/F of Aprepitant in Participants 2 to &lt;6 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Aprepitant in Participants 6 to &lt;12 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax of Aprepitant in Participants 6 to &lt;12 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC 0-∞ of Aprepitant in Participants 6 to &lt;12 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC 0-24hr of Aprepitant in Participants 6 to &lt;12 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>t1/2 of Aprepitant in Participants 6 to &lt;12 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>C24hr of Aprepitant in Participants 6 to &lt;12 Years of Age</measure>
    <time_frame>Approximately 24 hours (from 23 to 25 hours) post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>C48hr of Aprepitant in Participants 6 to &lt;12 Years of Age</measure>
    <time_frame>Approximately 48 hours (from 46 to 50 hours) post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CL/F of Aprepitant in Participants 6 to &lt;12 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Aprepitant in Participants 12 to 17 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax of Aprepitant in Participants 12 to 17 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC 0-∞ of Aprepitant in Participants 12 to 17 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC 0-24hr of Aprepitant in Participants 12 to 17 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>t1/2 of Aprepitant in Participants 12 to 17 Years of Age Hours</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>C24hr of Aprepitant in Participants 12 to 17 Years of Age</measure>
    <time_frame>Approximately 24 hours (from 23 to 25 hours) post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>C48hr of Aprepitant in Participants 12 to 17 Years of Age</measure>
    <time_frame>Approximately 48 hours (from 46 to 50 hours) post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CL/F of Aprepitant in Participants 12 to 17 Years of Age</measure>
    <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
    <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycle 1</measure>
    <time_frame>Up to 14 days postdose in Cycle 1</time_frame>
    <description>AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycles 2-6</measure>
    <time_frame>Up to 14 days postdose for each cycle (Cycles 2-6)</time_frame>
    <description>AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.</description>
  </primary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Chemotherapy-induced Nausea and Vomiting</condition>
  <arm_group>
    <arm_group_label>Fosaprepitant 5 mg/kg-Cycle 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to &lt;12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to &lt;4 months old were administered 2.5 mg/kg; participants 0 to &lt;1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fosaprepitant 3 mg/kg-Cycle 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to &lt;12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fosaprepitant 1.2 mg/kg-Cycle 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to &lt;12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fosaprepitant 0.4 mg/kg-Cycle 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to &lt;12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Control-Cycle 1</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fosaprepitant 5 mg/kg-Cycles 2-6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For optional Cycles 2-6, participants from the 5 mg/kg fosaprepitant arm in Cycle 1 were administered fosaprepitant 5 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5- hydroxytryptamine 3 (5-HT3) antagonist with or without dexamethasone. Participants 1 year or less were required to receive ondansetron in all cycles as the 5-HT3 antagonist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fosaprepitant 3 mg/kg-Cycles 2-6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For optional Cycles 2-6, participants from Cycle 1 fosaprepitant arms (3, 1.2, or 0.4 mg/kg) or Cycle 1 control arm were administered fosaprepitant 3 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5-HT3 antagonist with or without dexamethasone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fosaprepitant</intervention_name>
    <description>Administered intravenously (IV) as a single dose</description>
    <arm_group_label>Fosaprepitant 0.4 mg/kg-Cycle 1</arm_group_label>
    <arm_group_label>Fosaprepitant 1.2 mg/kg-Cycle 1</arm_group_label>
    <arm_group_label>Fosaprepitant 3 mg/kg-Cycle 1</arm_group_label>
    <arm_group_label>Fosaprepitant 3 mg/kg-Cycles 2-6</arm_group_label>
    <arm_group_label>Fosaprepitant 5 mg/kg-Cycle 1</arm_group_label>
    <arm_group_label>Fosaprepitant 5 mg/kg-Cycles 2-6</arm_group_label>
    <other_name>Fosaprepitant dimeglumine</other_name>
    <other_name>MK-0517</other_name>
    <other_name>EMEND® for Injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fosaprepitant Placebo</intervention_name>
    <description>Administered IV as a single dose</description>
    <arm_group_label>Placebo Control-Cycle 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ondansetron</intervention_name>
    <description>Administered IV according to local labeling and/or local standard of care</description>
    <arm_group_label>Fosaprepitant 0.4 mg/kg-Cycle 1</arm_group_label>
    <arm_group_label>Fosaprepitant 1.2 mg/kg-Cycle 1</arm_group_label>
    <arm_group_label>Fosaprepitant 3 mg/kg-Cycle 1</arm_group_label>
    <arm_group_label>Fosaprepitant 5 mg/kg-Cycle 1</arm_group_label>
    <arm_group_label>Placebo Control-Cycle 1</arm_group_label>
    <other_name>Ondansetron hydrochloride</other_name>
    <other_name>Zofran® Injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5-hydroxytryptamine 3 antagonist</intervention_name>
    <description>Administered IV according to local labeling and/or local standard of care</description>
    <arm_group_label>Fosaprepitant 3 mg/kg-Cycles 2-6</arm_group_label>
    <arm_group_label>Fosaprepitant 5 mg/kg-Cycles 2-6</arm_group_label>
    <other_name>5-HT3</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is 0 months (at least 37 weeks gestation) to &lt;18 years of age&#xD;
&#xD;
          -  Scheduled to receive chemotherapeutic agent(s) associated with moderate, high, or very&#xD;
             high risk of emetogenicity for no more than 5 consecutive days for a documented&#xD;
             malignancy, or a chemotherapy regimen not previously tolerated due to vomiting&#xD;
&#xD;
          -  Expected to receive ondansetron as part of antiemetic regimen (Cycle 1); Expected to&#xD;
             receive a 5-HT3 antagonist as part of antiemetic regimen (Cycles 2-6)&#xD;
&#xD;
          -  If female and has begun menstruating, must have a negative pregnancy test prior to&#xD;
             study participation and agree to remain abstinent or use a barrier form of&#xD;
             contraception&#xD;
&#xD;
          -  Predicted life expectancy of ≥3 months&#xD;
&#xD;
          -  Pre-existing functioning central venous catheter&#xD;
&#xD;
          -  Weight ≥3rd percentile for age and gender (and ≥3.0 kg)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vomited in the 24 hours prior study drug administration (Cycle 1)&#xD;
&#xD;
          -  Current user of any illicit drugs (including marijuana) or current evidence of alcohol&#xD;
             abuse&#xD;
&#xD;
          -  Scheduled to receive stem cell rescue therapy in conjunction with study related&#xD;
             course(s) of emetogenic chemotherapy&#xD;
&#xD;
          -  Received or will receive radiation therapy to the abdomen or pelvis in the week prior&#xD;
             to study drug administration and/or during the course of the study&#xD;
&#xD;
          -  Pregnant or breast feeding&#xD;
&#xD;
          -  Allergic to fosaprepitant, aprepitant, ondansetron, or any other 5-HT3 antagonist&#xD;
&#xD;
          -  Has a symptomatic central nervous system (CNS) tumor causing nausea and/or vomiting&#xD;
&#xD;
          -  Has an active infection, congestive heart failure, slow heart rate, or other&#xD;
             uncontrolled disease other than cancer&#xD;
&#xD;
          -  Mentally incapacitated or has a significant emotional or psychiatric disorder&#xD;
&#xD;
          -  Known history of QT prolongation or is taking any medication known to lead to QT&#xD;
             prolongation&#xD;
&#xD;
          -  Taking other excluded medications&#xD;
&#xD;
          -  Participated in any previous study of aprepitant or fosaprepitant, or taken an&#xD;
             investigational drug within 4 weeks prior to study participation&#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>Argentina</country>
    <country>Austria</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Colombia</country>
    <country>Estonia</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Lithuania</country>
    <country>Mexico</country>
    <country>Peru</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </removed_countries>
  <results_reference>
    <citation>Mora J, Valero M, DiCristina C, Jin M, Chain A, Bickham K. Pharmacokinetics/pharmacodynamics, safety, and tolerability of fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric cancer patients. Pediatr Blood Cancer. 2019 Jun;66(6):e27690. doi: 10.1002/pbc.27690. Epub 2019 Mar 21.</citation>
    <PMID>30900392</PMID>
  </results_reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <results_first_submitted>October 18, 2017</results_first_submitted>
  <results_first_submitted_qc>October 18, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 21, 2017</results_first_posted>
  <last_update_submitted>June 14, 2019</last_update_submitted>
  <last_update_submitted_qc>June 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2019</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ondansetron</mesh_term>
    <mesh_term>Fosaprepitant</mesh_term>
    <mesh_term>Aprepitant</mesh_term>
    <mesh_term>Serotonin</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>
      <recruitment_details>This study enrolled participants scheduled to receive chemotherapeutic agent(s) associated with moderate, high, or very high risk of emetogenicity for no more than 5 consecutive days and were expected to receive ondansetron as part of their antiemetic regimen. Additional inclusion and exclusion criteria applied.</recruitment_details>
      <pre_assignment_details>Participants (2 to &lt;6, 6 to &lt;12 and 12 to17 years-old) were enrolled in a randomized, partially-blinded study of 4 doses of fosaprepitant and a control in Cycle 1. Participants (0 to &lt;2, 2 to &lt;6 and 6 to &lt;12 years-old) were invited to participate in optional Cycles 2-6 which was an open-label study of 2 doses of fosaprepitant.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Fosaprepitant 5 mg/Kg-Cycle 1</title>
          <description>Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to &lt;12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to &lt;4 months old were administered 2.5 mg/kg; participants 0 to &lt;1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
        </group>
        <group group_id="P2">
          <title>Fosaprepitant 3 mg/Kg-Cycle 1</title>
          <description>Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to &lt;12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
        </group>
        <group group_id="P3">
          <title>Fosaprepitant 1.2 mg/Kg-Cycle 1</title>
          <description>Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to &lt;12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
        </group>
        <group group_id="P4">
          <title>Fosaprepitant 0.4 mg/Kg-Cycle 1</title>
          <description>Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to &lt;12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
        </group>
        <group group_id="P5">
          <title>Placebo Control-Cycle 1</title>
          <description>Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
        </group>
        <group group_id="P6">
          <title>Fosaprepitant 5 mg/Kg-Cycles 2-6</title>
          <description>For optional Cycles 2-6, participants from the 5 mg/kg fosaprepitant arm in Cycle 1 were administered fosaprepitant 5 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5- hydroxytryptamine 3 (5-HT3) antagonist with or without dexamethasone. Participants 1 year or less were required to receive ondansetron in all cycles as the 5-HT3 antagonist.</description>
        </group>
        <group group_id="P7">
          <title>Fosaprepitant 3 mg/Kg-Cycles 2-6</title>
          <description>For optional Cycles 2-6, participants from Cycle 1 fosaprepitant arms (3, 1.2, or 0.4 mg/kg) or Cycle 1 control arm were administered fosaprepitant 3 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5-HT3 antagonist with or without dexamethasone.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Base Study-Cycle 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="74">Participants who completed Cycle 1 were invited to participate in optional Cycles 2-6 arms.</participants>
                <participants group_id="P2" count="43">Participants who completed Cycle 1 were invited to participate in optional Cycles 2-6 arms.</participants>
                <participants group_id="P3" count="44">Participants who completed Cycle 1 were invited to participate in optional Cycles 2-6 arms.</participants>
                <participants group_id="P4" count="41">Participants who completed Cycle 1 were invited to participate in optional Cycles 2-6 arms.</participants>
                <participants group_id="P5" count="38">Participants who completed Cycle 1 were invited to participate in optional Cycles 2-6 arms.</participants>
                <participants group_id="P6" count="0">Enrollment in Cycles 2-6 was optional.</participants>
                <participants group_id="P7" count="0">Enrollment in Cycles 2-6 was optional.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
                <participants group_id="P2" count="42"/>
                <participants group_id="P3" count="43"/>
                <participants group_id="P4" count="40"/>
                <participants group_id="P5" count="35"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Parent/Guardian</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Consent Withdrawn by Participant</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 group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Technical Problems</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="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Optional Extension-Cycles 2-6</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0">47 participants from this arm in Cycle 1 entered optional Cycles 2-6 at 5 mg/kg</participants>
                <participants group_id="P2" count="0">33 participants from this arm in Cycle 1 entered optional Cycles 2-6 at 3 mg/kg</participants>
                <participants group_id="P3" count="0">25 participants from this arm in Cycle 1 entered optional Cycles 2-6 at 3 mg/kg</participants>
                <participants group_id="P4" count="0">27 participants from this arm in Cycle 1 entered optional Cycles 2-6 at 3 mg/kg</participants>
                <participants group_id="P5" count="0">21 participants from this arm in Cycle 1 entered optional Cycles 2-6 at 3 mg/kg</participants>
                <participants group_id="P6" count="47">Enrollment in Cycles 2-6 was optional.</participants>
                <participants group_id="P7" count="106">Enrollment in Cycles 2-6 was optional.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="12"/>
                <participants group_id="P7" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="35"/>
                <participants group_id="P7" count="69"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Parent/Guardian</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="7"/>
                <participants group_id="P7" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Excluded Medication</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did Not Respond To Chemotherapy Regimen</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Completed Chemotherapy Regimen</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="15"/>
                <participants group_id="P7" count="24"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did Not Meet Cycle Eligibility Criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Consent Withdrawn by Participant</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Technical Problems</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant Moved</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance With Protocol</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Fosaprepitant 5 mg/Kg-Cycle 1</title>
          <description>Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to &lt;12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to &lt;4 months old were administered 2.5 mg/kg; participants 0 to &lt;1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
        </group>
        <group group_id="B2">
          <title>Fosaprepitant 3 mg/Kg-Cycle 1</title>
          <description>Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to &lt;12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
        </group>
        <group group_id="B3">
          <title>Fosaprepitant 1.2 mg/Kg-Cycle 1</title>
          <description>Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to &lt;12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
        </group>
        <group group_id="B4">
          <title>Fosaprepitant 0.4 mg/Kg-Cycle 1</title>
          <description>Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to &lt;12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
        </group>
        <group group_id="B5">
          <title>Placebo Control-Cycle 1</title>
          <description>Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
        </group>
        <group group_id="B6">
          <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="74"/>
            <count group_id="B2" value="43"/>
            <count group_id="B3" value="44"/>
            <count group_id="B4" value="41"/>
            <count group_id="B5" value="38"/>
            <count group_id="B6" value="240"/>
          </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="60.2" spread="42.3"/>
                    <measurement group_id="B2" value="123.8" spread="51.3"/>
                    <measurement group_id="B3" value="119.4" spread="52.7"/>
                    <measurement group_id="B4" value="119.2" spread="54.3"/>
                    <measurement group_id="B5" value="122.5" spread="54.0"/>
                    <measurement group_id="B6" value="102.4" spread="57.0"/>
                  </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="32"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="19"/>
                    <measurement group_id="B6" value="111"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="19"/>
                    <measurement group_id="B6" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximum Concentration (Cmax) of Aprepitant in Participants 0 to &lt;2 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 0 to &lt;2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 0 to &lt;2 Years-Cycle 1</title>
            <description>Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to &lt;12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to &lt;4 months old were administered 2.5 mg/kg; and participants 0 to &lt;1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Concentration (Cmax) of Aprepitant in Participants 0 to &lt;2 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 0 to &lt;2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3550" spread="1500"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time to Maximum Concentration (Tmax) of Aprepitant in Participants 0 to &lt;2 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 0 to &lt;2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 0 to &lt;2 Years-Cycle 1</title>
            <description>Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to &lt;12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to &lt;4 months old were administered 2.5 mg/kg; and participants 0 to &lt;1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Maximum Concentration (Tmax) of Aprepitant in Participants 0 to &lt;2 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 0 to &lt;2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.01" spread="2.10"/>
                  </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 (AUC 0-∞) in Participants 0 to &lt;2 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 0 to &lt;2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 0 to &lt;2 Years-Cycle 1</title>
            <description>Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to &lt;12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to &lt;4 months old were administered 2.5 mg/kg; and participants 0 to &lt;1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC 0-∞) in Participants 0 to &lt;2 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 0 to &lt;2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>hr•ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37200" spread="15800"/>
                  </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 24 Hours (AUC 0-24hr) in Participants 0 to &lt;2 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 0 to &lt;2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 0 to &lt;2 Years-Cycle 1</title>
            <description>Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to &lt;12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to &lt;4 months old were administered 2.5 mg/kg; and participants 0 to &lt;1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve of Aprepitant From Time 0 to 24 Hours (AUC 0-24hr) in Participants 0 to &lt;2 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 0 to &lt;2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>hr•ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36800" spread="21800"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Apparent Terminal Half-life (t1/2) of Aprepitant in Participants 0 to &lt;2 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 0 to &lt;2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 0 to &lt;2 Years-Cycle 1</title>
            <description>Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to &lt;12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to &lt;4 months old were administered 2.5 mg/kg; and participants 0 to &lt;1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Terminal Half-life (t1/2) of Aprepitant in Participants 0 to &lt;2 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 0 to &lt;2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.94" spread="2.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Concentration of Aprepitant After 24 Hours (C24hr) in Participants 0 to &lt;2 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.</description>
        <time_frame>Approximately 24 hours (from 23 to 25 hours) post-infusion</time_frame>
        <population>All participants 0 to &lt;2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 0 to &lt;2 Years-Cycle 1</title>
            <description>Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to &lt;12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to &lt;4 months old were administered 2.5 mg/kg; and participants 0 to &lt;1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>Concentration of Aprepitant After 24 Hours (C24hr) in Participants 0 to &lt;2 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.</description>
          <population>All participants 0 to &lt;2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="691" spread="852"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Concentration of Aprepitant After 48 Hours (C48hr) in Participants 0 to &lt;2 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.</description>
        <time_frame>Approximately 48 hours (from 46 to 50 hours) post-infusion</time_frame>
        <population>All participants 0 to &lt;2 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 0 to &lt;2 Years-Cycle 1</title>
            <description>Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to &lt;12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to &lt;4 months old were administered 2.5 mg/kg; and participants 0 to &lt;1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>Concentration of Aprepitant After 48 Hours (C48hr) in Participants 0 to &lt;2 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.</description>
          <population>All participants 0 to &lt;2 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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="352" spread="929"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Apparent Total Body Clearance (CL/F) of Aprepitant in Participants 0 to &lt;2 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 0 to &lt;2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 0 to &lt;2 Years-Cycle 1</title>
            <description>Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to &lt;12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to &lt;4 months old were administered 2.5 mg/kg; and participants 0 to &lt;1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Total Body Clearance (CL/F) of Aprepitant in Participants 0 to &lt;2 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 0 to &lt;2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.2" spread="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Aprepitant in Participants 2 to &lt;6 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 2 to &lt;6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 3 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 1.2 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O4">
            <title>Fosaprepitant 0.4 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Aprepitant in Participants 2 to &lt;6 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 2 to &lt;6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4270" spread="2370"/>
                    <measurement group_id="O2" value="2320" spread="1540"/>
                    <measurement group_id="O3" value="2030" spread="1780"/>
                    <measurement group_id="O4" value="323" spread="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax of Aprepitant in Participants 2 to &lt;6 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 2 to &lt;6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 3 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 1.2 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O4">
            <title>Fosaprepitant 0.4 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of Aprepitant in Participants 2 to &lt;6 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 2 to &lt;6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.90" spread="2.16"/>
                    <measurement group_id="O2" value="2.29" spread="2.14"/>
                    <measurement group_id="O3" value="1.36" spread="0.868"/>
                    <measurement group_id="O4" value="1.34" spread="0.771"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC 0-∞ of Aprepitant in Participants 2 to &lt;6 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 2 to &lt;6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 3 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 1.2 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O4">
            <title>Fosaprepitant 0.4 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC 0-∞ of Aprepitant in Participants 2 to &lt;6 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 2 to &lt;6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>hr•ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46400" spread="18600"/>
                    <measurement group_id="O2" value="15300" spread="11100"/>
                    <measurement group_id="O3" value="16000" spread="9680"/>
                    <measurement group_id="O4" value="2070" spread="992"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC 0-24hr of Aprepitant in Participants 2 to &lt;6 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 2 to &lt;6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 3 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 1.2 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O4">
            <title>Fosaprepitant 0.4 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC 0-24hr of Aprepitant in Participants 2 to &lt;6 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 2 to &lt;6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>hr•ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45000" spread="23800"/>
                    <measurement group_id="O2" value="21800" spread="22200"/>
                    <measurement group_id="O3" value="19700" spread="18500"/>
                    <measurement group_id="O4" value="1840" spread="742"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>t1/2 of Aprepitant in Participants 2 to &lt;6 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 2 to &lt;6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 3 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 1.2 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O4">
            <title>Fosaprepitant 0.4 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>t1/2 of Aprepitant in Participants 2 to &lt;6 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 2 to &lt;6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.27" spread="4.17"/>
                    <measurement group_id="O2" value="6.55" spread="3.62"/>
                    <measurement group_id="O3" value="7.27" spread="3.47"/>
                    <measurement group_id="O4" value="6.18" spread="3.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>C24hr of Aprepitant in Participants 2 to &lt;6 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.</description>
        <time_frame>Approximately 24 hours (from 23 to 25 hours) post-infusion</time_frame>
        <population>All participants 2 to &lt;6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 3 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 1.2 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O4">
            <title>Fosaprepitant 0.4 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>C24hr of Aprepitant in Participants 2 to &lt;6 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.</description>
          <population>All participants 2 to &lt;6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1060" spread="1020"/>
                    <measurement group_id="O2" value="278" spread="398"/>
                    <measurement group_id="O3" value="332" spread="430"/>
                    <measurement group_id="O4" value="9.23" spread="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>C48hr of Aprepitant in Participants 2 to &lt;6 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.</description>
        <time_frame>Approximately 48 hours (from 46 to 50 hours) post-infusion</time_frame>
        <population>All participants 2 to &lt;6 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 3 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 1.2 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O4">
            <title>Fosaprepitant 0.4 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>C48hr of Aprepitant in Participants 2 to &lt;6 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.</description>
          <population>All participants 2 to &lt;6 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="232" spread="471"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>CL/F of Aprepitant in Participants 2 to &lt;6 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 2 to &lt;6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 3 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 1.2 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O4">
            <title>Fosaprepitant 0.4 mg/kg: 2 to &lt;6 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>CL/F of Aprepitant in Participants 2 to &lt;6 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 2 to &lt;6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.8" spread="13.8"/>
                    <measurement group_id="O2" value="66.2" spread="25.5"/>
                    <measurement group_id="O3" value="29.6" spread="22.1"/>
                    <measurement group_id="O4" value="48.5" spread="28.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Aprepitant in Participants 6 to &lt;12 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 6 to &lt;12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 3 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 1.2 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O4">
            <title>Fosaprepitant 0.4 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Aprepitant in Participants 6 to &lt;12 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 6 to &lt;12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4400" spread="1910"/>
                    <measurement group_id="O2" value="3550" spread="2460"/>
                    <measurement group_id="O3" value="1360" spread="903"/>
                    <measurement group_id="O4" value="507" spread="443"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax of Aprepitant in Participants 6 to &lt;12 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 6 to &lt;12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 3 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 1.2 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O4">
            <title>Fosaprepitant 0.4 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of Aprepitant in Participants 6 to &lt;12 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 6 to &lt;12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.92" spread="5.09"/>
                    <measurement group_id="O2" value="1.99" spread="1.62"/>
                    <measurement group_id="O3" value="2.14" spread="1.96"/>
                    <measurement group_id="O4" value="1.68" spread="2.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC 0-∞ of Aprepitant in Participants 6 to &lt;12 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 6 to &lt;12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 3 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 1.2 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O4">
            <title>Fosaprepitant 0.4 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC 0-∞ of Aprepitant in Participants 6 to &lt;12 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 6 to &lt;12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>hr•ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55300" spread="11900"/>
                    <measurement group_id="O2" value="34300" spread="20300"/>
                    <measurement group_id="O3" value="10700" spread="5440"/>
                    <measurement group_id="O4" value="2860" spread="1120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC 0-24hr of Aprepitant in Participants 6 to &lt;12 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 6 to &lt;12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 3 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 1.2 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O4">
            <title>Fosaprepitant 0.4 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC 0-24hr of Aprepitant in Participants 6 to &lt;12 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 6 to &lt;12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>hr•ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47400" spread="17300"/>
                    <measurement group_id="O2" value="29200" spread="14300"/>
                    <measurement group_id="O3" value="12000" spread="11000"/>
                    <measurement group_id="O4" value="4260" spread="5040"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>t1/2 of Aprepitant in Participants 6 to &lt;12 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 6 to &lt;12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 3 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 1.2 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O4">
            <title>Fosaprepitant 0.4 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>t1/2 of Aprepitant in Participants 6 to &lt;12 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 6 to &lt;12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.77" spread="2.49"/>
                    <measurement group_id="O2" value="7.69" spread="2.09"/>
                    <measurement group_id="O3" value="8.23" spread="1.83"/>
                    <measurement group_id="O4" value="6.58" spread="2.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>C24hr of Aprepitant in Participants 6 to &lt;12 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.</description>
        <time_frame>Approximately 24 hours (from 23 to 25 hours) post-infusion</time_frame>
        <population>All participants 6 to &lt;12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 3 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 1.2 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O4">
            <title>Fosaprepitant 0.4 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>C24hr of Aprepitant in Participants 6 to &lt;12 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.</description>
          <population>All participants 6 to &lt;12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1210" spread="1000"/>
                    <measurement group_id="O2" value="589" spread="433"/>
                    <measurement group_id="O3" value="219" spread="379"/>
                    <measurement group_id="O4" value="70.4" spread="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>C48hr of Aprepitant in Participants 6 to &lt;12 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.</description>
        <time_frame>Approximately 48 hours (from 46 to 50 hours) post-infusion</time_frame>
        <population>All participants 6 to &lt;12 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 3 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 1.2 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O4">
            <title>Fosaprepitant 0.4 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>C48hr of Aprepitant in Participants 6 to &lt;12 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.</description>
          <population>All participants 6 to &lt;12 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="164" spread="124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>CL/F of Aprepitant in Participants 6 to &lt;12 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 6 to &lt;12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 3 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 1.2 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O4">
            <title>Fosaprepitant 0.4 mg/kg: 6 to &lt;12 Years-Cycle 1</title>
            <description>Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>CL/F of Aprepitant in Participants 6 to &lt;12 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 6 to &lt;12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.1" spread="12.7"/>
                    <measurement group_id="O2" value="69.2" spread="66.4"/>
                    <measurement group_id="O3" value="78.8" spread="39.1"/>
                    <measurement group_id="O4" value="89.6" spread="40.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Aprepitant in Participants 12 to 17 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Aprepitant in Participants 12 to 17 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3500" spread="972"/>
                    <measurement group_id="O2" value="1180" spread="408"/>
                    <measurement group_id="O3" value="582" spread="437"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax of Aprepitant in Participants 12 to 17 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of Aprepitant in Participants 12 to 17 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.546" spread="0.144"/>
                    <measurement group_id="O2" value="0.722" spread="0.608"/>
                    <measurement group_id="O3" value="0.736" spread="0.561"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC 0-∞ of Aprepitant in Participants 12 to 17 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC 0-∞ of Aprepitant in Participants 12 to 17 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>hr•ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33800" spread="7180"/>
                    <measurement group_id="O2" value="12300" spread="4660"/>
                    <measurement group_id="O3" value="3500" spread="1430"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC 0-24hr of Aprepitant in Participants 12 to 17 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC 0-24hr of Aprepitant in Participants 12 to 17 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>hr•ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30400" spread="8290"/>
                    <measurement group_id="O2" value="9700" spread="4200"/>
                    <measurement group_id="O3" value="4820" spread="7240"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>t1/2 of Aprepitant in Participants 12 to 17 Years of Age Hours</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>t1/2 of Aprepitant in Participants 12 to 17 Years of Age Hours</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5" spread="1.00"/>
                    <measurement group_id="O2" value="7.92" spread="1.38"/>
                    <measurement group_id="O3" value="8.27" spread="1.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>C24hr of Aprepitant in Participants 12 to 17 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.</description>
        <time_frame>Approximately 24 hours (from 23 to 25 hours) post-infusion</time_frame>
        <population>All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>C24hr of Aprepitant in Participants 12 to 17 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.</description>
          <population>All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="735" spread="310"/>
                    <measurement group_id="O2" value="142" spread="86.4"/>
                    <measurement group_id="O3" value="101" spread="247"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>C48hr of Aprepitant in Participants 12 to 17 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.</description>
        <time_frame>Approximately 48 hours (from 46 to 50 hours) post-infusion</time_frame>
        <population>All participants 12 to 17 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>C48hr of Aprepitant in Participants 12 to 17 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.</description>
          <population>All participants 12 to 17 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</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_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>CL/F of Aprepitant in Participants 12 to 17 Years of Age</title>
        <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
        <time_frame>Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion</time_frame>
        <population>All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1</title>
            <description>Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>CL/F of Aprepitant in Participants 12 to 17 Years of Age</title>
          <description>Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.</description>
          <population>All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.</population>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.2" spread="16.2"/>
                    <measurement group_id="O2" value="91.7" spread="32.5"/>
                    <measurement group_id="O3" value="105" spread="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycle 1</title>
        <description>AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.</description>
        <time_frame>Up to 14 days postdose in Cycle 1</time_frame>
        <population>All randomized participants who received at least one dose of study treatment in Cycle 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/Kg-Cycle 1</title>
            <description>Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to &lt;12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to &lt;4 months old were administered 2.5 mg/kg; participants 0 to &lt;1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 3 mg/Kg-Cycle 1</title>
            <description>Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to &lt;12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
          </group>
          <group group_id="O3">
            <title>Fosaprepitant 1.2 mg/Kg-Cycle 1</title>
            <description>Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to &lt;12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
          </group>
          <group group_id="O4">
            <title>Fosaprepitant 0.4 mg/Kg-Cycle 1</title>
            <description>Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to &lt;12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
          </group>
          <group group_id="O5">
            <title>Placebo Control-Cycle 1</title>
            <description>Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycle 1</title>
          <description>AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.</description>
          <population>All randomized participants who received at least one dose of study treatment in Cycle 1.</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="74"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="43"/>
                <count group_id="O4" value="40"/>
                <count group_id="O5" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.8"/>
                    <measurement group_id="O2" value="83.3"/>
                    <measurement group_id="O3" value="90.7"/>
                    <measurement group_id="O4" value="80.0"/>
                    <measurement group_id="O5" value="77.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycles 2-6</title>
        <description>AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.</description>
        <time_frame>Up to 14 days postdose for each cycle (Cycles 2-6)</time_frame>
        <population>All randomized participants who received at least one dose of study treatment in Cycles 2-6.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosaprepitant 5 mg/Kg-Cycles 2-6</title>
            <description>For optional Cycles 2-6, participants from the 5 mg/kg fosaprepitant arm in Cycle 1 were administered fosaprepitant 5 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5- hydroxytryptamine 3 (5-HT3) antagonist with or without dexamethasone. Participants 1 year or less were required to receive ondansetron in all cycles as the 5-HT3 antagonist.</description>
          </group>
          <group group_id="O2">
            <title>Fosaprepitant 3 mg/Kg-Cycles 2-6</title>
            <description>For optional Cycles 2-6, participants from Cycle 1 fosaprepitant arms (3, 1.2, or 0.4 mg/kg) or Cycle 1 control arm were administered fosaprepitant 3 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5-HT3 antagonist with or without dexamethasone.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycles 2-6</title>
          <description>AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.</description>
          <population>All randomized participants who received at least one dose of study treatment in Cycles 2-6.</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="44"/>
                <count group_id="O2" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.6"/>
                    <measurement group_id="O2" value="75.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total)</time_frame>
      <desc>AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.</desc>
      <group_list>
        <group group_id="E1">
          <title>Fosaprepitant 0.4 mg/Kg-Cycle 1</title>
          <description>Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to &lt;12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
        </group>
        <group group_id="E2">
          <title>Fosaprepitant 1.2 mg/Kg-Cycle 1</title>
          <description>Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to &lt;12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
        </group>
        <group group_id="E3">
          <title>Fosaprepitant 3 mg/Kg-Cycle 1</title>
          <description>Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to &lt;12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.</description>
        </group>
        <group group_id="E4">
          <title>Fosaprepitant 5 mg/Kg-Cycle 1</title>
          <description>Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to &lt;12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to &lt;4 months old were administered 2.5 mg/kg; participants 0 to &lt;1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
        </group>
        <group group_id="E5">
          <title>Placebo Control-Cycle 1</title>
          <description>Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children &lt;6 months of age), with or without dexamethasone.</description>
        </group>
        <group group_id="E6">
          <title>Fosaprepitant 3 mg/Kg-Cycles 2-6</title>
          <description>For optional Cycles 2-6, participants from Cycle 1 fosaprepitant arms (3, 1.2, or 0.4 mg/kg) or Cycle 1 control arm were administered fosaprepitant 3 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5-HT3 antagonist with or without dexamethasone.</description>
        </group>
        <group group_id="E7">
          <title>Fosaprepitant 5 mg/Kg-Cycles 2-6</title>
          <description>For optional Cycles 2-6, participants from the 5 mg/kg fosaprepitant arm in Cycle 1 were administered fosaprepitant 5 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5- hydroxytryptamine 3 (5-HT3) antagonist with or without dexamethasone. Participants 1 year or less were required to receive ondansetron in all cycles as the 5-HT3 antagonist.</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="11" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="24" subjects_at_risk="74"/>
                <counts group_id="E5" subjects_affected="12" subjects_at_risk="35"/>
                <counts group_id="E6" subjects_affected="46" subjects_at_risk="106"/>
                <counts group_id="E7" subjects_affected="24" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="40"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="43"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="42"/>
                <counts group_id="E4" events="13" subjects_affected="13" subjects_at_risk="74"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="35"/>
                <counts group_id="E6" events="47" subjects_affected="26" subjects_at_risk="106"/>
                <counts group_id="E7" events="32" subjects_affected="18" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E6" events="9" subjects_affected="4" subjects_at_risk="106"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E6" events="13" subjects_affected="7" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Thrombocytopaenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E6" events="4" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis norovirus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Herpes virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Neutropenic sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="3" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Febrile infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="3" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood magnesium decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Blood phosphorous decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Drug level increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetitie</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hydrocephalus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Febrile convulsion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Neurotoxicity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device breakage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Cystitis haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>air embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </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="27" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="32" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="60" subjects_at_risk="74"/>
                <counts group_id="E5" subjects_affected="24" subjects_at_risk="35"/>
                <counts group_id="E6" subjects_affected="69" subjects_at_risk="106"/>
                <counts group_id="E7" subjects_affected="31" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="40"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="43"/>
                <counts group_id="E3" events="12" subjects_affected="12" subjects_at_risk="42"/>
                <counts group_id="E4" events="28" subjects_affected="27" subjects_at_risk="74"/>
                <counts group_id="E5" events="10" subjects_affected="10" subjects_at_risk="35"/>
                <counts group_id="E6" events="54" subjects_affected="33" subjects_at_risk="106"/>
                <counts group_id="E7" events="18" subjects_affected="14" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="42"/>
                <counts group_id="E4" events="8" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="35"/>
                <counts group_id="E6" events="22" subjects_affected="10" subjects_at_risk="106"/>
                <counts group_id="E7" events="16" subjects_affected="6" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="40"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="43"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="42"/>
                <counts group_id="E4" events="19" subjects_affected="18" subjects_at_risk="74"/>
                <counts group_id="E5" events="8" subjects_affected="8" subjects_at_risk="35"/>
                <counts group_id="E6" events="19" subjects_affected="14" subjects_at_risk="106"/>
                <counts group_id="E7" events="8" subjects_affected="4" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="40"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="43"/>
                <counts group_id="E3" events="11" subjects_affected="11" subjects_at_risk="42"/>
                <counts group_id="E4" events="11" subjects_affected="11" subjects_at_risk="74"/>
                <counts group_id="E5" events="9" subjects_affected="9" subjects_at_risk="35"/>
                <counts group_id="E6" events="44" subjects_affected="19" subjects_at_risk="106"/>
                <counts group_id="E7" events="19" subjects_affected="10" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E7" events="5" subjects_affected="4" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="11" subjects_affected="6" subjects_at_risk="40"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="43"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="42"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="35"/>
                <counts group_id="E6" events="30" subjects_affected="19" subjects_at_risk="106"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E4" events="9" subjects_affected="9" subjects_at_risk="74"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="35"/>
                <counts group_id="E6" events="9" subjects_affected="9" subjects_at_risk="106"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="74"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E6" events="10" subjects_affected="10" subjects_at_risk="106"/>
                <counts group_id="E7" events="5" subjects_affected="4" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="40"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E4" events="21" subjects_affected="8" subjects_at_risk="74"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E6" events="40" subjects_affected="23" subjects_at_risk="106"/>
                <counts group_id="E7" events="8" subjects_affected="6" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E6" events="4" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E6" events="8" subjects_affected="8" subjects_at_risk="106"/>
                <counts group_id="E7" events="4" subjects_affected="3" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="40"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="43"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="42"/>
                <counts group_id="E4" events="20" subjects_affected="14" subjects_at_risk="74"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E6" events="69" subjects_affected="30" subjects_at_risk="106"/>
                <counts group_id="E7" events="17" subjects_affected="12" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="43"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="9" subjects_affected="6" subjects_at_risk="106"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="74"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E6" events="19" subjects_affected="13" subjects_at_risk="106"/>
                <counts group_id="E7" events="8" subjects_affected="4" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="74"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E6" events="22" subjects_affected="15" subjects_at_risk="106"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="74"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E6" events="21" subjects_affected="13" subjects_at_risk="106"/>
                <counts group_id="E7" events="5" subjects_affected="4" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="43"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E4" events="11" subjects_affected="11" subjects_at_risk="74"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E6" events="38" subjects_affected="15" subjects_at_risk="106"/>
                <counts group_id="E7" events="17" subjects_affected="11" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="43"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E4" events="16" subjects_affected="16" subjects_at_risk="74"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E6" events="37" subjects_affected="15" subjects_at_risk="106"/>
                <counts group_id="E7" events="8" subjects_affected="5" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="40"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E6" events="23" subjects_affected="13" subjects_at_risk="106"/>
                <counts group_id="E7" events="6" subjects_affected="5" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E6" events="8" subjects_affected="5" subjects_at_risk="106"/>
                <counts group_id="E7" events="7" subjects_affected="3" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E6" events="6" subjects_affected="4" subjects_at_risk="106"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E6" events="25" subjects_affected="15" subjects_at_risk="106"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E6" events="18" subjects_affected="9" subjects_at_risk="106"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" events="9" subjects_affected="6" subjects_at_risk="43"/>
                <counts group_id="E3" events="7" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E6" events="15" subjects_affected="11" subjects_at_risk="106"/>
                <counts group_id="E7" events="5" subjects_affected="2" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="74"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E6" events="13" subjects_affected="12" subjects_at_risk="106"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" events="10" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </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 guidelines.</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/NCT01697579
org study id: 0517-029
secondary id: 2012-002340-24
secondary id: MK-0517-029
nct id: NCT01697579
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study was to determine the appropriate dosing regimen of fosaprepitant,
      when administered with ondansetron (with or without dexamethasone), for the prevention of
      CINV in children from birth to <17 years of age. Fosaprepitant is a prodrug to aprepitant.
      All participants who completed the randomized Cycle 1 could elect to receive open-label
      fosaprepitant during optional Cycles 2-6.
Under Amendment 01, 0517-029 enrolled participants in the following age cohorts: 2-<6, 6-<12
      and 12-17 years old. The study was randomized, partially-blinded, with parallel group
      assignment. Participants were randomized to one of three fosaprepitant doses or the control
      group. (Amendment 02 and Amendment 03 were country-specific amendments in Brazil that were
      required as per local regulations with no change in study design.) Under Amendment 04, the
      12-17 year-old cohort was closed since that cohort fully enrolled. An additional
      fosaprepitant dose was added and all participants were allocated to this one treatment group.
      Amendment 04 was open-label and enrolled participants in the following age cohorts: 0-<2,
      2-<6 and 6-<12 years old.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Maximum Concentration (Cmax) of Aprepitant in Participants 0 to <2 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: Time to Maximum Concentration (Tmax) of Aprepitant in Participants 0 to <2 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC 0-∞) in Participants 0 to <2 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: Area Under the Concentration-time Curve of Aprepitant From Time 0 to 24 Hours (AUC 0-24hr) in Participants 0 to <2 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: Apparent Terminal Half-life (t1/2) of Aprepitant in Participants 0 to <2 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: Concentration of Aprepitant After 24 Hours (C24hr) in Participants 0 to <2 Years of Age
time frame: Approximately 24 hours (from 23 to 25 hours) post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.
measure: Concentration of Aprepitant After 48 Hours (C48hr) in Participants 0 to <2 Years of Age
time frame: Approximately 48 hours (from 46 to 50 hours) post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.
measure: Apparent Total Body Clearance (CL/F) of Aprepitant in Participants 0 to <2 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: Cmax of Aprepitant in Participants 2 to <6 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: Tmax of Aprepitant in Participants 2 to <6 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: AUC 0-∞ of Aprepitant in Participants 2 to <6 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: AUC 0-24hr of Aprepitant in Participants 2 to <6 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: t1/2 of Aprepitant in Participants 2 to <6 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: C24hr of Aprepitant in Participants 2 to <6 Years of Age
time frame: Approximately 24 hours (from 23 to 25 hours) post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.
measure: C48hr of Aprepitant in Participants 2 to <6 Years of Age
time frame: Approximately 48 hours (from 46 to 50 hours) post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.
measure: CL/F of Aprepitant in Participants 2 to <6 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: Cmax of Aprepitant in Participants 6 to <12 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: Tmax of Aprepitant in Participants 6 to <12 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: AUC 0-∞ of Aprepitant in Participants 6 to <12 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: AUC 0-24hr of Aprepitant in Participants 6 to <12 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: t1/2 of Aprepitant in Participants 6 to <12 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: C24hr of Aprepitant in Participants 6 to <12 Years of Age
time frame: Approximately 24 hours (from 23 to 25 hours) post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.
measure: C48hr of Aprepitant in Participants 6 to <12 Years of Age
time frame: Approximately 48 hours (from 46 to 50 hours) post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.
measure: CL/F of Aprepitant in Participants 6 to <12 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: Cmax of Aprepitant in Participants 12 to 17 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: Tmax of Aprepitant in Participants 12 to 17 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: AUC 0-∞ of Aprepitant in Participants 12 to 17 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: AUC 0-24hr of Aprepitant in Participants 12 to 17 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: t1/2 of Aprepitant in Participants 12 to 17 Years of Age Hours
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: C24hr of Aprepitant in Participants 12 to 17 Years of Age
time frame: Approximately 24 hours (from 23 to 25 hours) post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.
measure: C48hr of Aprepitant in Participants 12 to 17 Years of Age
time frame: Approximately 48 hours (from 46 to 50 hours) post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.
measure: CL/F of Aprepitant in Participants 12 to 17 Years of Age
time frame: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
description: Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
measure: Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycle 1
time frame: Up to 14 days postdose in Cycle 1
description: AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.
measure: Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycles 2-6
time frame: Up to 14 days postdose for each cycle (Cycles 2-6)
description: AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.
arm group label: Fosaprepitant 5 mg/kg-Cycle 1
arm group type: Experimental
description: Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
arm group label: Fosaprepitant 3 mg/kg-Cycle 1
arm group type: Experimental
description: Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
arm group label: Fosaprepitant 1.2 mg/kg-Cycle 1
arm group type: Experimental
description: Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
arm group label: Fosaprepitant 0.4 mg/kg-Cycle 1
arm group type: Experimental
description: Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
arm group label: Placebo Control-Cycle 1
arm group type: Placebo Comparator
description: Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
arm group label: Fosaprepitant 5 mg/kg-Cycles 2-6
arm group type: Experimental
description: For optional Cycles 2-6, participants from the 5 mg/kg fosaprepitant arm in Cycle 1 were administered fosaprepitant 5 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5- hydroxytryptamine 3 (5-HT3) antagonist with or without dexamethasone. Participants 1 year or less were required to receive ondansetron in all cycles as the 5-HT3 antagonist.
arm group label: Fosaprepitant 3 mg/kg-Cycles 2-6
arm group type: Experimental
description: For optional Cycles 2-6, participants from Cycle 1 fosaprepitant arms (3, 1.2, or 0.4 mg/kg) or Cycle 1 control arm were administered fosaprepitant 3 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5-HT3 antagonist with or without dexamethasone.
intervention type: Drug
intervention name: Fosaprepitant
description: Administered intravenously (IV) as a single dose
arm group label: Fosaprepitant 0.4 mg/kg-Cycle 1
arm group label: Fosaprepitant 1.2 mg/kg-Cycle 1
arm group label: Fosaprepitant 3 mg/kg-Cycle 1
arm group label: Fosaprepitant 3 mg/kg-Cycles 2-6
arm group label: Fosaprepitant 5 mg/kg-Cycle 1
arm group label: Fosaprepitant 5 mg/kg-Cycles 2-6
other name: Fosaprepitant dimeglumine
other name: MK-0517
other name: EMEND® for Injection
intervention type: Drug
intervention name: Fosaprepitant Placebo
description: Administered IV as a single dose
arm group label: Placebo Control-Cycle 1
intervention type: Drug
intervention name: Ondansetron
description: Administered IV according to local labeling and/or local standard of care
arm group label: Fosaprepitant 0.4 mg/kg-Cycle 1
arm group label: Fosaprepitant 1.2 mg/kg-Cycle 1
arm group label: Fosaprepitant 3 mg/kg-Cycle 1
arm group label: Fosaprepitant 5 mg/kg-Cycle 1
arm group label: Placebo Control-Cycle 1
other name: Ondansetron hydrochloride
other name: Zofran® Injection
intervention type: Drug
intervention name: 5-hydroxytryptamine 3 antagonist
description: Administered IV according to local labeling and/or local standard of care
arm group label: Fosaprepitant 3 mg/kg-Cycles 2-6
arm group label: Fosaprepitant 5 mg/kg-Cycles 2-6
other name: 5-HT3
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: Argentina
country: Austria
country: Brazil
country: Canada
country: Chile
country: Colombia
country: Estonia
country: Germany
country: Greece
country: Hungary
country: Italy
country: Korea, Republic of
country: Lithuania
country: Mexico
country: Peru
country: Portugal
country: Romania
country: Russian Federation
country: South Africa
country: Spain
country: Switzerland
country: Taiwan
country: Turkey
country: Ukraine
country: United Kingdom
country: United States
citation: Mora J, Valero M, DiCristina C, Jin M, Chain A, Bickham K. Pharmacokinetics/pharmacodynamics, safety, and tolerability of fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric cancer patients. Pediatr Blood Cancer. 2019 Jun;66(6):e27690. doi: 10.1002/pbc.27690. Epub 2019 Mar 21.
PMID: 30900392
responsible party type: Sponsor
mesh term: Nausea
mesh term: Vomiting
mesh term: Ondansetron
mesh term: Fosaprepitant
mesh term: Aprepitant
mesh term: Serotonin
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: 