<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/NCT01700140</url>
  </required_header>
  <id_info>
    <org_study_id>2010003</org_study_id>
    <nct_id>NCT01700140</nct_id>
  </id_info>
  <brief_title>Phase II Study of SyB D-0701 for Radiotherapy-Induced Nausea and Vomiting (RINV)</brief_title>
  <official_title>Phase II Clinical Study of SyB D-0701 for Radiotherapy Induced Nausea and Vomiting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SymBio Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SymBio Pharmaceuticals</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to explore the dose response of SyB D-0701 for preventing nausea&#xD;
      and emesis associated with radiotherapy (fractionated/localized irradiation) in cancer&#xD;
      patients scheduled to receive radiotherapy (fractionated/localized irradiation) alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Exploratory study of dose response of SyB D-0701 to preventing effects for nausea and emesis&#xD;
      associated with radiotherapy (fractionated/localized irradiation)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete Control (no Signs of Emesis or Moderate to Severe Nausea and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation</measure>
    <time_frame>72 hours</time_frame>
    <description>The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete Response (no Signs of Emesis and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation</measure>
    <time_frame>72 hours</time_frame>
    <description>The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Emesis</measure>
    <time_frame>24-72 hours</time_frame>
    <description>Time from the start of radiotherapy to the onset of first emesis. The median (50% point) of time to first emesis was estimated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Nausea</measure>
    <time_frame>24-72 hours</time_frame>
    <description>Time from the start of radiotherapy to the onset of first nausea. The median (50% point) of time to first nausea was estimated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Control Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3</measure>
    <time_frame>24-72 hours</time_frame>
    <description>Complete control rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy.&#xD;
The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Response Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3</measure>
    <time_frame>24-72 hours</time_frame>
    <description>Complete response rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy.&#xD;
The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Up to 192 hours</time_frame>
    <description>Adverse event is any untoward medical occurrence experienced by a subject irrespective of causal relationship with the study drug, and includes the unexpected signs, clinically significant fluctuations of laboratory data, and aggravation of disease, symptoms or complications. Adverse events are coded using the preferred terms (PT) of Medical Dictionary for Regulatory Activities (MedDRA) version 15.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe (Grade 3 or More) Adverse Events</measure>
    <time_frame>Up to 192 hours</time_frame>
    <description>The severity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.&#xD;
Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin Manifestations at Study Drug Application Site</measure>
    <time_frame>Up to 192 hours</time_frame>
    <description>The investigator or sub-investigator recorded skin manifestations observed after removal of the study drug.&#xD;
Skin manifestations were counted for each type of patches (placebo patch, SyB D-0701 15 cm2 patch, SyB D-0701 25 cm2 patch).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">189</enrollment>
  <condition>Radiotherapy-induced Nausea and Vomiting (RINV)</condition>
  <arm_group>
    <arm_group_label>SyB D-0701: high dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>SyB D-0701: low dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SyB D-0701</intervention_name>
    <description>Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch, High dose group (30.00 mg): SyB D-0701 15 cm2 patch + SyB D-0701 25 cm2 patch] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
    <arm_group_label>SyB D-0701: high dose group</arm_group_label>
    <arm_group_label>SyB D-0701: low dose group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
    <arm_group_label>SyB D-0701: low dose group</arm_group_label>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria Patients must satisfy the following conditions listed below.&#xD;
&#xD;
          1. Patients with histologically verified malignant tumors&#xD;
&#xD;
          2. Patients receiving radiotherapy alone who are scheduled for at least 3 fractions, each&#xD;
             at a radiation dose of 1.5 to 3.0 Gy&#xD;
&#xD;
          3. Cancer patients scheduled for radiotherapy over a field of at least 100 cm2 (50 cm2 or&#xD;
             more in cases of irradiation of the vertebrae only) that includes the abdomen and&#xD;
             pelvis (region with upper edge at the 11th thoracic vertebrae and lower edge at pelvic&#xD;
             cavity)&#xD;
&#xD;
          4. Patients not scheduled to receive anti-tumor agents between the first and the fifth&#xD;
             day of radiotherapy. If the patient has a history of anti-tumor agent therapy,&#xD;
             however, at the time of the patient's registration, at least 5 days must have elapsed&#xD;
             since drug administration was terminated, and the patient must not be scheduled to&#xD;
             receive any anti-tumor agent from the first to the fifth day of radiotherapy&#xD;
&#xD;
          5. Male patients who are surgically sterilized, or who agree to practice adequate&#xD;
             contraception during the study&#xD;
&#xD;
          6. Female patients of child-bearing potential who agree to practice adequate&#xD;
             contraception during the study&#xD;
&#xD;
          7. Patients whose performance status (PS) of Eastern Cooperative Oncology Group (ECOG) is&#xD;
             0 to 2&#xD;
&#xD;
          8. Patients who were at least 20 years of age when their consent was obtained&#xD;
&#xD;
          9. Patients who have given consent in writing to participate in the study with full&#xD;
             understanding of the explanatory documents&#xD;
&#xD;
        Exclusion Criteria Patients who satisfy any of the following conditions will not be&#xD;
        enrolled in the study.&#xD;
&#xD;
          1. Patients with nausea and/or emesis; patients who also have intestinal obstruction,&#xD;
             vestibular dysfunction (e.g., epilepsy), Meniere's syndrome, cerebral metastasis,&#xD;
             electrolyte imbalance (hypercalcemia, hyperglycemia, hyponatremia), uremia, etc., and&#xD;
             patients for whom it is judged that there is a high probability that their nausea or&#xD;
             emesis arises from the aforementioned causes. Registration is possible, however, for&#xD;
             patients with motion sickness (vehicle sickness) or patients with temporary&#xD;
             nausea/emesis arising from routine activities.&#xD;
&#xD;
          2. Patients with primary or metastasized brain tumors who show signs of elevated&#xD;
             intracranial pressure&#xD;
&#xD;
          3. Patients who previously received radiotherapy to the brain or to the region that&#xD;
             includes the abdomen and pelvis (region with upper edge at the 11th thoracic vertebrae&#xD;
             and lower edge at pelvic cavity)&#xD;
&#xD;
          4. Patients who take drugs that affect the evaluation of nausea or emesis (rescue&#xD;
             medication and 5-hydroxytryptamine 3 (5-HT3) receptor antagonists, neurokinin 1 (NK1)&#xD;
             receptor antagonists, anxiolytics, psychotropic drug, opioid analgesics and&#xD;
             corticosteroid [systemic administration] except for rescue medication)&#xD;
&#xD;
          5. Patients with abnormal findings (e.g., erythema, rash, wounds) at sites where the&#xD;
             study drug has been applied&#xD;
&#xD;
          6. Patients with a history of hypersensitivity to study drug ingredients or to other&#xD;
             5-HT3 receptor antagonists&#xD;
&#xD;
          7. Patients with a history of allergy involving dermal symptoms&#xD;
&#xD;
          8. Patients with clear signs of infection (including viral infection)&#xD;
&#xD;
          9. Patients with complications from drug or alcohol dependence, or with a history of the&#xD;
             same&#xD;
&#xD;
         10. Patients who have participated in some type of clinical study (including&#xD;
             physician-initiated clinical studies or clinical research) within 3 months prior to&#xD;
             their registration for the present study and who have been given a study drug&#xD;
             (including drugs not yet approved). Patients can be registered for this study,&#xD;
             however, if they have participated in a clinical study, etc., in which only drugs&#xD;
             already approved have been used.&#xD;
&#xD;
         11. Patients with serious hepatic or renal damage [Grade 3 or above in the Common&#xD;
             Terminology Criteria for Adverse Events (CTCAE) (ver. 4.0-JCOG)]&#xD;
&#xD;
         12. Patients with cardiac dysfunction&#xD;
&#xD;
         13. Patients who are pregnant, who might be pregnant or who are currently lactating&#xD;
&#xD;
         14. Other patients judged as unsuitable by the investigator or sub-investigators&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Kashiwa</city>
        <state>Chiba</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Matsuyama</city>
        <state>Ehime</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Kurume</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Maebashi</city>
        <state>Gunma</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Ota</city>
        <state>Gunma</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Sagamihara</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Kashihara</city>
        <state>Nara</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Nakagami</city>
        <state>Okinawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Sayama</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Hidaka</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Kitaadachi</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Koshigaya</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Niigata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reseach site</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Yamagata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <results_first_submitted>October 1, 2014</results_first_submitted>
  <results_first_submitted_qc>November 11, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 19, 2014</results_first_posted>
  <last_update_submitted>November 11, 2014</last_update_submitted>
  <last_update_submitted_qc>November 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo Group</title>
          <description>Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
        </group>
        <group group_id="P2">
          <title>SyB D-0701: Low Dose Group</title>
          <description>Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
        </group>
        <group group_id="P3">
          <title>SyB D-0701: High Dose Group</title>
          <description>Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="66"/>
                <participants group_id="P3" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="57"/>
                <participants group_id="P3" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Use of rescue drugs</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Discontinuation of radiotherapy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Use of chemotherapy or surgical therapy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Aggravation of symptoms</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Inclusion/exclusion criteria deviation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Per protocol set:&#xD;
Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo Group</title>
          <description>Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
        </group>
        <group group_id="B2">
          <title>SyB D-0701: Low Dose Group</title>
          <description>Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
        </group>
        <group group_id="B3">
          <title>SyB D-0701: High Dose Group</title>
          <description>Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
        </group>
        <group group_id="B4">
          <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="56"/>
            <count group_id="B2" value="59"/>
            <count group_id="B3" value="60"/>
            <count group_id="B4" value="175"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>20-40 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40-50 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50-60 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60-70 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>70≤ years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="55"/>
                  </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="38"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="108"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Metastasis</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Absent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Present</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of radiotherapy</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Absent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="60"/>
                    <measurement group_id="B4" value="167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Present</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of recent chemotherapy</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Absent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Present</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Complication</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Absent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Present</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="50"/>
                    <measurement group_id="B4" value="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diseases in the past 5 years</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Absent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Present</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of smoking habit</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Absent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Present</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Alcohol consumption history</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Absent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Present</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Motion sickness (vehicle sickness)</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Absent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="55"/>
                    <measurement group_id="B4" value="166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Present</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Performance status</title>
          <description>The criteria of Eastern Cooperative Oncology Group (ECOG) performance status are shown below.&#xD;
0: Fully active, able to carry on all pre-disease performance without restriction, 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours</description>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="50"/>
                    <measurement group_id="B4" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Nausea/emesis</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Absent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="60"/>
                    <measurement group_id="B4" value="175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Present</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Complete Control (no Signs of Emesis or Moderate to Severe Nausea and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation</title>
        <description>The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.</description>
        <time_frame>72 hours</time_frame>
        <population>Per protocol set:&#xD;
Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
          <group group_id="O2">
            <title>SyB D-0701: Low Dose Group</title>
            <description>Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
          <group group_id="O3">
            <title>SyB D-0701: High Dose Group</title>
            <description>Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Control (no Signs of Emesis or Moderate to Severe Nausea and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation</title>
          <description>The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.</description>
          <population>Per protocol set:&#xD;
Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.7"/>
                    <measurement group_id="O2" value="84.7"/>
                    <measurement group_id="O3" value="93.3"/>
                  </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 or Other</non_inferiority_type>
            <p_value>1.0000</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2284</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2549</p_value>
            <method>Cochran-Armitage test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complete Response (no Signs of Emesis and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation</title>
        <description>The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.</description>
        <time_frame>72 hours</time_frame>
        <population>Per protocol set:&#xD;
Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
          <group group_id="O2">
            <title>SyB D-0701: Low Dose Group</title>
            <description>Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
          <group group_id="O3">
            <title>SyB D-0701: High Dose Group</title>
            <description>Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Response (no Signs of Emesis and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation</title>
          <description>The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.</description>
          <population>Per protocol set:&#xD;
Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.3"/>
                    <measurement group_id="O2" value="88.1"/>
                    <measurement group_id="O3" value="96.7"/>
                  </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 or Other</non_inferiority_type>
            <p_value>1.0000</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1527</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1864</p_value>
            <method>Cochran-Armitage test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Emesis</title>
        <description>Time from the start of radiotherapy to the onset of first emesis. The median (50% point) of time to first emesis was estimated.</description>
        <time_frame>24-72 hours</time_frame>
        <population>Per protocol set:&#xD;
Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
          <group group_id="O2">
            <title>SyB D-0701: Low Dose Group</title>
            <description>Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
          <group group_id="O3">
            <title>SyB D-0701: High Dose Group</title>
            <description>Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Emesis</title>
          <description>Time from the start of radiotherapy to the onset of first emesis. The median (50% point) of time to first emesis was estimated.</description>
          <population>Per protocol set:&#xD;
Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set.</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="56"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">The estimated non-incidence of emesis by the Kaplan-Meier method exceeded 50%.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">The estimated non-incidence of emesis by the Kaplan-Meier method exceeded 50%.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">The estimated non-incidence of emesis by the Kaplan-Meier method exceeded 50%.</measurement>
                  </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 or Other</non_inferiority_type>
            <p_value>0.8361</p_value>
            <method>Generalized Wilcoxon test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.918</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.266</ci_lower_limit>
            <ci_upper_limit>3.172</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0724</p_value>
            <method>Generalized Wilcoxon test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.423</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.144</ci_lower_limit>
            <ci_upper_limit>1.237</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Nausea</title>
        <description>Time from the start of radiotherapy to the onset of first nausea. The median (50% point) of time to first nausea was estimated.</description>
        <time_frame>24-72 hours</time_frame>
        <population>Per protocol set:&#xD;
Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
          <group group_id="O2">
            <title>SyB D-0701: Low Dose Group</title>
            <description>Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
          <group group_id="O3">
            <title>SyB D-0701: High Dose Group</title>
            <description>Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Nausea</title>
          <description>Time from the start of radiotherapy to the onset of first nausea. The median (50% point) of time to first nausea was estimated.</description>
          <population>Per protocol set:&#xD;
Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set.</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="56"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">The estimated non-incidence of nausea by the Kaplan-Meier method exceeded 50%.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">The estimated non-incidence of nausea by the Kaplan-Meier method exceeded 50%.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">The estimated non-incidence of nausea by the Kaplan-Meier method exceeded 50%.</measurement>
                  </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 or Other</non_inferiority_type>
            <p_value>0.6466</p_value>
            <method>Generalized Wilcoxon test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.213</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.616</ci_lower_limit>
            <ci_upper_limit>2.388</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2701</p_value>
            <method>Generalized Wilcoxon test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.828</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.566</ci_lower_limit>
            <ci_upper_limit>1.210</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complete Control Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3</title>
        <description>Complete control rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy.&#xD;
The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs.</description>
        <time_frame>24-72 hours</time_frame>
        <population>Per protocol set:&#xD;
Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
          <group group_id="O2">
            <title>SyB D-0701: Low Dose Group</title>
            <description>Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
          <group group_id="O3">
            <title>SyB D-0701: High Dose Group</title>
            <description>Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Control Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3</title>
          <description>Complete control rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy.&#xD;
The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs.</description>
          <population>Per protocol set:&#xD;
Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>First irradiation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.1"/>
                    <measurement group_id="O2" value="89.8"/>
                    <measurement group_id="O3" value="98.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Second irradiation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.9"/>
                    <measurement group_id="O2" value="94.7"/>
                    <measurement group_id="O3" value="98.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Third irradiation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.1"/>
                    <measurement group_id="O2" value="96.4"/>
                    <measurement group_id="O3" value="94.9"/>
                  </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>Statistical analysis for complete control rate after the first irradiation</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1.0000</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for complete control rate after the first irradiation</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1051</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for complete control rate after the second irradiation</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4856</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for complete control rate after the second irradiation</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1047</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for complete control rate after the third irradiation</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1617</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for complete control rate after the third irradiation</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3099</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complete Response Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3</title>
        <description>Complete response rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy.&#xD;
The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs.</description>
        <time_frame>24-72 hours</time_frame>
        <population>Per protocol set:&#xD;
Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
          <group group_id="O2">
            <title>SyB D-0701: Low Dose Group</title>
            <description>Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
          <group group_id="O3">
            <title>SyB D-0701: High Dose Group</title>
            <description>Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Response Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3</title>
          <description>Complete response rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy.&#xD;
The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs.</description>
          <population>Per protocol set:&#xD;
Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>First irraditation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.1"/>
                    <measurement group_id="O2" value="91.5"/>
                    <measurement group_id="O3" value="98.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Second irradiation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.5"/>
                    <measurement group_id="O2" value="96.5"/>
                    <measurement group_id="O3" value="98.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Third irradiation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.7"/>
                    <measurement group_id="O2" value="98.2"/>
                    <measurement group_id="O3" value="100.0"/>
                  </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>Statistical analysis for complete response rate after the first irradiation</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1.0000</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for complete response rate after the first irradiation</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1051</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for complete response rate after the second irradiation</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.6761</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for complete response rate after the second irradiation</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3513</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for complete response rate after the third irradiation</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2060</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for complete response rate after the third irradiation</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0511</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Events</title>
        <description>Adverse event is any untoward medical occurrence experienced by a subject irrespective of causal relationship with the study drug, and includes the unexpected signs, clinically significant fluctuations of laboratory data, and aggravation of disease, symptoms or complications. Adverse events are coded using the preferred terms (PT) of Medical Dictionary for Regulatory Activities (MedDRA) version 15.0.</description>
        <time_frame>Up to 192 hours</time_frame>
        <population>Safety population:&#xD;
The safety population consisted of all subjects enrolled, except for subjects with Good Clinical Practice (GCP) non-compliance and those who failed to receive the study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
          <group group_id="O2">
            <title>SyB D-0701: Low Dose Group</title>
            <description>Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
          <group group_id="O3">
            <title>SyB D-0701: High Dose Group</title>
            <description>Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events</title>
          <description>Adverse event is any untoward medical occurrence experienced by a subject irrespective of causal relationship with the study drug, and includes the unexpected signs, clinically significant fluctuations of laboratory data, and aggravation of disease, symptoms or complications. Adverse events are coded using the preferred terms (PT) of Medical Dictionary for Regulatory Activities (MedDRA) version 15.0.</description>
          <population>Safety population:&#xD;
The safety population consisted of all subjects enrolled, except for subjects with Good Clinical Practice (GCP) non-compliance and those who failed to receive the study treatment.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of subjects with any adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="55"/>
                    <measurement group_id="O3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of subjects with adverse drug reaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of subjects with SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severe (Grade 3 or More) Adverse Events</title>
        <description>The severity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.&#xD;
Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE</description>
        <time_frame>Up to 192 hours</time_frame>
        <population>Safety population:&#xD;
The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
          <group group_id="O2">
            <title>SyB D-0701: Low Dose Group</title>
            <description>Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
          <group group_id="O3">
            <title>SyB D-0701: High Dose Group</title>
            <description>Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
          </group>
        </group_list>
        <measure>
          <title>Severe (Grade 3 or More) Adverse Events</title>
          <description>The severity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.&#xD;
Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE</description>
          <population>Safety population:&#xD;
The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.</population>
          <units>Number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 3 : lymphopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 : nausea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 : urethritis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 : lymph node abscess</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 : blood pressure increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 : C-reactive protein increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 : lymphocyte count decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 : neutrophil count increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 : white blood cell count decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 : blood alkaline phosphatase increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 : hyponatraemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 : decreased appetite</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 : rash maculo-papular</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 : lymphocyte count decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Skin Manifestations at Study Drug Application Site</title>
        <description>The investigator or sub-investigator recorded skin manifestations observed after removal of the study drug.&#xD;
Skin manifestations were counted for each type of patches (placebo patch, SyB D-0701 15 cm2 patch, SyB D-0701 25 cm2 patch).</description>
        <time_frame>Up to 192 hours</time_frame>
        <population>Skin manifestations were counted for each type of patch applied to the subjects in the safety population.&#xD;
Placebo patch : 60-1+63+60=182 (One subject in placebo group did not applied 15 cm2 patch.)&#xD;
SyB D-0701 15 cm2 patch : 62&#xD;
SyB D-0701 25 cm2 patch : 62+63=125</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Patch</title>
            <description>Placebo 15 cm2 patch was applied to subjects in placebo group and low dose group.&#xD;
Placebo 25 cm2 patch was applied to subjects in placebo group.</description>
          </group>
          <group group_id="O2">
            <title>SyB D-0701 15 cm2 Patch</title>
            <description>SyB D-0701 15 cm2 patch (11.25 mg) was applied to subjects in high dose group.</description>
          </group>
          <group group_id="O3">
            <title>SyB D-0701 25 cm2 Patch</title>
            <description>SyB D-0701 25 cm2 patch (18.75 mg) was applied to subjects in low dose group and high dose group.</description>
          </group>
        </group_list>
        <measure>
          <title>Skin Manifestations at Study Drug Application Site</title>
          <description>The investigator or sub-investigator recorded skin manifestations observed after removal of the study drug.&#xD;
Skin manifestations were counted for each type of patches (placebo patch, SyB D-0701 15 cm2 patch, SyB D-0701 25 cm2 patch).</description>
          <population>Skin manifestations were counted for each type of patch applied to the subjects in the safety population.&#xD;
Placebo patch : 60-1+63+60=182 (One subject in placebo group did not applied 15 cm2 patch.)&#xD;
SyB D-0701 15 cm2 patch : 62&#xD;
SyB D-0701 25 cm2 patch : 62+63=125</population>
          <units>Number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="182"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Skin manifestations: reacted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clearly identifiable erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema + papules</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema + papules + small blisters</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 192 hours</time_frame>
      <desc>The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo Group</title>
          <description>Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
        </group>
        <group group_id="E2">
          <title>SyB D-0701: Low Dose Group</title>
          <description>Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
        </group>
        <group group_id="E3">
          <title>SyB D-0701: High Dose Group</title>
          <description>Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Ver 15.0</default_vocab>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Lymph node abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA Ver 15.0</default_vocab>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="51" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="55" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="45" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Application site erythema</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Application site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Application site rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Application site vesicles</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Application site papules</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Application site swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Urethritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Post procedural infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Gastroenteritis radiation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Radiation associated pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Blood potassium decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Glucose urine present</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="29" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Neutrophil count increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Protein total decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Platelet count increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Periarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Anxiety disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Laryngeal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Eczema asteatotic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </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>Principal Investigator is not permitted to discuss or publish trial results without prior approval from the sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Nobuyuki Koseki</name_or_title>
      <organization>SymBio Pharmaceuticals</organization>
      <phone>+81-3-5472-1127</phone>
    </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/NCT01700140
org study id: 2010003
nct id: NCT01700140
lead sponsor: 
The purpose of this study is to explore the dose response of SyB D-0701 for preventing nausea
      and emesis associated with radiotherapy (fractionated/localized irradiation) in cancer
      patients scheduled to receive radiotherapy (fractionated/localized irradiation) alone.
Exploratory study of dose response of SyB D-0701 to preventing effects for nausea and emesis
      associated with radiotherapy (fractionated/localized irradiation)
intervention model: Parallel Assignment
masking: Double
measure: Complete Control (no Signs of Emesis or Moderate to Severe Nausea and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation
time frame: 72 hours
description: The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.
measure: Complete Response (no Signs of Emesis and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation
time frame: 72 hours
description: The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.
measure: Time to First Emesis
time frame: 24-72 hours
description: Time from the start of radiotherapy to the onset of first emesis. The median (50% point) of time to first emesis was estimated.
measure: Time to First Nausea
time frame: 24-72 hours
description: Time from the start of radiotherapy to the onset of first nausea. The median (50% point) of time to first nausea was estimated.
measure: Complete Control Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3
time frame: 24-72 hours
description: Complete control rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy.
The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs.
measure: Complete Response Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3
time frame: 24-72 hours
description: Complete response rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy.
The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs.
measure: Adverse Events
time frame: Up to 192 hours
description: Adverse event is any untoward medical occurrence experienced by a subject irrespective of causal relationship with the study drug, and includes the unexpected signs, clinically significant fluctuations of laboratory data, and aggravation of disease, symptoms or complications. Adverse events are coded using the preferred terms (PT) of Medical Dictionary for Regulatory Activities (MedDRA) version 15.0.
measure: Severe (Grade 3 or More) Adverse Events
time frame: Up to 192 hours
description: The severity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE
measure: Skin Manifestations at Study Drug Application Site
time frame: Up to 192 hours
description: The investigator or sub-investigator recorded skin manifestations observed after removal of the study drug.
Skin manifestations were counted for each type of patches (placebo patch, SyB D-0701 15 cm2 patch, SyB D-0701 25 cm2 patch).
arm group label: SyB D-0701: high dose group
arm group type: Experimental
arm group label: SyB D-0701: low dose group
arm group type: Experimental
arm group label: placebo group
arm group type: Placebo Comparator
intervention type: Drug
intervention name: SyB D-0701
description: Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch, High dose group (30.00 mg): SyB D-0701 15 cm2 patch + SyB D-0701 25 cm2 patch] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
arm group label: SyB D-0701: high dose group
arm group label: SyB D-0701: low dose group
intervention type: Drug
intervention name: Placebo
description: Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
arm group label: SyB D-0701: low dose group
arm group label: placebo group
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
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facility: 
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facility: 
country: Japan
responsible party type: Sponsor
mesh term: Nausea
mesh term: Vomiting
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 