<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/NCT02246439</url>
  </required_header>
  <id_info>
    <org_study_id>RHB-102-01</org_study_id>
    <nct_id>NCT02246439</nct_id>
  </id_info>
  <brief_title>BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis</brief_title>
  <acronym>GUARD</acronym>
  <official_title>Randomized, Placebo-Controlled, Phase 3 Trial of BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis (The GUARD Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RedHill Biopharma Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RedHill Biopharma Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized, Placebo-Controlled, Phase 3 Trial of RHB-102 (BEKINDA) (Ondansetron 24 mg Bimodal&#xD;
      Release Tablets) for Acute Gastroenteritis.&#xD;
&#xD;
      The study will evaluate the safety and efficacy of RHB-102 (BEKINDA) in treating Acute&#xD;
      Gastroenteritis, by comparing it to placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized, Placebo-Controlled, Phase 3 Trial of RHB-102 (BEKINDA) (Ondansetron 24 mg Bimodal&#xD;
      Release Tablets) for Acute Gastroenteritis.&#xD;
&#xD;
      The study will evaluate the safety and efficacy of RHB-102 (BEKINDA) in treating Acute&#xD;
      Gastroenteritis, by comparing it to placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 8, 2014</start_date>
  <completion_date type="Actual">February 16, 2017</completion_date>
  <primary_completion_date type="Actual">February 13, 2017</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population</measure>
    <time_frame>24 Hours</time_frame>
    <description>Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Responders Through 4 Days After First Dose of Study Medication - ITT Population</measure>
    <time_frame>4 Days</time_frame>
    <description>Treatment success, as defined in the primary outcome, through 4 days following first dose of study medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Vomited - ITT Population</measure>
    <time_frame>24 Hours</time_frame>
    <description>Analysis of vomiting from 30 minutes after first administration of study medication until 24 hours post first dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Receiving Rescue Antiemetic Therapy - ITT Population</measure>
    <time_frame>24 Hours</time_frame>
    <description>Patients receiving rescue antiemetic therapy within 24 hours after the first dose of study medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Receiving Intravenous Fluids - ITT Population</measure>
    <time_frame>24 Hours</time_frame>
    <description>Patients receiving parenteral hydration within 24 hours after the first dose of study medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of Nausea at Baseline - ITT Population</measure>
    <time_frame>Day 1 - Baseline through 5 Hours Post Dose</time_frame>
    <description>Severity of nausea was assessed using a 5-point Likert scale: 0=no nausea; 1=mild nausea; 2=moderate nausea; 3=severe nausea; 4=nausea as bad as can be.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and Severity of Diarrhea - ITT Population</measure>
    <time_frame>From 30 Minutes Through 24 Hours after First Dose of Study Medication</time_frame>
    <description>Severity of diarrhea for patients having bowel movements was assessed using the Bristol Stool Scale (&quot;BSS&quot;), a Likert scale rating bowel movements from 1=separate hard lumps, like nuts, to 7=watery, no solid pieces; entirely liquid. The BSS was added to the emergency room day and follow-up diaries beginning with protocol amendment 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Discharge From Emergency Department (ED), Extended Observation Unit, or Hospital - ITT Population</measure>
    <time_frame>Hours from first dose of study medication to discharge from ED, extended observation unit or hospital, whichever comes last</time_frame>
    <description>Time from first dose of study medication to discharge from ED, extended observation unit or hospital, whichever comes last, and when clinically appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Resumption of Normal Activities (Work/School/Household) - ITT Population</measure>
    <time_frame>Hours from first dose of study medication to resumption of normal activities</time_frame>
    <description>Time from first dose of study medication to resumption of normal activities (work/school/household).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Requiring Hospitalization - ITT Population</measure>
    <time_frame>Day 1 of Study - Day 5 of Study</time_frame>
    <description>Number of patients requiring hospitalization. 4 patients in the RHB-102 treatment group and 1 patient in the placebo treatment group were hospitalized due to lack of efficacy. The remaining patients hospitalized were admitted for reasons other than gastroenteritis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Returning to Emergency Department - ITT Population</measure>
    <time_frame>Day 1 of Study - Day 5 of Study</time_frame>
    <description>Proportion of patients returning to emergency department for gastrointestinal symptoms within 4 days of initial discharge</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication by Baseline Nausea Severity - ITT Population, All Ages</measure>
    <time_frame>24 Hours</time_frame>
    <description>Proportion of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - PP Population</measure>
    <time_frame>24 Hours</time_frame>
    <description>Proportion of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">330</enrollment>
  <condition>Gastroenteritis</condition>
  <condition>Gastritis</condition>
  <arm_group>
    <arm_group_label>RHB-102</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RHB-102, Bimodal Release Ondansetron Tablets</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RHB-102</intervention_name>
    <description>RHB-102, Bimodal Release Ondansetron Tablets</description>
    <arm_group_label>RHB-102</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have vomited at least twice in the 4 hours preceding signing informed&#xD;
             consent. A vomiting episode is defined as an episode of forceful expulsion of stomach&#xD;
             contents. Retching if a patient has already emptied his or her gastric contents is&#xD;
             also considered vomiting episode. A distinct episode is characterized by a clear break&#xD;
             in vomiting activity of at least 5 minutes&#xD;
&#xD;
          -  Emesis must have been nonbloody (streaks of blood presumed due to force of retching&#xD;
             are allowed)&#xD;
&#xD;
          -  All patients (and a parent or guardian for patients &lt;age 18) must sign informed&#xD;
             consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe dehydration. Severe dehydration is defined as two or more of the following&#xD;
             criteria in the presence of decreased intake and increased output due to vomiting or&#xD;
             diarrhea: Absent or severely decreased urine output; weak pulse and/or low blood&#xD;
             pressure; parched mucous membranes; lethargy, confusion, delirium or loss of&#xD;
             consciousness&#xD;
&#xD;
          -  Signs and symptoms severe enough to require immediate parenteral hydration and/or&#xD;
             parenteral antiemetic medication&#xD;
&#xD;
          -  Temperature&gt;39.0&#xD;
&#xD;
          -  Likely etiologies for acute vomiting and diarrhea other than acute infectious or toxic&#xD;
             gastroenteritis or gastritis. This includes signs of an acute abdomen, which may&#xD;
             require surgical intervention&#xD;
&#xD;
          -  Chemically-induced gastroenteritis, e.g., from alcohol, other drugs of abuse or other&#xD;
             irritant chemicals&#xD;
&#xD;
          -  Use within 24 hours of study entry of specific medication for treatment of nausea&#xD;
             and/or vomiting, e.g., 5-HT3 antagonists or phenothiazines, or receipt of any IV fluid&#xD;
             for any reason. Nonspecific gastrointestinal remedies, such as antacids, proton pump&#xD;
             inhibitors and homeopathic remedies, are permitted.&#xD;
&#xD;
          -  Congestive heart failure, bradyarrhythmia (baseline pulse&lt;55/min), known long QT&#xD;
             syndrome&#xD;
&#xD;
          -  Patient who have known QTc prolongation &gt; 450 msec, noted on prior or screening ECG,&#xD;
             or who are taking medication known to cause QT prolongation. Note: for current list of&#xD;
             medications known to cause QT prolongation see:&#xD;
             https://www.crediblemeds.org/healthcare-providers/drug-list/ Use list showing drugs&#xD;
             with known risk TdP.&#xD;
&#xD;
          -  Known underlying disease which could affect assessment of hydration or modify outcome&#xD;
             of treatment, e.g., renal failure, diabetes mellitus, liver disease, alcoholism.&#xD;
             Patients with type 2 diet-controlled diabetes mellitus whose baseline blood glucose is&#xD;
             &lt;200 may be entered into the study&#xD;
&#xD;
          -  Abdominal surgery within the past 3 months&#xD;
&#xD;
          -  History of bariatric surgery or bowel obstruction at any time&#xD;
&#xD;
          -  Hypersensitivity or other known intolerance to ondansetron or other 5-HT3 antagonists&#xD;
&#xD;
          -  Patient has taken apomorphine within 24 hours of screening&#xD;
&#xD;
          -  Patient has previously participated in this study&#xD;
&#xD;
          -  Patient has participated in another interventional clinical trial, for any indication,&#xD;
             in the past 30 days&#xD;
&#xD;
          -  For women of childbearing potential: documented or possible pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Silverman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Long Island Jewish Hospital (LIJ)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kern Medical Center</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93311</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Olive View- UCLA Medical Center</name>
      <address>
        <city>Sylmar</city>
        <state>California</state>
        <zip>91342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>George Washington University</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Shore Hospital</name>
      <address>
        <city>South Weymouth</city>
        <state>Massachusetts</state>
        <zip>02190</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wayne State University - Sinai Grace Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hennepin County Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University - St. Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kings County Hospital</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Brooklyn</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore University Hospital</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cohen's Children's Medical Center of NY</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Island Jewish Medical Center</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Staten Island University Hospital North</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook University</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Mercy</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15261</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CityDoc Urgent Care</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McAllen Primary Care</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <results_first_submitted>November 30, 2018</results_first_submitted>
  <results_first_submitted_qc>January 28, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">February 20, 2019</results_first_posted>
  <disposition_first_submitted>February 8, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>February 8, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 12, 2018</disposition_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastroenteritis</keyword>
  <keyword>Gastritis</keyword>
  <keyword>Vomiting</keyword>
  <keyword>Nausea</keyword>
  <keyword>Diarrhea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroenteritis</mesh_term>
    <mesh_term>Gastritis</mesh_term>
    <mesh_term>Vomiting</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 9, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT02246439/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 29, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT02246439/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>First patient randomized: 08 December 2014 Last patient completed: 17 February 2017&#xD;
This study was conducted in Emergency Departments (EDs) and urgent care centers across the United States. Only 2 sites were urgent care centers; the rest were EDs.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>RHB-102</title>
          <description>1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>1 tablet of matching placebo, once daily for up to 4 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="192">6 participants that enrolled in the study did not receive allocated intervention.</participants>
                <participants group_id="P2" count="129">3 participants that enrolled in the study did not receive allocated intervention.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Randomized</title>
              <participants_list>
                <participants group_id="P1" count="198"/>
                <participants group_id="P2" count="132"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="180"/>
                <participants group_id="P2" count="118"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="5"/>
              </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="2"/>
              </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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unkonwn</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>RHB-102</title>
          <description>1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>1 tablet of matching placebo, once daily for up to 4 days.</description>
        </group>
        <group group_id="B3">
          <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="192"/>
            <count group_id="B2" value="129"/>
            <count group_id="B3" value="321"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.5" spread="11.92"/>
                    <measurement group_id="B2" value="28.4" spread="9.69"/>
                    <measurement group_id="B3" value="29.0" spread="11.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>18 years or older</title>
                  <measurement_list>
                    <measurement group_id="B1" value="177"/>
                    <measurement group_id="B2" value="118"/>
                    <measurement group_id="B3" value="295"/>
                  </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="122"/>
                    <measurement group_id="B2" value="73"/>
                    <measurement group_id="B3" value="195"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>American Indian or Alaskan Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic/Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic/Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="140"/>
                    <measurement group_id="B2" value="99"/>
                    <measurement group_id="B3" value="239"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Nausea</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No nausea</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild nausea</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate nausea</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe nausea</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nausea as bad as could be</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population</title>
        <description>Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose</description>
        <time_frame>24 Hours</time_frame>
        <population>The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.</population>
        <group_list>
          <group group_id="O1">
            <title>RHB-102</title>
            <description>1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Tablet</title>
            <description>1 tablet of matching placebo, once daily for up to 4 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population</title>
          <description>Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose</description>
          <population>The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="192"/>
                <count group_id="O2" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All ages</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="192"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt;18 years of age</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 years of age or older</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The odds ratio and p-value were from a Cochran-Mantel-Haenszel test. For the 'All ages' category, the odds ratio and p-value were stratified by age.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0406</p_value>
            <p_value_desc>This P-Value is for the &quot;All ages&quot; group</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by age.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.6081</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.0194</ci_lower_limit>
            <ci_upper_limit>2.5368</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0729</p_value>
            <p_value_desc>This P-Value is for the &quot;&lt;18 years of age&quot; group.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.800</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.8470</ci_lower_limit>
            <ci_upper_limit>27.2024</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1089</p_value>
            <p_value_desc>This P-Value is for the &quot;18 years of age and older&quot; group</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.4755</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9170</ci_lower_limit>
            <ci_upper_limit>2.3741</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Responders Through 4 Days After First Dose of Study Medication - ITT Population</title>
        <description>Treatment success, as defined in the primary outcome, through 4 days following first dose of study medication.</description>
        <time_frame>4 Days</time_frame>
        <population>The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.</population>
        <group_list>
          <group group_id="O1">
            <title>RHB-102</title>
            <description>1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Tablet</title>
            <description>1 tablet of matching placebo, once daily for up to 4 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Responders Through 4 Days After First Dose of Study Medication - ITT Population</title>
          <description>Treatment success, as defined in the primary outcome, through 4 days following first dose of study medication.</description>
          <population>The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="192"/>
                <count group_id="O2" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114"/>
                    <measurement group_id="O2" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1843</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by age.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.3545</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.8647</ci_lower_limit>
            <ci_upper_limit>2.1216</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Vomited - ITT Population</title>
        <description>Analysis of vomiting from 30 minutes after first administration of study medication until 24 hours post first dose</description>
        <time_frame>24 Hours</time_frame>
        <population>The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.</population>
        <group_list>
          <group group_id="O1">
            <title>RHB-102</title>
            <description>1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Tablet</title>
            <description>1 tablet of matching placebo, once daily for up to 4 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Vomited - ITT Population</title>
          <description>Analysis of vomiting from 30 minutes after first administration of study medication until 24 hours post first dose</description>
          <population>The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="192"/>
                <count group_id="O2" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="131"/>
                    <measurement group_id="O2" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0166</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by age.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.7520</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.1058</ci_lower_limit>
            <ci_upper_limit>2.7760</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Receiving Rescue Antiemetic Therapy - ITT Population</title>
        <description>Patients receiving rescue antiemetic therapy within 24 hours after the first dose of study medication.</description>
        <time_frame>24 Hours</time_frame>
        <population>The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.</population>
        <group_list>
          <group group_id="O1">
            <title>RHB-102</title>
            <description>1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Tablet</title>
            <description>1 tablet of matching placebo, once daily for up to 4 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Receiving Rescue Antiemetic Therapy - ITT Population</title>
          <description>Patients receiving rescue antiemetic therapy within 24 hours after the first dose of study medication.</description>
          <population>The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="192"/>
                <count group_id="O2" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1049</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by age.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.6677</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.4093</ci_lower_limit>
            <ci_upper_limit>1.0892</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Receiving Intravenous Fluids - ITT Population</title>
        <description>Patients receiving parenteral hydration within 24 hours after the first dose of study medication.</description>
        <time_frame>24 Hours</time_frame>
        <population>The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.</population>
        <group_list>
          <group group_id="O1">
            <title>RHB-102</title>
            <description>1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Tablet</title>
            <description>1 tablet of matching placebo, once daily for up to 4 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Receiving Intravenous Fluids - ITT Population</title>
          <description>Patients receiving parenteral hydration within 24 hours after the first dose of study medication.</description>
          <population>The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="192"/>
                <count group_id="O2" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1235</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by age.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.6566</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.3826</ci_lower_limit>
            <ci_upper_limit>1.1268</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severity of Nausea at Baseline - ITT Population</title>
        <description>Severity of nausea was assessed using a 5-point Likert scale: 0=no nausea; 1=mild nausea; 2=moderate nausea; 3=severe nausea; 4=nausea as bad as can be.</description>
        <time_frame>Day 1 - Baseline through 5 Hours Post Dose</time_frame>
        <population>The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.</population>
        <group_list>
          <group group_id="O1">
            <title>RHB-102</title>
            <description>1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Tablet</title>
            <description>1 tablet of matching placebo, once daily for up to 4 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of Nausea at Baseline - ITT Population</title>
          <description>Severity of nausea was assessed using a 5-point Likert scale: 0=no nausea; 1=mild nausea; 2=moderate nausea; 3=severe nausea; 4=nausea as bad as can be.</description>
          <population>The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="192"/>
                <count group_id="O2" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="1.03"/>
                    <measurement group_id="O2" value="2.6" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 1 Post Dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="1.10"/>
                    <measurement group_id="O2" value="1.3" spread="1.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 2 Post Dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.97"/>
                    <measurement group_id="O2" value="0.9" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 3 Post Dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.85"/>
                    <measurement group_id="O2" value="0.8" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 4 Post Dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.75"/>
                    <measurement group_id="O2" value="0.6" spread="1.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 5 Post Dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.42"/>
                    <measurement group_id="O2" value="0.2" spread="0.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence and Severity of Diarrhea - ITT Population</title>
        <description>Severity of diarrhea for patients having bowel movements was assessed using the Bristol Stool Scale (&quot;BSS&quot;), a Likert scale rating bowel movements from 1=separate hard lumps, like nuts, to 7=watery, no solid pieces; entirely liquid. The BSS was added to the emergency room day and follow-up diaries beginning with protocol amendment 3.</description>
        <time_frame>From 30 Minutes Through 24 Hours after First Dose of Study Medication</time_frame>
        <population>The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.</population>
        <group_list>
          <group group_id="O1">
            <title>RHB-102</title>
            <description>1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Tablet</title>
            <description>1 tablet of matching placebo, once daily for up to 4 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence and Severity of Diarrhea - ITT Population</title>
          <description>Severity of diarrhea for patients having bowel movements was assessed using the Bristol Stool Scale (&quot;BSS&quot;), a Likert scale rating bowel movements from 1=separate hard lumps, like nuts, to 7=watery, no solid pieces; entirely liquid. The BSS was added to the emergency room day and follow-up diaries beginning with protocol amendment 3.</description>
          <population>The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No bowel movement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>BSS 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>BSS 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>BSS 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>BSS 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>BSS 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>BSS 6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>BSS 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5890</p_value>
            <p_value_desc>This P-Value is for the BSS=7 group.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Discharge From Emergency Department (ED), Extended Observation Unit, or Hospital - ITT Population</title>
        <description>Time from first dose of study medication to discharge from ED, extended observation unit or hospital, whichever comes last, and when clinically appropriate.</description>
        <time_frame>Hours from first dose of study medication to discharge from ED, extended observation unit or hospital, whichever comes last</time_frame>
        <population>Patients were required to stay in the ED for at least 2 hours (first 172 patients) and subsequently, when post-treatment ECGs were introduced, for 4 hours. Since not all patients had prolonged ED stays, a difference in time until patients were clinically eligible for discharge may have been masked.</population>
        <group_list>
          <group group_id="O1">
            <title>RHB-102</title>
            <description>1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Tablet</title>
            <description>1 tablet of matching placebo, once daily for up to 4 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Discharge From Emergency Department (ED), Extended Observation Unit, or Hospital - ITT Population</title>
          <description>Time from first dose of study medication to discharge from ED, extended observation unit or hospital, whichever comes last, and when clinically appropriate.</description>
          <population>Patients were required to stay in the ED for at least 2 hours (first 172 patients) and subsequently, when post-treatment ECGs were introduced, for 4 hours. Since not all patients had prolonged ED stays, a difference in time until patients were clinically eligible for discharge may have been masked.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="192"/>
                <count group_id="O2" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All ages</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="192"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" lower_limit="4.1" upper_limit="4.5"/>
                    <measurement group_id="O2" value="4.3" lower_limit="4.0" upper_limit="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt; 18 years of age</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" lower_limit="2.9" upper_limit="4.7"/>
                    <measurement group_id="O2" value="4.8" lower_limit="3.0" upper_limit="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 years of age or older</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" lower_limit="4.1" upper_limit="4.5"/>
                    <measurement group_id="O2" value="4.2" lower_limit="4.0" upper_limit="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8487</p_value>
            <p_value_desc>This P-Value is for the &quot;All ages&quot; group.</p_value_desc>
            <method>Cox proportioanl hazards method</method>
            <method_desc>Stratified by age.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.9782</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.7803</ci_lower_limit>
            <ci_upper_limit>1.2264</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3479</p_value>
            <p_value_desc>This P-Value is for the &quot;&lt;18 years of age&quot; group.</p_value_desc>
            <method>Cox proportional hazards method</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.4756</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.6549</ci_lower_limit>
            <ci_upper_limit>3.3250</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6332</p_value>
            <p_value_desc>This P-Value is for the &quot;18 years of age of older&quot; group.</p_value_desc>
            <method>Cox proportional hazards method</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.9445</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.7469</ci_lower_limit>
            <ci_upper_limit>1.1943</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Resumption of Normal Activities (Work/School/Household) - ITT Population</title>
        <description>Time from first dose of study medication to resumption of normal activities (work/school/household).</description>
        <time_frame>Hours from first dose of study medication to resumption of normal activities</time_frame>
        <population>The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.</population>
        <group_list>
          <group group_id="O1">
            <title>RHB-102</title>
            <description>1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Tablet</title>
            <description>1 tablet of matching placebo, once daily for up to 4 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Resumption of Normal Activities (Work/School/Household) - ITT Population</title>
          <description>Time from first dose of study medication to resumption of normal activities (work/school/household).</description>
          <population>The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="192"/>
                <count group_id="O2" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All ages</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="192"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="3" upper_limit="4"/>
                    <measurement group_id="O2" value="3" lower_limit="3" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt; 18 years of age</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="O2" value="4" lower_limit="2" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 years of age or older</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="3" upper_limit="4"/>
                    <measurement group_id="O2" value="3" lower_limit="NA" upper_limit="NA"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8289</p_value>
            <p_value_desc>This P-Value was for the &quot;All ages&quot; group.</p_value_desc>
            <method>Cox proportional hazards method</method>
            <method_desc>Stratified by age.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.0275</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.8036</ci_lower_limit>
            <ci_upper_limit>1.3138</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3241</p_value>
            <p_value_desc>This P-Value is for the &quot;&lt;18 years of age&quot; group.</p_value_desc>
            <method>Cox proportional hazards method</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.5744</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.6388</ci_lower_limit>
            <ci_upper_limit>3.8802</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9511</p_value>
            <p_value_desc>This P-Value is for the &quot;18 years of age or older&quot; group.</p_value_desc>
            <method>Cox proportional hazards method</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.9920</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.7688</ci_lower_limit>
            <ci_upper_limit>1.2801</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Requiring Hospitalization - ITT Population</title>
        <description>Number of patients requiring hospitalization. 4 patients in the RHB-102 treatment group and 1 patient in the placebo treatment group were hospitalized due to lack of efficacy. The remaining patients hospitalized were admitted for reasons other than gastroenteritis.</description>
        <time_frame>Day 1 of Study - Day 5 of Study</time_frame>
        <population>The number of treated patients requiring hospitalization was low in this study (14 patients). In the RHB-102 group, 11 patients (5.7%) were hospitalized, including one who returned to the ED for gastrointestinal symptoms 2 days after initial treatment. In the placebo treatment group, 3 patients (2.3%) were hospitalized.</population>
        <group_list>
          <group group_id="O1">
            <title>RHB-102</title>
            <description>1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Tablet</title>
            <description>1 tablet of matching placebo, once daily for up to 4 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Requiring Hospitalization - ITT Population</title>
          <description>Number of patients requiring hospitalization. 4 patients in the RHB-102 treatment group and 1 patient in the placebo treatment group were hospitalized due to lack of efficacy. The remaining patients hospitalized were admitted for reasons other than gastroenteritis.</description>
          <population>The number of treated patients requiring hospitalization was low in this study (14 patients). In the RHB-102 group, 11 patients (5.7%) were hospitalized, including one who returned to the ED for gastrointestinal symptoms 2 days after initial treatment. In the placebo treatment group, 3 patients (2.3%) were hospitalized.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="192"/>
                <count group_id="O2" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2005</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.3012</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.6221</ci_lower_limit>
            <ci_upper_limit>8.5129</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Returning to Emergency Department - ITT Population</title>
        <description>Proportion of patients returning to emergency department for gastrointestinal symptoms within 4 days of initial discharge</description>
        <time_frame>Day 1 of Study - Day 5 of Study</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RHB-102</title>
            <description>1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Tablet</title>
            <description>1 tablet of matching placebo, once daily for up to 4 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Returning to Emergency Department - ITT Population</title>
          <description>Proportion of patients returning to emergency department for gastrointestinal symptoms within 4 days of initial discharge</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="192"/>
                <count group_id="O2" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5720</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.6674</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1638</ci_lower_limit>
            <ci_upper_limit>2.7191</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication by Baseline Nausea Severity - ITT Population, All Ages</title>
        <description>Proportion of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose</description>
        <time_frame>24 Hours</time_frame>
        <population>The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.</population>
        <group_list>
          <group group_id="O1">
            <title>RHB-102</title>
            <description>1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Tablet</title>
            <description>1 tablet of matching placebo, once daily for up to 4 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication by Baseline Nausea Severity - ITT Population, All Ages</title>
          <description>Proportion of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose</description>
          <population>The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="192"/>
                <count group_id="O2" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No nausea or mild nausea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate nausea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe nausea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea as bad as it could have been</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3186</p_value>
            <p_value_desc>This P-Value is for the &quot;No nausea or mild nausea&quot; group.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by age.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.1591</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.4770</ci_lower_limit>
            <ci_upper_limit>9.7735</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3473</p_value>
            <p_value_desc>This P-Value is for the &quot;Moderate nausea&quot; group.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by age.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.5750</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.6096</ci_lower_limit>
            <ci_upper_limit>4.0696</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0633</p_value>
            <p_value_desc>This P-Value is for the &quot;Severe nausea&quot; group.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by age.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.0971</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9614</ci_lower_limit>
            <ci_upper_limit>4.5747</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2797</p_value>
            <p_value_desc>This P-Value is for the &quot;Nausea as bad as it could have been&quot; group.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by age.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.6397</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.6649</ci_lower_limit>
            <ci_upper_limit>4.0437</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - PP Population</title>
        <description>Proportion of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose</description>
        <time_frame>24 Hours</time_frame>
        <population>The Per Protocol Population contained all patients who met all inclusion/exclusion criteria, received a second dose of study medication if they vomited within 15 minutes of receiving the first dose, &amp; did not have a primary diagnosis upon discharge from ED (or, if admitted, discharge from the hospital) other than acute gastroenteritis/gastritis.</population>
        <group_list>
          <group group_id="O1">
            <title>RHB-102</title>
            <description>1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Tablet</title>
            <description>1 tablet of matching placebo, once daily for up to 4 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - PP Population</title>
          <description>Proportion of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose</description>
          <population>The Per Protocol Population contained all patients who met all inclusion/exclusion criteria, received a second dose of study medication if they vomited within 15 minutes of receiving the first dose, &amp; did not have a primary diagnosis upon discharge from ED (or, if admitted, discharge from the hospital) other than acute gastroenteritis/gastritis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All ages</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="122"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="123"/>
                    <measurement group_id="O2" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt;18 years of age</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 years of age or older</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="163"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112"/>
                    <measurement group_id="O2" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0103</p_value>
            <p_value_desc>This P-Value is for the &quot;All ages&quot; group.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by age.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.8673</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.1572</ci_lower_limit>
            <ci_upper_limit>3.0131</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0934</p_value>
            <p_value_desc>This P-Value is for the &quot;&lt;18 years of age&quot; group.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.4000</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.7699</ci_lower_limit>
            <ci_upper_limit>25.1450</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0303</p_value>
            <p_value_desc>This P-Value is for the &quot;18 years of age or older&quot; group.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.7356</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.0527</ci_lower_limit>
            <ci_upper_limit>2.8615</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Primary Endpoint Subgroup Analysis - PP Population</title>
        <description>Examination of treatment success rates by age (&lt;18 and ≥18 years).</description>
        <time_frame>24 Hours</time_frame>
        <population>The Per Protocol (PP) Population contained all patients who met all inclusion/exclusion criteria, received a second dose of medication if they vomited within 15 minutes of receiving first dose, and did not have a primary diagnosis upon discharge from the ED (or, if admitted, discharge from the hospital) other than acute gastroenteritis/gastritis.</population>
        <group_list>
          <group group_id="O1">
            <title>RHB-102</title>
            <description>1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Tablet</title>
            <description>1 tablet of matching placebo, once daily for up to 4 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Endpoint Subgroup Analysis - PP Population</title>
          <description>Examination of treatment success rates by age (&lt;18 and ≥18 years).</description>
          <population>The Per Protocol (PP) Population contained all patients who met all inclusion/exclusion criteria, received a second dose of medication if they vomited within 15 minutes of receiving first dose, and did not have a primary diagnosis upon discharge from the ED (or, if admitted, discharge from the hospital) other than acute gastroenteritis/gastritis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&lt; 18 years of age</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 years of age or older</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="163"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112"/>
                    <measurement group_id="O2" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0924</p_value>
            <p_value_desc>This P-Value is for the &quot;&lt;18 years of age&quot; group.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.4000</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.7699</ci_lower_limit>
            <ci_upper_limit>25.1450</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0303</p_value>
            <p_value_desc>This P-Value is for the &quot;18 years of age or older&quot; group.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.7356</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.0527</ci_lower_limit>
            <ci_upper_limit>2.8615</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population (Logistic Regression Adjusted by Baseline Nausea Severity)</title>
        <description>Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose (analyzed using logistic regression with treatment as a factor and baseline nausea severity as a continuous variable)</description>
        <time_frame>24 Hours</time_frame>
        <population>The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication. The primary efficacy analysis was conducted using the ITT Population.</population>
        <group_list>
          <group group_id="O1">
            <title>RHB-102</title>
            <description>1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Tablet</title>
            <description>1 tablet of matching placebo, once daily for up to 4 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population (Logistic Regression Adjusted by Baseline Nausea Severity)</title>
          <description>Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose (analyzed using logistic regression with treatment as a factor and baseline nausea severity as a continuous variable)</description>
          <population>The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication. The primary efficacy analysis was conducted using the ITT Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="192"/>
                <count group_id="O2" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0152</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.7922</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.1188</ci_lower_limit>
            <ci_upper_limit>2.8710</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - PP Population (Logistic Regression Adjusted by Baseline Nausea Severity)</title>
        <description>Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose (analyzed using logistic regression with treatment as a factor and baseline nausea severity as a continuous variable)</description>
        <time_frame>24 Hours</time_frame>
        <population>The Per Protocol Population contained all patients who met all inclusion/exclusion criteria, received a second dose of medication if they vomited within 15 minutes of receiving the first dose, and did not have a primary diagnosis upon discharge from the ED (or, if admitted, discharge from the hospital) other than acute gastroenteritis/gastritis.</population>
        <group_list>
          <group group_id="O1">
            <title>RHB-102</title>
            <description>1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Tablet</title>
            <description>1 tablet of matching placebo, once daily for up to 4 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - PP Population (Logistic Regression Adjusted by Baseline Nausea Severity)</title>
          <description>Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose (analyzed using logistic regression with treatment as a factor and baseline nausea severity as a continuous variable)</description>
          <population>The Per Protocol Population contained all patients who met all inclusion/exclusion criteria, received a second dose of medication if they vomited within 15 minutes of receiving the first dose, and did not have a primary diagnosis upon discharge from the ED (or, if admitted, discharge from the hospital) other than acute gastroenteritis/gastritis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="123"/>
                    <measurement group_id="O2" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0037</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.0789</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.2676</ci_lower_limit>
            <ci_upper_limit>3.4095</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 years, 3 months</time_frame>
      <desc>A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.</desc>
      <group_list>
        <group group_id="E1">
          <title>RHB-102</title>
          <description>1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>1 tablet of matching placebo, once daily for up to 4 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (13.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Sideroblastic Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Small Intestinal Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Diverticulitis Intestinal Haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile Duct Stone</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Hospitalization for further diagnosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic Ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Failure Acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA (13.1)</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="44" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="128"/>
              </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>Institution will provide to Sponsor, for review and comment, all manuscripts or other material prior to such publication. Sponsor shall have 30 days to review any such publication. The Sponsor can require changes to the communication and such confidential information shall be deleted and/or the submission of the proposed publication shall be delayed for an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Terry Plasse</name_or_title>
      <organization>RedHill Biopharma Ltd.</organization>
      <phone>+972-(0)3-541-3131</phone>
      <email>terry@redhillbio.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/NCT02246439
org study id: RHB-102-01
nct id: NCT02246439
lead sponsor: 
has dmc: No
Randomized, Placebo-Controlled, Phase 3 Trial of RHB-102 (BEKINDA) (Ondansetron 24 mg Bimodal
      Release Tablets) for Acute Gastroenteritis.

      The study will evaluate the safety and efficacy of RHB-102 (BEKINDA) in treating Acute
      Gastroenteritis, by comparing it to placebo.
Randomized, Placebo-Controlled, Phase 3 Trial of RHB-102 (BEKINDA) (Ondansetron 24 mg Bimodal
      Release Tablets) for Acute Gastroenteritis.

      The study will evaluate the safety and efficacy of RHB-102 (BEKINDA) in treating Acute
      Gastroenteritis, by comparing it to placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population
time frame: 24 Hours
description: Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose
measure: Responders Through 4 Days After First Dose of Study Medication - ITT Population
time frame: 4 Days
description: Treatment success, as defined in the primary outcome, through 4 days following first dose of study medication.
measure: Number of Participants Who Vomited - ITT Population
time frame: 24 Hours
description: Analysis of vomiting from 30 minutes after first administration of study medication until 24 hours post first dose
measure: Number of Patients Receiving Rescue Antiemetic Therapy - ITT Population
time frame: 24 Hours
description: Patients receiving rescue antiemetic therapy within 24 hours after the first dose of study medication.
measure: Number of Patients Receiving Intravenous Fluids - ITT Population
time frame: 24 Hours
description: Patients receiving parenteral hydration within 24 hours after the first dose of study medication.
measure: Severity of Nausea at Baseline - ITT Population
time frame: Day 1 - Baseline through 5 Hours Post Dose
description: Severity of nausea was assessed using a 5-point Likert scale: 0=no nausea; 1=mild nausea; 2=moderate nausea; 3=severe nausea; 4=nausea as bad as can be.
measure: Incidence and Severity of Diarrhea - ITT Population
time frame: From 30 Minutes Through 24 Hours after First Dose of Study Medication
description: Severity of diarrhea for patients having bowel movements was assessed using the Bristol Stool Scale ("BSS"), a Likert scale rating bowel movements from 1=separate hard lumps, like nuts, to 7=watery, no solid pieces; entirely liquid. The BSS was added to the emergency room day and follow-up diaries beginning with protocol amendment 3.
measure: Time to Discharge From Emergency Department (ED), Extended Observation Unit, or Hospital - ITT Population
time frame: Hours from first dose of study medication to discharge from ED, extended observation unit or hospital, whichever comes last
description: Time from first dose of study medication to discharge from ED, extended observation unit or hospital, whichever comes last, and when clinically appropriate.
measure: Time to Resumption of Normal Activities (Work/School/Household) - ITT Population
time frame: Hours from first dose of study medication to resumption of normal activities
description: Time from first dose of study medication to resumption of normal activities (work/school/household).
measure: Number of Patients Requiring Hospitalization - ITT Population
time frame: Day 1 of Study - Day 5 of Study
description: Number of patients requiring hospitalization. 4 patients in the RHB-102 treatment group and 1 patient in the placebo treatment group were hospitalized due to lack of efficacy. The remaining patients hospitalized were admitted for reasons other than gastroenteritis.
measure: Number of Patients Returning to Emergency Department - ITT Population
time frame: Day 1 of Study - Day 5 of Study
description: Proportion of patients returning to emergency department for gastrointestinal symptoms within 4 days of initial discharge
measure: Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication by Baseline Nausea Severity - ITT Population, All Ages
time frame: 24 Hours
description: Proportion of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose
measure: Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - PP Population
time frame: 24 Hours
description: Proportion of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose
arm group label: RHB-102
arm group type: Experimental
description: RHB-102, Bimodal Release Ondansetron Tablets
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: RHB-102
description: RHB-102, Bimodal Release Ondansetron Tablets
arm group label: RHB-102
intervention type: Drug
intervention name: Placebo Oral Tablet
description: Placebo
arm group label: Placebo
other name: Placebo
criteria: 
gender: All
minimum age: 12 Years
maximum age: 85 Years
healthy volunteers: No
last name: Robert Silverman, MD
role: Principal Investigator
affiliation: Long Island Jewish Hospital (LIJ)
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country: United States
responsible party type: Sponsor
mesh term: Gastroenteritis
mesh term: Gastritis
mesh term: Vomiting
provided document: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 