<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/NCT01684202</url>
  </required_header>
  <id_info>
    <org_study_id>156-12-001</org_study_id>
    <secondary_id>JapicCTI-121957</secondary_id>
    <nct_id>NCT01684202</nct_id>
  </id_info>
  <brief_title>A Multicenter, Open-label, Dose-finding Trial of OPC-41061 to Investigate Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety in Patients With Carcinomatous Edema (Phase 2)</brief_title>
  <official_title>A Multicenter, Open-label, Dose-finding Trial of OPC-41061 to Investigate Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety in Patients With Carcinomatous Edema (Phase 2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otsuka Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Otsuka Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      OPC-41061 will be administered to patients with volume overload associated with cancer, first&#xD;
      by dose-escalation and subsequently for 6 consecutive days at the fixed dose at which urine&#xD;
      volume is increased to investigate efficacy, pharmacokinetics, pharmacodynamic effects, and&#xD;
      safety and to determine the effective initial and maintenance doses of OPC-41061.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Body Weight From Baseline at Final IMP Administration</measure>
    <time_frame>Baseline, at the final IMP administration (shortest:7days longest:12days)</time_frame>
    <description>Body weight was measured in 100-g units before breakfast and after subjects had urinated at least once, taking care to minimize fluctuations due to defecation or clothing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Ascites Volume From Baseline Measured by Computer Tomography (CT) at Final IMP Administration</measure>
    <time_frame>Baseline, at the final IMP administration (shortest:7days longest:12days)</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Carcinomatous Edema</condition>
  <arm_group>
    <arm_group_label>OPC-41061</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OPC-41061</intervention_name>
    <description>orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days.</description>
    <arm_group_label>OPC-41061</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects judged as having cancer by biopsy or cytology&#xD;
&#xD;
          -  Subjects with carcinomatous ascites&#xD;
&#xD;
          -  Male or female subjects between the ages of 20 and 80, inclusive (at time of informed&#xD;
             consent)&#xD;
&#xD;
          -  Subjects with survival expectancy of at least 3 months and an Eastern Cooperative&#xD;
             Oncology Group (ECOG) Performance Status score (PS score) of 0 to 2&#xD;
&#xD;
          -  Subjects who are inpatients or who can be admitted to the trial site for the duration&#xD;
             of the trial&#xD;
&#xD;
          -  Subjects who, together with their partner, are able to practice one of the specified&#xD;
             contraceptive methods until 4 weeks after final trial drug administration&#xD;
&#xD;
          -  Subjects capable of giving informed consent to participate in the trial of their own&#xD;
             free will prior to start of the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with any of the following complications or symptoms:&#xD;
&#xD;
               -  Deep vein thrombosis&#xD;
&#xD;
               -  Intestinal obstruction or intestinal edema with symptoms similar to intestinal&#xD;
                  obstruction&#xD;
&#xD;
               -  Hepatic cirrhosis&#xD;
&#xD;
               -  Anuria&#xD;
&#xD;
               -  Urination impaired due to urinary tract stricture, urinary calculus, tumor in&#xD;
                  urinary tract, or other cause&#xD;
&#xD;
               -  Continuing symptoms of diarrhea or vomiting&#xD;
&#xD;
               -  Infection requiring systemic treatment&#xD;
&#xD;
          -  Subjects with any of the following medical histories:&#xD;
&#xD;
               -  History of cerebrovascular disorder or coronary disease within 4 weeks prior to&#xD;
                  start of the pre-observation period&#xD;
&#xD;
               -  History of hypersensitivity or idiosyncratic reaction to benzazepine derivatives&#xD;
                  such as mozavaptan hydrochloride or benazepril hydrochloride&#xD;
&#xD;
               -  History of gastrectomy or enterectomy to an extent affecting absorption of oral&#xD;
                  medication&#xD;
&#xD;
          -  Subjects with any of the following abnormal laboratory values:&#xD;
&#xD;
        Platelet count of &lt; 75,000/mm3, hemoglobin of &lt; 8.0 g/dL, neutrophil count of &lt; 1,000/mm3,&#xD;
        total bilirubin of &gt; 4.0 g/dL, serum creatinine of &gt; 3.0 mg/dL, serum sodium of &gt; 147&#xD;
        mEq/L, or serum potassium of &gt; 5.5 mEq/L&#xD;
&#xD;
          -  Subjects who have used albumin products (agents for treating hypoalbuminemia) or blood&#xD;
             products containing albumins within 1 week prior to start of the pre-observation&#xD;
             period, or after start of the pre-observation period&#xD;
&#xD;
          -  Subjects who have received any investigational drug within 4 weeks prior to start of&#xD;
             the pre-observation period&#xD;
&#xD;
          -  Subjects who have previously received OPC-41061&#xD;
&#xD;
          -  Subjects who have received surgical treatment or radiation therapy for cancer within 4&#xD;
             weeks prior to start of the pre-observation period&#xD;
&#xD;
          -  Subjects for whom the investigator or subinvestigator judges that it would be&#xD;
             difficult to evaluate the efficacy and safety of OPC-41061 due to the effects of&#xD;
             ongoing chemotherapy or other therapies for cancer (eg, improvement of carcinomatous&#xD;
             ascites or development of edema due to adverse events related to therapeutic&#xD;
             interventions other than OPC-41061)&#xD;
&#xD;
          -  Subjects who are unable to sense thirst or who have difficulty with fluid or food&#xD;
             intake&#xD;
&#xD;
          -  Subjects who are unable to take oral medication&#xD;
&#xD;
          -  Female subjects who are pregnant, possibly pregnant, or nursing, or who plan to become&#xD;
             pregnant during the trial period Subjects otherwise judged by the investigator or&#xD;
             subinvestigator to be inappropriate for inclusion in the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Junichi Hahimoto, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Otsuka Pharmaceutical Co., Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Kansai Region</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <results_first_submitted>February 2, 2021</results_first_submitted>
  <results_first_submitted_qc>February 24, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 18, 2021</results_first_posted>
  <last_update_submitted>February 24, 2021</last_update_submitted>
  <last_update_submitted_qc>February 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2021</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>Edema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tolvaptan</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>OPC-41061 3.75 mg</title>
          <description>Orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days, first in a dose-escalation manner until daily urine volume increased by 500 mL or more from that at the end of the pretreatment observation period, and then for 6 consecutive days at the fixed dose at which that increase in daily urine volume was achieved. Each Arm/Group Title indicated the final dose.</description>
        </group>
        <group group_id="P2">
          <title>OPC-41061 7.5 mg</title>
          <description>Orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days, first in a dose-escalation manner until daily urine volume increased by 500 mL or more from that at the end of the pretreatment observation period, and then for 6 consecutive days at the fixed dose at which that increase in daily urine volume was achieved. Each Arm/Group Title indicated the final dose.</description>
        </group>
        <group group_id="P3">
          <title>OPC-41061 15 mg</title>
          <description>Orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days, first in a dose-escalation manner until daily urine volume increased by 500 mL or more from that at the end of the pretreatment observation period, and then for 6 consecutive days at the fixed dose at which that increase in daily urine volume was achieved. Each Arm/Group Title indicated the final dose.</description>
        </group>
        <group group_id="P4">
          <title>OPC-41061 30 mg</title>
          <description>Orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days, first in a dose-escalation manner until daily urine volume increased by 500 mL or more from that at the end of the pretreatment observation period, and then for 6 consecutive days at the fixed dose at which that increase in daily urine volume was achieved. Each Arm/Group Title indicated the final dose.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Dose-escalation Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Maintenance Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis set: all subjects who had been administered the investigational medicinal product (IMP) at least once and from whom data for efficacy endpoints were obtained after the start of IMP administration.</population>
      <group_list>
        <group group_id="B1">
          <title>OPC-41061 3.75 mg</title>
          <description>Orally administered at 3.75 mg once daily in maintenance period.</description>
        </group>
        <group group_id="B2">
          <title>OPC-41061 7.5 mg</title>
          <description>Orally administered at 7.5 mg once daily in maintenance period.</description>
        </group>
        <group group_id="B3">
          <title>OPC-41061 15 mg</title>
          <description>Orally administered at 15 mg once daily in maintenance period.</description>
        </group>
        <group group_id="B4">
          <title>OPC-41061 30 mg</title>
          <description>Orally administered at 30 mg once daily in maintenance period.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="9"/>
            <count group_id="B4" value="11"/>
            <count group_id="B5" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.3" spread="9.9"/>
                    <measurement group_id="B2" value="66.1" spread="8.5"/>
                    <measurement group_id="B3" value="62.2" spread="7.6"/>
                    <measurement group_id="B4" value="69.5" spread="7.9"/>
                    <measurement group_id="B5" value="65.3" spread="8.8"/>
                  </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="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Japanese</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Body Weight From Baseline at Final IMP Administration</title>
        <description>Body weight was measured in 100-g units before breakfast and after subjects had urinated at least once, taking care to minimize fluctuations due to defecation or clothing.</description>
        <time_frame>Baseline, at the final IMP administration (shortest:7days longest:12days)</time_frame>
        <population>Full analysis set: all subjects who had been administered the IMP at least once and from whom data for efficacy endpoints were obtained after the start of IMP administration.</population>
        <group_list>
          <group group_id="O1">
            <title>OPC-41061 3.75 mg</title>
            <description>Orally administered at 3.75 mg once daily in maintenance period.</description>
          </group>
          <group group_id="O2">
            <title>OPC-41061 7.5 mg</title>
            <description>Orally administered at 7.5 mg once daily in maintenance period.</description>
          </group>
          <group group_id="O3">
            <title>OPC-41061 15 mg</title>
            <description>Orally administered at 15 mg once daily in maintenance period.</description>
          </group>
          <group group_id="O4">
            <title>OPC-41061 30 mg</title>
            <description>Orally administered at 30 mg once daily in maintenance period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Weight From Baseline at Final IMP Administration</title>
          <description>Body weight was measured in 100-g units before breakfast and after subjects had urinated at least once, taking care to minimize fluctuations due to defecation or clothing.</description>
          <population>Full analysis set: all subjects who had been administered the IMP at least once and from whom data for efficacy endpoints were obtained after the start of IMP administration.</population>
          <units>Kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.69" spread="2.51"/>
                    <measurement group_id="O2" value="-0.34" spread="1.99"/>
                    <measurement group_id="O3" value="-1.13" spread="1.62"/>
                    <measurement group_id="O4" value="0.70" spread="1.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Ascites Volume From Baseline Measured by Computer Tomography (CT) at Final IMP Administration</title>
        <time_frame>Baseline, at the final IMP administration (shortest:7days longest:12days)</time_frame>
        <population>Full analysis set: all subjects who had been administered the IMP at least once and from whom data for efficacy endpoints were obtained after the start of IMP administration.</population>
        <group_list>
          <group group_id="O1">
            <title>OPC-41061 3.75 mg</title>
            <description>Orally administered at 3.75 mg once daily in maintenance period.</description>
          </group>
          <group group_id="O2">
            <title>OPC-41061 7.5 mg</title>
            <description>Orally administered at 7.5 mg once daily in maintenance period.</description>
          </group>
          <group group_id="O3">
            <title>OPC-41061 15 mg</title>
            <description>Orally administered at 15 mg once daily in maintenance period.</description>
          </group>
          <group group_id="O4">
            <title>OPC-41061 30 mg</title>
            <description>Orally administered at 30 mg once daily in maintenance period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Ascites Volume From Baseline Measured by Computer Tomography (CT) at Final IMP Administration</title>
          <population>Full analysis set: all subjects who had been administered the IMP at least once and from whom data for efficacy endpoints were obtained after the start of IMP administration.</population>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-77.20" spread="982.19"/>
                    <measurement group_id="O2" value="513.97" spread="653.30"/>
                    <measurement group_id="O3" value="153.72" spread="993.63"/>
                    <measurement group_id="O4" value="539.93" spread="659.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.</time_frame>
      <desc>Safety analysis set: all subjects who had been administered the IMP at least once.</desc>
      <group_list>
        <group group_id="E1">
          <title>OPC-41061 3.75 mg</title>
          <description>Orally administered at 3.75 mg once daily in maintenance period.</description>
        </group>
        <group group_id="E2">
          <title>OPC-41061 7.5 mg</title>
          <description>Orally administered at 7.5 mg once daily in maintenance period.</description>
        </group>
        <group group_id="E3">
          <title>OPC-41061 15 mg</title>
          <description>Orally administered at 15 mg once daily in maintenance period.</description>
        </group>
        <group group_id="E4">
          <title>OPC-41061 30 mg</title>
          <description>Orally administered at 30 mg once daily in maintenance period.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Ver. 16.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Gastric cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Ver. 16.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Intestinal infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Thirst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Stitch abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Biliary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Subcutaneous haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood glucose decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood osmolarity increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood urea increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Electrocardiogram T wave peaked</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood urine present</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Platelet count increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Urine ketone body</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Urine output decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hypophagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bile duct cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pelvic venous thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director of Clinical Trials</name_or_title>
      <organization>Otsuka Pharmaceutical Co., LTD.</organization>
      <phone>+81-3-6361-7366</phone>
      <email>CL_OPCJ_RDA_Team@otsuka.jp</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01684202
org study id: 156-12-001
secondary id: JapicCTI-121957
nct id: NCT01684202
lead sponsor: 
has dmc: No
OPC-41061 will be administered to patients with volume overload associated with cancer, first
      by dose-escalation and subsequently for 6 consecutive days at the fixed dose at which urine
      volume is increased to investigate efficacy, pharmacokinetics, pharmacodynamic effects, and
      safety and to determine the effective initial and maintenance doses of OPC-41061.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Body Weight From Baseline at Final IMP Administration
time frame: Baseline, at the final IMP administration (shortest:7days longest:12days)
description: Body weight was measured in 100-g units before breakfast and after subjects had urinated at least once, taking care to minimize fluctuations due to defecation or clothing.
measure: Change in Ascites Volume From Baseline Measured by Computer Tomography (CT) at Final IMP Administration
time frame: Baseline, at the final IMP administration (shortest:7days longest:12days)
arm group label: OPC-41061
arm group type: Experimental
intervention type: Drug
intervention name: OPC-41061
description: orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days.
arm group label: OPC-41061
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Junichi Hahimoto, PhD
role: Study Director
affiliation: Otsuka Pharmaceutical Co., Ltd.
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Edema
mesh term: Tolvaptan
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 