<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/NCT01696032</url>
  </required_header>
  <id_info>
    <org_study_id>SGI-110-02</org_study_id>
    <nct_id>NCT01696032</nct_id>
  </id_info>
  <brief_title>SGI-110 in Combination With Carboplatin in Ovarian Cancer</brief_title>
  <acronym>SGI-110</acronym>
  <official_title>A Randomized, Controlled, Open-Label, Phase 2 Trial of SGI-110 and Carboplatin in Subjects With Platinum-Resistant Recurrent Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astex Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astex Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A 2-part, Phase 2 controlled, open-label, randomized study in participants with&#xD;
      platinum-resistant recurrent ovarian cancer. In Part 1, participants received SGI-110 and&#xD;
      carboplatin. The optimum dose of SGI-110 (guadecitabine) was identified in Part 1 based on&#xD;
      safety and efficacy. In Part 2, participants were randomized to receive the dose identified&#xD;
      in Part 1 plus carboplatin or one of four treatment of choice at the discretion of the&#xD;
      investigator. The treatment of choice consisted of topotecan, pegylated liposomal&#xD;
      doxorubicin, paclitaxel or gemcitabine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stage 1: Dose Limiting Toxicities</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Number of participants with dose limiting toxicities (DLTs) in Stage 1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stage 2: Progression Free Survival</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Progression free survival (PFS) time was defined as the time interval from the date of the first dose of study medication until the earlier of disease progression or death. Participants were treated with their assigned treatment [guadecitabine+carboplatin (G+C) or treatment choice (TC)] until disease progression or unacceptable treatment-related toxicity occurred.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>The objective response rate (ORR) was defined as the proportion of participants who experienced an objective response (best overall response of complete response/full response or partial response, which was confirmed by a subsequent assessment at least 28 days later). Response categories were determined based on RECIST v1.1 criteria, or on modified Rustin (CA-125) criteria if response assessment could not be made using RECIST criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival at 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>Progression free survival rate at 6 months is the proportion of participants who were alive and did not have disease progression at 6 months after start of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Benefit Rate</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Clinical benefit rate (CBR) was defined as the proportion of subjects who experienced a best overall response of complete response/full response or partial response (confirmed by a subsequent assessment at least 28 days later), or documented stable disease for at least 3 months after the first dose. Response categories were determined based on RECIST v1.1 criteria, then based on modified Rustin (CA-125) criteria if assessment could not be made using RECIST criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CA-125 Levels</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Percentage of participants with CA-125 reduction by ≥ 50% from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Duration of response is defined as the time between the date of the first documentation of complete response/full response or partial response, and the date of disease progression or date of death due to any cause, or the last adequate tumor assessment prior to the start of subsequent anti-cancer therapy including crossing over to G+C from TC arm, whichever occurred earlier. Only participants who responded were included in the duration of response calculation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Overall survival was defined as the number of days from the day the participant was administered the first dose of study treatment to the date of death (regardless of cause). Survival time was censored on the last date the participant was known to be alive or lost to follow-up before reaching the event of death; in the TC group, time was censored at the date of crossover.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Pharmacokinetic Parameter Cmax</measure>
    <time_frame>Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)</time_frame>
    <description>Time to maximum plasma concentration for guadecitabine, decitabine and carboplatin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Pharmacokinetic Parameter Tmax</measure>
    <time_frame>Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)</time_frame>
    <description>Time to last measurable concentration for guadecitabine, decitabine and carboplatin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Pharmacokinetic Parameter AUC0-8</measure>
    <time_frame>Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)</time_frame>
    <description>Area under the concentration-time curve from 0 to 8 hours (AUC0-8) for guadecitabine, decitabine and carboplatin</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>SGI-110 + Carboplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stage 1 was a safety lead-in stage with a dose escalation design. Participants were evaluated with the combination of SGI-110 (guadecitabine) plus carboplatin (G+C), given as 28-day treatment cycles: guadecitabine administered subcutaneous (SC) daily on Days 1-5, at a starting dose of 45 mg/m2/day in Cohort 1, followed by carboplatin intravenous (IV) based on a targeted dose of area under the curve (AUC) 5 on Day 8. After dose limiting toxicities were noted, guadecitabine dose was reduced to 30 mg/m2/day for subsequent cycles for 4 participants. Cohort 2 received 30 mg/m2/day guadecitabine and carboplatin IV AUC 4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SGI-110 + Carboplatin or TC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stage 2 was an open-label, randomized, controlled trial. Eligible participants were randomly assigned in a 1:1 ratio to receive either (1) G+C combination treatment in 28-day cycles at 30 mg/m2 SC once daily on Days 1-5 and carboplatin IV AUC 4 on Day 8, or (2) treatment of choice (TC) of topotecan, pegylated liposomal doxorubicin (PLD), paclitaxel, or gemcitabine based on recommended dosing in 28-day cycles; participants initially randomized to TC were able to cross over to receive 30 mg/m2 G+C due to disease progression.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SGI-110</intervention_name>
    <arm_group_label>SGI-110 + Carboplatin</arm_group_label>
    <arm_group_label>SGI-110 + Carboplatin or TC</arm_group_label>
    <other_name>guadecitabine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine)</intervention_name>
    <description>Investigator chose to treat with either topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine</description>
    <arm_group_label>SGI-110 + Carboplatin or TC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <arm_group_label>SGI-110 + Carboplatin</arm_group_label>
    <arm_group_label>SGI-110 + Carboplatin or TC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participants who are women 18 years of age or older.&#xD;
&#xD;
          2. Participants who have histologically or cytologically confirmed recurrent high-grade&#xD;
             serous epithelial ovarian cancer (Grade 2 or 3), primary peritoneal carcinomatosis or&#xD;
             fallopian tube cancer.&#xD;
&#xD;
          3. Participants who have platinum-resistant disease (defined as having relapsed within 6&#xD;
             months of her last platinum-containing regimen). There is no limit on the number of&#xD;
             prior treatment regimens in Part 1. In Part 2, participants may have had no more than&#xD;
             3 prior cytotoxic treatment regimens, excluding adjuvant or maintenance therapy.&#xD;
&#xD;
          4. Participants must have had prior paclitaxel treatment.&#xD;
&#xD;
          5. Participants who have measurable disease according to RECIST v1.1 or detectable&#xD;
             disease.&#xD;
&#xD;
          6. Participants with ECOG performance status of 0 or 1.&#xD;
&#xD;
          7. Participants with acceptable organ function.&#xD;
&#xD;
          8. Participants must be at least 3 weeks from last chemotherapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participants who have hypersensitivity to SGI-110 and/or carboplatin or other&#xD;
             components of these drug products.&#xD;
&#xD;
          2. Participants who have received prior therapy with any hypomethylating agents.&#xD;
&#xD;
          3. Participants who are refractory to platinum treatment i.e., progressed while on&#xD;
             platinum treatment.&#xD;
&#xD;
          4. Participants with abnormal left ventricular ejection fraction.&#xD;
&#xD;
          5. Participants with Grade 2 or greater neuropathy.&#xD;
&#xD;
          6. Participants with known brain metastases.&#xD;
&#xD;
          7. Participants with known history of HIV, HCV or HBV.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Norris Comprehensive Cancer Center- University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida Shands Cancer Center</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Health Sciences University</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Melvin and Bren Simon Cancer Center- Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Cancer Care</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Kimmel Cancer Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Island Gynecologic Oncology</name>
      <address>
        <city>Brightwaters</city>
        <state>New York</state>
        <zip>11718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Cancer Institute- Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati Cancer Institute</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mary Crowley Medical Research Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inova Fairfax Hospital</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tom Baker Cancer Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juravinski Cancer Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUM Gynecologie-Oncologie, Notre Dame Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2L 4M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bristol Heamatology and Oncology Centre</name>
      <address>
        <city>Bristol</city>
        <zip>BS2 8ED</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. James Univesity Hospital - St. James Institute of Oncology</name>
      <address>
        <city>Leeds</city>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cambridge University Hospitals NHS Foundation and Trust</name>
      <address>
        <city>London</city>
        <zip>EC1V 4AD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univesity College Hospital</name>
      <address>
        <city>London</city>
        <zip>NW1 2PG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imperial College Health Care NHS Trust-Garry Weston Centre</name>
      <address>
        <city>London</city>
        <zip>W12 0NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Vernon Cancer Centre</name>
      <address>
        <city>Middlesex</city>
        <zip>HA6 2RN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Foundation Trust</name>
      <address>
        <city>Sutton</city>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <results_first_submitted>April 30, 2021</results_first_submitted>
  <results_first_submitted_qc>April 30, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 25, 2021</results_first_posted>
  <disposition_first_submitted>January 15, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>January 15, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">January 18, 2018</disposition_first_posted>
  <last_update_submitted>April 30, 2021</last_update_submitted>
  <last_update_submitted_qc>April 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ovarian Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Doxorubicin</mesh_term>
    <mesh_term>Liposomal doxorubicin</mesh_term>
    <mesh_term>Topotecan</mesh_term>
    <mesh_term>Guadecitabine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 124 participants were enrolled in the study and 120 were treated at 20 study centers, with 12 in the United States, 5 in the United Kingdom, and 3 in Canada. The enrollment period was 10 December 2012 (first participant dosed) to 12 May 2014 (last participant first dose).</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Stage 1: Guadecitabine+Carboplatin 30 mg/m2</title>
          <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
        </group>
        <group group_id="P2">
          <title>Stage 1: Guadecitabine+Carboplatin 45 mg/m2</title>
          <description>Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.</description>
        </group>
        <group group_id="P3">
          <title>Stage 2: Guadecitabine+Carboplatin 30 mg/m2</title>
          <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
        </group>
        <group group_id="P4">
          <title>Stage 2: Treatment Choice</title>
          <description>Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); pegylated liposomal doxorubicin (PLD) (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion). Participants initially randomized to TC were able to cross over to receive 30 mg/m2 G+C due to disease progression.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="51"/>
                <participants group_id="P4" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="51"/>
                <participants group_id="P4" count="22"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="43"/>
                <participants group_id="P4" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Database lock</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Includes all treated participants</population>
      <group_list>
        <group group_id="B1">
          <title>Stage 1: Guadecitabine+Carboplatin 30 mg/m2</title>
          <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
        </group>
        <group group_id="B2">
          <title>Stage 1: Guadecitabine+Carboplatin 45 mg/m2</title>
          <description>Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.</description>
        </group>
        <group group_id="B3">
          <title>Stage 2: Guadecitabine+Carboplatin 30 mg/m2</title>
          <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
        </group>
        <group group_id="B4">
          <title>Stage 2: Treatment Choice</title>
          <description>Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion. Participants initially randomized to TC were able to cross over to receive 30 mg/m2 G+C due to disease progression.</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="14"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="51"/>
            <count group_id="B4" value="49"/>
            <count group_id="B5" value="120"/>
          </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="57.99" spread="9.47"/>
                    <measurement group_id="B2" value="56.79" spread="13.20"/>
                    <measurement group_id="B3" value="61.96" spread="9.17"/>
                    <measurement group_id="B4" value="62.09" spread="9.62"/>
                    <measurement group_id="B5" value="61.29" spread="9.62"/>
                  </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="14"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="51"/>
                    <measurement group_id="B4" value="49"/>
                    <measurement group_id="B5" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <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 group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="49"/>
                    <measurement group_id="B4" value="46"/>
                    <measurement group_id="B5" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <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 group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <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 group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <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="1"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="40"/>
                    <measurement group_id="B5" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <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 group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Stage 1: Dose Limiting Toxicities</title>
        <description>Number of participants with dose limiting toxicities (DLTs) in Stage 1</description>
        <time_frame>Up to 12 months</time_frame>
        <population>Safety data set includes data from all participants who received any amount of study drug, including any component of a multi-dose study treatment regimen.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Guadecitabine+Carboplatin 45 mg/m2</title>
            <description>Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Dose Limiting Toxicities</title>
          <description>Number of participants with dose limiting toxicities (DLTs) in Stage 1</description>
          <population>Safety data set includes data from all participants who received any amount of study drug, including any component of a multi-dose study treatment regimen.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Stage 2: Progression Free Survival</title>
        <description>Progression free survival (PFS) time was defined as the time interval from the date of the first dose of study medication until the earlier of disease progression or death. Participants were treated with their assigned treatment [guadecitabine+carboplatin (G+C) or treatment choice (TC)] until disease progression or unacceptable treatment-related toxicity occurred.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Efficacy data set included all participants who received any amount of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 2: Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Stage 2: Treatment Choice</title>
            <description>Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2: Progression Free Survival</title>
          <description>Progression free survival (PFS) time was defined as the time interval from the date of the first dose of study medication until the earlier of disease progression or death. Participants were treated with their assigned treatment [guadecitabine+carboplatin (G+C) or treatment choice (TC)] until disease progression or unacceptable treatment-related toxicity occurred.</description>
          <population>Efficacy data set included all participants who received any amount of study drug.</population>
          <units>Days</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="51"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114" lower_limit="63" upper_limit="169"/>
                    <measurement group_id="O2" value="64" lower_limit="52" upper_limit="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0654</p_value>
            <method>Log Rank</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate</title>
        <description>The objective response rate (ORR) was defined as the proportion of participants who experienced an objective response (best overall response of complete response/full response or partial response, which was confirmed by a subsequent assessment at least 28 days later). Response categories were determined based on RECIST v1.1 criteria, or on modified Rustin (CA-125) criteria if response assessment could not be made using RECIST criteria.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Efficacy data set included all participants who received any amount of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Guadecitabine+Carboplatin 45 mg/m2</title>
            <description>Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.</description>
          </group>
          <group group_id="O3">
            <title>Stage 2: Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Stage 2: Treatment Choice</title>
            <description>Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).</description>
          </group>
          <group group_id="O5">
            <title>Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate</title>
          <description>The objective response rate (ORR) was defined as the proportion of participants who experienced an objective response (best overall response of complete response/full response or partial response, which was confirmed by a subsequent assessment at least 28 days later). Response categories were determined based on RECIST v1.1 criteria, or on modified Rustin (CA-125) criteria if response assessment could not be made using RECIST criteria.</description>
          <population>Efficacy data set included all participants who received any amount of study drug.</population>
          <units>Percent</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21" lower_limit="4.7" upper_limit="50.8"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="45.9"/>
                    <measurement group_id="O3" value="16" lower_limit="7.0" upper_limit="28.6"/>
                    <measurement group_id="O4" value="8" lower_limit="2.3" upper_limit="19.6"/>
                    <measurement group_id="O5" value="4" lower_limit="0.1" upper_limit="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival at 6 Months</title>
        <description>Progression free survival rate at 6 months is the proportion of participants who were alive and did not have disease progression at 6 months after start of treatment.</description>
        <time_frame>6 months</time_frame>
        <population>Efficacy data set included all participants who received any amount of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Guadecitabine+Carboplatin 45 mg/m2</title>
            <description>Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.</description>
          </group>
          <group group_id="O3">
            <title>Stage 2: Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Stage 2: Treatment Choice</title>
            <description>Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).</description>
          </group>
          <group group_id="O5">
            <title>Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival at 6 Months</title>
          <description>Progression free survival rate at 6 months is the proportion of participants who were alive and did not have disease progression at 6 months after start of treatment.</description>
          <population>Efficacy data set included all participants who received any amount of study drug.</population>
          <units>Percent of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.36" lower_limit="0.13" upper_limit="0.59"/>
                    <measurement group_id="O2" value="0.33" lower_limit="0.05" upper_limit="0.68"/>
                    <measurement group_id="O3" value="0.37" lower_limit="0.24" upper_limit="0.50"/>
                    <measurement group_id="O4" value="0.11" lower_limit="0.04" upper_limit="0.22"/>
                    <measurement group_id="O5" value="0.19" lower_limit="0.07" upper_limit="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Benefit Rate</title>
        <description>Clinical benefit rate (CBR) was defined as the proportion of subjects who experienced a best overall response of complete response/full response or partial response (confirmed by a subsequent assessment at least 28 days later), or documented stable disease for at least 3 months after the first dose. Response categories were determined based on RECIST v1.1 criteria, then based on modified Rustin (CA-125) criteria if assessment could not be made using RECIST criteria.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Efficacy data set included all participants who received any amount of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Guadecitabine+Carboplatin 45 mg/m2</title>
            <description>Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.</description>
          </group>
          <group group_id="O3">
            <title>Stage 2: Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Stage 2: Treatment Choice</title>
            <description>Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).</description>
          </group>
          <group group_id="O5">
            <title>Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Benefit Rate</title>
          <description>Clinical benefit rate (CBR) was defined as the proportion of subjects who experienced a best overall response of complete response/full response or partial response (confirmed by a subsequent assessment at least 28 days later), or documented stable disease for at least 3 months after the first dose. Response categories were determined based on RECIST v1.1 criteria, then based on modified Rustin (CA-125) criteria if assessment could not be made using RECIST criteria.</description>
          <population>Efficacy data set included all participants who received any amount of study drug.</population>
          <units>Percent of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43" lower_limit="17.7" upper_limit="71.1"/>
                    <measurement group_id="O2" value="50" lower_limit="11.8" upper_limit="88.2"/>
                    <measurement group_id="O3" value="41" lower_limit="27.6" upper_limit="55.8"/>
                    <measurement group_id="O4" value="29" lower_limit="16.6" upper_limit="43.3"/>
                    <measurement group_id="O5" value="19" lower_limit="6.3" upper_limit="38.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CA-125 Levels</title>
        <description>Percentage of participants with CA-125 reduction by ≥ 50% from baseline</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Efficacy data set included all participants who received any amount of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Guadecitabine+Carboplatin 45 mg/m2</title>
            <description>Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.</description>
          </group>
          <group group_id="O3">
            <title>Stage 2: Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Stage 2: Treatment Choice</title>
            <description>Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).</description>
          </group>
          <group group_id="O5">
            <title>Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>CA-125 Levels</title>
          <description>Percentage of participants with CA-125 reduction by ≥ 50% from baseline</description>
          <population>Efficacy data set included all participants who received any amount of study drug.</population>
          <units>Percent of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27" lower_limit="6.0" upper_limit="61.0"/>
                    <measurement group_id="O2" value="50" lower_limit="6.8" upper_limit="93.2"/>
                    <measurement group_id="O3" value="36" lower_limit="21.6" upper_limit="52.0"/>
                    <measurement group_id="O4" value="32" lower_limit="18.1" upper_limit="48.1"/>
                    <measurement group_id="O5" value="29" lower_limit="11.3" upper_limit="52.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response</title>
        <description>Duration of response is defined as the time between the date of the first documentation of complete response/full response or partial response, and the date of disease progression or date of death due to any cause, or the last adequate tumor assessment prior to the start of subsequent anti-cancer therapy including crossing over to G+C from TC arm, whichever occurred earlier. Only participants who responded were included in the duration of response calculation.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Efficacy data set included all participants who received any amount of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Guadecitabine+Carboplatin 45 mg/m2</title>
            <description>Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.</description>
          </group>
          <group group_id="O3">
            <title>Stage 2: Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Stage 2: Treatment Choice</title>
            <description>Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).</description>
          </group>
          <group group_id="O5">
            <title>Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response</title>
          <description>Duration of response is defined as the time between the date of the first documentation of complete response/full response or partial response, and the date of disease progression or date of death due to any cause, or the last adequate tumor assessment prior to the start of subsequent anti-cancer therapy including crossing over to G+C from TC arm, whichever occurred earlier. Only participants who responded were included in the duration of response calculation.</description>
          <population>Efficacy data set included all participants who received any amount of study drug.</population>
          <units>Days</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="6"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="14"/>
                <count group_id="O5" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="225" lower_limit="42.0" upper_limit="294.0"/>
                    <measurement group_id="O2" value="195" lower_limit="114.0" upper_limit="NA">Not estimable with current data</measurement>
                    <measurement group_id="O3" value="186" lower_limit="147.0" upper_limit="241.0"/>
                    <measurement group_id="O4" value="173" lower_limit="121.0" upper_limit="267.0"/>
                    <measurement group_id="O5" value="182" lower_limit="147.0" upper_limit="233.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival</title>
        <description>Overall survival was defined as the number of days from the day the participant was administered the first dose of study treatment to the date of death (regardless of cause). Survival time was censored on the last date the participant was known to be alive or lost to follow-up before reaching the event of death; in the TC group, time was censored at the date of crossover.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Efficacy data set included all participants who received any amount of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Guadecitabine+Carboplatin 45 mg/m2</title>
            <description>Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.</description>
          </group>
          <group group_id="O3">
            <title>Stage 2: Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Stage 2: Treatment Choice</title>
            <description>Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).</description>
          </group>
          <group group_id="O5">
            <title>Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>Overall survival was defined as the number of days from the day the participant was administered the first dose of study treatment to the date of death (regardless of cause). Survival time was censored on the last date the participant was known to be alive or lost to follow-up before reaching the event of death; in the TC group, time was censored at the date of crossover.</description>
          <population>Efficacy data set included all participants who received any amount of study drug.</population>
          <units>Days</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="14"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="341" lower_limit="100.0" upper_limit="567.0"/>
                    <measurement group_id="O2" value="195" lower_limit="25.0" upper_limit="NA">Not estimable with current data</measurement>
                    <measurement group_id="O3" value="331" lower_limit="231" upper_limit="415"/>
                    <measurement group_id="O4" value="221" lower_limit="145" upper_limit="372"/>
                    <measurement group_id="O5" value="279" lower_limit="161.0" upper_limit="413.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: Pharmacokinetic Parameter Cmax</title>
        <description>Time to maximum plasma concentration for guadecitabine, decitabine and carboplatin</description>
        <time_frame>Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)</time_frame>
        <population>The pharmacokinetic (PK) population included participants for which sufficient data were available to calculate PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Guadecitabine+Carboplatin 45 mg/m2</title>
            <description>Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Pharmacokinetic Parameter Cmax</title>
          <description>Time to maximum plasma concentration for guadecitabine, decitabine and carboplatin</description>
          <population>The pharmacokinetic (PK) population included participants for which sufficient data were available to calculate PK parameters.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Guadecitabine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.2" spread="78.3"/>
                    <measurement group_id="O2" value="109" spread="70.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decitabine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.6" spread="13.3"/>
                    <measurement group_id="O2" value="26.3" spread="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Carboplatin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19600" spread="5650"/>
                    <measurement group_id="O2" value="21900" spread="13800"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: Pharmacokinetic Parameter Tmax</title>
        <description>Time to last measurable concentration for guadecitabine, decitabine and carboplatin</description>
        <time_frame>Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)</time_frame>
        <population>The pharmacokinetic (PK) population included participants for which sufficient data were available to calculate PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Guadecitabine+Carboplatin 45 mg/m2</title>
            <description>Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Pharmacokinetic Parameter Tmax</title>
          <description>Time to last measurable concentration for guadecitabine, decitabine and carboplatin</description>
          <population>The pharmacokinetic (PK) population included participants for which sufficient data were available to calculate PK parameters.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Guadecitabine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.42" lower_limit="0.25" upper_limit="6.00"/>
                    <measurement group_id="O2" value="1.98" lower_limit="1.50" upper_limit="7.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decitabine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.98" lower_limit="1.00" upper_limit="6.00"/>
                    <measurement group_id="O2" value="3.95" lower_limit="1.67" upper_limit="7.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Carboplatin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.03" lower_limit="0.48" upper_limit="1.20"/>
                    <measurement group_id="O2" value="1.05" lower_limit="0.48" upper_limit="1.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: Pharmacokinetic Parameter AUC0-8</title>
        <description>Area under the concentration-time curve from 0 to 8 hours (AUC0-8) for guadecitabine, decitabine and carboplatin</description>
        <time_frame>Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)</time_frame>
        <population>The pharmacokinetic (PK) population included participants for which sufficient data were available to calculate PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: Guadecitabine+Carboplatin 30 mg/m2</title>
            <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Guadecitabine+Carboplatin 45 mg/m2</title>
            <description>Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Pharmacokinetic Parameter AUC0-8</title>
          <description>Area under the concentration-time curve from 0 to 8 hours (AUC0-8) for guadecitabine, decitabine and carboplatin</description>
          <population>The pharmacokinetic (PK) population included participants for which sufficient data were available to calculate PK parameters.</population>
          <units>Hours*ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Guadecitabine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="239" spread="136"/>
                    <measurement group_id="O2" value="416" spread="217"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decitabine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.1" spread="26.6"/>
                    <measurement group_id="O2" value="129" spread="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Carboplatin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51200" spread="12100"/>
                    <measurement group_id="O2" value="41900" spread="31700"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Approximately 4 years</time_frame>
      <desc>Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Stage 1: Guadecitabine+Carboplatin 30 mg/m2</title>
          <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
        </group>
        <group group_id="E2">
          <title>Stage 1: Guadecitabine+Carboplatin 45 mg/m2</title>
          <description>Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.</description>
        </group>
        <group group_id="E3">
          <title>Stage 2: Guadecitabine+Carboplatin 30 mg/m2</title>
          <description>Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.</description>
        </group>
        <group group_id="E4">
          <title>Stage 2: Treatment Choice</title>
          <description>Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).</description>
        </group>
        <group group_id="E5">
          <title>Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2</title>
          <description>Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (19.0)</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="14" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="43" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="18" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="22" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="24" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="12" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="51"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Gastrointestinal hemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Elective procedure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Portal vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infections</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Postoperative fever</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>International normalized ratio increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Peripheral neuropathy sensory</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Radicular pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental status change</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pulmonary edema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pyoderma gangrenosum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (19.0)</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="14" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="50" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="49" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="27" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="14"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E3" events="36" subjects_affected="36" subjects_at_risk="51"/>
                <counts group_id="E4" events="16" subjects_affected="16" subjects_at_risk="49"/>
                <counts group_id="E5" events="18" subjects_affected="18" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="16" subjects_affected="16" subjects_at_risk="51"/>
                <counts group_id="E4" events="11" subjects_affected="11" subjects_at_risk="49"/>
                <counts group_id="E5" events="12" subjects_affected="12" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="14"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E3" events="16" subjects_affected="16" subjects_at_risk="51"/>
                <counts group_id="E4" events="25" subjects_affected="25" subjects_at_risk="49"/>
                <counts group_id="E5" events="8" subjects_affected="8" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E3" events="12" subjects_affected="12" subjects_at_risk="51"/>
                <counts group_id="E4" events="12" subjects_affected="12" subjects_at_risk="49"/>
                <counts group_id="E5" events="10" subjects_affected="10" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="38" subjects_affected="38" subjects_at_risk="51"/>
                <counts group_id="E4" events="28" subjects_affected="28" subjects_at_risk="49"/>
                <counts group_id="E5" events="12" subjects_affected="12" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="32" subjects_affected="32" subjects_at_risk="51"/>
                <counts group_id="E4" events="15" subjects_affected="15" subjects_at_risk="49"/>
                <counts group_id="E5" events="10" subjects_affected="10" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="14"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E3" events="22" subjects_affected="22" subjects_at_risk="51"/>
                <counts group_id="E4" events="17" subjects_affected="17" subjects_at_risk="49"/>
                <counts group_id="E5" events="10" subjects_affected="10" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="21" subjects_affected="21" subjects_at_risk="51"/>
                <counts group_id="E4" events="17" subjects_affected="17" subjects_at_risk="49"/>
                <counts group_id="E5" events="8" subjects_affected="8" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="21" subjects_affected="21" subjects_at_risk="51"/>
                <counts group_id="E4" events="11" subjects_affected="11" subjects_at_risk="49"/>
                <counts group_id="E5" events="9" subjects_affected="9" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="11" subjects_affected="11" subjects_at_risk="51"/>
                <counts group_id="E4" events="12" subjects_affected="12" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="51"/>
                <counts group_id="E4" events="12" subjects_affected="12" subjects_at_risk="49"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="51"/>
                <counts group_id="E4" events="10" subjects_affected="10" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Gastroesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="51"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Anorectal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Epigastric discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Gastrointestinal hemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Lip dry</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Rectal hemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="14"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E3" events="33" subjects_affected="33" subjects_at_risk="51"/>
                <counts group_id="E4" events="26" subjects_affected="26" subjects_at_risk="49"/>
                <counts group_id="E5" events="14" subjects_affected="14" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="23" subjects_affected="23" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="9" subjects_affected="9" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Peripheral edema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="51"/>
                <counts group_id="E4" events="14" subjects_affected="14" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="51"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hernia pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Early satiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteriuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Breast cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Localized infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Rocky mountain spotted fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="51"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Vaginitis bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Enterococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Impetigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Stoma site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Anion gap increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Bilirubin urine present</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Blood albumin decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Blood chloride decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Carbon dioxide decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Protein urine present</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Specific gravity urine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Urine ketone body present</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Urine leukocyte esterase positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Blood phosphorous decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Protein total decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>International normalized ratio increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E3" events="15" subjects_affected="15" subjects_at_risk="51"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="49"/>
                <counts group_id="E5" events="9" subjects_affected="9" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="14" subjects_affected="14" subjects_at_risk="51"/>
                <counts group_id="E4" events="13" subjects_affected="13" subjects_at_risk="49"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="51"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hypoglycemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hypophosphatemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </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" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="51"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="49"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="11" subjects_affected="11" subjects_at_risk="51"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="51"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Joint stiffness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="51"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="51"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="51"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Parasthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="51"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E4" events="13" subjects_affected="13" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Libido decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Micturition urgency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Perineal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Vaginal discharge</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Vaginal ulceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Vulvovaginal swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Vaginal hemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="14" subjects_affected="14" subjects_at_risk="51"/>
                <counts group_id="E4" events="15" subjects_affected="15" subjects_at_risk="49"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="51"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="49"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dyspnea exertional</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hemoptysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Paranasal sinus hypersecretion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pulmonary edema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="51"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="51"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Onycholysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Palmar-plantar erythrodysesthesia syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="51"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Lymphedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </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 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>Dr. Harold Keer</name_or_title>
      <organization>Astex Pharmaceuticals, Inc.</organization>
      <phone>925-719-0741</phone>
      <email>Harold.Keer@astx.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01696032
org study id: SGI-110-02
nct id: NCT01696032
lead sponsor: 
has dmc: No
A 2-part, Phase 2 controlled, open-label, randomized study in participants with
      platinum-resistant recurrent ovarian cancer. In Part 1, participants received SGI-110 and
      carboplatin. The optimum dose of SGI-110 (guadecitabine) was identified in Part 1 based on
      safety and efficacy. In Part 2, participants were randomized to receive the dose identified
      in Part 1 plus carboplatin or one of four treatment of choice at the discretion of the
      investigator. The treatment of choice consisted of topotecan, pegylated liposomal
      doxorubicin, paclitaxel or gemcitabine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Stage 1: Dose Limiting Toxicities
time frame: Up to 12 months
description: Number of participants with dose limiting toxicities (DLTs) in Stage 1
measure: Stage 2: Progression Free Survival
time frame: Up to 24 months
description: Progression free survival (PFS) time was defined as the time interval from the date of the first dose of study medication until the earlier of disease progression or death. Participants were treated with their assigned treatment [guadecitabine+carboplatin (G+C) or treatment choice (TC)] until disease progression or unacceptable treatment-related toxicity occurred.
measure: Objective Response Rate
time frame: Up to 24 months
description: The objective response rate (ORR) was defined as the proportion of participants who experienced an objective response (best overall response of complete response/full response or partial response, which was confirmed by a subsequent assessment at least 28 days later). Response categories were determined based on RECIST v1.1 criteria, or on modified Rustin (CA-125) criteria if response assessment could not be made using RECIST criteria.
measure: Progression Free Survival at 6 Months
time frame: 6 months
description: Progression free survival rate at 6 months is the proportion of participants who were alive and did not have disease progression at 6 months after start of treatment.
measure: Clinical Benefit Rate
time frame: Up to 24 months
description: Clinical benefit rate (CBR) was defined as the proportion of subjects who experienced a best overall response of complete response/full response or partial response (confirmed by a subsequent assessment at least 28 days later), or documented stable disease for at least 3 months after the first dose. Response categories were determined based on RECIST v1.1 criteria, then based on modified Rustin (CA-125) criteria if assessment could not be made using RECIST criteria.
measure: CA-125 Levels
time frame: Up to 24 months
description: Percentage of participants with CA-125 reduction by ≥ 50% from baseline
measure: Duration of Response
time frame: Up to 24 months
description: Duration of response is defined as the time between the date of the first documentation of complete response/full response or partial response, and the date of disease progression or date of death due to any cause, or the last adequate tumor assessment prior to the start of subsequent anti-cancer therapy including crossing over to G+C from TC arm, whichever occurred earlier. Only participants who responded were included in the duration of response calculation.
measure: Overall Survival
time frame: Up to 24 months
description: Overall survival was defined as the number of days from the day the participant was administered the first dose of study treatment to the date of death (regardless of cause). Survival time was censored on the last date the participant was known to be alive or lost to follow-up before reaching the event of death; in the TC group, time was censored at the date of crossover.
measure: Stage 1: Pharmacokinetic Parameter Cmax
time frame: Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)
description: Time to maximum plasma concentration for guadecitabine, decitabine and carboplatin
measure: Stage 1: Pharmacokinetic Parameter Tmax
time frame: Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)
description: Time to last measurable concentration for guadecitabine, decitabine and carboplatin
measure: Stage 1: Pharmacokinetic Parameter AUC0-8
time frame: Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)
description: Area under the concentration-time curve from 0 to 8 hours (AUC0-8) for guadecitabine, decitabine and carboplatin
arm group label: SGI-110 + Carboplatin
arm group type: Experimental
description: Stage 1 was a safety lead-in stage with a dose escalation design. Participants were evaluated with the combination of SGI-110 (guadecitabine) plus carboplatin (G+C), given as 28-day treatment cycles: guadecitabine administered subcutaneous (SC) daily on Days 1-5, at a starting dose of 45 mg/m2/day in Cohort 1, followed by carboplatin intravenous (IV) based on a targeted dose of area under the curve (AUC) 5 on Day 8. After dose limiting toxicities were noted, guadecitabine dose was reduced to 30 mg/m2/day for subsequent cycles for 4 participants. Cohort 2 received 30 mg/m2/day guadecitabine and carboplatin IV AUC 4.
arm group label: SGI-110 + Carboplatin or TC
arm group type: Experimental
description: Stage 2 was an open-label, randomized, controlled trial. Eligible participants were randomly assigned in a 1:1 ratio to receive either (1) G+C combination treatment in 28-day cycles at 30 mg/m2 SC once daily on Days 1-5 and carboplatin IV AUC 4 on Day 8, or (2) treatment of choice (TC) of topotecan, pegylated liposomal doxorubicin (PLD), paclitaxel, or gemcitabine based on recommended dosing in 28-day cycles; participants initially randomized to TC were able to cross over to receive 30 mg/m2 G+C due to disease progression.
intervention type: Drug
intervention name: SGI-110
arm group label: SGI-110 + Carboplatin
arm group label: SGI-110 + Carboplatin or TC
other name: guadecitabine
intervention type: Drug
intervention name: Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine)
description: Investigator chose to treat with either topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine
arm group label: SGI-110 + Carboplatin or TC
intervention type: Drug
intervention name: Carboplatin
arm group label: SGI-110 + Carboplatin
arm group label: SGI-110 + Carboplatin or TC
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Canada
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Paclitaxel
mesh term: Carboplatin
mesh term: Gemcitabine
mesh term: Doxorubicin
mesh term: Liposomal doxorubicin
mesh term: Topotecan
mesh term: Guadecitabine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 