<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/NCT03830866</url>
  </required_header>
  <id_info>
    <org_study_id>D9100C00001</org_study_id>
    <secondary_id>2018-002872-42</secondary_id>
    <nct_id>NCT03830866</nct_id>
  </id_info>
  <brief_title>Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)</brief_title>
  <acronym>CALLA</acronym>
  <official_title>A Phase III, Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With and Following Chemoradiotherapy Compared to Chemoradiotherapy Alone for Treatment in Women With Locally Advanced Cervical Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>Yes</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 randomized, multi-center, double-blind, placebo-controlled, global, Phase III study&#xD;
      to determine the efficacy and safety of durvalumab + Chemoradiotherapy versus&#xD;
      Chemoradiotherapy alone as treatment in Women With Locally Advanced Cervical Cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women will be randomized in a 1:1 ratio to receive treatment with concurrent durvalumab +&#xD;
      standard of care (SoC) or Placebo + Soc, followed by durvalumab/placebo maintenance for 24&#xD;
      months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Actual">July 3, 2023</completion_date>
  <primary_completion_date type="Actual">January 20, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression</measure>
    <time_frame>Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months</time_frame>
    <description>PFS defined as time from date of randomisation until date of tumour progression or death by any cause, regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression, PD-L1 Expression &gt;= 1%</measure>
    <time_frame>Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months</time_frame>
    <description>PFS defined as time from date of randomisation until date of tumour progression or death by any cause, regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (Count)</measure>
    <time_frame>Time from date of randomisation until date of death by any cause, assessed up to the data cut-off date (20th January 2022), assessed up to a maximum of 34.3 months</time_frame>
    <description>Number of Participants with Overall Survival (OS) where OS was defined as the time from the date of randomisation until death by any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (Duration)</measure>
    <time_frame>Time from date of randomisation until date of death by any cause, assessed up to the data cut-off date (20th January 2022), assessed up to a maximum of 34.3 months</time_frame>
    <description>Time from the date of randomisation until death by any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months</time_frame>
    <description>Percentage of evaluable patients with an Investigator-assessed visit response of complete response (CR) or partial response (PR). CR defined as disappearance of all target and non-target lesions and no new lesions. PR defined as &gt;= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Response Rate</measure>
    <time_frame>Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months</time_frame>
    <description>Percentage of evaluable patients with an overall visit response of Complete Response (disappearance of all target and non-target lesions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DoR) in Patients With Complete Response (CR)</measure>
    <time_frame>Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months</time_frame>
    <description>Time from date of first documented CR until date of documented progression or death in the absence of progression. For patients who did not progress their DoR was their Progression-free survival censoring time</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">770</enrollment>
  <condition>Locally Advanced Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>Durvalumab (intravenous infusion)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>durvalumab + standard of care concurrent chemoradiation therapy(SoC CCRT) followed by durvalumab monotherapy up to 24 months or until PD from the date of randomization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (matching placebo for intravenous infusion)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo + standard of care concurrent chemoradiation therapy(SoC CCRT)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Durvalumab</intervention_name>
    <description>IV infusion every 4 weeks</description>
    <arm_group_label>Durvalumab (intravenous infusion)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy</description>
    <arm_group_label>Durvalumab (intravenous infusion)</arm_group_label>
    <arm_group_label>Placebo (matching placebo for intravenous infusion)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>For patients enrolled under CSP v2 and prior - platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy</description>
    <arm_group_label>Durvalumab (intravenous infusion)</arm_group_label>
    <arm_group_label>Placebo (matching placebo for intravenous infusion)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>external beam radiation therapy (EBRT) + brachytherapy</intervention_name>
    <description>Radiation therapy per standard of care</description>
    <arm_group_label>Durvalumab (intravenous infusion)</arm_group_label>
    <arm_group_label>Placebo (matching placebo for intravenous infusion)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For inclusion in the study, patients should fulfill the following criteria:&#xD;
&#xD;
          1. Female&#xD;
&#xD;
          2. Aged at least 18 years&#xD;
&#xD;
          3. Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO (2009)&#xD;
             Stages IB2 to IIB node positive or FIGO (2009) IIIA-IVA any node&#xD;
&#xD;
          4. No prior chemotherapy or radiotherapy for cervical cancer&#xD;
&#xD;
          5. WHO/ECOG performance status of 0-1&#xD;
&#xD;
          6. At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target&#xD;
             Lesion at baseline.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients should not enter the study if any of the following exclusion criteria are&#xD;
        fulfilled:&#xD;
&#xD;
          1. Diagnosis of small cell (neuroendocrine) histology or mucinous adenocarcinoma cervical&#xD;
             cancer&#xD;
&#xD;
          2. Intent to administer a fertility-sparing treatment regimen&#xD;
&#xD;
          3. Undergone a previous hysterectomy&#xD;
&#xD;
          4. Evidence of metastatic disease per RECIST 1.1 including lymph nodes ≥15 mm (short&#xD;
             axis) above the L1 cephalad body, in the inguinal region or outside the planned&#xD;
             radiation field.&#xD;
&#xD;
          5. History of allogeneic organ transplantation&#xD;
&#xD;
          6. Active or prior documented autoimmune or inflammatory disorders&#xD;
&#xD;
          7. Uncontrolled intercurrent illness&#xD;
&#xD;
          8. History of another primary malignancy and active primary immunodeficiency&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female: only female participants are being studied</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Urban Scheuring, M.D., Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>AstraZeneca</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bradley Monk, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arizona, Arizona, USA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</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>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</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>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Spring</city>
        <state>Texas</state>
        <zip>77380</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Barretos</city>
        <zip>14784-400</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fortaleza</city>
        <zip>60336-045</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Londrina</city>
        <zip>86015-520</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Porto Alegre</city>
        <zip>90050-170</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Porto Alegre</city>
        <zip>90110-270</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Porto Alegre</city>
        <zip>90610-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Porto Alegre</city>
        <zip>91350-200</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>20220-410</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01246-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01317-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01509-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>São José do Rio Preto</city>
        <zip>15090-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>São Paulo</city>
        <zip>03102-002</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Antofagasta</city>
        <zip>1267348</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Santiago</city>
        <zip>7500921</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Santiago</city>
        <zip>7630370</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Santiago</city>
        <zip>8380455</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Temuco</city>
        <zip>4810218</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Temuco</city>
        <zip>4810469</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Viña del Mar</city>
        <zip>2540488</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Changchun</city>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Changsha</city>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chengdu</city>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chongqing</city>
        <zip>400030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Guangzhou</city>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hangzhou</city>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hefei</city>
        <zip>230001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hefei</city>
        <zip>230031</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shenyang</city>
        <zip>100003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shenyang</city>
        <zip>110016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tianjin</city>
        <zip>300052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wuhan</city>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wuhan</city>
        <zip>430079</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Budapest</city>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Győr</city>
        <zip>9024</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kaposvár</city>
        <zip>7400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Szeged</city>
        <zip>6725</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ahmedabad</city>
        <zip>380015</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gurgaon</city>
        <zip>122001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Madurai</city>
        <zip>625107</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mumbai</city>
        <zip>400012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nagpur</city>
        <zip>440026</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nashik</city>
        <zip>422002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Delhi</city>
        <zip>110063</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vishakhapatnam</city>
        <zip>530017</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fukuoka-shi</city>
        <zip>811-1395</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kagoshima-shi</city>
        <zip>890-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Koto-ku</city>
        <zip>135-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyoto-shi</city>
        <zip>606-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nakagami-gun</city>
        <zip>903-0215</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Osaka-shi</city>
        <zip>541-8567</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sapporo-shi</city>
        <zip>003-0804</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sendai-shi</city>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shinjuku-ku</city>
        <zip>160-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toon-shi</city>
        <zip>791-0295</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yokohama-shi</city>
        <zip>236-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <zip>08826</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Alc. Cuauhtémoc</city>
        <zip>06700</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Deleg. Tlalpan</city>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Guadalajara Jalisco</city>
        <zip>44280</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Guadalajara</city>
        <zip>44680</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mérida</city>
        <zip>97134</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Luis Potosí</city>
        <zip>78250</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Veracruz</city>
        <zip>91900</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lima</city>
        <zip>L27</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lima</city>
        <zip>LIMA 27</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lima</city>
        <zip>LIMA 31</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lima</city>
        <zip>LIMA 34</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lima</city>
        <zip>LIMA 41</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Baguio City</city>
        <zip>2600</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cebu</city>
        <zip>6000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Iloilo</city>
        <zip>5000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Makati</city>
        <zip>1229</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Manila</city>
        <zip>1015</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Quezon City</city>
        <zip>1112</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bialystok</city>
        <zip>15-027</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gdańsk</city>
        <zip>80-214</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gliwice</city>
        <zip>44-101</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lublin</city>
        <zip>20-090</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Łódź</city>
        <zip>90-513</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Arkhangelsk</city>
        <zip>163045</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chelyabinsk</city>
        <zip>454087</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kaluga</city>
        <zip>248007</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Moscow</city>
        <zip>115533</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Moscow</city>
        <zip>117997</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Moscow</city>
        <zip>125367</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630055</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Parktown</city>
        <zip>2193</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Port Elizabeth</city>
        <zip>6045</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tainan City</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taipei City</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taipei</city>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taipei</city>
        <zip>10449</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taipei</city>
        <zip>11490</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taoyuan City</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
    <country>Chile</country>
    <country>China</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Peru</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D9100C00001&amp;amp;attachmentIdentifier=456f5a65-1160-4292-a679-7ae588fa79b9&amp;amp;fileName=D9100C00001_Protocol_v4_Redacted_PDFA.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=D9100C00001&amp;amp;attachmentIdentifier=07a0b969-2fdc-441c-8de0-3dfc2cd06029&amp;amp;fileName=D9100C00001-SAP_Ed_3_Redacted_PDFA.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=D9100C00001&amp;amp;attachmentIdentifier=a290db6a-1ec0-4b2d-a142-1d9d56d6fffc&amp;amp;fileName=D9100C00001-CSR_synopsis_Redacted_PDFA.pdf&amp;amp;versionIdentifier=</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <results_first_submitted>January 13, 2023</results_first_submitted>
  <results_first_submitted_qc>March 2, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 6, 2023</results_first_posted>
  <last_update_submitted>July 28, 2023</last_update_submitted>
  <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Durvalumab</keyword>
  <keyword>Chemoradiotherapy</keyword>
  <keyword>Locally Advanced Cervical Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Durvalumab</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>March 11, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03830866/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>August 4, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03830866/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Durvalumab + SoC CCRT</title>
          <description>Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)</description>
        </group>
        <group group_id="P2">
          <title>Placebo + SoC CCRT</title>
          <description>Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="385"/>
                <participants group_id="P2" count="385"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="385"/>
                <participants group_id="P2" count="385"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Ongoing study at DCO</title>
              <participants_list>
                <participants group_id="P1" count="312"/>
                <participants group_id="P2" count="295"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="74"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer eligible due to additional cancer diagnosis</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Durvalumab + SoC CCRT</title>
          <description>Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)</description>
        </group>
        <group group_id="B2">
          <title>Placebo + SoC CCRT</title>
          <description>Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="385"/>
            <count group_id="B2" value="385"/>
            <count group_id="B3" value="770"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.6" spread="11.74"/>
                    <measurement group_id="B2" value="48.8" spread="11.67"/>
                    <measurement group_id="B3" value="49.2" spread="11.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="385"/>
                    <measurement group_id="B2" value="385"/>
                    <measurement group_id="B3" value="770"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                    <measurement group_id="B2" value="125"/>
                    <measurement group_id="B3" value="255"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="152"/>
                    <measurement group_id="B2" value="148"/>
                    <measurement group_id="B3" value="300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression</title>
        <description>PFS defined as time from date of randomisation until date of tumour progression or death by any cause, regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression</description>
        <time_frame>Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Durvalumab + SoC CCRT</title>
            <description>Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SoC CCRT</title>
            <description>Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression</title>
          <description>PFS defined as time from date of randomisation until date of tumour progression or death by any cause, regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression</description>
          <population>Full Analysis Set</population>
          <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="385"/>
                <count group_id="O2" value="385"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">NA - Not calculated, estimates cannot be calculated due to too few events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">NA - Not calculated, estimates cannot be calculated due to too few events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.174</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression, PD-L1 Expression &gt;= 1%</title>
        <description>PFS defined as time from date of randomisation until date of tumour progression or death by any cause, regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression</description>
        <time_frame>Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months</time_frame>
        <population>PD-L1 Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Durvalumab + SoC CCRT</title>
            <description>Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SoC CCRT</title>
            <description>Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression, PD-L1 Expression &gt;= 1%</title>
          <description>PFS defined as time from date of randomisation until date of tumour progression or death by any cause, regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression</description>
          <population>PD-L1 Analysis Set</population>
          <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="385"/>
                <count group_id="O2" value="385"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">NA - Not calculated, estimates cannot be calculated due to too few events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="26.9" upper_limit="NA">NA - Not calculated, estimates cannot be calculated due to too few events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.203</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>1.10</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (Count)</title>
        <description>Number of Participants with Overall Survival (OS) where OS was defined as the time from the date of randomisation until death by any cause</description>
        <time_frame>Time from date of randomisation until date of death by any cause, assessed up to the data cut-off date (20th January 2022), assessed up to a maximum of 34.3 months</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Durvalumab + SoC CCRT</title>
            <description>Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SoC CCRT</title>
            <description>Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (Count)</title>
          <description>Number of Participants with Overall Survival (OS) where OS was defined as the time from the date of randomisation until death by any cause</description>
          <population>Full Analysis Set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="385"/>
                <count group_id="O2" value="385"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Died</title>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Censored (includes subjects who withdrew consent and subjects who were lost to follow up)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="326"/>
                    <measurement group_id="O2" value="311"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (Duration)</title>
        <description>Time from the date of randomisation until death by any cause</description>
        <time_frame>Time from date of randomisation until date of death by any cause, assessed up to the data cut-off date (20th January 2022), assessed up to a maximum of 34.3 months</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Durvalumab + SoC CCRT</title>
            <description>Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SoC CCRT</title>
            <description>Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (Duration)</title>
          <description>Time from the date of randomisation until death by any cause</description>
          <population>Full Analysis Set</population>
          <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="385"/>
                <count group_id="O2" value="385"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">NA - Not calculated, estimates cannot be calculated due to too few events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">NA - Not calculated, estimates cannot be calculated due to too few events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.156</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.55</ci_lower_limit>
            <ci_upper_limit>1.10</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate (ORR)</title>
        <description>Percentage of evaluable patients with an Investigator-assessed visit response of complete response (CR) or partial response (PR). CR defined as disappearance of all target and non-target lesions and no new lesions. PR defined as &gt;= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion</description>
        <time_frame>Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Durvalumab + SoC CCRT</title>
            <description>Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SoC CCRT</title>
            <description>Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR)</title>
          <description>Percentage of evaluable patients with an Investigator-assessed visit response of complete response (CR) or partial response (PR). CR defined as disappearance of all target and non-target lesions and no new lesions. PR defined as &gt;= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion</description>
          <population>Full analysis set</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="385"/>
                <count group_id="O2" value="385"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.6"/>
                    <measurement group_id="O2" value="80.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.465</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.794</ci_lower_limit>
            <ci_upper_limit>1.657</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complete Response Rate</title>
        <description>Percentage of evaluable patients with an overall visit response of Complete Response (disappearance of all target and non-target lesions)</description>
        <time_frame>Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Durvalumab + SoC CCRT</title>
            <description>Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SoC CCRT</title>
            <description>Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Response Rate</title>
          <description>Percentage of evaluable patients with an overall visit response of Complete Response (disappearance of all target and non-target lesions)</description>
          <population>Full analysis set</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="385"/>
                <count group_id="O2" value="385"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.9"/>
                    <measurement group_id="O2" value="40.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.469</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.833</ci_lower_limit>
            <ci_upper_limit>1.487</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DoR) in Patients With Complete Response (CR)</title>
        <description>Time from date of first documented CR until date of documented progression or death in the absence of progression. For patients who did not progress their DoR was their Progression-free survival censoring time</description>
        <time_frame>Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Durvalumab + SoC CCRT</title>
            <description>Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SoC CCRT</title>
            <description>Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DoR) in Patients With Complete Response (CR)</title>
          <description>Time from date of first documented CR until date of documented progression or death in the absence of progression. For patients who did not progress their DoR was their Progression-free survival censoring time</description>
          <population>Full Analysis Set</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="385"/>
                <count group_id="O2" value="385"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">NA - Not calculated, estimates cannot be calculated due to too few events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">NA - Not calculated, estimates cannot be calculated due to too few events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the time of signature of informed consent throughout the treatment period (median duration of 472 and 452 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 35 months</time_frame>
      <desc>There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384</desc>
      <group_list>
        <group group_id="E1">
          <title>Durvalumab + SoC CCRT</title>
          <description>Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)</description>
        </group>
        <group group_id="E2">
          <title>Placebo + SoC CCRT</title>
          <description>Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.1</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="59" subjects_at_risk="385"/>
                <counts group_id="E2" subjects_affected="74" subjects_at_risk="385"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="106" subjects_at_risk="385"/>
                <counts group_id="E2" subjects_affected="89" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="19" subjects_affected="19" subjects_at_risk="385"/>
                <counts group_id="E2" events="19" subjects_affected="19" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Blood loss anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Immune thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Myelosuppression</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="385"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Endocrine disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="385"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Anal fistula</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Anorectal disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="385"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Duodenal perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Gastroduodenal ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Large intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Proctitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Rectal perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Rectal ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary aspergillosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Covid-19</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Endometritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Gastroenteritis clostridial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Haemophilus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Hepatitis c</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Infected lymphocele</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Pelvic infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Pseudomembranous colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Retroperitoneal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Salpingitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Tubo-ovarian abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Ureteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="17" subjects_affected="15" subjects_at_risk="385"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Uterine infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Wound abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Cystitis radiation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Gastroenteritis radiation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Post procedural inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Radiation proctitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Uterine perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Electrocardiogram q wave abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Full blood count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="385"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </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="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute myeloid leukaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Breast cancer in situ</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Gastrointestinal stromal tumour</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Infected neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Thyroid cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Tumour haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Vulval cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Cerebral ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Depressed level of consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Peripheral motor neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Peripheral sensorimotor neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Vertebrobasilar insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Acute psychosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </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="6" subjects_affected="6" subjects_at_risk="385"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Cystitis haemorrhagic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Tubulointerstitial nephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Ureteric fistula</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Ureteric obstruction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Urogenital fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Cervix haemorrhage uterine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Endometriosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Female genital tract fistula</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="385"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Vaginal fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="385"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="385"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Exfoliative rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Telangiectasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Accelerated hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="385"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Venous thrombosis limb</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="385"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.1</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="372" subjects_at_risk="385"/>
                <counts group_id="E2" subjects_affected="368" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="44" subjects_affected="37" subjects_at_risk="385"/>
                <counts group_id="E2" events="38" subjects_affected="28" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="307" subjects_affected="211" subjects_at_risk="385"/>
                <counts group_id="E2" events="319" subjects_affected="198" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="92" subjects_affected="58" subjects_at_risk="385"/>
                <counts group_id="E2" events="119" subjects_affected="58" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="56" subjects_affected="39" subjects_at_risk="385"/>
                <counts group_id="E2" events="49" subjects_affected="29" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="107" subjects_affected="74" subjects_at_risk="385"/>
                <counts group_id="E2" events="99" subjects_affected="54" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="27" subjects_affected="26" subjects_at_risk="385"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="60" subjects_affected="58" subjects_at_risk="385"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="21" subjects_affected="20" subjects_at_risk="385"/>
                <counts group_id="E2" events="13" subjects_affected="11" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="69" subjects_affected="49" subjects_at_risk="385"/>
                <counts group_id="E2" events="65" subjects_affected="52" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="30" subjects_affected="29" subjects_at_risk="385"/>
                <counts group_id="E2" events="23" subjects_affected="20" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="118" subjects_affected="96" subjects_at_risk="385"/>
                <counts group_id="E2" events="106" subjects_affected="87" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="249" subjects_affected="175" subjects_at_risk="385"/>
                <counts group_id="E2" events="285" subjects_affected="189" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="385"/>
                <counts group_id="E2" events="24" subjects_affected="23" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="288" subjects_affected="213" subjects_at_risk="385"/>
                <counts group_id="E2" events="290" subjects_affected="201" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="194" subjects_affected="104" subjects_at_risk="385"/>
                <counts group_id="E2" events="201" subjects_affected="106" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="45" subjects_affected="34" subjects_at_risk="385"/>
                <counts group_id="E2" events="43" subjects_affected="35" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="53" subjects_affected="51" subjects_at_risk="385"/>
                <counts group_id="E2" events="78" subjects_affected="70" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="51" subjects_affected="35" subjects_at_risk="385"/>
                <counts group_id="E2" events="36" subjects_affected="31" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Covid-19</sub_title>
                <counts group_id="E1" events="22" subjects_affected="22" subjects_at_risk="385"/>
                <counts group_id="E2" events="40" subjects_affected="35" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="25" subjects_affected="23" subjects_at_risk="385"/>
                <counts group_id="E2" events="20" subjects_affected="18" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="25" subjects_affected="24" subjects_at_risk="385"/>
                <counts group_id="E2" events="15" subjects_affected="11" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="117" subjects_affected="88" subjects_at_risk="385"/>
                <counts group_id="E2" events="116" subjects_affected="88" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Radiation proctitis</sub_title>
                <counts group_id="E1" events="24" subjects_affected="22" subjects_at_risk="385"/>
                <counts group_id="E2" events="24" subjects_affected="24" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Radiation skin injury</sub_title>
                <counts group_id="E1" events="18" subjects_affected="17" subjects_at_risk="385"/>
                <counts group_id="E2" events="27" subjects_affected="27" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="35" subjects_affected="28" subjects_at_risk="385"/>
                <counts group_id="E2" events="34" subjects_affected="26" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="27" subjects_affected="16" subjects_at_risk="385"/>
                <counts group_id="E2" events="46" subjects_affected="34" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="199" subjects_affected="74" subjects_at_risk="385"/>
                <counts group_id="E2" events="213" subjects_affected="85" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="79" subjects_affected="48" subjects_at_risk="385"/>
                <counts group_id="E2" events="105" subjects_affected="62" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="44" subjects_affected="43" subjects_at_risk="385"/>
                <counts group_id="E2" events="53" subjects_affected="41" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="272" subjects_affected="71" subjects_at_risk="385"/>
                <counts group_id="E2" events="327" subjects_affected="85" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="54" subjects_affected="36" subjects_at_risk="385"/>
                <counts group_id="E2" events="44" subjects_affected="35" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="49" subjects_affected="31" subjects_at_risk="385"/>
                <counts group_id="E2" events="36" subjects_affected="29" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="42" subjects_affected="31" subjects_at_risk="385"/>
                <counts group_id="E2" events="28" subjects_affected="23" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="103" subjects_affected="89" subjects_at_risk="385"/>
                <counts group_id="E2" events="74" subjects_affected="64" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="26" subjects_affected="25" subjects_at_risk="385"/>
                <counts group_id="E2" events="22" subjects_affected="18" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="31" subjects_affected="24" subjects_at_risk="385"/>
                <counts group_id="E2" events="33" subjects_affected="26" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="60" subjects_affected="44" subjects_at_risk="385"/>
                <counts group_id="E2" events="74" subjects_affected="46" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="48" subjects_affected="40" subjects_at_risk="385"/>
                <counts group_id="E2" events="58" subjects_affected="38" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="40" subjects_affected="29" subjects_at_risk="385"/>
                <counts group_id="E2" events="29" subjects_affected="23" subjects_at_risk="384"/>
              </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="48" subjects_affected="42" subjects_at_risk="385"/>
                <counts group_id="E2" events="49" subjects_affected="42" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="44" subjects_affected="37" subjects_at_risk="385"/>
                <counts group_id="E2" events="43" subjects_affected="41" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="28" subjects_affected="25" subjects_at_risk="385"/>
                <counts group_id="E2" events="17" subjects_affected="13" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="21" subjects_affected="17" subjects_at_risk="385"/>
                <counts group_id="E2" events="25" subjects_affected="20" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="54" subjects_affected="41" subjects_at_risk="385"/>
                <counts group_id="E2" events="51" subjects_affected="43" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="46" subjects_affected="41" subjects_at_risk="385"/>
                <counts group_id="E2" events="33" subjects_affected="32" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="72" subjects_affected="60" subjects_at_risk="385"/>
                <counts group_id="E2" events="79" subjects_affected="70" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" events="47" subjects_affected="39" subjects_at_risk="385"/>
                <counts group_id="E2" events="37" subjects_affected="33" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Vaginal discharge</sub_title>
                <counts group_id="E1" events="37" subjects_affected="30" subjects_at_risk="385"/>
                <counts group_id="E2" events="30" subjects_affected="27" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" events="27" subjects_affected="23" subjects_at_risk="385"/>
                <counts group_id="E2" events="33" subjects_affected="29" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="28" subjects_affected="26" subjects_at_risk="385"/>
                <counts group_id="E2" events="23" subjects_affected="21" subjects_at_risk="384"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="25" subjects_affected="16" subjects_at_risk="385"/>
                <counts group_id="E2" events="30" subjects_affected="23" subjects_at_risk="384"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Clinical Lead</name_or_title>
      <organization>AstraZeneca Clinical Study Information Center</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/NCT03830866
org study id: D9100C00001
secondary id: 2018-002872-42
nct id: NCT03830866
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, multi-center, double-blind, placebo-controlled, global, Phase III study
      to determine the efficacy and safety of durvalumab + Chemoradiotherapy versus
      Chemoradiotherapy alone as treatment in Women With Locally Advanced Cervical Cancer
Women will be randomized in a 1:1 ratio to receive treatment with concurrent durvalumab +
      standard of care (SoC) or Placebo + Soc, followed by durvalumab/placebo maintenance for 24
      months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression
time frame: Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months
description: PFS defined as time from date of randomisation until date of tumour progression or death by any cause, regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression
measure: Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression, PD-L1 Expression >= 1%
time frame: Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months
description: PFS defined as time from date of randomisation until date of tumour progression or death by any cause, regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression
measure: Overall Survival (Count)
time frame: Time from date of randomisation until date of death by any cause, assessed up to the data cut-off date (20th January 2022), assessed up to a maximum of 34.3 months
description: Number of Participants with Overall Survival (OS) where OS was defined as the time from the date of randomisation until death by any cause
measure: Overall Survival (Duration)
time frame: Time from date of randomisation until date of death by any cause, assessed up to the data cut-off date (20th January 2022), assessed up to a maximum of 34.3 months
description: Time from the date of randomisation until death by any cause
measure: Objective Response Rate (ORR)
time frame: Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months
description: Percentage of evaluable patients with an Investigator-assessed visit response of complete response (CR) or partial response (PR). CR defined as disappearance of all target and non-target lesions and no new lesions. PR defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion
measure: Complete Response Rate
time frame: Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months
description: Percentage of evaluable patients with an overall visit response of Complete Response (disappearance of all target and non-target lesions)
measure: Duration of Response (DoR) in Patients With Complete Response (CR)
time frame: Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months
description: Time from date of first documented CR until date of documented progression or death in the absence of progression. For patients who did not progress their DoR was their Progression-free survival censoring time
arm group label: Durvalumab (intravenous infusion)
arm group type: Experimental
description: durvalumab + standard of care concurrent chemoradiation therapy(SoC CCRT) followed by durvalumab monotherapy up to 24 months or until PD from the date of randomization
arm group label: Placebo (matching placebo for intravenous infusion)
arm group type: Placebo Comparator
description: placebo + standard of care concurrent chemoradiation therapy(SoC CCRT)
intervention type: Biological
intervention name: Durvalumab
description: IV infusion every 4 weeks
arm group label: Durvalumab (intravenous infusion)
intervention type: Drug
intervention name: Cisplatin
description: Platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy
arm group label: Durvalumab (intravenous infusion)
arm group label: Placebo (matching placebo for intravenous infusion)
intervention type: Drug
intervention name: Carboplatin
description: For patients enrolled under CSP v2 and prior - platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy
arm group label: Durvalumab (intravenous infusion)
arm group label: Placebo (matching placebo for intravenous infusion)
intervention type: Radiation
intervention name: external beam radiation therapy (EBRT) + brachytherapy
description: Radiation therapy per standard of care
arm group label: Durvalumab (intravenous infusion)
arm group label: Placebo (matching placebo for intravenous infusion)
criteria: 
gender: Female
gender based: Yes
gender description: Female: only female participants are being studied
minimum age: 18 Years
maximum age: 130 Years
healthy volunteers: No
last name: Urban Scheuring, M.D., Ph.D.
role: Study Director
affiliation: AstraZeneca
last name: Bradley Monk, M.D
role: Principal Investigator
affiliation: University of Arizona, Arizona, USA
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Brazil
country: Chile
country: China
country: Hungary
country: India
country: Japan
country: Korea, Republic of
country: Mexico
country: Peru
country: Philippines
country: Poland
country: Russian Federation
country: South Africa
country: Taiwan
country: United States
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D9100C00001&amp;attachmentIdentifier=456f5a65-1160-4292-a679-7ae588fa79b9&amp;fileName=D9100C00001_Protocol_v4_Redacted_PDFA.pdf&amp;versionIdentifier=
description: Related Info
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D9100C00001&amp;attachmentIdentifier=07a0b969-2fdc-441c-8de0-3dfc2cd06029&amp;fileName=D9100C00001-SAP_Ed_3_Redacted_PDFA.pdf&amp;versionIdentifier=
description: Related Info
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D9100C00001&amp;attachmentIdentifier=a290db6a-1ec0-4b2d-a142-1d9d56d6fffc&amp;fileName=D9100C00001-CSR_synopsis_Redacted_PDFA.pdf&amp;versionIdentifier=
description: Related Info
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms
mesh term: Carboplatin
mesh term: Durvalumab
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: 