<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/NCT02983799</url>
  </required_header>
  <id_info>
    <org_study_id>D0816L00003</org_study_id>
    <nct_id>NCT02983799</nct_id>
  </id_info>
  <brief_title>Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status</brief_title>
  <official_title>Non-Randomized, Open-Label Phase II Study to Assess Olaparib Tablets as a Treatment for Subjects With Different HRD Tumor Status and With Platinum-Sensitive, Relapsed, High-Grade Serous or High-Grade Endometrioid Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer That Have Received at Least 1 Prior Line of Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a non-randomized, open-label study to assess olaparib tablets as a treatment for&#xD;
      subjects with different homologous recombination deficiency (HRD) tumor status and with&#xD;
      platinum-sensitive, relapsed, high-grade serous or high-grade endometrioid ovarian cancer.&#xD;
      Subjects should have received at least 1 prior line of platinum-based chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase II, open-label, non-randomized, multi-center study assessing the efficacy and&#xD;
      safety of olaparib tablets 300 mg (two 150 mg tablets) given orally twice daily (bid) in&#xD;
      subjects with platinum-sensitive or partially platinum-sensitive, relapsed, high-grade serous&#xD;
      or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer,&#xD;
      who have received at least 1 prior line of platinum-based chemotherapy.&#xD;
&#xD;
      The study will assess the effectiveness of olaparib tablets as measured by the objective&#xD;
      response rate (ORR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST)&#xD;
      v1.1, in subjects with germline BRCA mutations (gBRCAm), somatic BRCA mutations (sBRCAm), or&#xD;
      potential aberrations in homologous recombination deficiency (HRD) as determined by myChoice®&#xD;
      HRD, as well as in subjects without identifiable HRD. This study will utilize Myriad&#xD;
      BRACAnalysis CDx® for germline BRCA analysis and a tumor test (myChoice® HRD) for tumor BRCA&#xD;
      analysis and HRD status. Four cohorts will be identified based upon the genetic testing&#xD;
      described above:&#xD;
&#xD;
        -  Cohort 1: gBRCAm,&#xD;
&#xD;
        -  Cohort 2: sBRCAm and germline BRCA wild type,&#xD;
&#xD;
        -  Cohort 3: myChoice® HRD positive (genomic instability positive) and BRCA wild type&#xD;
           (BRCAwt) (no BRCA mutation),&#xD;
&#xD;
        -  Cohort 4: myChoice® HRD negative (genomic instability negative) and BRCAwt (no BRCA&#xD;
           mutation).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 22, 2016</start_date>
  <completion_date type="Actual">December 3, 2020</completion_date>
  <primary_completion_date type="Actual">December 3, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Response Rate, Defined as the Percentage of Subjects With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)</measure>
    <time_frame>From first dose up until progression, or last evaluable assessment in the absence of progression (up to 36 months)</time_frame>
    <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using ORR according to RECIST v1.1 criteria (Investigator determined)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Response, for Those Subjects With a Confirmed Response of CR or PR</measure>
    <time_frame>From the date of the measurement criteria for CR or PR are first met until the date of documented progression or death in the absence of disease progression (up to 36 months)</time_frame>
    <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using duration of response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CA-125 Response Rate, Defined as the Percentage of Subjects With a CA-125 Response According to GCIG Criteria Divided by the Number of Subjects Evaluable for CA-125 Response</measure>
    <time_frame>From baseline to Day 1 of each cycle and end of study treatment visit (up to 36 months)</time_frame>
    <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using CA-125 response rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate Defined as the Percentage of Subjects Who Have a Best Overall Response of CR or PR or SD at Greater Than or Equal to 8 Weeks Divided by the Number of Subjects in the Efficacy Analysis Set, Prior to Any PD Event</measure>
    <time_frame>From first dose up until progression, or last evaluable assessment in the absence of progression</time_frame>
    <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using disease control rate (DCR). DCR is defined as the percentage of subjects with a best overall response of CR or PR (at any time up to and including the defined analysis cut-off point) or who have demonstrated stable disease (SD) for at least 8 weeks from first dose, divided by the number of subjects in the efficacy analysis set.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>From first dose to earlier date of assessment of objective progression or death by any cause in the absence of progression (up to 36 months)</time_frame>
    <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using progression free survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Any Progression</measure>
    <time_frame>From first dose to earlier date of CA-125 progression or RECIST v1.1 progression, or death by any cause in absence of progression (up to 36 months)</time_frame>
    <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using time to any progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>From date of first dose to date of death from any cause (up to 48 months)</time_frame>
    <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using overall survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HRD Status as Per HRRm Gene Panel Assessment Will be Correlated With Clinical Outcome (ORR) for Subjects Enrolled in the 2 Cohorts With BRCAwt (Cohorts 3 and 4)</measure>
    <time_frame>At baseline</time_frame>
    <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using HRRm gene panel status related to clinical outcome</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">272</enrollment>
  <condition>Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity</condition>
  <arm_group>
    <arm_group_label>gBRCAm;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>germline BRCA mutant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sBRCAm and germline BRCA wild type;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>somatic BRCA mutant, germline BRCA wild type</description>
  </arm_group>
  <arm_group>
    <arm_group_label>myChoice® HRD positive and BRCAwt;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>genomic instability positive and no BRCA mutation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>myChoice® HRD negative and BRCAwt</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>genomic instability negative and no BRCA mutation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OLAPARIB</intervention_name>
    <description>300 mg olaparib tablets taken orally twice daily</description>
    <arm_group_label>gBRCAm;</arm_group_label>
    <arm_group_label>myChoice® HRD negative and BRCAwt</arm_group_label>
    <arm_group_label>myChoice® HRD positive and BRCAwt;</arm_group_label>
    <arm_group_label>sBRCAm and germline BRCA wild type;</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provision of written signed informed consent prior to any study specific procedures;&#xD;
&#xD;
          -  Female subjects with histologically diagnosed relapsed high-grade serous or high-grade&#xD;
             endometrioid ovarian cancer;&#xD;
&#xD;
          -  At least 1 lesion (measurable by RECIST v1.1) that can be accurately assessed at&#xD;
             baseline by computed tomography (CT)/magnetic resonance imaging (MRI) and is suitable&#xD;
             for repeated assessment;&#xD;
&#xD;
          -  Subjects must have received at least 1 prior platinum-based line of chemotherapy for&#xD;
             ovarian cancer. Note: There is no limit on the number of lines of chemotherapy;&#xD;
&#xD;
          -  Subjects must be partially-platinum-sensitive (defined as progression 6 to 12 months&#xD;
             after the end of the last platinum-based chemotherapy) or platinum sensitive (defined&#xD;
             as progression &gt; 12 months after the end of the last platinum-based chemotherapy);&#xD;
&#xD;
          -  Subjects must have normal organ and bone marrow function measured within 28 days prior&#xD;
             to administration of study treatment;&#xD;
&#xD;
          -  ECOG performance status 0 to 1;&#xD;
&#xD;
          -  Subjects must have a life expectancy greater than or equal to 16 weeks;&#xD;
&#xD;
          -  Postmenopausal or evidence of non-childbearing status for women of childbearing&#xD;
             potential: negative urine or serum pregnancy test within 28 days of study treatment&#xD;
             and confirmed prior to treatment on Day 1;&#xD;
&#xD;
          -  Subject is willing and able to comply with the protocol for the duration of the study&#xD;
             including undergoing treatment and scheduled visits and examinations; and&#xD;
&#xD;
          -  Formalin fixed, paraffin embedded tumor sample (either archival or fresh sample) from&#xD;
             the primary or recurrent cancer must be available for central testing. If there is not&#xD;
             written confirmation of the availability of an archived or fresh tumor sample prior to&#xD;
             enrollment, the subject is not eligible for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Involvement in the planning and/or conduct of the study (applies to both AstraZeneca&#xD;
             Representative staff and/or staff at the study site);&#xD;
&#xD;
          -  Previous enrollment in the present study;&#xD;
&#xD;
          -  Exposure to any investigational product (IP) within 30 days or 5 half-lives (whichever&#xD;
             is longer) prior to start of study treatment;&#xD;
&#xD;
          -  Any previous treatment with a PARP inhibitor, including olaparib;&#xD;
&#xD;
          -  Subjects who have platinum-resistant or refractory disease defined as progression&#xD;
             during or within 6 months of the last platinum-based chemotherapy;&#xD;
&#xD;
          -  Other malignancy within the last 5 years (few exceptions apply);&#xD;
&#xD;
          -  Resting ECG with clinically significant abnormal findings;&#xD;
&#xD;
          -  Subjects receiving any systemic chemotherapy or radiotherapy (except for palliative&#xD;
             reasons) within 3 weeks prior to study treatment;&#xD;
&#xD;
          -  Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors;&#xD;
&#xD;
          -  Concomitant use of known strong or moderate CYP3A inducers;&#xD;
&#xD;
          -  Persistent toxicities (&gt; Common Terminology Criteria for Adverse Event [CTCAE] grade&#xD;
             2) caused by previous cancer therapy, excluding alopecia;&#xD;
&#xD;
          -  Subjects with MDS/AML or with features suggestive of MDS/AML;&#xD;
&#xD;
          -  Subjects with pneumonitis or at risk of pneumonitis;&#xD;
&#xD;
          -  Subjects with symptomatic uncontrolled brain metastases;&#xD;
&#xD;
          -  Major surgery within 2 weeks of starting study treatment, and subjects must have&#xD;
             recovered from any effects of any major surgery;&#xD;
&#xD;
          -  Subjects considered a poor medical risk due to a serious, uncontrolled medical&#xD;
             disorder, non-malignant systemic disease, or active, uncontrolled infection;&#xD;
&#xD;
          -  Breast feeding women;&#xD;
&#xD;
          -  Immunocompromised subjects, e.g., subjects who are known to be serologically positive&#xD;
             for human immunodeficiency virus;&#xD;
&#xD;
          -  Subjects with known active hepatitis (i.e., Hepatitis B or C) due to risk of&#xD;
             transmitting the infection through blood or other body fluids&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Skokie</city>
        <state>Illinois</state>
        <zip>60077</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Silver Spring</city>
        <state>Maryland</state>
        <zip>20910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01199</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Berkeley Heights</city>
        <state>New Jersey</state>
        <zip>07922</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Teaneck</city>
        <state>New Jersey</state>
        <zip>07666</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Abington</city>
        <state>Pennsylvania</state>
        <zip>19001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Annandale</city>
        <state>Virginia</state>
        <zip>22003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>VSZ 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 0V9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 1V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>L5M 2N1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.CancerStudyLocator.com</url>
    <description>Cancer Study Locator 1-877-400-4656 AstraZeneca@emergingmed.com</description>
  </link>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D0816L00003&amp;amp;attachmentIdentifier=1cc548a0-e0d8-4e45-a4e7-e90632b8c2cd&amp;amp;fileName=D0816L00003_SAP_Redacted.pdf&amp;amp;versionIdentifier=</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D0816L00003&amp;amp;attachmentIdentifier=4d8b8e75-6c5a-4aa7-aa28-8963de9d23cd&amp;amp;fileName=D0816L00003-CSP-V3__Redacted.pdf&amp;amp;versionIdentifier=</url>
    <description>Related Info</description>
  </link>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <results_first_submitted>December 3, 2021</results_first_submitted>
  <results_first_submitted_qc>March 22, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 13, 2022</results_first_posted>
  <last_update_submitted>March 22, 2022</last_update_submitted>
  <last_update_submitted_qc>March 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BRCA, ovarian, platinum, chemotherapy</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>Olaparib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_time_frame>
    <ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_access_criteria>
    <ipd_url>https://astrazenecagroup-dt.pharmacm.com/DT/Home</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT02983799/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 3, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT02983799/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 272 subjects enrolled. One subject did not receive treatment and was excluded from analysis (Cohort 2 patient).&#xD;
All participants received a dose of 300mg BID of study drug</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>COHORT 1</title>
          <description>germline BRCA mutant</description>
        </group>
        <group group_id="P2">
          <title>COHORT 2</title>
          <description>somatic BRCA mutant, germline BRCA wild type</description>
        </group>
        <group group_id="P3">
          <title>COHORT 3</title>
          <description>HRD positive and no BRCA mutation</description>
        </group>
        <group group_id="P4">
          <title>COHORT 4</title>
          <description>HRD negative and no BRCA mutation</description>
        </group>
        <group group_id="P5">
          <title>Unassigned</title>
          <description>Cohort unassigned</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="68"/>
                <participants group_id="P4" count="90"/>
                <participants group_id="P5" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="18"/>
                <participants group_id="P4" count="14"/>
                <participants group_id="P5" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="50"/>
                <participants group_id="P4" count="76"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawn from study before data cut-off</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="23"/>
                <participants group_id="P4" count="25"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="23"/>
                <participants group_id="P4" count="47"/>
                <participants group_id="P5" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>COHORT 1</title>
          <description>germline BRCA mutant</description>
        </group>
        <group group_id="B2">
          <title>COHORT 2</title>
          <description>somatic BRCA mutant, germline BRCA wild type</description>
        </group>
        <group group_id="B3">
          <title>COHORT 3</title>
          <description>HRD positive and no BRCA mutation</description>
        </group>
        <group group_id="B4">
          <title>COHORT 4</title>
          <description>HRD negative and no BRCA mutation</description>
        </group>
        <group group_id="B5">
          <title>Unassigned</title>
          <description>Cohort unassigned</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="75"/>
            <count group_id="B2" value="26"/>
            <count group_id="B3" value="68"/>
            <count group_id="B4" value="90"/>
            <count group_id="B5" value="13"/>
            <count group_id="B6" value="272"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>A total of 272 subjects enrolled. One subject did not receive treatment and was excluded from analysis (Cohort 2 patient).</population>
          <units>Age Continuous</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="68"/>
                    <count group_id="B4" value="90"/>
                    <count group_id="B5" value="13"/>
                    <count group_id="B6" value="271"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.7" spread="9.3"/>
                    <measurement group_id="B2" value="69.7" spread="9.0"/>
                    <measurement group_id="B3" value="63.2" spread="9.9"/>
                    <measurement group_id="B4" value="67.8" spread="9.5"/>
                    <measurement group_id="B5" value="69.8" spread="10.0"/>
                    <measurement group_id="B6" value="64.9" spread="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Female</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="26"/>
                    <count group_id="B3" value="68"/>
                    <count group_id="B4" value="90"/>
                    <count group_id="B5" value="13"/>
                    <count group_id="B6" value="272"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="68"/>
                    <measurement group_id="B4" value="90"/>
                    <measurement group_id="B5" value="13"/>
                    <measurement group_id="B6" value="272"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>WHITE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="26"/>
                    <count group_id="B3" value="68"/>
                    <count group_id="B4" value="90"/>
                    <count group_id="B5" value="13"/>
                    <count group_id="B6" value="272"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="50"/>
                    <measurement group_id="B4" value="78"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="220"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BLACK OR AFRICAN AMERICAN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="26"/>
                    <count group_id="B3" value="68"/>
                    <count group_id="B4" value="90"/>
                    <count group_id="B5" value="13"/>
                    <count group_id="B6" value="272"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ASIAN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="26"/>
                    <count group_id="B3" value="68"/>
                    <count group_id="B4" value="90"/>
                    <count group_id="B5" value="13"/>
                    <count group_id="B6" value="272"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="26"/>
                    <count group_id="B3" value="68"/>
                    <count group_id="B4" value="90"/>
                    <count group_id="B5" value="13"/>
                    <count group_id="B6" value="272"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AMERICAN INDIAN OR ALASKA NATIVE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="26"/>
                    <count group_id="B3" value="68"/>
                    <count group_id="B4" value="90"/>
                    <count group_id="B5" value="13"/>
                    <count group_id="B6" value="272"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OTHER</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="26"/>
                    <count group_id="B3" value="68"/>
                    <count group_id="B4" value="90"/>
                    <count group_id="B5" value="13"/>
                    <count group_id="B6" value="272"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Objective Response Rate, Defined as the Percentage of Subjects With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)</title>
        <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using ORR according to RECIST v1.1 criteria (Investigator determined)</description>
        <time_frame>From first dose up until progression, or last evaluable assessment in the absence of progression (up to 36 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>germline BRCA mutant</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>somatic BRCA mutant, germline BRCA wild type</description>
          </group>
          <group group_id="O3">
            <title>COHORT 3</title>
            <description>HRD positive and no BRCA mutation</description>
          </group>
          <group group_id="O4">
            <title>COHORT 4</title>
            <description>HRD negative and no BRCA mutation</description>
          </group>
          <group group_id="O5">
            <title>Unassigned</title>
            <description>Cohort unassigned</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate, Defined as the Percentage of Subjects With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)</title>
          <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using ORR according to RECIST v1.1 criteria (Investigator determined)</description>
          <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="75"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="68"/>
                <count group_id="O4" value="89"/>
                <count group_id="O5" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.3" lower_limit="57.6" upper_limit="79.5"/>
                    <measurement group_id="O2" value="64.0" lower_limit="42.5" upper_limit="82.0"/>
                    <measurement group_id="O3" value="29.4" lower_limit="19.0" upper_limit="41.7"/>
                    <measurement group_id="O4" value="10.1" lower_limit="4.7" upper_limit="18.3"/>
                    <measurement group_id="O5" value="30.8" lower_limit="9.1" upper_limit="61.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response, for Those Subjects With a Confirmed Response of CR or PR</title>
        <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using duration of response</description>
        <time_frame>From the date of the measurement criteria for CR or PR are first met until the date of documented progression or death in the absence of disease progression (up to 36 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>germline BRCA mutant</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>somatic BRCA mutant, germline BRCA wild type</description>
          </group>
          <group group_id="O3">
            <title>COHORT 3</title>
            <description>HRD positive and no BRCA mutation</description>
          </group>
          <group group_id="O4">
            <title>COHORT 4</title>
            <description>HRD negative and no BRCA mutation</description>
          </group>
          <group group_id="O5">
            <title>Unassigned</title>
            <description>Cohort unassigned</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response, for Those Subjects With a Confirmed Response of CR or PR</title>
          <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using duration of response</description>
          <units>Months</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="52"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.4" lower_limit="7.5" upper_limit="12.5"/>
                    <measurement group_id="O2" value="14.7" lower_limit="5.7" upper_limit="NA">Not estimable due to limited data.</measurement>
                    <measurement group_id="O3" value="10.0" lower_limit="5.6" upper_limit="NA">Not estimable due to limited data.</measurement>
                    <measurement group_id="O4" value="5.3" lower_limit="3.7" upper_limit="7.3"/>
                    <measurement group_id="O5" value="7.5" lower_limit="6.0" upper_limit="NA">Not estimable due to limited data.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CA-125 Response Rate, Defined as the Percentage of Subjects With a CA-125 Response According to GCIG Criteria Divided by the Number of Subjects Evaluable for CA-125 Response</title>
        <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using CA-125 response rate</description>
        <time_frame>From baseline to Day 1 of each cycle and end of study treatment visit (up to 36 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>germline BRCA mutant</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>somatic BRCA mutant, germline BRCA wild type</description>
          </group>
          <group group_id="O3">
            <title>COHORT 3</title>
            <description>HRD positive and no BRCA mutation</description>
          </group>
          <group group_id="O4">
            <title>COHORT 4</title>
            <description>HRD negative and no BRCA mutation</description>
          </group>
          <group group_id="O5">
            <title>Unassigned</title>
            <description>Cohort unassigned</description>
          </group>
        </group_list>
        <measure>
          <title>CA-125 Response Rate, Defined as the Percentage of Subjects With a CA-125 Response According to GCIG Criteria Divided by the Number of Subjects Evaluable for CA-125 Response</title>
          <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using CA-125 response rate</description>
          <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="44"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="64"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.2" lower_limit="81.3" upper_limit="98.6"/>
                    <measurement group_id="O2" value="70.0" lower_limit="45.7" upper_limit="88.1"/>
                    <measurement group_id="O3" value="47.9" lower_limit="33.3" upper_limit="62.8"/>
                    <measurement group_id="O4" value="26.6" lower_limit="16.3" upper_limit="39.1"/>
                    <measurement group_id="O5" value="66.7" lower_limit="34.9" upper_limit="90.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate Defined as the Percentage of Subjects Who Have a Best Overall Response of CR or PR or SD at Greater Than or Equal to 8 Weeks Divided by the Number of Subjects in the Efficacy Analysis Set, Prior to Any PD Event</title>
        <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using disease control rate (DCR). DCR is defined as the percentage of subjects with a best overall response of CR or PR (at any time up to and including the defined analysis cut-off point) or who have demonstrated stable disease (SD) for at least 8 weeks from first dose, divided by the number of subjects in the efficacy analysis set.</description>
        <time_frame>From first dose up until progression, or last evaluable assessment in the absence of progression</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>germline BRCA mutant</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>somatic BRCA mutant, germline BRCA wild type</description>
          </group>
          <group group_id="O3">
            <title>COHORT 3</title>
            <description>HRD positive and no BRCA mutation</description>
          </group>
          <group group_id="O4">
            <title>COHORT 4</title>
            <description>HRD negative and no BRCA mutation</description>
          </group>
          <group group_id="O5">
            <title>Unassigned</title>
            <description>Cohort unassigned</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate Defined as the Percentage of Subjects Who Have a Best Overall Response of CR or PR or SD at Greater Than or Equal to 8 Weeks Divided by the Number of Subjects in the Efficacy Analysis Set, Prior to Any PD Event</title>
          <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using disease control rate (DCR). DCR is defined as the percentage of subjects with a best overall response of CR or PR (at any time up to and including the defined analysis cut-off point) or who have demonstrated stable disease (SD) for at least 8 weeks from first dose, divided by the number of subjects in the efficacy analysis set.</description>
          <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="75"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="68"/>
                <count group_id="O4" value="89"/>
                <count group_id="O5" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.0" lower_limit="88.8" upper_limit="99.2"/>
                    <measurement group_id="O2" value="100.0" lower_limit="86.3" upper_limit="100.0"/>
                    <measurement group_id="O3" value="79.4" lower_limit="67.9" upper_limit="88.3"/>
                    <measurement group_id="O4" value="75.3" lower_limit="65.0" upper_limit="83.8"/>
                    <measurement group_id="O5" value="92.3" lower_limit="64.0" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival</title>
        <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using progression free survival</description>
        <time_frame>From first dose to earlier date of assessment of objective progression or death by any cause in the absence of progression (up to 36 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>germline BRCA mutant</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>somatic BRCA mutant, germline BRCA wild type</description>
          </group>
          <group group_id="O3">
            <title>COHORT 3</title>
            <description>HRD positive and no BRCA mutation</description>
          </group>
          <group group_id="O4">
            <title>COHORT 4</title>
            <description>HRD negative and no BRCA mutation</description>
          </group>
          <group group_id="O5">
            <title>Unassigned</title>
            <description>Cohort unassigned</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival</title>
          <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using progression free survival</description>
          <units>Months</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="75"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="68"/>
                <count group_id="O4" value="89"/>
                <count group_id="O5" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" lower_limit="8.3" upper_limit="12.2"/>
                    <measurement group_id="O2" value="10.8" lower_limit="7.3" upper_limit="NA">Not estimable due to limited data.</measurement>
                    <measurement group_id="O3" value="7.2" lower_limit="5.3" upper_limit="7.6"/>
                    <measurement group_id="O4" value="5.4" lower_limit="3.7" upper_limit="5.6"/>
                    <measurement group_id="O5" value="9.2" lower_limit="3.5" upper_limit="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Any Progression</title>
        <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using time to any progression</description>
        <time_frame>From first dose to earlier date of CA-125 progression or RECIST v1.1 progression, or death by any cause in absence of progression (up to 36 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>germline BRCA mutant</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>somatic BRCA mutant, germline BRCA wild type</description>
          </group>
          <group group_id="O3">
            <title>COHORT 3</title>
            <description>HRD positive and no BRCA mutation</description>
          </group>
          <group group_id="O4">
            <title>COHORT 4</title>
            <description>HRD negative and no BRCA mutation</description>
          </group>
          <group group_id="O5">
            <title>Unassigned</title>
            <description>Cohort unassigned</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Any Progression</title>
          <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using time to any progression</description>
          <units>Months</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="75"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="68"/>
                <count group_id="O4" value="89"/>
                <count group_id="O5" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9" lower_limit="7.4" upper_limit="13.3"/>
                    <measurement group_id="O2" value="11.1" lower_limit="6.6" upper_limit="NA">Not estimable due to limited data.</measurement>
                    <measurement group_id="O3" value="7.2" lower_limit="3.8" upper_limit="7.6"/>
                    <measurement group_id="O4" value="5.3" lower_limit="3.7" upper_limit="5.5"/>
                    <measurement group_id="O5" value="7.3" lower_limit="3.5" upper_limit="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival</title>
        <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using overall survival</description>
        <time_frame>From date of first dose to date of death from any cause (up to 48 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>germline BRCA mutant</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>somatic BRCA mutant, germline BRCA wild type</description>
          </group>
          <group group_id="O3">
            <title>COHORT 3</title>
            <description>HRD positive and no BRCA mutation</description>
          </group>
          <group group_id="O4">
            <title>COHORT 4</title>
            <description>HRD negative and no BRCA mutation</description>
          </group>
          <group group_id="O5">
            <title>Unassigned</title>
            <description>Cohort unassigned</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using overall survival</description>
          <units>Months</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="75"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="68"/>
                <count group_id="O4" value="89"/>
                <count group_id="O5" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="29.2" upper_limit="NA">Not estimable due to limited data.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Not estimable due to limited data.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="22.8" upper_limit="NA">Not estimable due to limited data.</measurement>
                    <measurement group_id="O4" value="23.8" lower_limit="16.6" upper_limit="31.4"/>
                    <measurement group_id="O5" value="18" lower_limit="8" upper_limit="NA">Not estimable due to limited data.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HRD Status as Per HRRm Gene Panel Assessment Will be Correlated With Clinical Outcome (ORR) for Subjects Enrolled in the 2 Cohorts With BRCAwt (Cohorts 3 and 4)</title>
        <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using HRRm gene panel status related to clinical outcome</description>
        <time_frame>At baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 3, HRRm Pos</title>
            <description>HRD positive and no BRCA mutation, HRRm positive</description>
          </group>
          <group group_id="O2">
            <title>Cohort 3, HRRm Neg</title>
            <description>HRD positive and no BRCA mutation, HRRm negative</description>
          </group>
          <group group_id="O3">
            <title>Cohort 4, HRRm Pos</title>
            <description>HRD negative and no BRCA mutation, HRRm positive</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4, HRRm Neg</title>
            <description>HRD negative and no BRCA mutation, HRRm negative</description>
          </group>
        </group_list>
        <measure>
          <title>HRD Status as Per HRRm Gene Panel Assessment Will be Correlated With Clinical Outcome (ORR) for Subjects Enrolled in the 2 Cohorts With BRCAwt (Cohorts 3 and 4)</title>
          <description>To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using HRRm gene panel status related to clinical outcome</description>
          <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="9"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1" lower_limit="0.3" upper_limit="48.2"/>
                    <measurement group_id="O2" value="32.1" lower_limit="20.3" upper_limit="46.0"/>
                    <measurement group_id="O3" value="8.3" lower_limit="0.2" upper_limit="38.5"/>
                    <measurement group_id="O4" value="10.5" lower_limit="4.7" upper_limit="19.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs), serious AEs, AEs of special interest (AESIs), and AEs leading to discontinuation were collected from signature of informed consent for study participation. Treatment emerging AEs were reported from date of first dose of study treatment and continued throughout the active treatment period and the follow-up period 30 days after the last dose of olaparib. After the primary analysis data cut-off till study completion, only deaths, SAEs, AESIs and DAEs were collected/reported.</time_frame>
      <desc>Adverse events and serious adverse events are reported in the safety analysis set including all patients who received at least one dose of study treatment. Between the primary analysis data cut-off and final data cut-off (12-month overall survival), only serious adverse events, adverse events of special interest, and adverse events leading to discontinuation were collected.</desc>
      <group_list>
        <group group_id="E1">
          <title>COHORT 1</title>
          <description>germline BRCA mutant</description>
        </group>
        <group group_id="E2">
          <title>COHORT 2</title>
          <description>somatic BRCA mutant, germline BRCA wild type</description>
        </group>
        <group group_id="E3">
          <title>COHORT 3</title>
          <description>HRD positive and no BRCA mutation</description>
        </group>
        <group group_id="E4">
          <title>COHORT 4</title>
          <description>HRD negative and no BRCA mutation</description>
        </group>
        <group group_id="E5">
          <title>UNASSIGNED</title>
          <description>Cohort unassigned</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="23" subjects_at_risk="68"/>
                <counts group_id="E4" subjects_affected="47" subjects_at_risk="90"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="68"/>
                <counts group_id="E4" subjects_affected="35" subjects_at_risk="90"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Anaemia macrocytic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Atrioventricular block</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Duodenal ulcer perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Intestinal pseudo-obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Large intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Gastrointestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E5" events="6" subjects_affected="4" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Small intestinal perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Escherichia bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal stoma complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Incisional hernia, obstructive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sternal fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Strangulated incisional hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </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="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Food intolerance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hydroureter</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pulmonary fibrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Umbilical erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypertensive emergency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vena cava thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="75" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="67" subjects_at_risk="68"/>
                <counts group_id="E4" subjects_affected="88" subjects_at_risk="90"/>
                <counts group_id="E5" subjects_affected="12" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="25" subjects_affected="18" subjects_at_risk="75"/>
                <counts group_id="E2" events="13" subjects_affected="7" subjects_at_risk="25"/>
                <counts group_id="E3" events="16" subjects_affected="14" subjects_at_risk="68"/>
                <counts group_id="E4" events="38" subjects_affected="31" subjects_at_risk="90"/>
                <counts group_id="E5" events="6" subjects_affected="5" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Macrocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sinus arrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Tachycardia paroxysmal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoacusis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Goitre</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival hyperaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Ocular discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Papilloedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vitreous floaters</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="75"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="68"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="90"/>
                <counts group_id="E5" events="3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="20" subjects_affected="15" subjects_at_risk="75"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="68"/>
                <counts group_id="E4" events="17" subjects_affected="13" subjects_at_risk="90"/>
                <counts group_id="E5" events="9" subjects_affected="7" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="8" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Anal incontinence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="8" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Breath odour</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="19" subjects_affected="15" subjects_at_risk="75"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="25"/>
                <counts group_id="E3" events="19" subjects_affected="19" subjects_at_risk="68"/>
                <counts group_id="E4" events="28" subjects_affected="24" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="23" subjects_affected="17" subjects_at_risk="75"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E3" events="20" subjects_affected="15" subjects_at_risk="68"/>
                <counts group_id="E4" events="25" subjects_affected="18" subjects_at_risk="90"/>
                <counts group_id="E5" events="6" subjects_affected="5" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="75"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="68"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="75"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="68"/>
                <counts group_id="E4" events="11" subjects_affected="11" subjects_at_risk="90"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Frequent bowel movements</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="18" subjects_affected="11" subjects_at_risk="75"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E4" events="8" subjects_affected="7" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Lip pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="84" subjects_affected="50" subjects_at_risk="75"/>
                <counts group_id="E2" events="38" subjects_affected="20" subjects_at_risk="25"/>
                <counts group_id="E3" events="66" subjects_affected="42" subjects_at_risk="68"/>
                <counts group_id="E4" events="76" subjects_affected="60" subjects_at_risk="90"/>
                <counts group_id="E5" events="11" subjects_affected="8" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="75"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Tongue discolouration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="37" subjects_affected="21" subjects_at_risk="75"/>
                <counts group_id="E2" events="17" subjects_affected="12" subjects_at_risk="25"/>
                <counts group_id="E3" events="27" subjects_affected="15" subjects_at_risk="68"/>
                <counts group_id="E4" events="56" subjects_affected="35" subjects_at_risk="90"/>
                <counts group_id="E5" events="10" subjects_affected="6" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Intra-abdominal fluid collection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Tongue ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Axillary pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Early satiety</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="55" subjects_affected="50" subjects_at_risk="75"/>
                <counts group_id="E2" events="16" subjects_affected="15" subjects_at_risk="25"/>
                <counts group_id="E3" events="46" subjects_affected="43" subjects_at_risk="68"/>
                <counts group_id="E4" events="56" subjects_affected="50" subjects_at_risk="90"/>
                <counts group_id="E5" events="13" subjects_affected="9" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Feeling jittery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Localised oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="75"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="24" subjects_affected="14" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Performance status decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Physical deconditioning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Suprapubic pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Temperature intolerance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Food allergy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Contrast media allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Arthritis infective</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cellulitis orbital</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Eye infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Genital herpes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Impetigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="75"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Skin candida</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="15" subjects_affected="10" subjects_at_risk="75"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E4" events="12" subjects_affected="11" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Catheter site infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="75"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E3" events="6" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Incisional hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Stoma site erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood chloride decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="75"/>
                <counts group_id="E2" events="18" subjects_affected="9" subjects_at_risk="25"/>
                <counts group_id="E3" events="14" subjects_affected="13" subjects_at_risk="68"/>
                <counts group_id="E4" events="16" subjects_affected="13" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood magnesium decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood urea decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood urea increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Carbohydrate antigen 125 increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Creatinine renal clearance decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Electrocardiogram qt prolonged</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Electrocardiogram abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Glomerular filtration rate decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Haematocrit decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Red blood cell count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urine leukocyte esterase positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E4" events="8" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="5" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>White blood cells urine positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Cachexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cardiometabolic syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="14" subjects_affected="11" subjects_at_risk="75"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="25"/>
                <counts group_id="E3" events="16" subjects_affected="16" subjects_at_risk="68"/>
                <counts group_id="E4" events="25" subjects_affected="21" subjects_at_risk="90"/>
                <counts group_id="E5" events="6" subjects_affected="5" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="8" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Increased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Iron deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="75"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="75"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E4" events="9" subjects_affected="8" subjects_at_risk="90"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Fibromyalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Limb discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Muscle tightness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="75"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Osteopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="8" subjects_affected="7" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Plantar fasciitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Temporomandibular joint syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Torticollis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acrochordon</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Benign neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Melanocytic naevus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Seborrhoeic keratosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Amnesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dementia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="75"/>
                <counts group_id="E2" events="10" subjects_affected="7" subjects_at_risk="25"/>
                <counts group_id="E3" events="14" subjects_affected="11" subjects_at_risk="68"/>
                <counts group_id="E4" events="14" subjects_affected="12" subjects_at_risk="90"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="75"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E3" events="15" subjects_affected="13" subjects_at_risk="68"/>
                <counts group_id="E4" events="14" subjects_affected="14" subjects_at_risk="90"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Poor quality sleep</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Restless legs syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Taste disorder</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="28" subjects_affected="19" subjects_at_risk="75"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="25"/>
                <counts group_id="E3" events="17" subjects_affected="13" subjects_at_risk="68"/>
                <counts group_id="E4" events="13" subjects_affected="11" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sinus headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Bladder discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Bladder spasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cystitis interstitial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Micturition urgency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urinary tract pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dyspareunia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pruritus genital</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vaginal lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vulvovaginal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vulvovaginal dryness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vulvovaginal rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vaginal discharge</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Choking</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="75"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E3" events="14" subjects_affected="12" subjects_at_risk="68"/>
                <counts group_id="E4" events="14" subjects_affected="14" subjects_at_risk="90"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dry throat</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="75"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="68"/>
                <counts group_id="E4" events="22" subjects_affected="20" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nasal dryness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="75"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pharyngeal swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Upper-airway cough syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Actinic keratosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Lichen sclerosus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Lipohypertrophy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nail discolouration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Neurodermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Onychoclasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Scar pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Skin discolouration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Skin hyperpigmentation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nail disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Collateral circulation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Intermittent claudication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Lymphoedema</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pallor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Institution and PI shall be entitled to publish the results of, or make presentations related to, the Study, provided that any publications or presentations to be made within two (2) years of completion of the Study shall require the Sponsor's prior written consent. Sponsor to be consulted prior to presentation or publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Clinical Lead</name_or_title>
      <organization>AstraZeneca</organization>
      <phone>1-877-240-9479</phone>
      <email>information.center@astrazeneca.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/NCT02983799
org study id: D0816L00003
nct id: NCT02983799
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a non-randomized, open-label study to assess olaparib tablets as a treatment for
      subjects with different homologous recombination deficiency (HRD) tumor status and with
      platinum-sensitive, relapsed, high-grade serous or high-grade endometrioid ovarian cancer.
      Subjects should have received at least 1 prior line of platinum-based chemotherapy.
This is a Phase II, open-label, non-randomized, multi-center study assessing the efficacy and
      safety of olaparib tablets 300 mg (two 150 mg tablets) given orally twice daily (bid) in
      subjects with platinum-sensitive or partially platinum-sensitive, relapsed, high-grade serous
      or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer,
      who have received at least 1 prior line of platinum-based chemotherapy.

      The study will assess the effectiveness of olaparib tablets as measured by the objective
      response rate (ORR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST)
      v1.1, in subjects with germline BRCA mutations (gBRCAm), somatic BRCA mutations (sBRCAm), or
      potential aberrations in homologous recombination deficiency (HRD) as determined by myChoice®
      HRD, as well as in subjects without identifiable HRD. This study will utilize Myriad
      BRACAnalysis CDx® for germline BRCA analysis and a tumor test (myChoice® HRD) for tumor BRCA
      analysis and HRD status. Four cohorts will be identified based upon the genetic testing
      described above:

        -  Cohort 1: gBRCAm,

        -  Cohort 2: sBRCAm and germline BRCA wild type,

        -  Cohort 3: myChoice® HRD positive (genomic instability positive) and BRCA wild type
           (BRCAwt) (no BRCA mutation),

        -  Cohort 4: myChoice® HRD negative (genomic instability negative) and BRCAwt (no BRCA
           mutation).
allocation: N/A
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate, Defined as the Percentage of Subjects With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)
time frame: From first dose up until progression, or last evaluable assessment in the absence of progression (up to 36 months)
description: To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using ORR according to RECIST v1.1 criteria (Investigator determined)
measure: Duration of Response, for Those Subjects With a Confirmed Response of CR or PR
time frame: From the date of the measurement criteria for CR or PR are first met until the date of documented progression or death in the absence of disease progression (up to 36 months)
description: To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using duration of response
measure: CA-125 Response Rate, Defined as the Percentage of Subjects With a CA-125 Response According to GCIG Criteria Divided by the Number of Subjects Evaluable for CA-125 Response
time frame: From baseline to Day 1 of each cycle and end of study treatment visit (up to 36 months)
description: To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using CA-125 response rate
measure: Disease Control Rate Defined as the Percentage of Subjects Who Have a Best Overall Response of CR or PR or SD at Greater Than or Equal to 8 Weeks Divided by the Number of Subjects in the Efficacy Analysis Set, Prior to Any PD Event
time frame: From first dose up until progression, or last evaluable assessment in the absence of progression
description: To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using disease control rate (DCR). DCR is defined as the percentage of subjects with a best overall response of CR or PR (at any time up to and including the defined analysis cut-off point) or who have demonstrated stable disease (SD) for at least 8 weeks from first dose, divided by the number of subjects in the efficacy analysis set.
measure: Progression Free Survival
time frame: From first dose to earlier date of assessment of objective progression or death by any cause in the absence of progression (up to 36 months)
description: To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using progression free survival
measure: Time to Any Progression
time frame: From first dose to earlier date of CA-125 progression or RECIST v1.1 progression, or death by any cause in absence of progression (up to 36 months)
description: To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using time to any progression
measure: Overall Survival
time frame: From date of first dose to date of death from any cause (up to 48 months)
description: To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using overall survival
measure: HRD Status as Per HRRm Gene Panel Assessment Will be Correlated With Clinical Outcome (ORR) for Subjects Enrolled in the 2 Cohorts With BRCAwt (Cohorts 3 and 4)
time frame: At baseline
description: To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using HRRm gene panel status related to clinical outcome
arm group label: gBRCAm;
arm group type: Experimental
description: germline BRCA mutant
arm group label: sBRCAm and germline BRCA wild type;
arm group type: Experimental
description: somatic BRCA mutant, germline BRCA wild type
arm group label: myChoice® HRD positive and BRCAwt;
arm group type: Experimental
description: genomic instability positive and no BRCA mutation
arm group label: myChoice® HRD negative and BRCAwt
arm group type: Experimental
description: genomic instability negative and no BRCA mutation
intervention type: Drug
intervention name: OLAPARIB
description: 300 mg olaparib tablets taken orally twice daily
arm group label: gBRCAm;
arm group label: myChoice® HRD negative and BRCAwt
arm group label: myChoice® HRD positive and BRCAwt;
arm group label: sBRCAm and germline BRCA wild type;
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 130 Years
healthy volunteers: No
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country: Canada
country: United States
url: http://www.CancerStudyLocator.com
description: Cancer Study Locator 1-877-400-4656 AstraZeneca@emergingmed.com
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D0816L00003&amp;attachmentIdentifier=1cc548a0-e0d8-4e45-a4e7-e90632b8c2cd&amp;fileName=D0816L00003_SAP_Redacted.pdf&amp;versionIdentifier=
description: Related Info
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D0816L00003&amp;attachmentIdentifier=4d8b8e75-6c5a-4aa7-aa28-8963de9d23cd&amp;fileName=D0816L00003-CSP-V3__Redacted.pdf&amp;versionIdentifier=
description: Related Info
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Olaparib
sharing ipd: Yes
ipd description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd url: https://astrazenecagroup-dt.pharmacm.com/DT/Home
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 